OAR Chapter 855 — Board of Pharmacy

Division 6 DEFINITIONS

Or. Admin. R. 855-006-0005 Definitions

As used in OAR Chapter 855:

(1) “Adulterated” has the same meaning as set forth in 21 USC 351 (v. 02/26/2026).

(2) “Alarm system” means a device or series of devices, which emit or transmit an audible or remote visual or electronic alarm signal, which is intended to summon a response.

(3) “Audiovisual communication system” means a continuously accessible, two-way audiovisual link that allows audiovisual communication in real-time and that prevents unauthorized disclosure of protected health information.

(4) “Biological product” means, with respect to the prevention, treatment or cure of a disease or condition of human beings, a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, blood derivative, allergenic product, protein other than a chemically synthesized polypeptide, analogous products or arsphenamine or any other trivalent organic arsenic compound.

(5) “Biosimilar” product means a biological product licensed by the United States Food and Drug Administration pursuant to 42 USC 262(k)(3)(A)(i) (v. 02/26/2026).

(6) “Board” means the Oregon Board of Pharmacy unless otherwise specified or required by the context.

(7) “Certified health care interpreter” has the meaning given that term in ORS 413.550.

(8) “Certified Oregon Pharmacy Technician” means a person who has taken and passed a national pharmacy technician certification examination offered by the Pharmacy Technician Certification Board (PTCB) or National Healthcareer Association (NHA) and is licensed by the State Board of Pharmacy who assists the Pharmacist in the practice of pharmacy pursuant to rules of the board.

(9) “Clinical Pharmacy Agreement” means an agreement between a Pharmacist or pharmacy and a health care organization, or a physician as defined in ORS 677.010 or a naturopathic physician as defined in ORS 685.010 that permits the Pharmacist to engage in the practice of clinical pharmacy for the benefit of the patients of the health care organization, or physician or naturopathic physician.

(10) “Collaborative Drug Therapy Management” means the participation by a Pharmacist in the management of drug therapy pursuant to a written protocol that includes information specific to the dosage, frequency, duration, and route of administration of the drug, authorized by a practitioner and initiated upon a prescription order for an individual patient and:

(a) Is agreed to by one Pharmacist and one practitioner; or

(b) Is agreed to by one or more Pharmacists at a single pharmacy registered by the board and one or more practitioners in a single organized medical group, such as a hospital medical staff, clinic, or group practice, including but not limited to organized medical groups using a pharmacy and therapeutics committee.

(11) “Compounding” means the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug product or bulk drug substance in accordance with a licensed practitioner’s prescription drug order for a patient specific prescription. Compounding includes the following:

(a) Preparation of drug dosage forms for both human and animal patients;

(b) Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing or ordering patterns;

(d) Manipulation of commercial products for patient-specific needs beyond FDA-approved labeling.

(12) “Confidential Information” means any patient information obtained by a Pharmacist or pharmacy.

(13) “Consulting Pharmacist” means a Pharmacist that provides a consulting service regarding a patient medication, therapy management, drug storage and management, security, education, or any other pharmaceutical service.

(14) “Counseling” or “Counsel” means communication between a pharmacist and a patient or a patient's agent in which the pharmacist provides the patient or patient's agent with advice regarding the safe and effective use of a drug or device.

(15) The “Container” is the device that holds the drug and that is or may be in direct contact with the drug.

(16) “Custodian of pharmacy records” means a board licensee or registrant who is responsible for the maintenance, care or keeping of pharmacy records based on the services provided by the pharmacy, regardless of whether the records are in that person's actual physical custody and control.

(17) “Dispensing or Dispense” means the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.

(18) “Drug Regimen Review” or “DRR” means the process conducted by a Pharmacist who is consulting for a long-term-care facility or other institution, either prior to dispensing or at a later time, with the goal of ensuring that optimal patient outcomes are achieved from the drug therapy.

(19) “Drug utilization review” or “DUR” means evaluation of a prescription to identify and resolve potential problems through the review of information provided to the Pharmacist by the patient, patient's agent, prescriber and the patient's record.

(20) “Entry system” enables control of access to a secured area.

(21) “Final verification” means after prescription information is entered into a pharmacy’s electronic system and reviewed by a Pharmacist for accuracy, a physical verification that the drug and drug dosage, device or product selected from a pharmacy’s inventory pursuant to the electronic system entry is the prescribed drug and drug dosage, device, or product.

(22) “Good standing” means a license or registration that is not suspended, revoked, or otherwise restricted from the practice of pharmacy or subject to a current disciplinary order.

(23) “Health care interpreter” has the meaning given that term in ORS 413.550.

(24) “Health care interpreter registry” means the registry described in ORS 413.558 that is administered by the Oregon Health Authority.

(25) “Individual with limited English proficiency” means a person who, by reason of place of birth or culture, communicates in a language other than English and does not communicate in English with adequate ability to communicate effectively with a health care provider.

(26) “Interchangeable” means, in reference to a biological product, that the United States Food and Drug Administration has determined that a biosimilar product meets the safety standards set forth in 42 USC 262(k)(4) (v. 02/26/2026).

(27) “Intern” means a person who is enrolled in or has completed a course of study at a board approved college or school of pharmacy and who is licensed with the board as an Intern.

(28) “Interpretation and evaluation of prescription orders” means the review of the order for therapeutic and legal correctness. Therapeutic review includes identification of the prescription drug ordered, its applicability and its relationship to the other known medications used by the patient and determination of whether or not the dose and time interval of administration are within accepted limits of safety. The legal review for correctness of the prescription order includes a determination that the order is valid and has not been altered, is not a forgery, is prescribed for a legitimate medical purpose, contains all information required by federal and state law, and is within the practitioner's scope of practice.

(29) “Labeling” means the process of preparing and affixing of a label to any drug container exclusive, however, of the labeling by a manufacturer, packer or distributor of a non-prescription drug or commercially packaged legend drug or device.

(30) “Misbranded” has the same definition as set forth in 21 USC 352 (v. 02/26/2026).

(31) “Monitoring of therapeutic response or adverse effect of drug therapy” means the follow up of the therapeutic or adverse effect of medication upon a patient, including direct consultation with the patient or his agent and review of patient records, as to result and side effect, and the analysis of possible interactions with other medications that may be in the medication regimen of the patient. This section shall not be construed to prohibit monitoring by practitioners or their agents.

(32) “Medication Therapy Management (MTM)” means a distinct service or group of services that is intended to optimize therapeutic outcomes for individual patients. Medication Therapy Management services are independent of, but can occur in conjunction with, the provision of a medication product.

(33) “Nationally Certified Exam” means an exam that is approved by the board which demonstrates successful completion of a Specialized Education Program. The exam must be reliable, psychometrically sound, legally defensible, and valid.

(34) “Non-legend drug” means a drug which does not require dispensing by prescription and which is not restricted to use by practitioners only.

(35) “Offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of pharmacy” means, among other things:

(a) The creation and retention of accurate and complete patient records;

(b) Assuming authority and responsibility for product selection of drugs and devices;

(c) Developing and maintaining a safe practice setting for the Pharmacist, for pharmacy staff and for the general public;

(d) Maintaining confidentiality of patient information.

(36) “Official compendium” means the official United States Pharmacopeia , official National Formulary (v. USP NF 2026, Issue 1), official Homeopathic Pharmacopoeia of the United States (v. 2026), or any supplement to any of these.

(37) “Pharmaceutical Care” means the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life. These outcomes include:

(a) Cure of a disease;

(b) Elimination or reduction of a patient's symptomatology;

(d) Prevention of a disease or symptomatology.

(38) “Pharmacist” means an individual licensed by this state to engage in the practice of pharmacy or to engage in the practice of clinical pharmacy.

(39) “Pharmacy Technician” means a person licensed by the State Board of Pharmacy who assists the Pharmacist in the practice of pharmacy pursuant to rules of the board.

(40) “Practice of clinical pharmacy” means:

(a) The health science discipline in which, in conjunction with the patient’s other practitioners, a Pharmacist provides patient care to optimize medication therapy and to promote disease prevention and the patient’s health and wellness;

(b) The provision of patient care services, including but not limited to post-diagnostic disease state management services; and

(41) “Practice of pharmacy” is as defined in ORS 689.005.

(42) “Prescription drug” or “legend drug” is as defined in ORS 689.005 and:

(a) Required by federal law, prior to being dispensed or delivered, to be labeled with “Rx only”; or

(b) Required by any applicable federal or state law or regulation to be dispensed on prescription only or is restricted to use by practitioners only.

(43) “Prescription released by the Pharmacist” means, a prescription which has been reviewed by the Pharmacist that does not require further Pharmacist intervention such as reconstitution or counseling.

(44) “Prohibited conduct” means conduct by a licensee that:

(a) Constitutes a criminal act against a patient or client; or

(b) Constitutes a criminal act that creates a risk of harm to a patient or client.

(45) “Proper and safe storage of drugs and devices and maintenance of proper records therefore” means housing drugs and devices under conditions and circumstances that:

(a) Assure retention of their purity and potency;

(b) Avoid confusion due to similarity of appearance, packaging, labeling or for any other reason;

(d) Accurately account for and record their receipt, retention, dispensing, distribution or destruction;

(e) Protect the health, safety and welfare of the Pharmacist, pharmacy staff and the general public from harmful exposure to hazardous substances.

(46) “Quality Assurance Plan” is a written set of procedures to ensure that a pharmacy has a planned and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services and for identifying and resolving problems.

(47) “Reasonable professional judgment” means an objectively reasonable and impartial belief, opinion or conclusion held with confidence, and founded on appropriate professional knowledge, skills, abilities, qualifications, and competencies, after careful review, analysis and consideration of the relevant subject matter and all relevant facts and circumstances that were then known by, or reasonably available to, the person or party holding such belief, opinion, or conclusion.

(48) “Reference biological product” means the biological product licensed pursuant to 42 USC 262(a) (v. 02/26/2026) against which a biological product is evaluated in an application submitted to the United States Food and Drug Administration for licensure of a biological product as a biosimilar product or for determination that a biosimilar product is interchangeable.

(49) “Repackage” means the act of taking a drug from the container in which it was distributed by the manufacturer and placing it into a different container without further manipulation of the drug.

(50) “Still image capture” means a specific image captured electronically from a video or other image capture device.

(51) “Store and forward” means a video or still image record which is saved electronically for future review.

(52) “Supervision by a Pharmacist” means being stationed within the same work area, except as authorized under OAR 855-041-3200 through OAR 855-041-3250, as the Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician being supervised, coupled with the ability to control and be responsible for the Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician's action.

(53) “Surveillance system” means a system of video cameras, monitors, recorders, and other equipment used for surveillance.

(54) “Tamper-resistant Prescription” means a form for the purpose of issuing a handwritten or typed prescription, intended to be manually delivered to a pharmacy, which has been developed, and formatted to ensure security, integrity and authenticity using currently accepted technologies. Formatted features may include but are not limited to characteristics such as:

(a) The word “void” appears when photocopies are attempted;

(b) Background ink which reveals attempted alterations;

(d) Penetrating ink to prevent chemical alterations;

(e) A watermark which cannot be photocopied;

(f) Coin reactive ink that reveals word when rubbed with a coin;

(g) Sequential numbering.

(55) “Therapeutic substitution” means the act of dispensing a drug product with a different chemical structure for the drug product prescribed under circumstances where the prescriber has not given clear and conscious direction for substitution of the particular drug for the one which may later be ordered.

(56) “Verification” means the confirmation by the Pharmacist of the correctness, exactness, accuracy and completeness of the acts, tasks, or functions performed by an Intern, a Certified Oregon Pharmacy Technician, or a Pharmacy Technician.

[Publications: Publications referenced are available for review at the agency or from United States Pharmacopoeia.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.005, ORS 689.151, ORS 689.155 & ORS 689.703
BP 14-2026, minor correction filed 07/10/2026, effective 07/10/2026
BP 8-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 12-2024, amend filed 02/15/2024, effective 03/01/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 57-2022, amend filed 12/20/2022, effective 12/21/2022
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 25-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 15-2022, amend filed 04/20/2022, effective 04/20/2022
BP 32-2021, temporary amend filed 12/10/2021, effective 12/10/2021 through 06/07/2022
BP 29-2021, amend filed 12/10/2021, effective 12/10/2021
BP 15-2021, amend filed 06/15/2021, effective 06/15/2021
BP 87-2020, amend filed 09/11/2020, effective 09/11/2020
BP 1-2020, temporary amend filed 03/23/2020, effective 03/23/2020 through 09/17/2020
BP 12-2019, amend filed 12/20/2019, effective 12/20/2019
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
BP 8-2015, f. & cert. ef. 12-23-15
BP 3-2012, f. & cert. ef. 6-19-12
BP 6-2010, f. & cert. ef. 6-29-10
BP 2-2008, f. & cert. ef. 2-20-08
BP 12-2006, f. & cert. ef. 12-19-06
BP 1-2006, f. & cert. ef. 6-9-06
BP 4-1998, f. & cert. ef. 8-14-98
PB 1-1994, f. & cert. ef. 2-2-94
PB 4-1992, f. & cert. ef. 8-25-92
PB 2-1989, f. & cert. ef. 1-30-89
PB 2-1988, f. & cert. ef. 5-3-88
1PB 3-1984, f. & ef. 4-16-84
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-006-0020 Unprofessional Conduct Defined

"Unprofessional conduct" means conduct unbecoming of a licensee or detrimental to the best interests of the public, including conduct contrary to recognized standards of ethics of pharmacy or conduct that endangers the health, safety or welfare of a patient or client. Unprofessional conduct includes but is not limited to:

(a) Fraud or misrepresentation in dealings relating to pharmacy practice with:

(A) Customers, patients or the public;

(B) Practitioners authorized to prescribe drugs, medications or devices;

(D) Wholesalers, manufactures or distributors of drugs, medications or devices;

(E) Health care facilities;

(F) Government agencies; or

(G) Drug outlets.

(b) Illegal use of drugs, medications or devices without a practitioner's prescription, or otherwise contrary to federal or state law or regulation;

(d) Theft of drugs, medications or devices, or theft of any other property or services under circumstances which bear a demonstrable relationship to the practice of pharmacy;

(e) Dispensing a drug, medication or device where the pharmacist knows or should know due to the apparent circumstances that the purported prescription is bogus or that the prescription is issued for other than a legitimate medical purpose, including circumstances such as:

(A) Type of drug prescribed;

(B) Amount prescribed; or

(f) Any act or practice relating to the practice of pharmacy that is prohibited by state or federal law or regulation;

(g) The disclosure of confidential information in violation of Board rule;

(h) Engaging in collaborative drug therapy management in violation of ORS Chapter 689 and the rules of the Board;

(i) Authorizing or permitting any person to practice pharmacy in violation of the Oregon Pharmacy Act or the rules of the Board;

(j) Any conduct or practice by a licensee or registrant which the Board determines is contrary to accepted standards of practice; or

(k) Failure to cooperate with the Board pursuant to OAR 855-104-0005.

History

Statutory/Other Authority: 689.205
Statutes/Other Implemented: ORS 689.005 and 689.155
BP 41-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Division 7 PUBLIC HEALTH EMERGENCY

Or. Admin. R. 855-007-0010 Declaration of Emergency

(1) With the exception of OAR 855-007-0060(2)(a) and (b), 855-007-0080(2), 855-007-0080(8)(a) and (b), and 855-007-0120 that are always in effect, the rules in this Division are only effective when:

(a) A State of Emergency or a Public Health Emergency has been declared by the Governor of Oregon under ORS 401.055 or 433.441 through 433.452;

(b) The provisions of any relevant rules in chapter 855 Oregon Administrative Rules have been suspended by the Governor under the authority of ORS 401.065(2);

(c) A signatory to the Pacific Northwest Emergency Management Arrangement (the states of Alaska, Idaho, Oregon, Washington, the Province of British Columbia, and Yukon) has requested assistance during a civil emergency as authorized in Chapter 25 Oregon Laws 2008;

(d) A signatory to the Emergency Management Assistance Compact has requested assistance during a civil emergency as authorized in ORS 401.043;

(e) The President of the United States or another federal official has declared a public health emergency; or

(f) The Governor has authorized the Public Health Director to take the actions described in ORS 431.264.

(2) When these rules are authorized by any one of the actions listed in (1)(a)–(f) they are in effect to the extent necessitated by the scope of the declaration, and control to the extent that they are in conflict with other divisions of OAR chapter 855.

History

Statutory/Other Authority: ORS 401.043, 401.065, 433.441 & 689.205
Statutes/Other Implemented: 2008 OL Ch. 25, ORS 401.055 & 689.155
BP 4-2009, f. & cert. ef. 12-24-09
BP 3-2009(Temp), f. & cert. ef. 8-19-09 thru 2-15-10
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0020 Applicability

(1) These rules apply to all persons licensed or registered with the Board under OAR chapter 855 and to any persons acting under the authority of Oregon State Public Health Division or any other state agency, or any local or county health department or emergency manager, during a Declared Emergency or a Public Health Emergency, or to any such person acting in preparation for a Public Health Emergency.

(2) These rules may apply to the whole state of Oregon or only to a county or area included in the declared emergency. They also apply to the activities of any licensee or registrant who is working during a declared emergency in the state or territory of any of the signatories of Pacific Northwest Emergency Management Arrangement or the Emergency Management Assistance Compact.

(3) These rules apply to the dispensing and administration of drugs and vaccines to any person within an area subject to an emergency declaration or to any person who has been displaced from their place of residence even if the place to which they have been displaced has not been included in the emergency declaration.

(4) Insofar as neither the Governor of Oregon nor the Board has the authority to waive any provisions of Federal Law, nothing in these rules that conflicts with the Federal Controlled Substances Act (CSA) or the implementing regulations in 21 CFR, shall apply to federal controlled substances as listed in division 80 of this chapter of rules, unless an agency of the US Government has waived the appropriate section of the CSA or the implementing regulations in 21 CFR.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: 2008 OL Ch. 25 & ORS 689.155
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0030 Definitions

(1) “Administer” has the meaning given that term in ORS 689.005.

(2) “Community Partner” has the meaning given that term in OAR 855-007-0080.

(3) “Dispense” has the meaning given that term in ORS 689.005.

(4) “Distribute” has the meaning given that term in ORS 689.005.

(5) “Drug” in this division of rules, the term “drug” means a drug or vaccine or medical device, or any combination of these terms.

(6) “Emergency” has the meaning given that term in ORS 401.025.

(7) “Emergency Management Assistance Compact” (EMAC) means the compact for mutual assistance that was ratified by Congress and signed by all states, and is codified in ORS 401.043.

(8) “Emergency Prescription” means a record that is created in a pharmacy that records the dispensing of a refill of a drug, or a new or modified drug therapy to a patient in the absence of a valid prescription.

(9) “Health-care provider” means an individual licensed, certified or otherwise authorized or permitted by the laws of this state or another state to administer health-care services within their scope of practice.

(10) “Mobile Pharmacy” means a pharmacy that is located in a vehicle or a trailer.

(11) “Oregon State Public Health Division” (OSPHD) means that division of the Oregon Department of Human Services (DHS) that is responsible for planning for and responding to a public health emergency.

(12) “Pacific Northwest Emergency Management Arrangement” (PNEMA) means the compact, ratified in Chapter 25 Oregon Laws 2008, between the states of Alaska, Idaho, Oregon and Washington, and the Province of British Columbia, and Yukon, to provide mutual assistance in an emergency or public health emergency.

(13) “Public Health Emergency” has the meaning given that term in ORS 433.442.

(14) “Strategic National Stockpile” (SNS) means the US Government stockpile of antiviral drugs and other drugs and medical supplies that can be made available to a state in an emergency.

(15) “Temporary Pharmacy” means a facility established under these rules to temporarily provide pharmacy services within or adjacent to an area subject to a State of Emergency.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: 2008 OL Ch. 25 & ORS 689.155
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0040 Delegation of Authority

When these rules are in effect, any authority vested in the Board may be exercised by the Executive Director (ED), any person acting as Executive Director in the ED’s absence or incapacity, or any person the ED designates to make such decisions on the ED’s behalf.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.165
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0050 Emergency Licensure

(1) Article V of ORS 401.043 (EMAC) and Article V of Annex B of PNEMA provide that whenever a person holds a license, certificate or other permit issued by a signatory to the compact evidencing the meeting of qualifications for professional, mechanical or other skills, and when such assistance is requested by the receiving signatory, the person is deemed to be licensed, certified or permitted by the signatory requesting assistance to render aid involving the skill to meet an emergency or disaster, to the extent allowed by law and subject to limitations and conditions as the requesting signatory prescribes by executive order or otherwise.

(2) When an emergency has been declared, a drug outlet may employ a pharmacist, intern or pharmacy technician who does not hold a license issued by the Board, provided that the individual provides evidence that they hold a comparable license issued by any other state or signatory to PNEMA or EMAC.

(3) In an emergency, the Board may grant an emergency temporary license to a licensee of the board of pharmacy of any state, province, foreign state or political sub-division that is not a signatory to PNEMA or EMAC as follows:

(a) A pharmacist, intern, pharmacy technician or certified pharmacy technician who holds an active license in another state, province, foreign state or political sub-division that is not suspended or restricted for any reason and who is sponsored by a pharmacy that has an active registration from the Board may be granted an emergency temporary license subject to approval by the Board of an application that contains:

(A) The name, permanent address and phone number of the applicant;

(B) The license number and state, province or political sub-division of permanent licensure;

(D) Any other information requested by the Board.

(b) The emergency temporary license issued under these rules shall be valid for a period determined by the Board, but not exceeding six months. If the emergency still exists after six months, the Board may renew any emergency temporary license for an additional six months.

(d) A licensee granted an emergency temporary license under this rule may only practice in the sponsoring pharmacy or a pharmacy under common ownership with the sponsoring pharmacy, except that the licensee may transfer to another pharmacy that is not under common ownership with the sponsoring pharmacy, provided that the licensee notifies the Board within three days.

(4) Inactive License Reactivation: In an emergency, the Board may allow a pharmacist whose license has been inactive for no more than two years to reactivate their license without completing any required continuing education or MPJE. The license will revert to an inactive status at the end of six months unless all required continuing education has been completed.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: 2008 OL Ch. 25, ORS 689.151 & 689.155
BP 13-2022, temporary amend filed 03/28/2022, effective 03/29/2022 through 09/24/2022
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0060 SNS and State Stockpile Emergency Drugs

(1) General: When drugs from the Strategic National Stockpile (SNS) are delivered to the state, the drugs may be delivered to a state Receipt, Staging and Storage center (RSS) for further distribution to Points of Dispensing (PODs) selected by OSPHD. State drugs (state stockpile) may also be delivered to the RSS.

(2) Temporary storage of drugs from SNS or state stockpile:

(a) The RSS, PODs and local health departments (LHD) are authorized to store any drugs from the SNS or state stockpile prior to and during an emergency without any registration from the Board.

(b) All such drugs must be stored in accordance with manufacturers’ guidelines.

(c) This authority to possess drugs shall extend beyond the declared emergency until procedures issued by OSPHD for the return or destruction of unused drugs have been completed.

(3) A long-term drug storage area for state and federal emergency medications not otherwise registered as a drug outlet must be approved by the Board, comply with storage and security requirements, and register as a Drug Room.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: ORS 689.155
BP 1-2017, f. & cert. ef. 2-23-17
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0080 Emergency Immunization and Drug Distribution

When a public health emergency has been declared, the following principles and procedures shall apply to the distribution, dispensing and administration of vaccines or drugs:

(1) The distribution of vaccines and drugs is to be in accordance with instructions provided by OSPHD.

(2) LHDs are authorized to distribute SNS or state stockpile drugs to designated Treatment Centers (TC) or health-care providers designated by the State Public Health Director or a local health administrator.

(3) A TC may include but is not limited to:

(a) A LHD;

(b) A clinician;

(d) An independent or chain pharmacy;

(e) A hospital or other health-care facility;

(f) A temporary pharmacy;

(g) A mobile pharmacy; or

(h) A tribal health-care facility.

(4) A TC may possess, distribute, dispense and administer vaccines and drugs if these rules are in effect.

(5) A health-care provider, designated by the local health administrator, at a TC shall be responsible for administration, distribution and tracking of vaccines and drugs in accordance with procedures established by OSPHD.

(6) A health-care provider may, if permitted under that provider’s scope of practice and these rules, distribute, dispense and administer vaccines and drugs.

(7) An Individual Data Collection Form (IDCF) shall be filled out for each person receiving a vaccine or drug at a TC or from a health-care provider, and this IDCF shall be treated as a valid prescription and retained as follows:

(a) An IDCF initiated at a pharmacy or other licensed health-care facility shall be filed and retained for three years;

(b) An IDCF initiated at a facility that is not a licensed health-care facility or at a temporary or mobile pharmacy shall be sent to OSPHD at the end of the state of emergency except that where the temporary or mobile facility has been established under the authority of OAR 855-007-0100 all records shall be filed and retained in accordance with 855-007-0110.

(8) Community Partner: A Community Partner means any entity that is authorized by OSPHD or OBOP to:

(a) Purchase and store vaccines or drugs prior to a pandemic event;

(b) Store vaccines or drugs in a Board registered facility or at a tribal site;

(c) Take possession of the vaccines or drugs and distribute to critical infrastructure and key resources when so directed by OSPHD in accordance with OSPHD protocols and procedures.

(d) A Community Partner shall:

(A) Distribute all drugs within 72 hours of removal from the storage site;

(B) Store all drugs in accordance with manufacture’s guidelines;

(i) The name and age of the person receiving the drugs;

(ii) The name, strength and quantity of the drugs;

(iii) The date and the time of the distribution.

(e) The Distribution Log shall be treated as a valid prescription and stored or otherwise disposed of as specified in 855-007-0110;

(9) This authority for LHDs, TCs, health-care providers and Community Partners to possess drugs shall extend beyond the declared emergency until procedures issued by OSPHD for the return or destruction of unused drugs have been completed.

(10) A pharmacist may administer a vaccine to a person who is at least three years of age or older.

(11) For immunization clinics, an immunizing pharmacist may supervise as many Oregon-licensed immunizing interns as that pharmacist determines, in their own professional judgment, will maintain public health and safety.

History

Statutory/Other Authority: ORS 401.065, ORS 433.441 & ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.645
BP 13-2021, amend filed 06/15/2021, effective 06/15/2021
BP 93-2020, temporary amend filed 12/22/2020, effective 12/22/2020 through 06/19/2021
BP 2-2014, f. & cert. ef. 1-24-14
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0086 Compliance with Governor’s Executive Orders

(1) During a declared emergency, unprofessional conduct includes failing to comply with any applicable provision of a Governor’s Executive Orders or any provision of this rule.

(2) Failing to comply as described in subsection (1) includes, but is not limited to:

(a) Failing to comply with any requirements of a Board of Pharmacy guidance implementing an Executive Order; and,

(b) Failing to comply with Oregon Health Authority (OHA) guidance implementing an Executive Order, including but not limited to:

(A) Failing to satisfy required criteria in OHA guidance prior to resuming elective and non-emergent patient care services or procedures;

(B) Failing to implement a measured approach when resuming elective and non-emergent patient care services or procedures in accordance with OHA guidance;

(D) Failing to implement OHA guidance on mask and face covering and physical distancing for businesses; and

(E) Failing to clean and disinfect in accordance with OHA guidance.

(3)No disciplinary action or penalty action shall be taken under this rule if the Executive Order alleged to have been violated is not in effect at the time of the alleged violation.

(4) Penalties for violating this rule may include, but are not limited to: civil penalties, restrictions on licensure, probation, suspension, and revocation. Any such penalties shall be imposed in accordance with ORS Ch. 183.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 95-2020, adopt filed 12/23/2020, effective 12/23/2020
BP 10-2020, temporary adopt filed 07/16/2020, effective 07/16/2020 through 01/11/2021

Or. Admin. R. 855-007-0090 Emergency Pharmacy Rules

(1) Refills: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may dispense a refill of a prescription drug without a valid prescription provided that:

(a) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or the continuation of therapy; and

(b) The pharmacist provides no more than a 30-day supply; and

(d) The pharmacist informs the patient or the patient’s agent that the drug is being provided without a prescriber’s authorization and that a prescriber authorization is required for any additional refill.

(e) If the refill is for a controlled substance, permission has been granted by the DEA for this type of refill, either by waiver of appropriate controlled substance regulations or by notification to the Board.

(2) New and modified drug therapy: A pharmacist in the area covered by a declared emergency or in an area engaged in disaster assistance may, after consultation with any authorized prescriber, initiate or modify any drug therapy, and dispense an amount of the drug to meet the patient’s health needs until that patient can be seen by a health-care practitioner, provided that:

(a) The pharmacist acts in accordance with currently accepted standards of care; and

(b) In the pharmacist’s professional judgment, the drug is essential to the maintenance of the patient’s health or to the continuation of therapy; and

(c) The pharmacist records all relevant information to a form and indicates that a drug therapy has been initiated or modified and that this is an Emergency Prescription; and

(d) The pharmacist informs the patient or the patient’s agent at the time of dispensing that the drug is being provided in the absence of a valid patient — prescriber relationship but that a prescriber was consulted regarding the appropriateness of the drug therapy; and

(e) The pharmacist informs the patient or the patient’s agent that a prescriber authorization is required for any refill.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0100 Temporary Pharmacies

(1) When these rules are in effect, the Board may issue a Temporary Pharmacy Registration to any facility or mobile facility.

(2) A facility, including a mobile pharmacy, holding a Temporary Pharmacy Registration may store and dispense drugs in accordance with the requirements of OAR 855-041 and these rules. The supervising pharmacist of a mobile pharmacy shall notify the Board of the pharmacy location within three working days of commencing business, and within three working days of any change in location.

(3) A Temporary Pharmacy Registration automatically expires when the state of emergency ends unless specifically extended by the Board.

(4) Within 30 days of the end of the declared emergency, the holder of a Temporary Pharmacy Registration shall notify the Board as to the disposition of its drug inventory and records.

(5) A temporary or mobile pharmacy that is established for the sole purpose of expediting distribution of emergency immunizations, antibiotics or antiviral drugs under OAR 855-007-0080, is located adjacent to an existing pharmacy registered with the Board and is under the supervision of the PIC of the existing pharmacy, does not need to be registered as a temporary pharmacy.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0110 Emergency Recordkeeping

All records initiated during a state of emergency shall be disposed of as follows:

(1) POD intake forms and Individual Data Collection Forms or electronic records shall be transferred to OSPHD at the end of the emergency;

(2) Community Partner’s Logs:

(a) Vaccines: Logs shall be transferred to OSPHD within 14 days of administration to be entered into the statewide immunization information system. If the Community Partner is a registered health-care facility or under the control of a licensed health-care provider, a copy of the log shall be made before submission and retained for three years.

(b) Antivirals and other drugs: Logs shall be transferred to OSPHD at the end of the emergency unless the Community Partner is a registered health-care facility or under the control of a licensed health-care provider in which case logs shall be stored securely by the Community Partner;

(3) Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a pharmacy that is not a Temporary or Mobile Pharmacy shall be stored at the pharmacy.

(4) Emergency Prescriptions and Individual Data Collection Forms for drugs dispensed from a Temporary or Mobile Pharmacy shall be stored at whichever of the following locations is most appropriate:

(a) At the parent pharmacy that provided the majority of the drugs to the Temporary or Mobile Pharmacy; or

(b) At the pharmacy that employs the supervising pharmacist of the Temporary or Mobile Pharmacy; or

(5) Unless otherwise specified, all records are to be retained for three years and must be made available to the Board upon request.

History

Statutory/Other Authority: ORS 401.065, 433.441 & 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Or. Admin. R. 855-007-0120 Damage to a Pharmacy and Drug Integrity

(1) If a pharmacy prescription department sustains damage, whether by flood or otherwise, the entire drug inventory, including any prescriptions that are awaiting pickup, is unfit for dispensing, must be classified as adulterated and must be destroyed unless, the drugs are deemed safe for dispensing pursuant to OAR 855-041-1036. Any incident of this nature must be reported to the board within three working days.

(2) If a pharmacy loses power that affects temperature or humidity controls such that the proper storage of drugs pursuant to OAR 855-041-1036 has been violated, such drugs must be classified as adulterated and may not be dispensed.

(3) Controlled substances damaged, lost or stolen must be documented and reported to the DEA and the board on DEA Form 41, DEA Form 106, or DEA Form 107 as appropriate.

(4) A pharmacy that is required to temporarily close or relocate due to an emergency must report this event to the board within three working days.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
BP 4-2009, f. & cert. ef. 12-24-09
BP 1-2009, f. & cert. ef. 6-22-09
BP 4-2008(Temp), f. 12-31-08, cert. ef. 1-5-09 thru 7-3-09

Division 11 HEALTH PROFESSIONAL’S SERVICE PROGRAM

Or. Admin. R. 855-011-0005 Definitions

When used in this division of rules:

(1) “Health Professionals’ Service Program (the Program)” means the impaired health professional program established by the Oregon Health Authority pursuant to authority granted by ORS 676.190.

(2) “Impaired” means that the licensee is unable to practice with professional skill and safety by reason of habitual or excessive use or abuse of drugs, alcohol or other substances that impair ability, or by reason of a mental health disorder.

(3) “Mental-health disorder” means a clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is associated with present distress or disability or with a significantly increased risk of suffering death, pain, disability, or an important loss of freedom that is identified in the DSM-IV-TR, (published by the American Psychiatric Association). “Mental-health disorder” includes gambling disorders.

(4) “Non-treatment compliance monitoring,” means the non-medical, non-therapeutic services employed by the vendor to track and report the licensee’s compliance with the monitoring agreement.

(5) "Substance Abuse Disorder" means a disorder related to the taking of a drug of abuse including alcohol, to the side effects of a medication, and to a toxin exposure. The disorders include: substance abuse disorders such as substance dependence and substance abuse, and substance-induced disorders, including substance intoxication, withdrawal, delirium, and dementia, as well as substance induced psychotic disorder, mood disorder, etc, as defined in DSM-IV-TR, (published by the American Psychiatric Association) criteria.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.200
BP 12-2010, f. & cert. ef. 12-23-10
BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10

Or. Admin. R. 855-011-0020 Participation in Health Professional’s Service Program

(1) Effective July 1, 2010, the Oregon Board of Pharmacy (Board) will participate in the Program.

(2) The Board may only refer licensees of the Board to the Program if they meet the referral criteria established by the Board.

(3) The Board may refer a licensee to the Program in lieu of or in addition to public discipline.

(4) A licensee who has not been referred to the Program by the Board may participate in the Program as permitted by ORS 676.190. Licensees may not refer themselves to the Program unless they certify that, to the best of their knowledge, they are not currently under investigation by the Board.

History

Statutory/Other Authority: ORS 689.205 & 2013 OL Ch 367
Statutes/Other Implemented: ORS 676.200 & 2013 OL Ch 367
BP 2-2014, f. & cert. ef. 1-24-14
BP 12-2010, f. & cert. ef. 12-23-10
BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10

Or. Admin. R. 855-011-0030 Procedure to refer Board licensees to the Program

(1) When the Board has information that a licensee may be impaired by alcohol or a substance abuse disorder or dependency, or a mental-health disorder, the Board may consider referring the licensee to the Program.

(2) Before the Board refers a licensee to the Program, the Board shall:

(a) Obtain a copy of a written report that diagnoses the licensee with alcohol or a substance abuse disorder or dependency, or a mental-health disorder and provides treatment options;

(b) Investigate to determine whether the licensee’s professional practice while impaired has presented or presents a danger to the public;

(c) Obtain the licensee’s written agreement to report any arrest for or conviction of a misdemeanor or felony to the Board within three business days after the licensee is arrested or convicted;

(d) Obtain the licensee’s written agreement to pay the costs of participation in the Program, including the cost of laboratory or toxicology tests, treatment, consultation group meetings and evaluations; and

(e) Obtain the licensee’s written consent allowing disclosure and exchange of information between the Program, the Board, the monitoring entity, the licensee’s employers, and evaluators and treatment entities.

(3) The report referred to in subsection (2)(a) of this rule must be prepared by an independent evaluator approved by the Board under OAR 855-011-0040 to evaluate alcohol or a substance abuse disorder or dependency, and mental-health disorders.

(4) The Board may only refer to the Program a licensee who has been diagnosed with alcohol or a substance abuse disorder or dependency, or a mental health disorder.

(5) The Board will consider all relevant factors before determining whether to refer a licensee to the Program. Relevant factors shall include but are not limited to:

(a) Licensee’s disciplinary history;

(b) The severity and duration of the licensee’s impairment;

(d) The likelihood that licensee’s impairment can be managed with treatment; and

(e) The likelihood that the licensee will follow the conditions of the program.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.200
BP 12-2010, f. & cert. ef. 12-23-10
BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10

Or. Admin. R. 855-011-0040 Approval by the Board of an Independent Evaluator

(1) The Board may approve a person to act as an evaluator provided that the person:

(a) Is licensed as required by the jurisdiction in which they work;

(b) Possesses a master’s degree or a doctorate in a mental health discipline;

(A) US Department of Transportation, Substance Abuse Professional Qualification training;

(B) Certification by the National Association of Alcoholism and Drug Abuse Counselors Certification Commission as a Certified Alcohol and Drug Abuse Counselor (CADC) level II or III; or

(C) Board certification in Addiction Medicine by either the American Society of Addiction Medicine or American Board of Psychiatry and Neurology.

(d) Is able to provide a multi-disciplinary assessment and written report describing a licensee’s diagnosis, degree of impairment and treatment options; and

(e) Certifies that, if required, they are willing to defend their evaluation in a court of law.

(2) The Board may not approve an evaluator in a case if, in the Board’s judgment, the evaluator’s judgment is likely to be influenced by a personal or professional relationship with a licensee.

(3) The Board shall maintain a list of approved independent evaluators on the Board’s website or the Board may approve a list of evaluators that meet the above criteria that is approved and published by the Program contractor.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.200
BP 12-2010, f. & cert. ef. 12-23-10
BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10

Or. Admin. R. 855-011-0050 Additional requirements for licensees referred to the Program

(1) In addition to the requirements established by ORS 676.185 to 676.200, a licensee who participates in the Program must:

(a) Participate in the Program for as long as specified in the disciplinary order but not less than two years, except that a licensee who has been enrolled in a prior Board approved program for at least two years may count up to one year of that program towards this requirement;

(b) Meet all conditions of probation specified in the disciplinary order; and

(2) A licensee may petition the Board for early removal from the Program if:

(a) They are in good standing with the Program;

(b) They have been in the Program for at least two years; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.200
BP 12-2010, f. & cert. ef. 12-23-10
BP 7-2010(Temp), f. & cert. ef. 6-29-10 thru 12-24-10

Division 35 OPERATION OF NONPRESCRIPTION AND MEDICAL DEVICE, EQUIPMENT AND GAS (MDEG) OUTLETS

Or. Admin. R. 855-035-0005 Applications

(1) All applications for registration of a new or relocated proprietary drug outlet shall be accompanied by the required fees as set forth in 855-110-0007.

(2) Application shall specify the location of the proprietary drug outlet. When the applicant is not the owner of the business, the application shall indicate the owner and the applicant's affiliation with the owner:

(a) If the owner is a partnership or other multiple owner, the names of the partners or persons holding the five largest interests shall be indicated on the application.

(b) If the owner is a corporation, the name filed shall be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests shall be indicated on the application.

(c) Upon request by the Board, the applicant shall furnish such information as required by the Board regarding the partners, stockholders, or other persons not named in the application.

(3) All registration renewal applications shall be accompanied by the annual fee and contain the same information required in subsections (2)(a), (b) and (c) of this rule.

(4) If the annual registration fee referred to in section (1) of this rule is not paid by January 31 of the current year, a delinquent fee as set forth in OAR 855-110-0007 shall be included with the application for registration renewal.

(5) A change of ownership or location requires a new application, fee and registration within 15 days of the change .

(6) The registration certificate is issued to a person or firm and is non-transferable. Additions or deletions of a partner/partners shall be considered as a change of ownership.

(7) The registration fee cannot be prorated.

(8) No nonprescription drug or medical gas authorized to be sold at retail under this registration shall be sold, given away, or otherwise disposed of until application has been approved and a certificate of registration issued. There shall be four types of drug outlet registrations:

(a) Class A shall be for all outlets except those that own more than one vending machine distributing more than six nonprescription drugs.

(b) Class B shall be for all outlets except those that own more than one vending machine distributing six or less nonprescription drugs.

(d) Class D shall be for all outlets with more than one vending machine distributing nonprescription drugs.

(e) Class E shall be for any nonprofit, tax exempt, food distribution facility that distributes food products and nonprescription drugs at no cost, other than nominal delivery charges, to charitable organizations including regional food banks, for distribution at no cost to individuals. This registration, which shall be issued at no cost to the registrant, expires on January 31st annually.

(f) The intention of this section is that an owner of a single vending machine that contains over-the-counter medications can register as either a Class A or Class B outlet based on the number of medications in the machine. The owner of more than one vending machine that contains over-the-counter medications shall register as a Class D outlet and inform the Board of their locations. Class E registration is intended for the Oregon Food Bank and other regional food banks located in Oregon.

(9) If there is more than one drug outlet under the same roof and each outlet is independently operated by different owners, a separate registration shall be obtained for each outlet.

(10) In case of loss of the certificate of registration, the Board may require a sworn statement before a notary public to be filed in the Board office before duplicate certificates of registration can be issued.

(11) Each vending machine that contains nonprescription drugs must have an obvious and legible statement on the machine that identifies the owner of the machine, advises the customer to check the expiration date of the product before using, and lists the phone number for the Board of Pharmacy.

(12) A Class D nonprescription drug outlet shall keep the Board informed in writing of the current location of all of its vending machines.

(13) Notwithstanding the requirements of this rule and the other rules in this Division, upon written request the Board may waive any of the requirements of this rule or the other rules in this Division if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing.

(14) A business or other establishment that is only distributing over-the-counter short-acting opioid antagonist drugs at no cost is not required to register with the board as a nonprescription drug outlet.

History

Statutory/Other Authority: ORS 689.155 & ORS 689.205
Statutes/Other Implemented: ORS 475.035, ORS 689.135 & ORS 689.305
BP 65-2024, amend filed 12/17/2024, effective 12/17/2024
BP 63-2024, temporary amend filed 10/10/2024, effective 10/11/2024 through 04/08/2025
BP 2-2008, f. & cert. ef. 2-20-08
PB 1-1997, f. & cert. ef. 9-22-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-035-0007 Sales

Sales by drug outlets except itinerant vendors shall be made only from the premises at the location registered by the Board.

History

Statutory/Other Authority: ORS 475.035 & 689.205
Statutes/Other Implemented: ORS 689.305, 689.315 & 689.325
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1981, f. & ef. 8-20-81

Or. Admin. R. 855-035-0010 Minimum Standards for Nonprescription and Medical Gas Drug Outlets

(1) Drug outlets shall have floor space and shelving to insure that drugs are stocked and stored in sanitary, well-lighted areas. Where applicable, temperature, ventilation and moisture controls shall be employed.

(2) Expiration dates on drug outlet drugs shall be the responsibility of each drug outlet to insure products are in date.

(3) There shall be no advertisements of any kind by a drug outlet using the following or similar terms: “drug store,” “pharmacy,” “apothecary.”

History

Statutory/Other Authority: ORS 475.035 & 689.205
Statutes/Other Implemented: ORS 689.305 & 689.325
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-035-0015 Change of Business Name, Closure

(1) Any change of business name of a drug outlet must be reported to the Board within 15 days by filing a new application for which no fee is required. New certificates of registration will be issued at the next regular renewal period.

(2) Any closure of a drug outlet shall be reported to the Board within 15 days.

History

Statutory/Other Authority: ORS 475.035 & 689.205
Statutes/Other Implemented: ORS 689.325
PB 1-1996, f. & cert. ef. 4-5-96
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-035-0020 Sales of Non-Prescription Drugs

Registered nonprescription drug outlets may sell or donate non-prescription drugs in the original and unbroken packages only, properly labeled according to state and federal law, in conformity with rules of the Board. A nonprescription drug outlet shall not purchase or receive nonprescription drugs from a source not registered with the Board.

History

Statutory/Other Authority: ORS 475.035 & 689.205
Statutes/Other Implemented: ORS 689.135 & 689.305 689.315
BP 2-2008, f. & cert. ef. 2-20-08
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-035-0023 Disposal of Drugs

Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

History

Statutory/Other Authority: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1984, f. & ef. 3-7-84

Or. Admin. R. 855-035-0025 Seasonal Nonprescription Drug Outlets

(1) Seasonal nonprescription drug outlets are defined as those outlets who either by location or weather are restricted to a seasonal demand for services.

(2) Seasonal nonprescription drug outlets shall be exempt from delinquent fees for nonprescription registration if renewals are paid no later than June 1 of current year.

History

Statutory/Other Authority: ORS 475.035 & 689.205
Statutes/Other Implemented: ORS 689.325
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1981, f. & ef. 8-20-81
1PB 1-1981(Temp), f. & ef. 4-1-81

Or. Admin. R. 855-035-0030 Medical Device, Equipment and Gas (MDEG) Outlet (Class C)

(1) Medical Device, Equipment and Gas (MDEG) Outlets may sell:

(a) Nonprescription drugs;

(b) Specific drugs and materials that require the order or prescription of a practitioner:

(A) USP Oxygen;

(B) USP Sodium Chloride Irrigation;

(D) Sterile water for irrigation;

(E) Urological catheters; and

(F) Respiratory devices.

(2) Medicinal Gas Drug Outlets shall distribute medicinal Nitrous Oxide only to practitioners or institutional drug outlets.

(3) Record keeping: All records of receipt and distribution of medical devices, equipment, and gas must be maintained for a minimum of three years and must be readily retrievable.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 1-2002, f. & cert. ef. 1-8-02
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1992, f. & cert. ef. 1-31-92

Division 41 OPERATION OF PHARMACIES

Or. Admin. R. 855-041-1001 Definitions

“Drug room” is a drug storage area registered with the board which is secure and lockable.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.522
Statutes/Other Implemented: ORS 689.155 & ORS 689.522
BP 15-2022, amend filed 04/20/2022, effective 04/20/2022
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
BP 1-2017, f. & cert. ef. 2-23-17
BP 2-2014, f. & cert. ef. 1-24-14

Or. Admin. R. 855-041-1010 Outlet (Both Retail and Institutional Drug Outlets): Personnel

Each Drug Outlet Pharmacy must:

(1) Have one Pharmacist-in-charge (PIC) employed on a regular basis at that location who shall be responsible for the daily operation of the pharmacy. The Pharmacist-in-charge shall be indicated on the application for a new or relocated pharmacy and for pharmacy renewal registration.

(2) Ensure the PIC is qualified per OAR 855-115-0205 and complies with OAR 855-115-0210.

(3) Report a change in PIC within 15 days of occurrence in the registrant’s electronic licensing record with the board.

(4) Report terminating or allowing a board licensee to resign in lieu of termination to the board within 10 working days. The report must include the name of licensee, license number, the date, and the reason for the termination.

(5) Provide a working environment that protects the health, safety and welfare of a patient which includes but not limited to:

(a) Sufficient personnel to prevent fatigue, distraction or other conditions that interfere with a pharmacist’s ability to practice with reasonable competency and safety.

(b) Appropriate opportunities for uninterrupted rest periods and meal breaks.

(d) Ensure there is sufficient staff to provide services in a safe manner. The outlet must abide by the Pharmacist-on-duty’s decision to temporarily shut down a service or services and must respond substantively to a Pharmacist who has identified staffing concerns.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.305
BP 34-2023, amend filed 12/19/2023, effective 03/01/2024
BP 7-2023, amend filed 02/14/2023, effective 02/14/2023
BP 1-2017, f. & cert. ef. 2-23-17
Renumbered from 855-041-0020, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2008, f. & cert. ef. 2-20-08
BP 1-2001, f. & cert. ef. 3-5-01
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1995, f. & cert. ef. 4-27-95
PB 1-1994, f. & cert. ef. 2-2-94
PB 4-1992, f. & cert. ef. 8-25-92
PB 9-1989, f. & cert. ef. 7-20-89
PB 10-1987, f. & ef. 12-8-87
1PB 3-1986, f. & ef. 12-8-86
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1015 Operation of Pharmacy (Both Retail and Institutional Drug Outlets)

(1) Supervision. A pharmacy may only be operated when a pharmacist licensed to practice in this state is present. This means that the pharmacist must be physically present in the pharmacy or institutional facility.

(2) Sanitation:

(a) Pharmacies shall be kept clean.

(b) Persons working in a pharmacy shall practice appropriate infection control.

History

Statutory/Other Authority: ORS 689.305
Statutes/Other Implemented: ORS 689.305
BP 19-2022, amend filed 04/20/2022, effective 04/20/2022
BP 28-2021, temporary amend filed 11/19/2021, effective 11/19/2021 through 05/17/2022
Renumbered from 855-041-0025, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1997, f. & cert. ef. 9-22-97
PB 12-1989, f. & cert. ef. 8-11-89
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1018 Outlet: General Requirements

A Drug Outlet Pharmacy must:

(1) Ensure each:

(a) Prescription is dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125, OAR 855-139, OAR 855-141 and OAR 855-143;

(b) Controlled substance is dispensed in compliance with OAR 855-080;

(d) Radiopharmaceutical is dispensed in compliance with OAR 855-042.

(2) Comply with all applicable federal and state laws and rules;

(3) Ensure all licensees are trained to appropriately perform their duties prior to engaging or assisting in the practice of pharmacy.

(4) Ensure each licensed and non-licensed individual only perform duties they are licensed and trained to perform.

(5) Be responsible for the actions of each licensed and non-licensed individual.

(6) Establish, maintain and enforce the drug outlet written procedures required in OAR 855-041-1040.

(7) Comply with the Pharmacist’s determination in OAR 855-115-0120(1)(k);

(8) Develop, implement and enforce a continuous quality improvement program for dispensing services from a Drug Outlet Pharmacy designed to objectively and systematically:

(a) Monitor, evaluate, document the quality and appropriateness of patient care;

(b) Improve patient care; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 8-2026, amend filed 06/17/2026, effective 06/17/2026
BP 34-2023, amend filed 12/19/2023, effective 03/01/2024
BP 40-2022, renumbered from 855-041-0018, filed 06/24/2022, effective 06/24/2022
BP 28-2022, adopt filed 06/15/2022, effective 06/16/2022

Or. Admin. R. 855-041-1020 Security of Prescription Area

(1) The area in a registered pharmacy where legend and/or controlled substances are stored, possessed, prepared, manufactured, compounded, or repackaged shall be restricted in access, in such a manner as to ensure the security of those drugs.

(2) The pharmacist-in-charge and each pharmacist while on duty shall be responsible for the security of the prescription area including provisions for adequate safeguards against theft or diversion of prescription drugs, and records for such drugs.

(3) When there is no pharmacist present, the pharmacy shall be secured to prevent entry. All entrances to the pharmacy shall be securely locked and any keys to the pharmacy shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge. When there is no pharmacist present, and it is necessary for non-pharmacist employees or owners to have access to the pharmacy, the prescription area shall be secured from entry as described in OAR 855-041- 2100.

(4) Prescription drugs and devices and non-prescription Schedule V controlled substances shall be stored within the prescription area or a secured storage area.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.205
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
Renumbered from 855-041-0026, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1987, f. & ef. 2-3-87
1PB 5-1982, f. & ef. 8-6-82

Or. Admin. R. 855-041-1025 Disposal of Drugs

Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

History

Statutory/Other Authority: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Renumbered from 855-041-0036, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 1-1990, f. & cert. ef. 1-23-90
1PB 2-1984, f. & ef. 3-7-84

Or. Admin. R. 855-041-1030 Reporting Drug Loss

(1) Disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices must immediately be reported to the board.

(2) The outlet must ensure that confirmed significant drug loss or any loss related to suspected drug theft of a controlled substance is reported to the board within one business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (DEA Form 106) or Report of Theft or Loss of Listed Chemicals (DEA Form 107) is sent to the Drug Enforcement Administration, a copy is sent to the board.

History

Statutory/Other Authority: ORS 475.035, ORS 689.155, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 2-2014, f. & cert. ef. 1-24-14
Renumbered from 855-041-0037, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
1PB 1-1986, f. & ef. 6-5-86
1PB 2-1981, f. & ef. 8-20-81

Or. Admin. R. 855-041-1035 Minimum Equipment Requirements

(1) Each retail drug outlet and institutional drug outlet must have the following:

(a) Appropriate and current pharmaceutical references (e.g., pharmacology, injectables, and veterinary drugs) based on services offered by the outlet;

(b) Appropriate and current Oregon Revised Statutes, Oregon Administrative Rules, United States Code, Code of Federal Regulations, standards adopted by reference (e.g., USP) based on services offered by the outlet and a minimum of three years of the Board of Pharmacy quarterly newsletters;

(c) Access to appropriate electronic reporting databases (e.g., PDMP, NPLEx, OHA ALERT-IIS) based on the services offered by the outlet;

(d) Appropriate equipment to maintain the proper storage of drugs;

(e) Appropriate equipment and supplies as required by Oregon Revised Statutes, Oregon Administrative Rules, United States Code, Code of Federal Regulations, and standards adopted by reference (e.g., USP) based on services offered by the outlet;

(f) A sink with running hot and cold water;

(g) Signage in a location easily seen by the public where prescriptions are dispensed or administered:

(A) Stating “This pharmacy may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on this sign must be in block letters not less than one inch in height.

(B) Providing notification in each of the languages required in OAR 855-041-1132 of the right to free, competent oral interpretation and translation services, including translated prescription labels, for patients who are of limited English proficiency, in compliance with federal and state regulations if the pharmacy dispenses prescriptions for a patient's self-administration;

(C) Providing notification by posting a closed sign at the entrances stating the hours of the pharmacy's operation when a pharmacist is not in attendance if the pharmacy operates as a double set-up pharmacy per OAR 855-041-2100;

(D) Providing written notice in a conspicuous manner that short-acting opioid antagonists (e.g., naloxone, nalmefene) and the necessary medical supplies to administer short-acting opioid antagonists are available at the pharmacy if short-acting opioid antagonist services are provided by the pharmacy; and

(E) Providing notification of accurate hours of operation at each pharmacy entrance; and

(h) Accurate hours of operation on each telephone greeting and pharmacy-operated internet (e.g. website, social media, mobile applications).

(i) Additional equipment and supplies that are determined as necessary by the Pharmacy or Pharmacist-in-Charge.

(2) Failure to have, use and maintain required equipment constitutes unprofessional conduct under ORS 689.405(1)(a).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.508, ORS 689.515, ORS 689.564, ORS 689.686 & 2023 HB 2395
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
BP 19-2022, amend filed 04/20/2022, effective 04/20/2022
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
BP 99-2020, amend filed 12/23/2020, effective 01/01/2021
Renumbered from 855-041-0040, BP 7-2012, f. & cert. ef. 12-17-12
BP 3-2005, f. & cert. ef. 4-14-05
PB 1-1994, f. & cert. ef. 2-2-94
PB 4-1992, f. & cert. ef. 8-25-92
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 4-1991, f. & cert. ef. 9-19-91
PB 12-1989, f. & cert. ef. 8-11-89
PB 8-1987, f. & ef. 9-30-87
1PB 4-1986, f. & ef. 12-8-86
1PB 2-1981, f. & ef. 8-20-81
1PB 1-1981(Temp), f. & ef. 4-1-81
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1036 Proper Storage of Drugs

(1) A pharmacy must maintain proper storage of all drugs. This includes, but is not limited to the following:

(a) All drugs must be stored according to manufacturer’s published or USP guidelines.

(b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

(d) A pharmacy must quarantine drugs which are outdated, adulterated, misbranded or suspect. Cold Storage and Monitoring.

(2) A pharmacy must store all drugs at the proper temperature according to manufacturer’s published guidelines (pursuant to FDA package insert or USP guidelines).

(a) All drug refrigeration systems must:

(A) Maintain refrigerated products between 2 to 8 °C (35 to 46 °F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer.

(B) Utilize a centrally placed, accurate, and calibrated thermometer;

(D) Be measured continuously and documented either manually twice daily to include minimum, maximum and current temperatures; or with an automated system capable of creating a producible history of temperature readings.

(b) A pharmacy must adhere to a monitoring plan, which includes, but is not limited to:

(A) Documentation of training of all personnel;

(B) Maintenance of manufacturer recommended calibration of thermometers;

(D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses;

(E) Documentation of action(s) taken, including decision to quarantine product for destruction, or determination that it is safe for continued use. This documentation must include details of the information source;

(F) A written emergency action plan; and

(G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment.

(3) Vaccine Drug Storage:

(a) A pharmacy that stores vaccines must comply with section two of this rule and the following:

(A) Vaccines must be stored in the temperature stable sections of the refrigerator;

(B) A centrally placed and accurate buffered probe thermometer, such as glycol or glass beads, calibrated within a plus or minus 0.5 °C variance must be utilized;

(D) A system of continuous temperature monitoring with automated data logging and physical confirmation must be utilized. Documentation of the temperature of each active storage unit must be logged at least twice daily, data must be downloaded weekly, and system validations must be conducted quarterly; and

(E) Must adhere to a written quality assurance process to avoid temperature excursions.

(4) A retail drug outlet may store drugs in another location that is registered as a Drug Room and meets all Pharmacy drug storage and security requirements.

History

Statutory/Other Authority: ORS 689.205 & 689.325
Statutes/Other Implemented: ORS 689.155
BP 1-2017, f. & cert. ef. 2-23-17
BP 3-2015, f. 7-1-15, cert. ef. 1-1-16

Or. Admin. R. 855-041-1040 Outlet: Policies and Procedures

(1) The drug outlet pharmacy and its Pharmacist in Charge is accountable for establishing, maintaining, and enforcing written policies and procedures for the drug outlet pharmacy in compliance with federal and state regulations. The written policies and procedures must be maintained at the drug outlet pharmacy and must be available to the board upon request.

(2) The written policies and procedures must include at a minimum the responsibilities of the drug outlet pharmacy including;

(a) Security;

(b) Operation, testing and maintenance of pharmacy systems and equipment;

(d) Storage of drugs;

(e) Dispensing;

(f) Pharmacist supervision, direction and control of non-Pharmacists;

(g) Documenting the date, time and identification of the licensee and the specific activity or function of the person performing each step in the dispensing process;

(h) Utilization of Certified Oregon Pharmacy Technicians or Pharmacy Technicians;

(i) Certified Oregon Pharmacy Technician or Pharmacy Technician final verification and/or vaccination, if utilized;

(j) Drug and/or device procurement;

(k) Receiving of drugs and/or devices;

(l) Disposal of drugs and/or devices including hazardous and pharmaceutical waste;

(m) Delivery of drugs and/or devices;

(n) Utilization of Oregon licensed Pharmacist (i.e. DUR, Counseling);

(o) Recordkeeping;

(p) Patient confidentiality;

(q) Continuous quality improvement;

(r) Plan for discontinuing and recovering services in the event of a pharmacy closure;

(s) Training: initial and ongoing; and

(t) Interpretation, translation and prescription reader services.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.508 & 2022 HB 4034
BP 28-2023, amend filed 12/19/2023, effective 01/01/2024
BP 28-2022, amend filed 06/15/2022, effective 06/16/2022
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
BP 99-2020, amend filed 12/23/2020, effective 01/01/2021
BP 5-2018, amend filed 10/18/2018, effective 10/18/2018
Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2008, f. & cert. ef. 2-20-08
BP 3-2005, f. & cert. ef. 4-14-05
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1045 Returned Drugs and Devices

(1) Pharmacists, pharmacy technicians, certified Oregon pharmacy technicians and interns may not accept the return of controlled substances.

(2) Pharmacists, pharmacies, pharmacy technicians, certified Oregon pharmacy technicians and interns may accept the return of drugs or devices as defined by ORS 689.005 once the drugs or devices have been removed from the pharmacy only if;

(a) The drugs or devices are accepted for destruction or disposal and;

(b) The drugs or devices were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, were unable to be delivered to the patient, or are subject of a drug or device recall; or

(c) After consultation, a pharmacist determines that, in the pharmacist’s professional judgment, harm could result to the public or a patient if the drugs or devices were not accepted for return.

(3) Not withstanding (2) of this rule, drugs or devices previously dispensed or distributed may be returned and redispensed or redistributed provided all the following conditions are met:

(a) The drug is in an unopened, tamper-evident unit;

(b) The drugs or devices have remained at all times in control of a person trained and knowledgeable in the storage and administration of drugs in long term care facilities or supervised living groups using the services of a consultant pharmacist;

(c) The drug or device has not been adulterated or misbranded and has been stored according to the manufacturer recommendations.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 17-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2017, f. & cert. ef. 2-23-17
BP 7-2012, f. & cert. ef. 12-17-12, Renumbered from 855-041-0080
BP 2-2006, f. & cert. ef. 6-9-06
PB 8-1990, f. & cert. ef. 12-5-90
PB 5-1989, f. & cert. ef. 1-30-89
1PB 2-1981, f. & cert. ef. 8-20-81
1PB 1-1981(Temp), f. & ef. 4-1-81
1PB 2-1980, f. & cert. ef. 4-3-80
1PB 2-1979(Temp), f. & cert. ef. 10-3-79

Or. Admin. R. 855-041-1046 Secure and Responsible Drug Disposal

(1) A pharmacy that operates a drug take back collection program or that participates in a drug take-back program under ORS 459A.200 to ORS 459A.266 as an authorized collector must be registered with the DEA as an authorized collector to collect controlled and non-controlled drugs for destruction.

(2) A pharmacy that operates as a Drug Enforcement Agency (DEA) authorized collector must notify the board within 30 days of initiating or terminating the program and must establish and enforce policies and procedures, including but not limited to:

(a) Provision of a secure location of the collection receptacle inside the retail drug outlet, which is accessible to the public, within view of the pharmacy counter and must not be located behind the pharmacy counter; and

(b) Provision of adequate security measures, including proper installation and maintenance of the collection receptacle, tracking of liners, documentation, and key accountability; and

(3) A pharmacy must inform consumers to directly deposit drugs into the collection receptacle. Pharmacy personnel must not count, sort, inventory, or otherwise handle drugs collected.

(4) A pharmacy must not dispose of drugs from pharmacy stock in a collection receptacle.

(5) The liner must be inserted and removed from a locked collection receptacle only by or under the supervision of two employees of the pharmacy. Upon removal, the liner must be immediately sealed, and the pharmacy employees must document their participation in the insertion and removal of each liner from a collection receptacle on a log. Sealed liners must not be opened, analyzed, or penetrated at any time by the pharmacy or pharmacy personnel.

(6) Liners that have been removed from a collection receptacle and immediately sealed must be directly transferred, or otherwise stored in a secured, locked location in the pharmacy for no longer than 14 days prior to being transferred, by two pharmacy personnel to a registered drug distribution agent (such as registered UPS, FedEx, or USPS) or a reverse wholesaler registered with the DEA and the board.

(7) Any tampering with a collection receptacle, liner or theft of deposited drugs must be reported to the board in writing within one day of discovery.

(8) A pharmacy must maintain all drug disposal records for a minimum of 3 years.

(9) Authorized collectors are required to comply with the following federal and state laws:

(a) ORS 459A.200, ORS 459A.203, ORS 459A.206, ORS 459A.209, ORS 459A.212, ORS 459A.215, ORS 459A.218, ORS 459A.221, ORS 459A.224, ORS 459A.227, ORS 459A.230, ORS 459A.233, ORS 459A.236, ORS 459A.239, ORS 459A.242, ORS 459A.245, ORS 459A.248, ORS 459A.251, ORS 459A.254, ORS 459A.257, ORS 459A.260, ORS 459A.263, and ORS 459A.266;

(b) OAR 340-098-0000, OAR 340-098-0010, OAR 340-098-0300, OAR 340-098-0350, OAR 340-098-0370, and OAR 340-098-0390;

(c) 21 CFR 1317.30 (v. 04/01/2025), 21 CFR 1317.35 (v. 04/01/2025), 21 CFR 1317.40 (v. 04/01/2025), 21 CFR 1317.55 (v. 04/01/2025), 21 CFR 1317.60 (v. 04/01/2025), 21 CFR 1317.65 (v. 04/01/2025), 21 CFR 1317.70 (v. 04/01/2025), 21 CFR 1317.75 (v. 04/01/2025), 21 CFR 1317.80 (v. 04/01/2025), and 21 CFR 1317.85 (v. 04/01/2025); and

(d) 21 USC 822 (v. 02/26/2026) and 21 USC 822a (v. 02/26/2026).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205 & ORS 459A.266
Statutes/Other Implemented: ORS 689.305, ORS 459A.203, ORS 459A.215 & ORS 495A.218
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 17-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2017, f. & cert. ef. 2-23-17

Or. Admin. R. 855-041-1050 Pharmacy Depots

(1) Except when delivering directly to a patient, licensed pharmacists may not participate in the transfer of completed prescription medication containers to or from any location that is not a licensed pharmacy, unless the transfer occurs to:

(a) The office of the patient’s health care practitioner; or

(b) The location of the patient; or

(A) Patient’s primary residence; or

(B) Alternate residence designated by the patient; or

(2) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689
Renumbered from 855-041-0095, BP 7-2012, f. & cert. ef. 12-17-12
BP 1-2012, f. 4-26-12, cert. ef. 5-1-12
BP 9-2011, f. 12-30-11, cert. ef. 1-1-12
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1055 Prohibited Practices: Disclosure of Patient Information

A Retail Drug Outlet or Institutional Drug Outlet:

(1) May not allow a licensee or registrant of the board who obtains any patient information to disclose that information to a third party without the consent of the patient except as provided in (a)-(e) of this rule. A licensee may disclose patient information:

(a) To the board;

(b) To a practitioner, Oregon licensed Pharmacist, Intern, Pharmacy Technician, or Certified Oregon Pharmacy Technician, if disclosure is authorized by an Oregon licensed Pharmacist who reasonably believes that disclosure is necessary to protect the patient's health or wellbeing; or

(d) As permitted pursuant to federal and state patient confidentiality laws; or

(e) To the patient or to persons as authorized by the patient.

(2) May not allow a licensee or registrant of the board to access or obtain any patient information unless it is accessed or obtained for the purpose of patient care except as provided in (1)(a)-(e) of this rule.

History

Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 22-2022, amend filed 04/20/2022, effective 04/20/2022
Renumbered from 855-041-0103, BP 7-2012, f. & cert. ef. 12-17-12
PB 5-1992, f. & cert. ef. 10-23-92

Or. Admin. R. 855-041-1060 Non-Resident Pharmacies

(1) For the purpose of these rules, a non-resident pharmacy is any establishment located out of Oregon that engages in the dispensing, delivery or distribution of drugs to Oregon. A non-resident pharmacy also includes entities that provide pharmacy services to Oregon, such as drugless/consulting outlets, even if the entity is not dispensing, delivering or distributing drugs into Oregon.

(2) Every non-resident pharmacy that provides drugs, devices or services to a person in Oregon must be registered with the Oregon Board of Pharmacy.

(3) To qualify for registration under these rules, every non-resident pharmacy must be registered with the Board of Pharmacy in the state where the pharmacy is physically located.

(4) Every non-resident pharmacy must designate an Oregon licensed Pharmacist-in-Charge (PIC), who must be responsible for all pharmacy services provided to residents in Oregon, and to provide supervision and control in the pharmacy. To qualify for this designation, the person must:

(a) Hold a license to practice pharmacy in the resident state;

(b) Be normally present in the pharmacy for a minimum of 20 hours per week;

(c) Annually complete a self-inspection form using the board's Non-Resident Retail Drug Outlet Self-Inspection Form prior to July 1; and

(d) Provide the PIC Self-Inspection Form as requested by the board.

(5) Every non-resident pharmacy will have a pharmacist-in-charge (PIC) who is licensed in Oregon within four months of initial licensure of the pharmacy.

(6) When a change of Pharmacist-in-Charge (PIC) occurs, the non-resident pharmacy will notify the board within ten business days and identify a contact person. The pharmacy will have an Oregon licensed PIC employed within 90 days. The contact person must be a licensed pharmacist in the pharmacy’s state of residence and is responsible for the following:

(a) Supervision of pharmacy staff and ensuring compliance with laws and rules; and

(b) Responding to board correspondence and inquiries.

(7) A new Pharmacist-in-Charge must be appointed, and communication made to the board within 90 days, or the non-resident pharmacy will cease drug distribution and provision of pharmacy services in Oregon.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.225
BP 34-2023, amend filed 12/19/2023, effective 03/01/2024
BP 12-2023, amend filed 06/13/2023, effective 08/01/2023
BP 37-2021, amend filed 12/16/2021, effective 12/16/2021
BP 4-2015, f. & cert. ef. 7-1-15
Renumbered from 855-041-0300, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2008, f. & cert. ef. 2-20-08
PB 1-1994, f. & cert. ef. 2-2-94

Or. Admin. R. 855-041-1080 Pharmacy Registration (Both Retail and Institutional Drug Outlets)

(1) Pharmacies must be registered as either retail drug outlets or institutional drug outlets or both.

(2) An application for registration of a new pharmacy must be accompanied by a floor plan drawn to scale and must be approved by the board prior to opening.

(3) The application must specify the location of the pharmacy and must indicate the owner, trustee, receiver, or other person applying for the registration. When an applicant is not the owner of the pharmacy, the application must indicate the owner and the applicant's affiliation with the owner:

(a) If the owner is a partnership or other multiple owner, the names of the partners or persons holding the five largest interests must be indicated on the application;

(b) If the owner is a corporation, the name filed must be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests must be indicated on the application.

(4) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

(5) The application must also identify any person who has incidents of ownership in the pharmacy who also has financial interest in any long-term care facility as defined in ORS 442.015.

(6) A certificate of registration will be issued upon board approval of the application.

(7) All registration renewal applications must be accompanied by the annual fee and must contain the same information required in sections (3) and (4) of this rule.

(8) The initial and annual registration fee for pharmacies is set out in OAR 855-110.

(9) Pharmacy registration expires March 31, annually. If the annual registration fee referred to in OAR 855-110 is not paid by March 31 of the current year, a late fee as set out in OAR 855-110 must be included with the application for registration renewal.

(10) The registration is not transferable and the registration fee cannot be prorated.

(11) A change of ownership requires the approval of the board and new certificate of registration. Application must be on a form supplied by the board.

(12) A change of ownership includes any change in the legal form of the business including additions or deletions of partners.

(13) Applicants for change in ownership must provide the board with the information required in sections (3), (4), and (5) of this rule.

(14) A change of ownership must be reported to the board 15 days prior to occurrence.

(15) No pharmacy may be operated until a certificate of registration has been issued to the pharmacy by the board.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
Renumbered from 855-041-0005, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1994, f. & cert. ef. 2-2-94
PB 4-1992, f. & cert. ef. 8-25-92
PB 5-1990, f. & cert. ef. 4-12-90
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1085 Change of Location of a Pharmacy (Both Retail and Institutional Drug Outlets)

(1) A change of location of a pharmacy requires the approval of the Board and a new certificate of registration.

(2) Application for approval to relocate shall be on a form provided by the Board and shall be accompanied by fees and a floor plan drawn to scale.

(3) A certificate of registration will be issued upon Board approval of the application.

(4) Following Board approval, a change of location, shall be reported to the Board within 15 days of the occurrence.

(5) No pharmacy shall be operated until a certificate of registration has been issued to the pharmacy by the Board.

History

Statutory/Other Authority: ORS 475.035 & 689.205
Renumbered from 855-041-0010, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1994, f. & cert. ef. 2-2-94
PB 5-1990, f. & cert. ef. 4-12-90
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1090 Registration: Change of Business Name (Both Retail and Institutional Drug Outlets)

A pharmacy must notify the board a minimum of 15 days prior to any change of business name of a pharmacy. The change must be reported by filing a new application for which no fee is required.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.205
BP 32-2022, amend filed 06/15/2022, effective 06/16/2022
BP 10-2022, temporary amend filed 02/16/2022, effective 02/16/2022 through 06/07/2022
Renumbered from 855-041-0015, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1092 Retail Drug Outlet Pharmacy Closures: Temporary, Permanent or Emergency

(1) Temporary Closing. Unless subject to an exemption in OAR 855-041-1092(3), when a Retail Drug Outlet pharmacy is temporarily closed to the public the pharmacy must:

(a) Post notification of closure on each pharmacy entrance as soon as the need to deviate from the posted hours is known by the pharmacy, but no later than 2 hours after the temporary closure begins. The posting must include:

(A) Estimated period of time the pharmacy will be closed; and

(B) Options for prescription pick-up (e.g. another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).

(b) Post notification of closure on each telephone greeting and pharmacy operated internet (e.g. website, social media, mobile applications) as soon as possible. The posting must include:

(A) Estimated period of time the pharmacy will be closed; and

(B) Options for prescription pick-up (e.g. another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).

(c) If the pharmacy is temporarily closed greater than 2 consecutive business days, notify the board office as soon as possible but no later than 72 hours after the temporary closure begins with the date and time the closure began, anticipated date and time of re-opening, and the reason for the temporary closure.

(d) Federal and state holidays are exempt from the requirements of (1).

(2) Permanent Closing. If a Retail Drug Outlet pharmacy is permanently closing to the public, the pharmacy must:

(a) Prior to closing, the pharmacy must comply with the following:

(A) Provide notification to each patient who has filled a prescription within the previous 12 months. This notification must be made a minimum of 15 calendar days prior to closing and must include:

(i) The last day the pharmacy will be open;

(ii) Name, address and telephone number of the pharmacy that will take possession of the pharmacy records or the person who will serve as the custodian of records;

(iii) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(iv) The last day a transfer may be initiated.

(B) The notification must be made via:

(i) Distribution by direct mail or written notice with each prescription dispensed;

(ii) Public notice in a newspaper of general circulation, if available, in the area served by the pharmacy; and

(iii) Posting a closing notice on each pharmacy entrance, on each telephone greeting, and pharmacy-operated internet (e.g. website, social media, mobile applications).

(iv) In addition to (i), (ii) and (iii), the pharmacy may also provide notification via email or text.

(C) Provide any new patients filling prescriptions during the 15 calendar day period prior to the pharmacy closing with written notification that includes:

(i) The last day the pharmacy will be open;

(ii) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the person who will serve as the custodian of pharmacy records;

(iii) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(iv) The last day a transfer may be initiated.

(D) Notify DEA of any controlled substances being transferred to another registrant as specified in 21 CFR 1301.52 (v. 04/01/2025).

(b) On the date of closing or up to 24 hours after the permanent closure begins, the Pharmacist-in-charge must comply with the following:

(A) Complete and document an inventory of all controlled substances.

(B) If the pharmacy dispenses prescriptions:

(i) Transfer the prescription drug order files, including refill information, and patient medication records to a licensed pharmacy or to an Oregon licensed Pharmacist who will serve as the custodian of records;

(ii) Update the pharmacy operating status with each electronic prescribing vendor; and

(iii) Remove all signs and symbols indicating the presence of the pharmacy including pharmacy-operated internet (e.g. website, social media, mobile applications).

(A) Complete and document an inventory of all non-controlled drugs and devices.

(B) Remove all prescription and non-prescription drugs, devices, and related supplies from the pharmacy by one or a combination of the following methods:

(i) Return to manufacturer or supplier (credit or disposal);

(ii) Transfer (sell or give away) to a licensed healthcare professional or outlet who is legally authorized to possess drugs; or

(iii) Destroy and document the destruction by two board licensees. For controlled substances, the registrant must comply with 21 CFR 1304.21 (v. 04/01/2025), 21 CFR 1304.22 (v. 04/01/2025), 21 CFR 1317.05 (v. 04/01/2025), 21 CFR 1317.90 (v. 04/01/2025) and 21 CFR 1317.95 (v. 04/01/2025).

(C) Provide the board a written notice of the closing on a board prescribed form which includes the following information:

(i) Date of closing to the public and discontinuance of the business;

(ii) Date and time the inventory of all prescription drugs and devices was conducted;

(iii) Name, address, phone number and applicable registration number where all legend and controlled substances possessed by the pharmacy were transferred or disposed;

(iv) If drugs were destroyed, name and license numbers of individuals that who witnessed the destruction;

(v) If the pharmacy is registered to possess controlled substances, confirmation that the pharmacy complied with all applicable federal requirements in 21 CFR 1301.52 (v. 04/01/2025) for discontinuing operation as a pharmacy that dispenses controlled substances.

(vi) The name, address and phone number of the pharmacy that took possession of the pharmacy records or the Oregon licensed Pharmacist who is serve as the custodian of pharmacy records which must be maintained according to OAR 855-041-1160;

(vii) Confirmation all pharmacy labels and blank prescriptions were destroyed;

(viii) Confirmation all signs and symbols indicating the presence of the pharmacy including pharmacy-operated internet (e.g. website, social media, mobile applications) have been removed; and

(ix) Confirmation that each registration certificate issued to the pharmacy by the board has been mailed to the board office.

(D) Once the pharmacy has notified the board that the pharmacy is permanently closed, the license may not be renewed. The pharmacy may apply for a new license as specified in OAR 855-041-1080.

(E) Unless a registration has expired, the registration will remain active until the board has notified the registrant that the notice of permanent closure has been received and the registration has been lapsed.

(3) Emergency closing. If a Retail Drug Outlet pharmacy is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, inclement weather, or other emergency circumstances and the Pharmacist-in-charge cannot provide notification as required in (1), the Pharmacist-in-charge must comply with the provisions of (1) as far in advance or as soon after the closing as allowed by the circumstances.

(4) Non-resident Retail Drug Outlet pharmacies are exempt from (1)-(3) and must follow laws and rules in the pharmacy's state of residence pertaining to temporary, permanent and emergency closures. The non-resident pharmacy must provide the board a written notice of the closing within 30 calendar days on a form prescribed by the board which includes the following information:

(a) Date of closing to the public and discontinuance of the business;

(b) If the pharmacy dispenses prescriptions, the name, address and phone number of the pharmacy or Oregon licensed Pharmacist who will serve as the custodian of records for Oregon patients to which the prescriptions, including refill information, and patient medication records were transferred; and

(c) Confirmation that each registration certificate issued to the pharmacy by the board has been mailed to the board office.

(5) The board may conduct an inspection to verify all requirements in subsection (1), (2), (3) and (4) of this section have been completed.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205 & ORS 475.035
Statutes/Other Implemented: ORS 689.205
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 32-2022, amend filed 06/15/2022, effective 06/16/2022
BP 19-2022, adopt filed 04/20/2022, effective 04/20/2022
BP 10-2022, temporary adopt filed 02/16/2022, effective 02/16/2022 through 06/07/2022
BP 33-2021, temporary adopt filed 12/10/2021, effective 12/10/2021 through 06/07/2022

Or. Admin. R. 855-041-1095 Pharmacy Advertising

No person shall advertise or otherwise purport to operate as a pharmacy or to advertise or purport to provide pharmacy services unless the person is registered with the Board pursuant to ORS 689.305.

History

Statutory/Other Authority: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Renumbered from 855-041-0017, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)

Or. Admin. R. 855-041-1105 Prescriptions: General Requirements

Each Drug Outlet Pharmacy must ensure that:

(1) Prescriptions, prescription refills, and drug orders are dispensed:

(a) Accurately;

(b) To the correct party;

(d) Pursuant to a valid patient-practitioner relationship;

(e) For a legitimate medical purpose; and

(f) In accordance with the prescribing practitioner's authorization.

(2) The following information is required for each new or refilled prescription drug or device:

(a) The name and date of birth of the patient for whom the drug is prescribed, unless for an animal. If for an animal, the name of the patient, name of the owner and the species of the animal;

(b) The full name and contact phone number of the prescriber and, in the case of controlled substances, the address and the Drug Enforcement Administration registration number of the practitioner;

(c) The name, strength, dosage form of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed;

(d) The directions for use;

(e) The date of issuance and, if different from the date of issuance, the date of filling;

(f) The total number of refills authorized by the prescribing practitioner;

(g) A valid signature:

(A) For non-controlled substances:

(i) Received by the pharmacy via a hard-copy written prescription, the prescribing practitioner or practitioner’s agent manual signature.

(ii) Received by the pharmacy via facsimile, the prescribing practitioner or practitioner’s agent manual or electronic signature.

(iii) Received by the pharmacy electronically, the prescribing practitioner's or practitioner’s agent electronic signature.

(B) For controlled substances:

(i) Received by the pharmacy via hard-copy written prescription, the prescription must have an original manually signed signature from the prescribing practitioner.

(ii) Received by the pharmacy via facsimile, the prescription must have an original manually signed signature from the prescribing practitioner.

(iii) Received by the pharmacy electronically, the prescribing practitioner’s digital signature that complies with the rules adopted by reference in OAR 855-080.

(C) In (g), manually signed specifically excludes a signature stamp or any form of electronic or digital signature unless permitted under federal regulations; and

(h) Any other information required for controlled substances pursuant to federal regulations.

(3) An oral prescription must be promptly reduced to writing or entered into an electronic record system and must include:

(a) The name, initials or electronic identifier of the licensee receiving the prescription;

(b) The name of the person transmitting the prescription.

(4) The prescription contains all of the information specified in (2) and for controlled substances in OAR 855-080-0085.

(5) In accordance with ORS 689.515(3) and ORS 689.522, the pharmacy dispenses the prescription pursuant to the prescribing practitioner's request that there may be no substitution for the specified brand name of a drug.

(a) For a hard copy prescription issued in writing or a prescription orally communicated over the telephone, instruction may use any one of the following phrases or notations:

(A) No substitution;

(B) N.S.;

(D) Brand necessary;

(E) Medically necessary;

(F) D.A.W. (Dispense As Written); or

(G) Words with similar meaning.

(b) For an electronically transmitted prescription, the prescriber or prescriber’s agent must clearly indicate substitution instructions by way of the text (without quotes) “brand medically necessary” or words with similar meaning, in the electronic prescription drug order, as well as all relevant electronic indicators sent as part of the electronic prescription transmission.

(6) The written or electronic record of each prescription must be retained on file as required by OAR 855-041-1160, and in the case of controlled substances, under rules adopted by reference in OAR 855-080.

(7) If the patient is relying on a standing order prescription issued by the Public Health Officer appointed under ORS 431.045, or a physician licensed under ORS chapter 677 who is employed by the Oregon Health Authority, to obtain a drug or device, the drug outlet does not need to ensure that:

(a) There is a patient-practitioner relationship as required in subsection (1)(e)(D) of this rule; and

(b) The prescription contains the name and date of birth of the patient for whom the drug is prescribed.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.522
Statutes/Other Implemented: ORS 689.505, ORS 689.515 & ORS 689.522
BP 16-2025, amend filed 12/16/2025, effective 12/16/2025
BP 34-2023, amend filed 12/19/2023, effective 03/01/2024
BP 2-2014, f. & cert. ef. 1-24-14
Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12
BP 12-2010, f. & cert. ef. 12-23-10
BP 1-2003, f. & cert. ef. 1-14-03
BP 1-2002, f. & cert. ef. 1-8-02
BP 6-2000, f. & cert. ef. 6-29-00
BP 3-2000, f. & cert. ef. 2-16-00
BP 2-2000, f. & cert. ef. 2-16-00
Reverted to BP 2-1998, f. & cert. ef. 3-23-98
BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00
BP 2-1998, f. & cert. ef. 3-23-98
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98
PB 3-1997(Temp), f. & cert. ef. 11-12-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1995, f. & cert. ef. 4-27-95
PB 4-1992, f. & cert. ef. 8-25-92
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 4-1991, f. & cert. ef. 9-19-91
PB 1-1991, f. & cert. ef. 1-24-91
PB 10-1989, f. & cert. ef. 7-20-89
PB 8-1987, f. & ef. 9-30-87
1PB 1-1986, f. & ef. 6-5-86
1PB 3-1984, f. & ef. 4-16-84
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1110 Tamper-resistant Prescription

When the use of a tamper-resistant prescription is required by any federal or state law or rule, the term “tamper-resistant” shall have the meaning as defined in OAR 855-006-0005.

History

Statutory/Other Authority: 689.205
Statutes/Other Implemented: ORS 689.155
BP 42-2024, minor correction filed 04/10/2024, effective 04/10/2024
Renumbered from 855-041-0061, BP 7-2012, f. & cert. ef. 12-17-12
BP 1-2008, f. & cert. ef. 2-5-08
BP 2-2007(Temp), f. & cert. ef. 8-27-07 thru 2-18-08

Or. Admin. R. 855-041-1115 Verification of Prescription Authenticity

Alteration of a written prescription, other than by a pharmacist's or practitioner's authorization, in any manner constitutes an invalid order unless verified with the prescriber.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, 689.155 & 689.508
Renumbered from 855-041-0086, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2008, f. & cert. ef. 2-20-08
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1120 Prescription Refills

(1) Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber's agent must be recorded. This documentation must be readily retrievable. Prescriptions for controlled substances in Schedules III and IV are limited to five refills or six months from date of issue, whichever comes first.

(2) If the practitioner is not available and in the professional judgment of the pharmacist an emergency need for the refill of a prescription drug has been demonstrated, the pharmacist may dispense a sufficient quantity of the drug consistent with the dosage regimen, provided it is not a controlled substance, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. The practitioner shall be promptly notified of the emergency refill.

(3) Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years. This record must include;

(a) The identity of the responsible pharmacist;

(b) Name of the patient;

(d) Date of refill; and

(e) Quantity dispensed.

(4) Refill quantities may be combined into a single filling if the prescription is not for a controlled substance or psychotherapeutic drug and the prescriber is notified of the change.

(5) A retail pharmacy may only dispense a prescription refill upon request of the patient or patient’s agent. A request specific to each prescription medication is required, unless the requested fill or refill is part of an auto-refill program and is a continuation of therapy.

(6) Auto-Refill Programs. A mail order or retail pharmacy, excluding cycle-fill for long term care, may use a program that automatically refills non-controlled prescription medications, that have existing refills available and are consistent with the patient’s current medication therapy only when the following conditions are met:

(a) A patient or patient’s agent must enroll each prescription medication in an auto-refill program before a pharmacy can include the prescription medication as part of the auto-refill program; and

(b) The prescription is not a controlled substance; and

(d) Pick-up notification to a patient or patient’s agent may be generated upon completion of a prescription refill; and

(e) When an auto-refill prescription is returned to stock or when delivery is refused that prescription medication is removed from the auto-refill program for that patient.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & ORS 689.515
BP 4-2018, amend filed 10/18/2018, effective 11/01/2018
BP 3-2018, temporary amend filed 07/16/2018, effective 07/17/2018 through 01/11/2019
BP 3-2017, f. 6-30-17, cert. ef. 7-1-17
BP 9-2015, f. 12-23-15, cert. ef. 7-1-16
BP 12-2014, f. 12-30-14, cert. ef. 1-1-16
Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12
BP 12-2010, f. & cert. ef. 12-23-10
BP 1-2003, f. & cert. ef. 1-14-03
BP 1-2002, f. & cert. ef. 1-8-02
BP 6-2000, f. & cert. ef. 6-29-00
BP 3-2000, f. & cert. ef. 2-16-00
BP 2-2000, f. & cert. ef. 2-16-00
Reverted to BP 2-1998, f. & cert. ef. 3-23-98
BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00
BP 2-1998, f. & cert. ef. 3-23-98
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98
PB 3-1997(Temp), f. & cert. ef. 11-12-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1995, f. & cert. ef. 4-27-95
PB 4-1992, f. & cert. ef. 8-25-92
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 4-1991, f. & cert. ef. 9-19-91
PB 1-1991, f. & cert. ef. 1-24-91
PB 10-1989, f. & cert. ef. 7-20-89
PB 8-1987, f. & ef. 9-30-87
1PB 1-1986, f. & ef. 6-5-86
1PB 3-1984, f. & ef. 4-16-84
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1125 Prescription Expiration

This section of rule addresses the expiration date of the prescription and not the expiration date of the drug.

(1) After one year from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber.

(2) When used alone as a prescription refill designation the abbreviation, "PRN" for a non-controlled substance means that the medication can be refilled in proper context for a period of one year.

(a) When this abbreviation is used alone as a means to authorize refills for a controlled substance, the medication can be refilled in proper context for a period of six months or five refills, whichever comes first.

(b) When this abbreviation is used in conjunction with a definite time period, or a specific number of refills, the non-controlled medication can be refilled in proper context for a period not to exceed one year.

(3) The prescription shall not be refilled out of context with the approximate dosage schedule unless specifically authorized by the prescriber.

(4) A "non-controlled substance" means those drugs defined as "legend" pursuant to ORS 689.005 but does not include those drugs or substances controlled under the jurisdiction of the United States Department of Justice Drug Enforcement Administration.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & 689.515
BP 47-2024, minor correction filed 04/11/2024, effective 04/11/2024
Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12
BP 12-2010, f. & cert. ef. 12-23-10
BP 1-2003, f. & cert. ef. 1-14-03
BP 1-2002, f. & cert. ef. 1-8-02
BP 6-2000, f. & cert. ef. 6-29-00
BP 3-2000, f. & cert. ef. 2-16-00
BP 2-2000, f. & cert. ef. 2-16-00
Reverted to BP 2-1998, f. & cert. ef. 3-23-98
BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00
BP 2-1998, f. & cert. ef. 3-23-98
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98
PB 3-1997(Temp), f. & cert. ef. 11-12-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1995, f. & cert. ef. 4-27-95
PB 4-1992, f. & cert. ef. 8-25-92
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 4-1991, f. & cert. ef. 9-19-91
PB 1-1991, f. & cert. ef. 1-24-91
PB 10-1989, f. & cert. ef. 7-20-89
PB 8-1987, f. & ef. 9-30-87
1PB 1-1986, f. & ef. 6-5-86
1PB 3-1984, f. & ef. 4-16-84
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1130 Retail Drug Outlet Pharmacy Prescription Labeling

Except as described in SB 450 (2023), prescriptions must be labeled with the following information:

(1) Name, address and telephone number of the pharmacy;

(2) Date of fill;

(3) Identifying number;

(4) Name of patient;

(5) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(6) Directions for use by the patient;

(7) Name of practitioner;

(8) Required precautionary information regarding controlled substances;

(9) Such other and further accessory cautionary information as required for patient safety;

(10) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must not exceed:

(a) That on the manufacturer’s container if dispensed in the manufacturer’s container; or

(b) The earliest date of either:

(A) The manufacturer’s expiration date; or

(B) One year from the date the drug was repackaged and dispensed.

(11) Any drug expiring before the expected length of time for the course of therapy must not be dispensed.

(12) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505, ORS 689.515 & 2023 SB 450
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
BP 49-2022, amend filed 12/20/2022, effective 12/21/2022
BP 45-2022, temporary amend filed 10/17/2022, effective 10/17/2022 through 04/14/2023
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
Renumbered from 855-041-0065, BP 7-2012, f. & cert. ef. 12-17-12
BP 12-2010, f. & cert. ef. 12-23-10
BP 1-2003, f. & cert. ef. 1-14-03
BP 1-2002, f. & cert. ef. 1-8-02
BP 6-2000, f. & cert. ef. 6-29-00
BP 3-2000, f. & cert. ef. 2-16-00
BP 2-2000, f. & cert. ef. 2-16-00
Reverted to BP 2-1998, f. & cert. ef. 3-23-98
BP 2-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00
BP 2-1998, f. & cert. ef. 3-23-98
BP 1-1998(Temp), f. & cert. ef. 1-27-98 thru 5-4-98
PB 3-1997(Temp), f. & cert. ef. 11-12-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1995, f. & cert. ef. 4-27-95
PB 4-1992, f. & cert. ef. 8-25-92
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 4-1991, f. & cert. ef. 9-19-91
PB 1-1991, f. & cert. ef. 1-24-91
PB 10-1989, f. & cert. ef. 7-20-89
PB 8-1987, f. & ef. 9-30-87
1PB 1-1986, f. & ef. 6-5-86
1PB 3-1984, f. & ef. 4-16-84
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1131 Prescription Reader Accessibility

A pharmacy shall notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information. A pharmacy that provides a prescription reader shall make it available to the person for at least the duration of the prescription, shall confirm it is appropriate to address the person’s visual impairment, and shall ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.561
BP 8-2020, adopt filed 06/22/2020, effective 06/23/2020
BP 8-2019, temporary adopt filed 12/17/2019, effective 01/01/2020 through 06/28/2020

Or. Admin. R. 855-041-1132 Limited English Proficiency and Accessibility

(1) Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by a pharmacy for a patient’s self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

(2) When dispensing a drug under (1), a pharmacy must provide labels and informational inserts in both English and one of the following languages:

(a) Spanish;

(b) Russian;

(d) Arabic;

(e) Chinese (simplified);

(f) Vietnamese;

(g) Farsi;

(h) Korean;

(i) Romanian;

(j) Swahili;

(k) Burmese;

(l) Nepali;

(m) Amharic; and

(n) Pashtu.

(3) The board must reassess and update (2) as necessary and at least every ten years.

History

Statutory/Other Authority: ORS 689.564
Statutes/Other Implemented: ORS 689.205
BP 99-2020, adopt filed 12/23/2020, effective 01/01/2021

Or. Admin. R. 855-041-1133 Dispensing: Interpretation

(1) Except as provided in subsection (2) of this section, a Pharmacist or Intern must work with a health care interpreter from the health care interpreter registry administered by the Oregon Health Authority under ORS 413.558 when communicating with a patient who prefers to communicate in a language other than English or who communicates in signed language, unless the Pharmacist is proficient in the preferred language of the person with limited English proficiency. The Pharmacist or drug outlet may not charge for these services.

(2) A Pharmacist or Intern who is otherwise required to work with a health care interpreter from the health care interpreter registry may work with a health care interpreter who is not listed on the health care interpreter registry only if the Pharmacist or Intern:

(a) Verifies that the Pharmacist or Intern has made a good faith effort needed to obtain a health care interpreter from the health care interpreter registry in accordance with rules adopted by the authority under ORS 413.558 and has found that none are available to provide interpretation; or

(b) Has offered the patient the services of a health care interpreter from the health care interpreter registry and the patient declined the offer and chose a different interpreter.

(3) A Pharmacist or Intern must provide personal protective equipment, consistent with established national standards, to health care interpreters providing services on-site at no cost to the health care interpreter and may not suggest to the health care interpreter that the health care interpreter should procure the health care interpreter’s own personal protective equipment as a condition of working with the Pharmacist or Intern.

(4) A Pharmacist or Intern must maintain records of:

(a) Each patient encounter in which the Pharmacist or Intern worked with a health care interpreter from the health care interpreter registry; or

(b) Each good faith effort to utilize a health care interpreter from the health care registry for each patient encounter in which the Pharmacist or Intern worked with an interpreter not on the health care interpreter registry and met one of the exceptions in (2) of this rule.

(5) The records required in (4) must include:

(a) The full name of the health care interpreter;

(b) The health care interpreter’s registry number, if applicable; and

(6) Pharmacists, Interns, Certified Oregon Pharmacy Technicians, Pharmacy Technicians and Pharmacies are required to comply with ORS 413.559.

History

Statutory/Other Authority: ORS 689.205 & 2021 HB 2359
Statutes/Other Implemented: ORS 689.155 & 2021 HB 2359
BP 29-2022, adopt filed 06/15/2022, effective 09/01/2022

Or. Admin. R. 855-041-1135 Defines Labeling and Container Requirements for Repackage Drugs

(1) Drugs prepackaged by a pharmacy for later own use dispensing on prescription shall be in a container meeting USP standards and labeled to identify at a minimum:

(a) Brand name, or generic name and manufacturer;

(b) Strength;

(d) Manufacturer’s expiration date, or any earlier date which, in the pharmacist’s professional judgment, is preferable.

(2) An internal control number which references manufacturer and lot number may be utilized.

History

Statutory/Other Authority: ORS 689
Renumbered from 855-041-0056, BP 7-2012, f. & cert. ef. 12-17-12
PB 6-1987, f. & ef. 5-1-87

Or. Admin. R. 855-041-1140 Customized Patient Medication Packages

In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient’s caregiver, or a prescriber, provide a customized patient medication package (patient med pak). A patient med pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed for each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken:

(1) Label:

(a) The patient med pak shall bear a label stating:

(A) The name of the patient;

(B) A serial number for each patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;

(C) The name, strength, physical description or identification, and total quantity of each drug product contained therein;

(D) The directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;

(E) Any storage instructions or cautionary statements required by the official compedia;

(F) The name of the prescriber of each drug product;

(G) The date of preparation of the patient med pak and the beyond-use date assigned to the patient med pak (such beyond-use date shall be no later than 60 days from the date of preparation);

(H) The name, address, and telephone number of the dispenser and the dispenser’s registration number where necessary; and

(I) Any other information, statements, or warnings required for any of the drug products contained therein.

(b) If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug products contained therein.

(2) Labeling: The patient med pak shall be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med pak.

(3) Packaging:

(a) In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak shall comply with the moisture permeation requirements for a Class B single-unit or unit-dose container. Each container shall be either not reclosable or so designed as to show evidence of having been opened;

(b) There is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards shall be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, shall be obtained.

(4) Guidelines: It is the responsibility of the dispenser, when preparing a patient med pak, to take into account any applicable compendia requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the medications. In this regard, pharmacists are encouraged to report to USP headquarters any observed or report incompatibilities.

(5) Recordkeeping: In addition to any individual prescription filing requirements, a record of each patient med pak shall be made and filed. Each record shall contain, as a minimum:

(a) The name and address of the patient;

(b) The serial number of the prescription order for each drug product contained therein;

(d) Information identifying or describing the design, characteristics, or specifications of the patient med pak sufficient to allow subsequent preparation of an identical patient med pak for the patient;

(e) The date of preparation of the patient med pak and the beyond-use date that was assigned;

(f) Any special labeling instructions; and

(g) The name or initials of the pharmacist who prepared the patient med pak.

(6) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2023, minor correction filed 02/08/2023, effective 02/08/2023
BP 8-2013, f. & cert. ef. 9-25-13
Renumbered from 855-041-0057, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1989, f. & cert. ef. 1-3-89

Or. Admin. R. 855-041-1145 New Containers

Each pharmacy must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2025), 16 CFR 1701 (v. 01/01/2025), and 16 CFR 1702 (v. 01/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
Renumbered from 855-041-0055, BP 7-2012, f. & cert. ef. 12-17-12
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1160 Records

(1) Definitions. The following definitions apply to this rule:

(a) An "original prescription" is a prescription maintained in the same physical manner in which a pharmacy first receives the prescription. For example, for a prescription received by the pharmacy in writing on a prescription form, the original prescription consists of the original writing on the prescription form. For a prescription received by the pharmacy orally over the telephone, the original consists of the writing or electronic record that reflects receipt of the oral prescription.

(b) "Filing" and "file" mean the storage of the original prescription in such a manner that the original prescription is safeguarded and readily retrievable.

(2) Every pharmacy and pharmacist-in-charge of a pharmacy must ensure that original prescriptions are properly filed in compliance with this rule.

(3) After 120 days, the paper prescription may be destroyed and filed in an electronic form if:

(a) The electronic form shows the exact and legible image of the original prescription;

(b) Notes of clarifications of and changes to the prescription are directly associated with the electronic form of the prescriptions; and

(4) This rule is not intended to alter or supersede the recordkeeping requirements of any other federal or Oregon statute or rule, including but not limited to ORS 689.508, OAR 855-041-1120, and rules related to records for prescriptions for controlled substances.

(5) All records and documents required by ORS 475, ORS 689, and OAR 855:

(a) Must be stored on-site for 12 months and must be provided to the board immediately upon request.

(b) May be stored in a secured off-site location after 12 months of on-site storage and must be provided to the board upon request within three business days; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.508
BP 14-2021, amend filed 06/15/2021, effective 06/15/2021
Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2008, f. & cert. ef. 2-20-08
BP 3-2005, f. & cert. ef. 4-14-05
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1165 Patient Medical Record

A patient record system must be maintained by pharmacies for all patients for whom prescription drug orders are dispensed. The patient record system must provide for readily retrievable information necessary for the dispensing Pharmacist to identify previously dispensed drugs at the time a prescription drug order is presented for dispensing. The Pharmacist must make a reasonable effort to obtain, record, and maintain the following information:

(1) Full name of the patient for whom the drug is intended;

(2) Address and telephone number of the patient;

(3) Patient's date of birth;

(4) Patient's gender;

(5) Patient’s preferred language for communication and prescription labeling;

(6) Chronic medical conditions;

(7) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record showing the name of the drug or device, prescription number, name and strength of the drug, the quantity and date received, and the name of the prescriber;

(8) Known allergies, drug reactions, and drug idiosyncrasies; and

(9) If deemed relevant in the Pharmacist's reasonable professional judgment:

(a) Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug; and

(b) Additional information such as chronic conditions or disease states of the patient, the patient's current weight, and the identity of any other drugs, including over-the-counter drugs, or devices currently being used by the patient which may relate to prospective drug review.

History

Statutory/Other Authority: ORS 689.205 & 2021 HB 2359
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.508 & 2021 HB 2359
BP 42-2022, minor correction filed 07/20/2022, effective 07/20/2022
BP 29-2022, amend filed 06/15/2022, effective 09/01/2022
Renumbered from 855-041-0060, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2008, f. & cert. ef. 2-20-08
BP 3-2005, f. & cert. ef. 4-14-05
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-1167 Patients Access to Pharmacy Records

(1) Licensees and registrants of the board must make protected health information in the pharmacy record available to the patient or the patient’s representative upon their request, to inspect and obtain a copy of protected health information about the individual, except as provided by law and this rule. The patient may request all or part of the record. A summary may substitute for the actual record only if the patient agrees to the substitution. Board licensees and registrants are encouraged to use the written authorization form provided by ORS 192.566.

(2) For the purpose of this rule, “health information in the pharmacy record” means any oral, written or electronic information in any form or medium that is created or received and relates to:

(a) The past, present, or future physical or mental health of the patient.

(b) The provision of healthcare to the patient.

(3) Upon request, the entire health information record in the possession of the board licensee will be provided to the patient. This includes records from other healthcare providers. Information which may be withheld includes:

(a) Information which was obtained from someone other than a healthcare provider under a promise of confidentiality and access to the information would likely reveal the source of the information;

(b) Psychotherapy notes;

(c) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding; and

(d) Other reasons specified by federal regulation.

(4) Registrants who have permanently closed must notify patients according to OAR 855-041-1092.

(5) A reasonable cost may be imposed for the costs incurred in complying with the patient’s request for health information pursuant to ORS 192.563.

(6) A patient may not be denied summaries or copies of pharmacy records because of inability to pay.

(7) Requests for pharmacy records must be complied with within a reasonable amount of time not to exceed 30 days from the receipt of the request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 192.553, ORS 192.556, ORS 192.558, ORS 192.563 & ORS 192.566
BP 32-2022, adopt filed 06/15/2022, effective 06/16/2022

Or. Admin. R. 855-041-1170 Outlet (RP & IP): Grounds for Discipline

The State Board of Pharmacy may impose one or more of the following penalties which includes: suspend, revoke, or restrict the license of an outlet or may impose a civil penalty upon the outlet upon the following grounds:

(1) Unprofessional conduct as defined in OAR 855-006-0020;

(2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that:

(a) Is false, fraudulent, deceptive, or misleading; or

(b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee.

(3) Failing to provide a working environment that protects the health, safety and welfare of a patient as required in OAR 855-041-1010.

(4) Incentivizing or inducing the transfer of a prescription.

(5) Overriding or interfering with the Pharmacist-on-duty’s control of all aspects of the practice of pharmacy.

(6) Any other grounds found in ORS 689.405 or ORS 689.490.

History

Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.155
BP 7-2023, amend filed 02/14/2023, effective 02/14/2023
BP 1-2019, minor correction filed 01/22/2019, effective 01/22/2019
Renumbered from 855-041-0016, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2012, f. & cert. ef 6-12-12

Or. Admin. R. 855-041-1190 Operation of a Laboratory in Drug Outlet Pharmacy

(1) A Drug Outlet pharmacy may perform a laboratory test when:

(a) The Drug Outlet pharmacy possesses a valid laboratory license, including a certificate of a 42 CFR 493.35 waiver;

(b) The laboratory test is permitted under the laboratory license; and

(c) Requested by a physician, dentist, pharmacist or other person authorized by law to use the findings of laboratory examinations or without a practitioner order as permitted in ORS 438.010, ORS 438.030, ORS 438.040, ORS 438.050, ORS 438.055, ORS 438.060, ORS 438.070, ORS 438.110, ORS 438.120, ORS 438.130, ORS 438.140, ORS 438.150, ORS 438.160, ORS 438.210, ORS 438.220, ORS 438.310, ORS 438.320, ORS 438.420, ORS 438.430, ORS 438.435, ORS 438.440, ORS 438.450, 438.510.

(2) The Drug Outlet pharmacy must:

(a) Display the laboratory license in a prominent place in view of the public; and

(b) Report, to the local health department or state, reportable conditions as required in OAR 333-018.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.661
BP 34-2023, adopt filed 12/19/2023, effective 03/01/2024

Or. Admin. R. 855-041-2100 Operation of a Double Set-Up Pharmacy in a Retail Drug Outlet

A double set-up is an establishment having both a retail drug outlet registration and a nonprescription drug outlet registration. In a double set-up:

(1) The retail drug outlet (pharmacy) must be a separate operation, completely contained by an enclosure which assures safe storage. This enclosure must be from floor to ceiling or be at least ten feet from the floor. This area is to be easily distinguished by the public. When the retail drug outlet (pharmacy department) is closed, then as a nonprescription drug outlet the establishment is subject to the provisions of OAR 855-035-0005 and 855-035-0020.

(2) When a pharmacist is not in attendance, a closed sign shall be posted at the entrances stating the hours of the pharmacy's operation. All entrances to the retail drug outlet shall be closed off and securely locked. Any keys to the retail drug outlet (pharmacy) shall remain in the possession of the pharmacist-in-charge and other employee pharmacists as authorized by the pharmacist-in-charge if the retail drug outlet (pharmacy) is closed while the nonprescription outlet (shopkeeper) remains open.

(3) Any system deviating from the requirement of this section, except as provided in OAR 855-041- 6310, shall be approved by the Board prior to implementation. Requests for such approval shall be in writing and provide a detailed description of the proposed system. A written description of such system, as approved by the Board, shall be maintained in the pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.205
Renumbered from 855-041-0035, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1989, f. & cert. ef. 1-3-89
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-2115 Prescription: Transfers

(1) Prescriptions may be transferred between pharmacies for the purpose of an initial or refill dispensing provided that:

(a) The prescription is invalidated at the sending pharmacy; and

(b) The receiving pharmacy obtains all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability.

(2) Prescriptions for controlled substances can only be transferred one time unless otherwise permitted or forbidden by federal regulation.

(3) A pharmacy that transmits or receives prescription information to or from another pharmacy electronically must ensure as appropriate:

(a) The accurate transfer of prescription information between pharmacies;

(b) The creation of an original prescription or image of an original prescription containing all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability and that the pharmacist will use in verifying the prescription;

(d) For controlled substances, complies with the rules adopted by reference in OAR 855-080.

(4) An Oregon registered pharmacy must transfer a prescription:

(a) To a pharmacy requesting a transfer on behalf of the patient or patient’s agent unless the transfer would compromise patient safety or violate state or federal laws or rules; and

(b) By the end of the next business day of the request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 34-2023, amend filed 12/19/2023, effective 03/01/2024
BP 32-2022, amend filed 06/15/2022, effective 06/16/2022
Renumbered from 855-041-0075, BP 7-2012, f. & cert. ef. 12-17-12
BP 6-2000, f. & cert. ef. 6-29-00
BP 2-1998, f. & cert. ef. 3-23-98
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 2-1990, f. & cert. ef. 2-9-90
1PB 1-1986, f. & ef. 6-5-86
1PB 3-1982, f. & ef. 3-8-82
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-041-2310 Definitions

The following words and terms, when used in OAR 855-041-2300 through 855-041-2320 shall have the following meanings, unless the context clearly indicates otherwise.

(1) “Allergic reaction” means a medical condition caused by exposure to an allergen, with physical symptoms that may be life threatening, ranging from localized itching to severe anaphylactic shock and death.

(2) “Authorization to Obtain Epinephrine” means a certificate that contains the name, signature, and license number of the supervising professional authorizing the dispensing of epinephrine to the individual whose name appears on the certificate. Additionally, the certificate contains a record of the number of epinephrine orders filled to date.

(3) “Statement of Completion” means a certificate that states the specific type of emergency the trainee was trained to respond to, the trainee’s name and address, the name of the authorized trainer and the date that the training was completed.

(4) “Trainee” means an individual who has attended and successfully completed the formal training pursuant to the protocols and criteria established by the Oregon Health Authority, Public Health Division.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.681
Statutes/Other Implemented: ORS 689.155 & ORS 689.681
BP 5-2019, minor correction filed 09/16/2019, effective 09/16/2019
BP 5-2017, amend filed 12/22/2017, effective 12/26/2017
BP 2-2014, f. & cert. ef. 1-24-14
BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14

Or. Admin. R. 855-041-2320 Epinephrine

(1) A pharmacist may fill an order for epinephrine to be used by trainees to treat an anaphylactic reaction. Trainees must be 18 years of age or older and must have responsibility for or contact with at least one (1) other person as a result of the trainee’s occupation or volunteer status, such as, but not limited to, a camp counselor, scout leader, forest ranger, school employee, tour guide or chaperone.

(2) Individuals must successfully complete a training program approved by the Oregon Health Authority, Public Health Division. Upon successful completion, the trainee will receive the following certificates:

(a) Statement of Completion; and

(b) Authorization to Obtain Epinephrine.

(3) Acquisition of epinephrine from a pharmacy to be used for the treatment of allergic emergencies may occur in the following manners:

(a) A pharmacist may dispense epinephrine to a trainee upon presentation of the Statement of Completion and Authorization to Obtain Epinephrine certificate to a pharmacy when:

(A) A pharmacist may generate a prescription for and dispense an emergency supply of epinephrine for not more than one adult and one child dose package, as specified by the supervising professional whose name, signature, and license number appear on the Authorization to Obtain Epinephrine certificate.

(B) The pharmacist who generates the hardcopy prescription for epinephrine in this manner shall reduce the prescription to writing and file the prescription in a manner appropriate for a non-controlled substance.

(C) Once the pharmacist generates the epinephrine prescription, the pharmacist shall write in the appropriate space provided on the Authorization to Obtain Epinephrine certificate the date and the number of doses dispensed and return the certificate to the trainee.

(D) The Statement of Completion and the Authorization to Obtain Epinephrine certificate may be used to obtain epinephrine up to four (4) times within three (3) years from the date of the initial training.

(E) Both the Statement of Completion and the Authorization to Obtain Epinephrine certificate expire three (3) years from the date of the trainee’s last Oregon Health Authority approved allergy response training.

(F) Upon completion of the training, the trainee will receive a new Statement of Completion and Authorization to Obtain Epinephrine certificate, with a valid duration of three (3) years.

(b) A pharmacist may dispense epinephrine to an entity when:

(A) The epinephrine is acquired by a valid prescription presented to the pharmacy;

(B) The prescription identifies the entity as the patient for the purpose of prescribing and labeling the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 433.825
BP 16-2021, amend filed 06/15/2021, effective 06/15/2021
BP 6-2021, temporary amend filed 03/24/2021, effective 03/24/2021 through 09/19/2021
BP 4-2016, f. & cert. ef. 8-26-16
BP 2-2014, f. & cert. ef. 1-24-14
BP 6-2013(Temp), f. 9-23-13, cert. ef. 9-24-13 thru 3-23-14

Or. Admin. R. 855-041-3000 Central Fill and Remote Processing Outlet Designations

(1) The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy.

(2) The purpose of OAR 855-041-3100 through 855-041-3130 is to provide minimum requirements of operation for remote prescription processing by a pharmacy.

(3) Prior to initiating one of the above drug outlet models, a description of how the model will be utilized must be submitted to the board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 6-2024, amend filed 02/15/2024, effective 02/29/2024
BP 11-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3005 Central Fill - Purpose and Scope

The purpose of OAR 855-041-3005 through 855-041-3045 is to provide minimum requirements of operation for centralized prescription drug filling by a pharmacy. Any facility established for the purpose of filling drug orders on behalf of an Oregon pharmacy shall be licensed as a retail or institutional drug outlet. An applicant must submit its policies and procedures to the Board of Pharmacy. An applicant must submit to the Board for approval policies and procedures and a description of how using central fill will improve patient safety and redirect a pharmacist at a primary pharmacy from a distributive task to a cognitive task.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 66-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3010 Central Fill - Definitions

The following words and terms, when used in OAR 855-041-3005 through 855-041-3045 shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the OAR chapter 855, division 006.

(1) “Central Fill Pharmacy” means an Oregon licensed pharmacy that provides centralized prescription filling for both initial or prescription refills on behalf of a primary pharmacy.

(2) “Primary Pharmacy” means a pharmacy located and licensed in Oregon that receives a patient’s or a prescribing practitioner’s request to fill a prescription, dispenses the prescription directly to the patient or patient’s agent, or the pharmacy delivers the drug to the patient’s agent for administration. The primary pharmacy maintains ownership of the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 68-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3015 Central Fill - General Requirements

An Oregon licensed pharmacy may outsource prescription drug filling to a central fill pharmacy provided that both pharmacies:

(1) Have the same owner; or

(2) Have a written shared pharmacy services contract or agreement that specifies:

(a) The services to be provided by each pharmacy;

(b) The responsibilities of each pharmacy; and

(3) Maintain a separate Oregon pharmacy license for each location involved in providing prescription drugs and services to Oregon patients;

(4) Share a common electronic file or have appropriate technology or interface to allow access to information required to fill a prescription drug order;

(5) Establish, maintain and enforce a policy and procedures manual as required by OAR 855-041-3020;

(6) Ensure that each prescription has been properly processed and filled and that counseling has been provided to the patient;

(7) Designate a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the state in which the pharmacy is located if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing boards;

(8) Conduct an annual review of the written policies and procedures and document such review;

(9) Comply with all applicable federal and state laws and rules;

(10) Direct all patient communication to the primary pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 70-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3020 Central Fill - Policies and Procedures

(1) In addition to the requirements of OAR 855-041-1040, the central fill pharmacy and the primary pharmacy is each accountable for establishing, maintaining, and enforcing its written policies and procedures manual. The policies and procedures manual must include, but need not be limited to the following:

(a) The responsibilities of each pharmacy;

(b) The policies and procedures that protect confidentiality and ensure integrity of patient information;

(d) Cancelation of a filled prescription after the prescription is filled by the primary pharmacy;

(e) Records sufficient to identify by name, initials or unique identification code, the identify and specific activities of each pharmacist or technician who performed any centralized filling function, and the pharmacy where each activity was performed;

(f) The mechanism for tracking the prescription drug order during each step in the filling and dispensing process;

(g) Pharmacist completion of a Drug Utilization Review (DUR) on each prescription;

(h) A continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, to pursue opportunities, to improve patient care, and to resolve identified problems;

(i) Documentation of any errors or irregularities identified by the quality improvement program;

(2) This manual shall be maintained at both the central fill and primary pharmacy and must be made available to the Board upon request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 71-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3025 Central Fill - Labeling

(1) The label affixed to the prescription container filled by a central fill pharmacy on behalf of the primary pharmacy shall:

(a) Include all information required by OAR 855-041-1130 and OAR 855-041-1140;

(b) Comply with all labeling requirements identifying only the primary pharmacy.

(2) If the Central Pharmacy dispenses the completed prescription to the patient, the label must also comply with retail labeling requirements in OAR 855-041-1130 through 855-041-1140.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 73-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3030 Central Fill - Records

(1) The recordkeeping requirements in OAR 855-041-3005 through 855-041-3045 are in addition to the requirements of other recordkeeping rules of the Board.

(2) Each recordkeeping system must include quality improvement program documentation.

(3) Unless otherwise specified, all records and documentation required by OAR 855-041-3005 through 855-041-3045 must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be kept in hard copy, electronic copy, or a combination of the two.

(4) Each pharmacy must be able to produce an audit trail which identifies each prescription process in their pharmacy.

(5) The primary pharmacy shall maintain the original prescription for a period of three years from the date the prescription was filled.

(6) The primary pharmacy must maintain records that:

(a) Identify by prescription or drug order, the name or unique identification code of the pharmacist who performed the drug utilization review. Identify by prescription drug order the pharmacist or technician that transmitted the prescription drug order to the central fill pharmacy. These records may be maintained separately by each pharmacy and pharmacist or technician or in a common electronic file, as long as the data processing system is capable of producing a printout that lists each function performed by each pharmacy and pharmacist or technician, and identifies the pharmacist or technician who performed each function;

(b) Document the date the filled prescription was received from the central fill pharmacy and the name of the person accepting delivery.

(7) The central fill pharmacy must maintain records that:

(a) List the name, address, telephone numbers, and all license and registration numbers of the pharmacies involved in centralized prescription filling; and

(A) Document verification of each license and registration; and

(B) Document the name of the individual responsible for verification of licensure and registration status.

(b) Track the prescription drug order during each step in the filling process and identify the name, initials, or unique identification code and specific activity of each pharmacist or pharmacy technician who performed any portion of the process including transmission, filling, dispensing and delivery of information.

(A) The date the prescription was received by the central fill pharmacy;

(B) The name and address where the filled prescription was shipped;

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 74-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3035 Central Fill - Delivery of Medications

(1) A central fill pharmacy may deliver or mail medications to the primary pharmacy or patient in compliance with OAR 855-041-1050.

(2) A central fill pharmacy must comply with all federal and state requirements when using private, common or contract carriers to transport filled prescriptions for delivery. When a central fill pharmacy contracts with private, common or contract carriers to transport filled prescriptions the central fill pharmacy is responsible for reporting any in-transit loss upon detection by use of DEA Form 106.

(3) A central fill pharmacy must maintain and use adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of packaging material and devices to ensure that the drug is maintained at the temperature range required to maintain the integrity of the medication throughout the delivery process.

(4) Filled prescriptions must be shipped in containers that are sealed in a manner that shows evidence of opening or tampering.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 76-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3040 Central Fill - Filled Prescriptions

(1) Any filled prescription that has not been picked up, may be put into the primary pharmacy’s inventory. Each pharmacy is responsible for documenting any such transfer of a drug.

(2) A prescription for a controlled substance may be filled by a central fill pharmacy when permitted by law, consistent with federal requirements set forth at 21 C.F.R. § 1300 et seq;

(3) The pharmacy that fills the prescription and the pharmacy to which the filled prescription is provided for dispensing to the patient shall each be responsible for ensuring the prescription has been properly filled.

(4) A primary pharmacy will notify the patient of the possible use of a central fill pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 78-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3045 Central Fill - Prohibited Practices

(1) A primary pharmacy may not use the services of a central fill pharmacy that is not registered with the Board.

(2) A central fill pharmacy may not fill a prescription on behalf of a primary pharmacy that is not registered with the Board if the laws and rules of Oregon require the primary pharmacy to be registered with the Board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 80-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3100 Remote Processing - Purpose and Scope

The purpose of OAR 855-041-3100 through 855-041-3130 is to provide minimum requirements of operation for remote prescription drug processing by a pharmacy. Any facility that processes drug orders on behalf of an Oregon pharmacy shall be licensed in Oregon as a retail or institutional drug outlet. An applicant must submit its policies and procedures to the Board of Pharmacy. An applicant must submit to the Board for approval policies and procedures and a description of how using remote processing will improve patient safety.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 81-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3105 Remote Processing - Definitions

The following words and terms, when used in OAR 855-041-3100 through 855-041-3130, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in OAR chapter 855, division 006.

(1) “Remote Processing Pharmacy” means an Oregon licensed pharmacy operated under the direction of a pharmacist-in-charge that processes information related to the practice of pharmacy and engages in remote prescription processing, including central processing.

(2) “Remote Processing Functions” may include, but are not limited to, data entry, prospective drug utilization reviews, refill authorizations and interventions. This does not include the filling process.

(3) “Primary Pharmacy” means an instate Oregon licensed pharmacy that receives a patient’s or a prescribing practitioner’s request to fill a prescription or drug order and delivers the drug or device directly to the patient or patient’s agent, and maintains ownership of the prescription or drug order.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 83-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3110 Remote Processing - General Requirements

An Oregon licensed pharmacy may outsource prescription drug processing to a remote processing pharmacy provided both pharmacies:

(1) Have the same owner; or

(2) Have a written shared pharmacy services contract or agreement that specifies:

(a) The services to be provided by each pharmacy;

(b) The responsibilities of each pharmacy; and

(3) Maintain a separate Oregon pharmacy license for each location involved in providing services;

(4) Share a common electronic file or have appropriate technology or interface to allow access to information required to process and fill a prescription drug order;

(5) Establish, maintain and enforce a policy and procedures manual as required by OAR 855-041-3115;

(6) Ensure that each prescription has been properly processed, filled and counseling has been provided to the patient;

(7) Designate a pharmacist-in-charge. To qualify for this designation, the person must hold a license to practice pharmacy in the state of Oregon and in the pharmacy’s resident state if the pharmacy is out-of-state. The pharmacist-in-charge must be in good standing with both licensing Boards;

(8) Allow prospective drug utilization reviews, refill authorizations, interventions, and patient counseling for an Oregon patient must be performed only by a licensed pharmacist in Oregon or in the state in which the pharmacy is located;

(9) Ensure that each technician processing an order for an Oregon patient is a Certified Oregon Pharmacy Technician and is supervised by a licensed pharmacist or is a licensed technician in the state in which the pharmacy is located and is supervised by a licensed pharmacist in the state in which the pharmacy is located;

(10) Comply with all applicable federal and state laws and rules;

(11) Conduct an annual review of the written policies and procedures and document such review.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 84-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3115 Remote Processing - Policies and Procedures

(1) In addition to the requirements of OAR 855-041-1040, the primary and the remote processing pharmacy is each accountable for establishing, maintaining, and enforcing its own written policies and procedures manual. The policies and procedures manual must include, but need not be limited to the following:

(a) The responsibilities of each pharmacy;

(b) The policies and procedures that protect confidentiality and ensure the integrity of patient information;

(d) Records sufficient to identify by name, initials, or unique identification code, the identity and the specific activities of each pharmacist or technician who performed any processing function, and the location where each activity was performed;

(e) A continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, to pursue opportunities to improve patient care, and to resolve identified problems; and

(f) Documentation of any errors or irregularities identified by the quality improvement program.

(2) The written policies and procedures manual shall be maintained at all pharmacies involved in remote processing and must be available to the Board upon request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 82-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3120 Remote Processing - Records

(1) The recordkeeping requirements OAR 855-041-3100 through 855-041-3130 are in addition to the requirements of other recordkeeping rules of the Board.

(2) The remote processing pharmacy must maintain all required records unless these records are maintained in the primary pharmacy.

(3) Both recordkeeping systems must:

(a) List the name, address, telephone number, and all license and registration numbers of each pharmacy involved in remote prescription processing;

(A) Document verification of each license and registration;

(B) Document the name of the individual responsible for verification of licensure and registration status.

(b) Identify by name, initials, or unique identification code the identity and the specific activities of each pharmacist or technician who performed any part of the prescription process;

(d) Be able to produce an audit trail showing each prescription process.

(4) Unless otherwise specified, all records and documentation required by these rules, must be retained for three years and made available to the Board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two;

(5) The primary pharmacy shall maintain records that:

(a) Indicate the date the request for processing was transmitted to the remote processing pharmacy; and

(b) Indicate the date the prescription information was received by the primary pharmacy.

(6) The remote processing pharmacy shall maintain records that:

(a) Track the prescription drug order during each step in the order entry process;

(b) Identify the name, initials, or unique identification code and the specific activity of each pharmacist or pharmacy technician who performed any activity related to processing the prescription including receipt, transmission or delivery of information.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 79-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3125 Remote Processing - Prescription or Drug Order Processing

A prescription or drug order for a controlled substance may be processed by a remote processing pharmacy when permitted by law and consistent with federal rules.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 77-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3130 Remote Processing - Prohibited Practices

A remote processing pharmacy may not process a prescription on behalf of a primary pharmacy that is not registered with the Board, if required by the laws and rules of Oregon to be registered.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 75-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 10-2013, f. & cert. ef. 11-6-13

Or. Admin. R. 855-041-3200 Telework: Purpose and Scope

The purpose of OAR 855-041-3200 through OAR 855-041-3250 is to provide minimum requirements for pharmacy services conducted via telework.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3205 Telework: Definitions

(1) “Telework” means the practice or assistance in the practice of pharmacy physically located outside of a registered drug outlet when working as a contractor or an employee of an Oregon registered drug outlet in a telework site.

(2) “Telework Site” means a location that is not a registered drug outlet where an Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician may assist in the practice of pharmacy as contractors or employees of an Oregon registered drug outlet.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3210 Telework: Registration

The Oregon registered Drug Outlet Pharmacy and the Pharmacist-in-charge of the Drug Outlet Pharmacy are responsible for all licensees assisting in the practice of pharmacy at Telework Sites.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3215 Telework: General Requirements

(1) Each Oregon registered Drug Outlet Pharmacy and Pharmacist-in-charge of a Drug Outlet Pharmacy must ensure that Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians working at a Telework Site work under the supervision, direction, and control of an Oregon licensed Pharmacist.

(2) A Pharmacist that engages in the practice of pharmacy and an Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician that assists in the practice of pharmacy at a Telework Site for any person or facility located in Oregon must:

(a) Be licensed by the board; and

(b) Comply with all applicable federal and state laws and rules.

(3) Drugs and devices may not be at a Telework Site.

(4) The Oregon registered Drug Outlet Pharmacy and the Pharmacist-in-charge of a Drug Outlet Pharmacy must:

(a) Have a written agreement that includes all conditions, duties and policies governing the licensee engaged in telework activities;

(b) Maintain a continuously updated list of all licensees engaged in telework and the Telework Sites to include:

(A) Address, and phone number for each Telework Site;

(B) Functions being performed by licensees engaged in telework; and

(c) Develop, implement and enforce a continuous quality improvement program for services provided via telework designed to objectively and systematically:

(A) Monitor, evaluate, document the quality and appropriateness of patient care;

(B) Improve patient care; and

(D) Implement measures to prevent reoccurrence;

(d) Develop, implement and enforce a procedure for identifying the Oregon licensed Pharmacist, Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician responsible for each telework function;

(e) Develop, implement and enforce a process for a virtual inspection of each Telework Site by an Oregon licensed Pharmacist at least once every 6 months or more frequently as deemed necessary by the Oregon licensed Pharmacist. The inspection must be documented and records retained; and

(f) Utilize an Oregon licensed Pharmacist and real-time audio communication to provide counseling or accept the refusal of counseling from the patient or the patient’s agent for each prescription being dispensed when counseling is required under OAR 855-115-0145 or when requested and document the interaction.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 27-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3220 Telework: Supervision Requirements

The Oregon registered Drug Outlet Pharmacy, Pharmacist-in-charge of the Drug Outlet and the supervising Oregon licensed Pharmacist from the Drug Outlet must:

(1) Utilize an audiovisual communication system and have appropriate technology or interface to allow access to information required to complete assigned duties;

(2) Ensure telephone audio is recorded and stored for all patient interactions completed by Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians;

(3) Ensure an Oregon licensed Pharmacist is supervising, directing and controlling each Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician and that the audiovisual communication system is fully operational;

(4) Ensure that an Oregon licensed Pharmacist using reasonable professional judgment, determines the frequency of “check-ins” for each licensee being supervised via the audiovisual communication system with a minimum of at least once per work shift to ensure patient safety, compliance with federal and state laws, and documents the interaction;

(5) Be readily available to answer questions and fully responsible for the practice and accuracy of the licensee; and

(6) Ensure the Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician knows the identity of the Oregon licensed Pharmacist who is providing supervision, direction, and control at all times.

(7) Ensure the Oregon licensed Pharmacist who is supervising an Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician at a Telework Site:

(a) Uses reasonable professional judgment to determine the percentage of patient interactions for each licensee that must be observed or reviewed to ensure public health and safety with a minimum of 5% of patient interactions observed or reviewed;

(b) Reviews patient interactions within 48 hours of the patient interaction to ensure that each licensee is acting within the authority permitted under their license and patients are connected with a pharmacist upon request;

(A) Number of each licensee’s patient interactions;

(B) Number of each licensee’s patient interactions Pharmacist has observed or reviewed;

(D) Date and time of Pharmacist observation or review of licensee’s patient interaction; and

(E) Pharmacist notes of each interaction observed or reviewed; and

(d) Reports any violation of OAR 855 to the Oregon registered Drug Outlet Pharmacy within 24 hours of discovery and to the board within 10 days.

(8) The Oregon registered Drug Outlet Pharmacy must comply with the Pharmacist’s determination in (7)(a); and

(9) Employ adequate staff to allow for:

(a) Observation or review within 48 hours; and

(b) Create records; and

(10) Retain records.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3225 Telework: Confidentiality

The Oregon registered Drug Outlet Pharmacy, Pharmacist-in-charge of the Drug Outlet Pharmacy, and the Pharmacist, Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician from the Drug Outlet Pharmacy must:

(1) Ensure patient and prescription information is managed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125, and OAR 855-139.

(2) Ensure the security and confidentiality of patient information and pharmacy records.

(3) Document and report any confirmed breach in the security of the system or breach of confidentiality. Report of each breach must be reported in writing to the board within ten days of discovery of the event.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 26-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3230 Telework: Technology

The Oregon registered Drug Outlet Pharmacy, Pharmacist-in-charge of the Drug Outlet and the Pharmacist from the Drug Outlet must:

(1) Test the audiovisual communication system with the Telework Site and document that it operates properly before the Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician engages in telework at the Telework Site.

(2) Develop, implement, and enforce a plan for responding to and recovering from an interruption of service which prevents an Oregon licensed Pharmacist from supervising, directing and controlling the Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician at the Telework Site.

(3) Ensure access to:

(a) Appropriate and current pharmaceutical references based on the services offered; and

(b) Appropriate and current Oregon Revised Statutes, Oregon Administrative Rules, United States Code, Code of Federal Regulations, standards adopted by reference (e.g. USP) based on services offered by the outlet and a minimum of three years of the Board of Pharmacy quarterly newsletters.

(4) Train the Oregon licensed Pharmacists, Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians in the operation of the audiovisual communication system.

(5) For verification of prescriptions, use still image capture or store and forward with a camera that is of sufficient quality and resolution so that the Oregon licensed Pharmacist from the Oregon registered Drug Outlet Pharmacy can visually identify each:

(a) Source container including manufacturer, name, strength, lot, and expiration;

(b) Dispensed product including the imprint and physical characteristics;

(d) Ancillary document provided to patient at the time of dispensing.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3235 Telework: Personnel

(1) The Oregon licensed Pharmacist-in-charge of the Drug Outlet Pharmacy is responsible for all operations at the Drug Outlet Pharmacy including responsibility for the audiovisual communication system and enforcing policies and procedures.

(2) A Drug Outlet Pharmacy may not utilize unlicensed personnel to engage in telework.

(3) Prior to working at a Telework Site, the Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician and the Oregon licensed Pharmacist supervising the Telework Site must have completed a training program on the use of all equipment necessary for secure operation of the Telework Site.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3240 Telework: Security

(1) Telework Sites must be located in a designated area where:

(a) All equipment is stored;

(b) All work is performed; and

(2) Confidentiality must be maintained such that patient information cannot be viewed or overheard by anyone other than the Pharmacist, Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician.

(3) The Pharmacist-in-charge of the Drug Outlet Pharmacy and each Oregon licensed Pharmacist supervising a Telework Site is responsible for ensuring the Telework Site has a designated work area that is secure and has been approved and documented by an Oregon licensed Pharmacist prior to utilization.

(4) All computer equipment used for telework must:

(a) Establish and maintain a secure connection to the pharmacy and patient information;

(b) Utilize equipment that prevents unauthorized access to the pharmacy and patient information; and

(A) There is no Oregon licensed Pharmacist actively supervising the Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician who is assisting in the practice of pharmacy at a Telework Site; or

(B) There is no Intern, Certified Oregon Pharmacy Technician, or Pharmacy Technician present at the Telework Site; or

(d) Be configured so information from any patient or pharmacy records are not duplicated, downloaded, or removed from the electronic database when an electronic database is accessed remotely; and

(e) Comply with all security and confidentiality requirements.

(5) A record must be maintained with the date, time and identification of the licensee accessing patient or pharmacy records at a Telework Site.

(6) Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians may only work at a Telework Site when authorized in real-time by an Oregon licensed Pharmacist who is supervising the licensee at the Telework Site.

(7) All records must be stored in a secure manner that prevents access by unauthorized persons.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3245 Telework: Policies and Procedures

(1) If a Drug Outlet Pharmacy utilizes licensees via telework, the Drug Outlet Pharmacy and the Oregon licensed Pharmacist-in-charge are accountable for establishing, maintaining, and enforcing written policies and procedures for the licensees working via telework. The written policies and procedures must be maintained at the Drug Outlet Pharmacy and must be available to the board upon request.

(2) The written policies and procedures must include at a minimum the services, responsibilities and accountabilities of the licensee engaging in telework including;

(a) Security;

(b) Operation, testing and maintenance of the audiovisual communication;

(d) Oregon licensed Pharmacist supervision, direction and control of Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians;

(e) Recordkeeping;

(f) Patient confidentiality;

(g) Continuous quality improvement;

(h) Plan for discontinuing and recovering services if the audiovisual communication system is disrupted;

(i) Confirmation of dedicated, secure Telework Sites;

(j) Documenting the identity, function, location, date and time of the licensees engaging in telework at a Telework Site;

(k) Written agreement with licensees engaging in telework outlining the specific functions performed and requirement to comply with telework policies and procedures; and

(l) Equipment.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-3250 Telework: Records

(1) If a Drug Outlet Pharmacy utilizes licensees via telework the recordkeeping requirements OAR 855-041-3205 through OAR 855-041-3250 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules must be retained for three years and made available to the board for inspection upon request. Records of Telework Site addresses must be made available within 3 business days. Records created via telework must be stored by the Drug Outlet for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) Physical records may not be stored at the Telework Site.

(3) Records may not be duplicated, downloaded, or removed when accessed via telework.

(4) Records must be stored in a manner that prevents unauthorized access.

(5) Records must include, but are not limited to:

(a) Patient profiles and records;

(b) Patient contact and services provided;

(d) If filling prescriptions, date, time and identification of the licensee and the specific activity or function of the person performing each step in the dispensing process;

(e) List of employees performing telework that includes:

(A) Name;

(B) License number and expiration date;

(D) Name of the Oregon licensed Pharmacist who:

(i) Verified (A-C);

(ii) Approved licensee to telework; and

(iii) Approved each Telework Site;

(f) Audiovisual communication system testing and training;

(g) Still image capture and store and forward images must be retained according to (1);

(h) Data and telephone audio must be retained for 6 months; and

(i) Any errors or irregularities identified by the quality improvement program.

History

Statutory/Other Authority: ORS 689.135, ORS 689.151, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 33-2022, amend filed 06/15/2022, effective 06/16/2022
BP 24-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 37-2021, adopt filed 12/16/2021, effective 12/16/2021

Or. Admin. R. 855-041-4000 Purpose - Expedited Partner Therapy (EPT)

(1) There is substantial evidence that rates of re-infection with certain sexually transmitted diseases can be reduced by treating all sexual partners for the disease, even when the treating clinician has not examined those partners. This practice is known as Expedited Partner Therapy.

(2) Because of the important public health implications, the 2009 Oregon Legislature passed HB 3022 authorizing this practice. This law permits health professional regulatory boards to adopt rules permitting practitioners to practice Expedited Partner Therapy.

(3) The law specifies that a prescription issued in the practice of Expedited Partner Therapy is valid, even if the name of the patient the prescription is intended for is not on the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505
BP 54-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 1-2010, f. & cert. ef. 2-8-10

Or. Admin. R. 855-041-4005 Expedited Partner Therapy (EPT) - Procedures

(1) Expedited Partner Therapy (EPT) means the practice of prescribing or dispensing an antibiotic drug for the treatment of a sexually transmitted disease to the partner of a patient without first examining that partner.

(2) Notwithstanding any other rules in this division that mandate requirements for a valid prescription and for labeling, when a prescription is marked EPT or a similar notation by the prescribing practitioner, this rule shall govern.

(3) An EPT prescription may only be dispensed for a drug that has been determined by the Department of Human Services (DHS) to be appropriately used for EPT.

Prescription

(4) An EPT treatment protocol must conform to the following:

(a) It must include a prescription for each named or unnamed partner of the patient;

(b) It must contain a hand written or electronic signature of the prescribing practitioner;

(A) Write “for EPT,” or a similar notation, on the face of the prescription;

(B) For a verbal order, the practitioner must identify the prescription as an “EPT Prescription,” or similar identification;

(C) The practitioner must identify the prescription for each partner either by including the name of the patient, such as “John Doe – Partner 1” or by labeling the prescription as “EPT Partner”

(d) An EPT Prescription expires 30 days after the date written;

(e) An EPT Prescription may not be refilled;

(f) If any component of the prescription is missing, the pharmacist must contact the prescriber or the prescriber’s agent and must record the additional information on the prescription.

(5) A patient may give the prescription to each unnamed partner for that person to fill at a pharmacy of their choice; or the patient may give all prescriptions to one pharmacy and then give the dispensed drugs to each unnamed partner.

Labeling

(6) The pharmacist must label the drug for the named patient in accordance with normal procedures as specified in the other rules of this division, however when either the patient or partner is unnamed, the pharmacy may create a unique identifier and use that instead of a name for both labeling and record keeping purposes.

(7) The pharmacist must assign a separate and unique identifier to each prescription and clearly identity this number on each corresponding prescription label.

Counseling

(8) The pharmacist is not required to obtain an EPT patient’s or partner’s name, address, or demographics; however, the pharmacist must:

(a) Provide counseling in the form of written patient information to accompany each prescription for each partner and ask the patient about any known allergies or other drugs being taken by each partner. The pharmacist should advise the patient to encourage each partner to call the pharmacist before taking the drug if they have experienced any adverse effect from a drug in the past or if they are taking other drugs;

(b) Document counseling.

Records

(9) All documentation required by this rule must be attached to the prescription and must be referenced to each partner’s prescription. Such documentation must be retained in accordance with the other rules in this division and must be made available to the Board upon request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505
BP 53-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 1-2010, f. & cert. ef. 2-8-10

Or. Admin. R. 855-041-4025 Purpose and Scope - Home Dialysis

A Retail Drug Outlet for Home Dialysis supplies may provide dialysis solutions under the general supervision and direction of a pharmacist with special training in renal disease and dialysis to end stage renal disease (ESRD) patients who have chosen the option of home dialysis therapy and who have been appropriately trained.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 52-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0350, BP 7-2012, f. & cert. ef. 12-17-12
BP 8-2000, f. & cert. ef. 6-29-00

Or. Admin. R. 855-041-4035 Home Dialysis - Definitions

“Dialysis solutions” means peritoneal dialysis solutions, dialysate solutions, and legend devices including hardware, bloodlines and dialysis tubing and connectors.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 51-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0355, BP 7-2012, f. & cert. ef. 12-17-12
BP 8-2000, f. & cert. ef. 6-29-00

Or. Admin. R. 855-041-4045 Home Dialysis - Drug Delivery and Control

(1) An Oregon licensed pharmacist must be designated as the pharmacist-in-charge who will provide direction and supervision of the operation and staff.

(2) Deliveries of supplies must be made only pursuant to a current prescription order from an authorized prescriber. The prescription order must be maintained on file at the outlet. Supplies will be limited to dialysis solutions as defined in OAR 855-041 — 4035. No other legend medication ordered for the patient may be provided by the outlet.

(3) All patient records must be maintained in a secure area with a locking door. Access to the patient records area is allowed only when a pharmacist is present except in the event of an emergency. In the event of an emergency, any entry by individuals other than the pharmacist must be documented. In the absence of a pharmacist, the door to the patient records area must remain locked at all times.

(4) Copies of all prescriptions must be reviewed by the pharmacist and a complete set of prescription records for all patients serviced by the outlet must be maintained in the patient records area for a minimum of three years.

(5) A minimum of two current reference books that are specific and relevant to dialysis therapy must be maintained in the outlet to assist in the appropriate delivery of care to patients. Other reference material and equipment must be maintained to be consistent with the scope of services provided by the outlet.

(6) A current copy of Oregon Revised Statutes, Chapter 689, a current copy of Oregon Administrative Rules, chapter 855, and a minimum of three years of the Oregon Board of Pharmacy quarterly newsletters must be maintained in a loose leaf binder or other readily retrievable means.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 50-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0360, BP 7-2012, f. & cert. ef. 12-17-12
BP 8-2000, f. & cert. ef. 6-29-00

Or. Admin. R. 855-041-4055 Home Dialysis - Duties of the Pharmacist

(1) The pharmacist-in-charge must review, at least weekly, the drug outlet operation and perform, at least monthly, quality assurance audits that include the review of prescription orders prior to delivery for accuracy and completeness, and the review of the assembled order with the prescription order prior to delivery for accuracy and completeness.

(2) The pharmacist-in-charge is responsible for the following on an ongoing basis:

(a) Ensure compliance of dialysis distribution operation to all applicable federal and state pharmacy laws and rules;

(b) Ensure valid prescriptions are received for all patient orders by performing periodic assessments of prescription files;

(d) Provide pharmaceutical care by reviewing all patient profiles and performing drug therapy assessments on those identified as abnormal;

(e) Provide pharmaceutical care by responding on a toll free telephone access to questions received from any patient or health care provider;

(f) Maintain, update and train personnel on policies and procedures specific to home dialysis patient deliveries and pharmacy requirements;

(g) Prepare educational materials for staff members of dialysis clinics as requested;

(h) Prepare and maintain on file monthly reports of activities performed;

(i) Ensure security of the patient record area; and

(j) Maintain a policy and procedure manual for the Drug Outlet operation that must include written protocols for the product delivery system, methods for supervising deliveries to patients, and a quality assurance program with which to monitor the qualifications, training and performance of personnel.

(3) The pharmacist-in-charge must perform an annual inspection of the outlet on a form provided by the Board, and must provide a copy of this inspection to the Board upon request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 49-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0365, BP 7-2012, f. & cert. ef. 12-17-12
BP 8-2000, f. & cert. ef. 6-29-00

Or. Admin. R. 855-041-4100 Definitions - Automated Pharmacy System

(1) "Automated Pharmacy System" (APS) means a mechanical system that performs operations or activities, including but not limited to, those related to the storage, packaging, dispensing, or distribution of medications, but not including compounding or administration, and that collects, controls, and maintains all transaction information.

(2) "Remote Dispensing Facility" (RDF) means a facility where drugs are prepared for administration and where requisite pharmacist supervision is provided remotely as approved by the Board.

(3) "Remote Dispensing Machine" (RDM) means a component of an Automated Pharmacy System that contains drugs for dispensing.

(4) "Responsible Pharmacy" means the licensed pharmacy that is responsible for the APS, and RDM.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 48-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 1-2017, f. & cert. ef. 2-23-17
Renumbered from 855-041-0600, BP 7-2012, f. & cert. ef. 12-17-12
BP 3-2011, f. & cert. ef. 4-18-11
Reverted to BP 2-2005, f. 2-14-05, cert. ef. 3-1-05
BP 9-2010(Temp), f. & cert. ef. 7-9-10 thru 12-24-10
BP 2-2005, f. 2-14-05, cert. ef. 3-1-05

Or. Admin. R. 855-041-4110 Remote Dispensing Machine (RDM) - Duties and Responsibilities of the Pharmacist-in-Charge

Each RDM must be under the supervision of the Pharmacist-in-Charge of the Responsible Pharmacy. The Pharmacist-in-Charge must:

(1) Develop written policies and procedures prior to installation of the RDM that:

(a) Ensure safety, accuracy, security, and patient confidentiality;

(b) Define access to the RDM and to medications contained within or associated with the RDM, including but not limited to policies that assign, discontinue, or change access to the RDM and medications.

(2) Obtain written approval by the Board prior to installing any RDM.

(3) Train all personnel who will access the APS (including the RDM) before being allowed access to the APS. Training must ensure the competence and ability of all personnel who operate any component of the APS. Documentation of original training and continuing education must be kept both in the pharmacy and at the site of the RDM, and readily available for inspection by the Board.

(4) Ensure that the RDM is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate record-keeping and security safeguards.

(5) Implement an ongoing quality assurance program that monitors performance of the APS, including the RDM, and the personnel who access it.

(6) Notify the Board within 15 days of removal or closure of the RDM and the disposition of drugs contained in the RDM before it was removed or closed.

(7) Ensure that the RDM is stocked accurately and in accordance with established, written policies and procedures. A pharmacist must check the accuracy of the product supplied for stocking the machine.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.305
BP 46-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0610, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2005, f. 2-14-05, cert. ef. 3-1-05

Or. Admin. R. 855-041-4120 Remote Dispensing Machine (RDM) - Drug Delivery and Control

(1) Each RDM must be registered with the Board, under the control of and connected via computer with a Responsible Pharmacy, but not located in a pharmacy. RDMs must be used only in settings with an established program of pharmaceutical care that ensures prescription orders are reviewed by a pharmacist before release to the patient. The Responsible Pharmacy must establish the policies and procedures necessary to fulfill the requirements of all applicable state and federal laws and regulations.

(2) The following must be conspicuously displayed at the site of the RDM:

(a) RDM license;

(b) DEA registration if required;

(d) A certified copy of the Pharmacist-In-Charge license.

(3) Documentation as to type of equipment, serial numbers, content, policies and procedures, and location shall be maintained in the pharmacy for review by the board. Such documentation must include, but is not limited to:

(a) Location of RDM(s);

(b) Manufacturer's name and model for each RDM;

(d) Quality assurance procedures to determine continued appropriate use of the automated device; and

(e) Policies and procedures for training of appropriate personnel, system operation, safety, security, accuracy, patient confidentiality, oral counseling by a pharmacist or pharmacist-intern, access, and malfunction.

(4) Policies and procedures addressing the operation of the RDM must be maintained in the pharmacy responsible for the APS and at the location at which the RDM has been installed.

(5) All events involving the contents of the RDM must be recorded electronically. Records must be maintained by the pharmacy for a minimum of three years and must be readily available to the Board. Such records shall include:

(a) Identity of RDM accessed;

(b) Identification of the individual accessing the RDM;

(d) Date and time of transaction;

(e) Name, strength, dosage form, and quantity of the drug accessed;

(f) Name of the patient for whom the drug was ordered;

(g) Name of the prescribing practitioner

(h) Such additional information as the pharmacist-in-charge may deem necessary; and

(6) Only an Oregon Licensed Pharmacist or Technician may have access to the RDM, except that a Registered Nurse, upon approval by the Board, may have access to the RDM.

(7) Only an Oregon licensed Pharmacist or Technician may stock medications in the RDM, except that a Registered Nurse, upon approval by the Board, may stock medications in the RDM.

(8) All containers of medications stored in the RDM shall be packaged and labeled in accordance with state and federal laws and regulations, including OAR 855-041-1130.

(9) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.

(10) Oral counseling, as required by OAR 855-115-0145, shall be provided by the pharmacist at the time of dispensing by a two-way audio and video hookup with the Responsible Pharmacy.

(11) The Automated Pharmacy Systems shall provide a mechanism for securing and accounting for wasted, discarded or unused medications in accordance with existing state and federal laws and regulations.

(12) The RDM must be clearly marked with the name, address, and phone number of the Responsible Pharmacy and Pharmacist-In-Charge.

(13) A Responsible Pharmacy located outside of Oregon that operates a RDM in Oregon must be currently licensed and in good standing in Oregon. The Pharmacist-In-Charge must also be currently licensed and in good-standing both in Oregon and in the state in which the Responsible Pharmacy is located.

(14) A Responsible Pharmacy may apply for the use of an RDM in a licensed residential facility that it provides services to, but only when the facility provides 24 hour nursing care.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.205
BP 28-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 44-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 1-2017, f. & cert. ef. 2-23-17
Renumbered from 855-041-0620, BP 7-2012, f. & cert. ef. 12-17-12
BP 2-2005, f. 2-14-05, cert. ef. 3-1-05

Or. Admin. R. 855-041-5005 Definitions - Institutional and Residential Pharmacy Drug Outlets

For purposes of these rules, OAR 855-041-5000 through 855-041-9999 the following definitions apply:

(1) "Institutional Facility" means a hospital or other health care facility which is an inpatient care facility referred to in ORS 442.015, which includes long-term care facilities and special inpatient care facilities, and such facility is licensed by the appropriate state agency. For the purpose of this rule, an Institutional Facility is a Residential Drug Outlet.

(2) "Institutional Pharmacy" means a pharmacy where medications are dispensed to other health care professionals for administration to institutionalized patients served by an institutional facility, and which is:

(a) Located within the institutional facility;

(b) Located outside the facility but provides pharmaceutical services to institutionalized patients; and

(3) "Drug Room" means a secure and lockable location within a facility that does not have a pharmacy and is a Board approved location associated with a licensed institutional pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.305
BP 41-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 1-2017, f. & cert. ef. 2-23-17
Renumbered from 855-041-0105 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12
PB 8-1990, f. & cert. ef. 12-5-90
1PB 2-1980, f. & ef. 4-3-80

Or. Admin. R. 855-041-5015 Registration

All residential drug outlets shall register annually with the Board of Pharmacy. Residential drug outlets which also provide outpatient pharmacy services shall also register as retail drug outlets.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
Renumbered from 855-041-0115 by BP 1-2012, f. 4-26-12, cert. ef. 5-1-12
1PB 2-1980, f. & ef. 4-3-80

Or. Admin. R. 855-041-5050 Remote Distribution Facility (RDF) - Definitions

(2) "Remote Distribution Facility" (RDF) means an in-state/resident facility where drugs are prepared for administration and where requisite pharmacist supervision is provided remotely as approved by the Board.

(3) "Responsible Pharmacy" means the licensed resident pharmacy that is responsible for the RDF.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2017, adopt filed 12/22/2017, effective 12/26/2017

Or. Admin. R. 855-041-5055 Remote Distribution Facility (RDF)

The purpose of these rules is to provide for the use of a Certified Oregon Pharmacy Technician functioning outside of a pharmacy to prepare drugs only for administration to a patient by another healthcare provider, and where requisite pharmacist supervision and verification is provided remotely by an Oregon licensed pharmacist via an audiovisual communication system.

(1) A pharmacy physically located in Oregon may make written application to operate a RDF.

(2) The board may approve an application for registration as a RDF which includes the following:

(a) An operation plan;

(b) Policies and Procedures;

(d) A quality assurance plan for ensuring that there is a planned and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services and for identifying and resolving problems; and

(e) The fee specified in Division 110.

(3) Notwithstanding the definition of “supervision by a pharmacist” in Division 006, supervision in a RDF may be accomplished by a pharmacist via an audiovisual communication system from the applying pharmacy.

(4) Notwithstanding rules in this Division and in Divisions 115 and 125, a Certified Oregon Pharmacy Technician who works in a RDF may have access to the facility without the physical presence of a pharmacist, but may only perform Board approved functions when under the supervision of a pharmacist.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 45-2024, minor correction filed 04/11/2024, effective 04/11/2024
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 8-2017, adopt filed 12/22/2017, effective 12/26/2017

Or. Admin. R. 855-041-6050 Definitions - Automated Distribution Cabinet (ADC)

In these rules, OAR 855-041-6000 through 855-041-6999, the terms below have these meanings:

(1) “Automated Distribution Cabinet” (ADC) means a computerized drug storage device or cabinet that allows a drug to be stored and dispensed near the point-of-care, while controlling and tracking drug distribution;

(2) “Drug” means a drug, a prescription device, a biological medication, a chemical or any combination of these terms;

(3) “Central pharmacy” means a pharmacy within a licensed hospital with a single location and inventory, which prepares and distributes drugs to secondary storage areas in the facility, and remote locations;

(4) “Chief Pharmacy Officer” (CPO) means an Oregon licensed Pharmacist who supervises the pharmacy operations in a hospital. The CPO may hold the title of Pharmacy Manager, Pharmacy Director, Director of Pharmacy, Pharmacy Administrator or other pharmacy supervisory management title within the organization. The PIC may also be the CPO if there is only one pharmacy in the hospital;

(5) “Drug profile” means a complete and comprehensive summary of a patient’s current drugs and details of each drug including information such as active ingredient, strength and form, dose and directions for use, and other supplementary information;

(6) “Licensed Independent Practitioner” (LIP) means an individual permitted by law and by the organization to provide care and services, without direction or supervision, within the scope of the individual's license;

(7) “Out-patient” means a person who is not residing in the facility but who is registered with the facility and is using the facility for treatment or diagnostic services;

(8) “Remote storage area” means a patient care area which is part of the hospital that is under the supervision and control of the hospital’s central pharmacy but is not located in the same building as the central pharmacy;

(9) “Secondary drug storage area” means an area in a hospital or licensed residential facility, which is supplied by a central pharmacy and may include facilities such as a drug room, a distribution cabinet or a hospital department;

(10) “Unit-dose” means a quantity of a drug designed to be administered to a patient, such as:

(a) An oral solid individually packaged or re-packaged;

(b) An oral liquid drawn up in a labeled oral syringe;

(d) A pre-mixed IV product.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 28-2022, amend filed 06/15/2022, effective 06/16/2022
BP 25-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 20-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6100 Registration

(1) Each central pharmacy must be registered with the Board. In a hospital with multiple central pharmacies, each pharmacy location must be registered with the Board.

(2) A secondary drug storage area within the hospital or in a structure physically attached to the hospital does not require a separate registration.

(3) A registered pharmacy in a hospital may use additional locations within the hospital, supervised by a pharmacist, without acquiring separate registrations for each additional location.

(4) A secondary drug storage area in a separate location must be registered as a drug room and must follow all rules that apply to secondary storage areas in the hospital.

(5) A residential healthcare facility that is licensed by DHS and that has a central pharmacy must register the pharmacy with the Board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 1-2023, minor correction filed 01/23/2023, effective 01/23/2023
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6150 General Pharmacy Requirements

(1) Each hospital pharmacy must have an Oregon licensed pharmacist designated as Pharmacist-in-Charge (PIC).

(2) A hospital that has more than one pharmacy must designate an Oregon licensed pharmacist as CPO or an equivalent position who has responsibility for directing pharmacy services in the hospital. The CPO may also be the PIC of one of the pharmacies.

(3) A hospital pharmacy may only be operated when under the direct supervision of an Oregon licensed pharmacist. The pharmacist shall be responsible for all areas of the hospital where drugs are stored, including remote storage areas

(4) The pharmacy must be operated at least part-time, five days a week.

(5) The hospital pharmacy must have adequate space so that drugs can be prepared in sanitary, well-lit, enclosed places. Space and equipment must be adequate for the pharmaceutical services provided including compounding, distributing, and storage of drugs and parenteral preparations.

(6) As a minimum, the pharmacy must have the following:

(a) Equipment listed in OAR 855-041-1035, except that a pharmacy that is only registered as an institutional drug outlet does not need to have an Official Poison and Exempt Narcotic Register;

(b) A drug formulary approved by the appropriate hospital committee;

(7) All areas occupied by a hospital pharmacy must be secured to prevent access by unauthorized personnel.

(a) Whenever any area of a hospital pharmacy is not under direct supervision of a pharmacist, the area must be secured;

(b) The CPO shall designate in writing, by title and specific area, those persons who may have access to specific areas within the pharmacy;

(c) Unless otherwise permitted by these rules, a non-pharmacist may not have access to the pharmacy unless a pharmacist is on duty and present in the hospital.

(8) A residential healthcare facility that has a central pharmacy must comply with these rules.

(9) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is in writing. A waiver is not valid for more than five years.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 48-2024, minor correction filed 04/11/2024, effective 04/11/2024
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6200 Chief Pharmacy Officer and Pharmacist in Charge

(1) The CPO must specify the respective responsibilities of the CPO and the PIC if separate individuals hold these positions.

(2) In addition to the duties listed in this rule, the PIC has the responsibilities listed in OAR 855-115-0210.

(3) The CPO must establish policies and procedures that include:

(a) Procedures for general distribution of drugs throughout the hospital;

(b) A procedure for review and revision of the policies and procedures not less than every three years;

(c) Procedures for the supervision of pharmacy services including storage, distribution, control and accountability for drugs including controlled drugs;

(d) Procedures to ensure that all areas of the hospital where drugs are stored are inspected not less than every two months to verify proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the emergency drug supplies;

(e) Policies and procedures that govern the preparation, verification and sterilization of parenteral drugs compounded within the hospital. Procedures must comply with OAR-183 and these rules;

(f) Procedures for administration of drugs, including self-administration;

(g) Procedures for labeling drugs;

(h) Policies and procedures that govern the filling and labeling of containers from which drugs are to be administered;

(i) Procedures for a Quality Assurance program to ensure that there is a planned, ongoing and systematic process for the monitoring and evaluation of the quality and appropriateness of pharmacy services, and for identifying and resolving problems. Such monitoring and evaluation must be accomplished through ongoing collection of information and periodic assessment of the collected information;

(j) Emergency drug distribution;

(k) Procedures for procurement of all drugs subject to approval of the appropriate committee of the hospital;

(l) Procedures to ensure that discontinued, outdated, adulterated or misbranded drugs are returned to the pharmacy for proper disposition, or that the PIC makes proper disposition or disposal of such drugs at the storage site;

(m) A recall procedure that can be quickly activated to assure the CPO and pharmacy staff, and the medical staff that all drugs included in the recall have been returned to the pharmacy for proper disposition;

(n) Policies and procedures for the use of investigational drugs;

(o) Procedures to be followed in the absence of the pharmacist.

(4) The CPO must:

(a) Participate in the development and revisions of a hospital formulary;

(b) Maintain an emergency and disaster plan for pharmacy services, and participate in the facility’s emergency and disaster plan;

(c) Ensure that records of all transactions of the hospital pharmacy that are required by state and federal laws and regulations are maintained, and maintain accurate control and accountability for all pharmaceutical materials;

(d) Participate in the hospital’s Quality Assurance program related to drugs;

(e) Comply with all inspection and other requirements of the pharmacy in accordance with all applicable state and federal laws and regulations.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 12-2026, minor correction filed 07/09/2026, effective 07/09/2026
BP 29-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6220 Records

(1) All records and documents required by ORS 475, ORS 689, and OAR 855:

(a) Must be stored on-site for 12 months and must be provided to the board immediately upon request.

(b) May be stored in a secured off-site location after 12 months of on-site storage and must be provided to the board upon request within three business days; and

(2) The PIC must ensure maintenance of written or electronic records and documents as necessary to ensure patient health, safety and welfare. Records must include:

(a) Patient profiles and drug administration records;

(b) Reports of suspected adverse drug reactions;

(d) Annual controlled substance inventories;

(e) Controlled drug accountability reports;

(f) Collaborative Drug Therapy agreements;

(g) Current hospital drug formulary;

(h) Any other records and reports required by state and federal laws and regulations.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.508
BP 14-2021, amend filed 06/15/2021, effective 06/15/2021
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6240 Drug Administration

(1) In a hospital, a drug may only be administered upon an order initiated by:

(a) A member of the medical staff who has been granted clinical privileges;

(b) An authorized member of the house staff; or

(2) Each administration of a drug must be in accordance with policies and procedures approved by the appropriate committee of the hospital, must comply with all applicable laws, rules and regulations, and must follow usual and customary standards of good medical practice.

(3) Self-administration. A patient may only be permitted to self-administer a drug when specifically authorized by the treating or ordering practitioner, and when the patient has been educated and trained in the proper self-administration of the drug.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6250 Patient’s Own Drugs and Other Drugs from Outside Sources

When a patient or a patient’s agent brings a drug into the hospital, the drug may only be administered to the patient if:

(1) The practitioner or pharmacist has identified it and it is in a pharmacy labeled container; and

(2) Any administration is pursuant to a practitioner’s order; or

(3) In the pharmacist’s professional judgment, withholding the drug would be detrimental to the patient’s health. In such a case, the pharmacist may authorize administration of the drug pursuant to a practitioner’s order.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6260 Investigational Drugs

(1) All in-patient investigational drugs must be stored in the pharmacy and may only be distributed from the pharmacy when properly labeled.

(2) Information concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of such drugs must be available in the pharmacy.

(3) Investigational drugs may only be ordered by a designated physician-investigator or their authorized clinician, subject to the prior approval of the appropriate hospital committee.

(4) Each order must include the appropriate protocol number.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6270 Institutional Drug Outlet Pharmacy Prescription Labeling

(1) Each pharmacy record keeping system must identify all pharmacy personnel involved in the repackaging including the pharmacist who verified the repackaged drug.

(2) Each repackaged drug, prepared by the pharmacy and intended for use within the facility must be in an appropriate container with a label that meets the requirements of OAR 855-041-1135 and includes:

(a) The brand or generic name and expiration date;

(b) The manufacturer and lot number, or an internal pharmacy code that references manufacturer and lot number;

(3) In-patient: Each drug dispensed to an in-patient other than in a unit-dose or manufacturer’s unit-of-use packaging must be labeled with the following information:

(a) Name and location of patient;

(b) Name and strength of drug;

(d) Manufacturer and lot number, or internal pharmacy code;

(e) Auxiliary labels as needed, and

(f) Expiration date.

(4) A drug that is provided for outpatient use must be dispensed by a retail drug outlet.

(5) When a new barcode or electronic label is used to identify a drug the pharmacist must verify and document the accuracy of the identification with all electronic verification systems prior to distribution.

(6) When a drug is added to a parenteral solution under the direct supervision of a pharmacist, the admixture must be labeled with a distinctive supplementary label that includes the:

(a) Name, quantity and concentration of the drug added and the primary solution;

(b) Date and time of addition;

(d) Scheduled time for administration;

(e) Infusion rate, when applicable;

(f) Name or initials of person performing admixture;

(g) Identification of the pharmacy where the admixture was performed; and

(h) Name or initials of the verifying pharmacist.

(7) The label applied at a secondary storage or remote storage area by a nurse or physician must include: the patient name or patient identifier, quantity and concentration of the drug added and the primary IV solution; the date and time of addition and the initials of the nurse or physician adding the drug.

(8) Nothing in this rule is intended to restrict or conflict with HB 2395 (2023), SB 450 (2023), SB 1043 (2023).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.505, 2023 HB 2395, 2023 SB 450 & 2023 SB 1043
BP 5-2024, amend filed 02/15/2024, effective 02/15/2024
BP 35-2023, temporary amend filed 12/20/2023, effective 01/01/2024 through 06/28/2024
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6300 Absence of the Pharmacist

The CPO must make appropriate arrangements for provision of drugs to the medical staff and other authorized personnel by use of a night cabinet or by access to the pharmacy, or both, for situations when hospital pharmacy services are not available.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.605
BP 5-2021, minor correction filed 03/11/2021, effective 03/11/2021
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6305 Night Cabinet

(1) If a night cabinet is used, the following procedures must be followed:

(a) The cabinet or other enclosure located outside the pharmacy must be secure from unauthorized access;

(b) Only one authorized registered nurse on a shift may have access to the night cabinet and may remove drugs. Such nurse must be designated in writing by the appropriate committee of the hospital and prior to being given access to the night cabinet, must receive appropriate training in the proper procedures for access, removal of drugs, and recordkeeping;

(A) A drug may only be removed from the night cabinet on a practitioner's written order or a verbal order that has been reduced to writing;

(B) A copy of the practitioner's order must be left in the night cabinet for the pharmacist to verify for accuracy. Both the nurse supervisor and the verifying pharmacist must initial the order.

(2) In conjunction with the appropriate hospital committee, the CPO must develop an inventory of those drugs to be included in each cabinet and establish procedures to ensure that:

(a) Drugs are available and labeled as required by these rules;

(b) Only prepackaged drugs are placed in the cabinet;

(d) Whenever a cabinet has been accessed, a written record is kept of the drug order and certification of the drug use;

(e) Controlled substances are kept securely and are accounted for using a reconciled perpetual inventory;

(f) An audit of controlled substances in the cabinet is conducted at least once per month. If a tamper-evident seal system is not used, a quality assurance program must be in place to identify any diversion.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & 689.605
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6310 After Hours Access to Pharmacy

When a drug required to treat the immediate needs of a patient is not available from floor-stock or a night cabinet, it may be obtained from the pharmacy in accordance with the following procedures:

(1) Only one registered nurse supervisor on a shift may have access to the pharmacy and may remove drugs. The nurse supervisor must be designated in writing by the appropriate hospital committee and prior to being permitted to obtain access to the pharmacy, must receive appropriate training in the proper procedures for access, removal of drugs, and recordkeeping;

(2) The PIC or designee must give such education and training, and must require, at a minimum, the following procedures:

(a) A drug may only be removed from the pharmacy on a practitioner's order that has been posted to the patient’s medical record;

(b) A copy of the practitioner's order must be left either with the container from which the drug was removed or with an identical unit-dose, and must be placed conspicuously for a pharmacist to verify for accuracy;

(A) Name and hospital location of the patient;

(B) Name and strength of drug distributed;

(D) Date and time of distribution;

(E) Initials of the nurse supervisor distributing the drug;

(F) Date and initials of the pharmacist who confirmed the accuracy of the transaction.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & 689.605
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6400 Emergency Dispensing by a Nurse

A hospital may provide for the emergency dispensing of a drug to an outpatient who is under the care of a practitioner who is a member of the hospital medical staff, when there is a legitimate medical need as described in hospital policies and procedures.

(1) A designated registered nurse may dispense a drug to an outpatient subject to the following:

(a) There is a prescription from a practitioner authorized to prescribe the drug or a verbal order that the nurse has reduced to writing. A practitioner who issues a verbal order or prescription must send a written prescription to the hospital pharmacy within seven days;

(b) The drug is in a manufacturer’s bulk unit-of-use, such as an inhaler, or hospital pre-pack that has been labeled by the pharmacy with;

(A) Name of drug, strength, and number of units. When a generic name is used, the label must also contain the name of the manufacturer or distributor;

(B) Accessory cautionary information as required for patient safety;

(D) An expiration date after which the patient should not use the drug;

(E) Name, address and phone number of the hospital pharmacy.

(A) Name of patient;

(B) Directions for use by the patient;

(D) Unique identifying number;

(E) Name of prescribing practitioner;

(F) Initials of the dispensing nurse or practitioner.

(d) The patient must be given instructions on the use and precautions for taking the drug;

(e) A prescription must be completed by the practitioner or nurse. This prescription must contain:

(A) Name of patient;

(B) Date of issuance;

(D) Units issued;

(E) Name of practitioner and initials of dispensing nurse;

(F) Instructions given to the patient.

(f) Any additional information required by state and federal laws and regulations for the distribution of a drug to an outpatient.

(2) The patient may not be given more than an emergency supply, as that is defined in the hospital policy and procedures.

(3) The pharmacist must verify, document and date the original prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & 689.505
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6410 Emergency Department Distribution

(1) A practitioner or associate practitioner with prescriptive authority in Oregon who is a member of the hospital's medical staff may dispense an emergency supply of drugs to a patient examined by them or by an associate practitioner subject to the following requirements:

(a) The prescriber must offer the patient the option of being provided a prescription that may be filled at the pharmacy of the patient’s choice;

(b) During consultation with the patient or the patient’s caregiver, the prescriber must clearly explain the appropriate use of the drug supplied and the need to have a prescription for any additional supply of the drug filled at a pharmacy of the patient’s choice;

(d) Except as described in SB 450 (2023), the drug is in a manufacturer’s unit-of-use container, such as an inhaler, or hospital pre-pack that has been labeled by the pharmacy with:

(A) Name of drug, strength, and number of units. When a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(B) Accessory cautionary information as required for patient safety;

(D) An expiration date after which the patient should not use the drug; and

(E) Name, address and phone number of the hospital pharmacy.

(e) Except as described in SB 450 (2023), the following information must be added to the drug container by the practitioner or nurse before dispensing to the patient:

(A) Name of patient;

(B) Directions for use by the patient;

(D) Unique identifying number as determined by policy and procedure;

(E) Name of prescribing practitioner; and

(F) Initials of the dispensing nurse or practitioner.

(f) A prescription or record of the distribution must be completed by the practitioner or nurse. This record must contain:

(A) Name of patient;

(B) Date of issuance;

(D) Units issued;

(E) Name of practitioner;

(F) Initials of the dispensing nurse or practitioner; and

(G) Instructions given to the patient as labeled.

(g) Any additional information required by state and federal laws and regulations for the distribution of a drug to an outpatient;

(h) The record must be reviewed and documented by a pharmacist for accuracy and completeness. The pharmacist must review the record of dispensing of drugs within 24 hours. However, if the pharmacy is closed, records shall be reviewed during the first day the pharmacy is open but not to exceed 72 hours following the dispensing; and

(i) Errors and discrepancies will be included in hospital and pharmacy QA review process and available to the board.

(2) A controlled substance may only be distributed or dispensed to an outpatient by the examining practitioner after the patient has been examined by the practitioner and a legitimate medical purpose for a controlled substance has been determined. Distribution of a controlled substance must comply with all applicable state and federal laws and regulations.

(3) The CPO or PIC and appropriate hospital committee will establish a limited selection and quantity of drugs to be included in the Emergency Department formulary and the amount contained in each pre-pack that may be distributed to meet only the acute care needs of a patient; for example, an emergency supply of drugs. The amount dispensed may not exceed a 48 hour supply except for:

(a) A drug in the manufacturer’s unit-of-use packaging such as an inhalant or a topical drug;

(b) A full course of therapy that may be dispensed if in the professional judgment of the pharmacist or practitioner this would be in the patient’s best interest such as an antibiotic;

(4) Any additional preparation for use of the medication must be completed prior to discharge; for example, reconstituting antibiotics;

(5) For the purpose of this rule an Automated Dispensing Machine (ADM) is a machine or contrivance which will prepare a completed and labeled prescription which is ready for dispensing to the patient or patient’s representative.

(6) An Automated Dispensing Machine; may only be located within the Emergency Department in a secure environment that has no direct public access, and when used, must be part of the discharge procedure;

(7) When the patient or patient’s representative receives the prescription from an ADM;

(a) A registered nurse or practitioner or pharmacist must be present at the time of dispensing; and

(b) A registered nurse or practitioner or pharmacist will grant access to the ADM for the release of the drugs to be dispensed using a password protected or biometric access; and

(8) Only a pharmacy technician, certified pharmacy technician, intern or pharmacist may access the drug supply in the ADM.

(9) The CPO or PIC will establish policies and procedures for use of the ADM including, but not limited to emergency access and down time procedures for the ADM.

(10) Upon written request, the board may waive any of the requirements of this rule if a waiver will further public health or safety. A waiver granted under this section must only be effective when it is issued in writing and will be time limited.

(11) Nothing in this rule is intended to restrict or conflict with HB 2395 (2023), SB 450 (2023), SB 1043 (2023).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.505, 2023 HB 2395, 2023 SB 450 & 2023 SB 1043
BP 5-2024, amend filed 02/15/2024, effective 02/15/2024
BP 35-2023, temporary amend filed 12/20/2023, effective 01/01/2024 through 06/28/2024
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 8-2012, f. & cert. ef. 12-21-12
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6420 Emergency Kit and Code Cart

An emergency kit consists of those drugs which may be required to meet the immediate therapeutic needs of in-patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients.

(1) An emergency kit may be placed in a code cart or as a stand-alone emergency kit.

(2) A pharmacist must verify and document the contents of each emergency kit.

(3) The CPO in cooperation with the appropriate hospital committee shall determine the list and quantity of drugs to be included in an emergency kit. The CPO must ensure that this list is reviewed annually.

(4) An emergency drug kit must use a tamper-evident system and be stored to prevent unauthorized access.

(5) All drugs in emergency kits and code carts must be labeled in accordance with OAR 855-041-6270.

(6) An emergency kit or code cart must be labeled to indicate that it is a drug supply for emergency use. A label must also contain the name, strength, quantity of all drugs in the kit or code cart and the expiration date of the kit. The label shall be affixed to or be available on the exterior of the code cart.

(7) The expiration date of an emergency kit or code cart must be the same as the earliest expiration date of any drug in the kit or cart. Prior to the expiration date, the pharmacist must replace expired drugs.

(8) Only an authorized person may remove a drug from an emergency kit or code cart. Any removal must be pursuant to a valid order or approved protocol.

(9) The pharmacy must be notified when an emergency kit or code cart has been opened or has expired and the pharmacist must restock or replace the emergency kit within a reasonable time.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6500 Practitioner’s Drug Order

(1) An order for a drug for an in-patient must be transmitted to the pharmacy using a system that produces a direct or an electronic copy.

(2) A pharmacist must review the drug order before the initial dose is dispensed, and must document the review and DUR except:

(a) When a drug is dispensed under OAR 855-041-6310;

(b) In an emergency;

(d) When a LIP is present.

(3) An order for a drug must contain:

(a) The patient’s name and location;

(b) The drug name and strength;

(d) Directions for use;

(e) The date and time; and

(f) The practitioner’s written or electronic signature, or the signature of the practitioner’s agent.

(4) The hospital must follow the following procedures for verbal drug orders:

(a) A verbal drug order should be used infrequently;

(b) A verbal drug order of an authorized individual may be accepted and transcribed only by a qualified person who has been identified by title or category in the hospital policies and procedures;

(d) A verbal order must be signed or initialed by the prescribing practitioner as soon as possible.

(5) A drug administered to a patient must be ordered by an authorized prescribing practitioner or otherwise allowed by these rules.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6510 In-patient Drug Profile

(1) Each pharmacist must ensure that a drug order for a patient requiring continuous drug therapy is entered into the patient’s drug profile. The profile must contain:

(a) The patient's name, location and important clinical data such as age, height, weight, sex, chronic disease states, problem list and allergies;

(b) The drug name, strength, dosage form, route of administration and directions for administration;

(d) The name or ID of the pharmacist responsible for entry or verification of the drug order.

(2) Prior to the drug being released for access by the nurse, a pharmacist must enter the drug order into a drug profile and perform a DUR except when:

(a) The drug is being dispensed from an after-hours cabinet in the absence of a pharmacist;

(b) The drug is from an emergency drug kit; or

(c) A system override is being used by a LIP or nurse to treat the emergency needs of a patient. Subject to a prescriber’s order, a sufficient quantity to meet the emergency needs of the patient may be used until a pharmacist is available to review and confirm the drug order.

(3) The pharmacist must continue to monitor the appropriateness of the patient’s drug utilization throughout the patient’s stay in the hospital.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6520 Cart-Fill

(1) A unit-dose cart-fill system is a pharmacy controlled unit-of-use drug distribution system.

(a) A unit-dose cart-fill system must provide for separation of drugs by patient name and location, and must be designed to record in an individual patient’s record:

(A) The drug, dose strength, and dosing regimen of those drugs dispensed by the pharmacy;

(B) The number of doses dispensed;

(b) The system must:

(A) Provide a means for the pharmacist to verify the prescriber's original order;

(B) Provide a means for the pharmacist to verify the accuracy of the selected drug before the dose is delivered for administration to the patient; and

(2) Controlled substances may be included in the unit-dose system if the system complies with all applicable state and federal laws and regulations.

(3) Each drug must be in unit-dose packaging when dispensed except when this is impracticable.

(4) A drug not dispensed in unit-dose packaging must be labeled in accordance with other rules in this Division.

(5) A drug in a single container multiple-dose package such as an inhaler or a topical drug must be labeled with the patient’s name and location within the facility.

(6) A pharmacy technician, certified pharmacy technician, intern or pharmacist may fill daily unit-dose drug supplies for a hospital in-patient or a nursing home patient.

(7) The pharmacist must verify the accuracy of a unit-dose package before the dose is delivered for administration to the patient.

(8) Each drug must be stored in a locked area or locked cart.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6530 Robotic Distribution Systems

(1) A robotic drug distribution system used in a central pharmacy must be in a secure area under the control of the PIC and must be connected with the system that contains the patient’s drug profile.

(2) The pharmacy must maintain the following documentation for each system:

(a) Details of the equipment including manufacturer's name, model and serial number;

(b) A description of how the system is used;

(A) Quality assurance performed at least quarterly including a requirement that a pharmacist visually verifies the accuracy of the electronic or bar code labeling using an audit procedure that includes random sampling;

(B) Procedures for training personnel in safe system operation, security, accuracy, patient confidentiality, access and downtime procedures.

(3) All distribution records must be recorded electronically and retained for 3 years or as approved by the Board. Records must include:

(a) Identity of robotic drug distribution system accessed;

(b) Type of transaction;

(d) Name, strength, dosage form, and quantity of the drug accessed;

(e) Identity of the patient for whom the drug was ordered;

(f) Any other information the PIC may deem necessary.

(4) Only a pharmacy technician, certified pharmacy technician, intern, pharmacist or a person designated by the PIC may have access to the system.

(5) Only a pharmacy technician, certified pharmacy technician, intern or pharmacist may stock drugs in the system.

(6) All drugs in the system must be packaged and labeled in accordance with state and federal laws and regulations.

(7) Controlled Substances:

(a) Controlled substances must be handled in accordance with all applicable state and federal laws and regulations;

(b) Schedule III, IV and V drugs may be stocked in a robotic drug distribution system provided there is adequate security to limit access to those personnel designated by the PIC;

(8) Drugs prepared by a robotic system must be packaged and separated by patient or as approved by hospital protocol, prior to distribution for administration.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & 689.508
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6540 Automated Distribution Cabinets

(1) Each ADC must be under the control of the pharmacy. The PIC must establish policies and procedures to meet the requirements of all applicable state and federal laws and regulations.

(2) Policies and procedures addressing the operation of the ADC must be maintained in the pharmacy. They must include:

(a) Training of personnel granted access to the ADC;

(b) System operation, safety, security, access, accuracy and patient confidentiality;

(d) Downtime procedures;

(e) A procedure for securing and accounting for any wasted, discarded or unused drug in accordance with existing state and federal laws and regulations.

(3) All events involving the contents of the ADC must be recorded and must include:

(a) Identity of ADC accessed;

(b) Identification of the individual accessing the ADC;

(d) Date and time of transaction;

(e) Name, strength, dosage form and quantity of the drug accessed;

(f) Name of the patient or patient identifier for whom the drug was ordered;

(g) Such additional information as the PIC may deem necessary.

(4) Only a pharmacist, pharmacy technician, certified pharmacy technician, intern or other person designated by the PIC may have access to the ADC.

(5) Stocking drugs in an ADC:

(a) Only a pharmacy technician, certified pharmacy technician, intern, pharmacist or other licensed healthcare personnel designated by the PIC may stock drugs in the ADC;

(b) A pharmacist must visually or electronically verify the name, strength and accuracy of the drug to be released from the central pharmacy for restocking;

(c) When a barcode or other electronic system is used to confirm the accuracy of the replenishment of the stock in an ADC, the system must receive an initial quality assurance validation;

(d) When all drug doses for an individual storage unit or bin have been packaged in one container, a single barcode verification may be used;

(e) The PIC must monitor the accuracy of the replenishment of drugs with a quality assurance process that includes:

(A) Reconciling the ADC fill list with established unit specific drugs using the drug profile, ADC discrepancy and inventory reports; and

(B) Monitoring the accuracy of the restocking and withdrawal procedures used by all hospital staff approved for drug administration.

(f) The PIC may permit medical supplies and devices to be included in the ADC.

(6) All drugs stored in the ADC must be packaged and labeled in accordance with state and federal laws and regulations.

(7) A drug that has been removed from the ADC for any purpose may not be returned to the system unless:

(a) A pharmacist has examined the drug, the packaging, and the labeling and determined that reuse of the drug is appropriate; or

(b) It is a drug, such as a multi-dose vial, which has been exempted by the appropriate hospital committee.

(8) At the time of loading, unloading, inventorying, removing or accessing any controlled substance from the ADC, a blind count or confirmation of the correct count must be conducted. Any discrepancy must be reported immediately to the PIC or pharmacist on duty who is responsible for reconciliation of the unresolved discrepancy or proper reporting of the loss.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6550 Secondary and Remote Storage

(1) All drugs must be stored in designated areas to ensure proper sanitation, temperature, light, ventilation, moisture control, and security.

(2) Drugs may only be stored in nursing units when space is available for the storage, security, and preparation of drug doses. Such space must include:

(a) A locked drug cabinet or room that is equipped so that each patient’s drugs are separated physically or electronically. Drugs may be stored in secured individual patient storage areas or individually labeled for each patient;

(b) A container or compartment that is permanently attached to a storage cart or the drug room in which controlled substances can be secured;

(c) Alcohol and other flammables must be stored in areas that meet local building code requirements for the storage of volatiles, and such other laws and regulations that apply.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6560 Floor-Stock

(1) A minimal quantity of drugs may be stocked in patient care areas to meet the immediate therapeutic needs of a patient where delay would interrupt the continuity of, or compromise the care of the patient.

(2) A hospital pharmacy must not use a floor-stock drug distribution system as its primary system of drug distribution except in departments staffed with a LIP such as the Emergency Room, Operating Rooms and Radiology.

(3) The CPO, in consultation with nursing staff, must prepare a list of drugs by identity and quantity for each area where such supplies are stocked. This list must be kept in the pharmacy.

(4) Floor-stock drug supplies must be stored in a secure area only accessible to pharmacy-authorized personnel.

(5) All drugs in floor-stock must be labeled in accordance with other rules in this Division.

(6) Drugs may only be removed from floor-stock by personnel authorized by the appropriate hospital committee. A drug may only be removed pursuant to a valid prescriber’s order. Removal from stock must be recorded in accordance with policy and in the patient's medical record.

(7) The CPO may permit medical supplies and devices to be included in the floor-stock.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6570 Trays and Kits

(1) All drug trays and kits must be prepared by the pharmacy prior to release from the central pharmacy except that trays and kits may be prepared from floor-stock by an LIP who administers the drug or by authorized hospital staff in the case of emergency use if:

(a) The pharmacy and appropriate hospital departments jointly develop guidelines for the proper use, preparation, and security for the trays or kits; and

(b) The pharmacy has a quality assurance program for monitoring the proper use, preparation and security of the kits.

(2) A pharmacist must verify the accuracy and secure the contents of each tray or kit prepared in the pharmacy prior to release from the central pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6600 Controlled Drug Accountability

(1) The hospital must establish procedures and maintain records to account for all controlled substances and any other drugs designated by the appropriate hospital committee. Records must include:

(a) Name of drug;

(b) Dose ordered, dose dispensed, and dose administered;

(d) Date and time of administration;

(e) Person administering the drug;

(f) Verification and documentation of any wasted drug including partial doses.

(2) The pharmacy must provide separately locked, securely affixed compartments for storage of controlled drugs and other drugs subject to abuse, except when the facility uses single-unit packaged drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.

(3) The pharmacy must obtain a delivery receipt for all controlled drugs supplied as floor-stock. This record must include the date, drug name and strength, quantity, hospital unit receiving drug and the signatures of the distributing pharmacist and the receiving nurse.

(4) A record must be kept of each administration of a controlled drug from floor-stock. The record must be returned to the pharmacy monthly and the PIC or designee must:

(a) Match returned records with delivery receipts to verify that all records are returned;

(b) Periodically audit administration records for completeness;

(c) Reconcile administration records with inventory and verify that sums carried from one record to the next are correctly recorded;

(d) Periodically verify that doses documented on administration records are reflected in the medical record; and

(e) Initial the returned record and file by date of issue.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.165 & 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6610 Schedule II Drugs

(1) In addition to the requirements above, Schedule II record keeping must include:

(a) A perpetual inventory system for all Schedule II drugs received, stored and distributed by the pharmacy. The perpetual inventory must be reconciled with an actual inventory at least monthly and the results and any discrepancies must be noted;

(b) Schedule II drugs stored as floor-stock in patient-care areas must be controlled with a perpetual inventory system that includes an actual inventory count and reconciliation when the department or nursing unit is open. The CPO must develop policies and procedure to ensure a regular audit of the inventory;

(c) Quality assurance procedures for the random sample of perpetual inventory sheets including sign-out sheets or other dose-by-dose documentation, must be performed at least quarterly and must be used to determine the accuracy and effectiveness of Schedule II floor-stock drug control;

(d) All Schedule II drugs stored in the pharmacy must be kept in a locked area or secured storage system that tracks the identity of each person making entry into and out of the system whenever a pharmacist is not physically present in the department.

(2) Policies and Procedures must specify the conditions under which Schedule II controlled substances can be transferred into or removed from an ADC.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.165 & 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6620 Electronic Safe Systems

(1) The pharmacy must maintain policies and procedures that address the operation of any electronic safe system. These policies must include:

(a) Training of personnel granted access to the electronic safe system;

(b) System operation, safety, security, access, accuracy and patient confidentiality;

(2) All events involving the contents of the electronic safe system must be recorded electronically. Such records must include:

(a) Identity of electronic safe system accessed;

(b) Identification of the individual accessing the electronic safe system;

(d) Date and time of transaction;

(e) Name, strength, dosage form, and quantity of the drug accessed;

(f) Name of the patient for whom the drug was ordered when applicable;

(g) Any additional information that the CPO requires.

(3) Only a pharmacist, pharmacy technician, certified pharmacy technician or intern may have access to the electronic safe system.

(4) Only a pharmacist, pharmacy technician, certified pharmacy technician or intern may stock drugs in the electronic safe system.

(5) All activities involving the electronic safe system must comply with all applicable state and federal laws and regulations.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.165 & 689.155
BP 3-2010, f. 4-29-10, cert. ef. 4-30-10

Or. Admin. R. 855-041-6800 Supervision of Consulting Pharmacist

(1) In a hospital having a drug room and no pharmacy, the drug room must be supervised by a licensed pharmacist who provides his or her services with sufficient professionalism, quality and availability to adequately protect the safety of the patients and to properly serve the needs of the facility. The arrangements for a consulting pharmacist shall be in writing, and shall, at a minimum, provide that:

(a) The pharmacist is to act in the capacity of a part-time director;

(b) The pharmacist shall provide on-call service at all times;

(d) All drugs supplies shall be labeled so as to insure that recalls can be effected and that proper control and supervision of such drugs may be exercised.

(2) One registered nurse supervisor and only one in any given shift may have access to the drug room and may remove drugs therefrom, except in an emergency situation. In that case, such nurse may designate another licensed nurse to obtain the required drug(s). Any access to the drug room deviating from the requirements of this section must be approved by the Board prior to implementation. The registered nurse supervisor shall be designated in writing by the appropriate committee of the hospital and shall, prior to being permitted to obtain access to the drug room, receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required. Such education and training shall be given by the director of pharmacy, who shall require, at a minimum, the following records and procedures:

(a) Drugs can only be removed from the drug room on a practitioner's written order, or verbal order which has been reduced to writing;

(b) A log of drugs withdrawn from a drug room shall be maintained and initialed by the registered nurse;

(3) The consultant pharmacist who is the part-time director of pharmaceutical services shall in concert with the appropriate committee of the hospital medical staff, develop policies and procedures which shall be implemented to provide emergency pharmaceuticals to outpatients during the hours when normal community or hospital pharmacy services are not available. Such policies shall allow the designated registered nurse supervisor to issue medications pursuant to the pharmacist's standing orders, which shall provide:

(a) A written order of a practitioner authorized to prescribe a drug is presented;

(b) The medication is prepackaged by a pharmacist and contains:

(A) Name, address and telephone number of the hospital;

(B) Name of drug, strength, and number of units; when a generic name is used, the label shall also contain the name of the manufacturer or distributor;

(D) Such other and further accessory cautionary information as required for patient safety;

(E) An expiration date after which the patient should not use the medication.

(c) No more than a 24-hour supply is provided to the patient, except when the pharmacist has informed the nurse supervisor that normal services will not be available within 24 hours;

(d) The container is labeled by the nurse supervisor before presenting to the patient, and shows the following:

(A) Name of patient;

(B) Directions for use to the patient;

(D) Identifying number;

(E) Name of prescribing practitioner;

(F) Initials of the supervisor.

(e) The original written order by the prescriber is retained for verification by the pharmacist after completion by the nurse supervisor and shall bear:

(A) Name and address of patient;

(B) Date of issuance;

(D) Initials of supervisor issuing medication.

(f) The original written order is verified by the pharmacist, initialed, dated, and filed in a separate location for a period of three years for Board inspection;

(g) The withdrawal of a single dose for immediate administration to the patient need not follow the requirements of subsection (d) of this section.

(4) Emergency Kits:

(a) Emergency Kit Drugs Defined. Emergency kit drugs are those drugs which may be required to meet the immediate therapeutic needs of in-patients, and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from such other source;

(b) Supplying Pharmacist. All emergency kit drugs shall be prepared by a licensed pharmacist;

(c) Drugs Included. The director of pharmacy and the medical staff of the hospital shall jointly determine and prepare a list of drugs, by identity and quantity, in amounts sufficient for immediate therapeutic requirements, to be included in emergency kits. Such list of drugs shall be reviewed annually by the appropriate medical staff committee;

(d) Storage. Emergency kits shall be stored in areas to prevent unauthorized access and to insure a proper environment for preservation of the drugs within them, as required in official compendia;

(e) Labeling — Interior. All drugs contained in emergency kits shall be labeled in accordance with OAR 855-041-6420;

(f) Labeling — Exterior. The exterior of emergency kits shall be labeled to clearly and unmistakably indicate that it is an emergency drug kit and it is for use in emergencies only; such label shall also contain a listing of the name, strength and quantity of the drugs contained therein and an expiration date;

(g) Expiration Date. The expiration date of an emergency kit shall be the earliest expiration date on any drug supplied in the kit. Upon the occurrence of the expiration date, the supplying pharmacist shall open the kit and replace expired drugs;

(h) Removal of Drugs. Drugs shall be removed from emergency kits by authorized personnel only pursuant to a valid order or by the supplying pharmacist;

(i) Notifications. Whenever an emergency kit is opened or has expired, the supplying pharmacist shall be notified and the pharmacist shall restock and reseal the kit within a reasonable time so as to prevent risk of harm to patients.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.205
Renumbered from 855-041-0135, BP 7-2012, f. & cert. ef. 12-17-12
PB 12-1989, f. & cert. ef. 8-11-89
1PB 2-1980, f. & ef. 4-3-80
1PB 3-1979(Temp), f. & ef. 10-31-79

Or. Admin. R. 855-041-6840 Drug Distribution and Control from a Drug Room in a Hospital

(1) General. The director of pharmacy shall establish and implement written procedures for the safe and efficient distribution of pharmaceutical products. An annually updated copy of such procedures shall be available for inspection by the Board.

(2) Availability. A pharmacist providing pharmaceutical services to a hospital maintaining a drug room shall be engaged by the hospital and shall schedule on-premises visits on at least a weekly basis.

(3) Span of Control. The pharmacist’s span of supervision shall extend to all areas of the hospital where drugs are stored. No less than every two months inspections of these areas shall be conducted and substantiated by records so as to verify at least proper drug storage, documentation of distribution and administration of controlled substances, absence of outdated drugs, and the integrity of the required emergency drug supply.

(4) Director’s Absence. In the absence of the director of the pharmaceutical service, pharmaceutical services shall be directed by a designated pharmacist.

(5) Responsibility. The director of pharmacy shall be responsible for procedures for the safe and efficient distribution of, control of and accountability for drugs. Accordingly, the director shall be responsible for, at a minimum, the following:

(a) Procedures for preparation and sterilization of parenteral medications manufactured within the hospital;

(b) Procedures for admixture of parenteral products, including education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information. When the admixture of parenteral products is not accomplished under the direct supervision of a pharmacist, such preparation shall be limited to a practitioner or registered nurse;

(d) Procedures for establishment of specifications for procurement of all pharmaceutical materials, including drugs, chemicals and biologicals, subject to approval of the appropriate committee of the hospital;

(e) Procedures for participation in the development and revisions of a hospital formulary system;

(f) Procedures for filling and labeling all stock containers from which drugs are to be administered;

(g) Maintaining and making available a sufficient inventory of antidotes and other emergency drugs, as well as current antidote information, telephone numbers of poison control center(s) and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the hospital;

(h) Records of all transactions of the hospital relating to pharmaceutical services as may be required by state or federal law, and maintenance of accurate control over and accountability for all pharmaceutical materials. The procedures shall include the keeping of accurate and complete records of the receipt, withdrawal from stock and use or other disposal of all legend drugs stored in the drug room and all other locations in the hospital;

(i) Participation in those aspects of the hospital’s patient care evaluation program which relate to pharmaceutical material utilization and effectiveness;

(j) Meeting all inspection and other requirements of the pharmacy and drug laws of this state and rules thereunder.

History

Statutory/Other Authority: ORS 689
Renumbered from 855-041-0140, BP 7-2012, f. & cert. ef. 12-17-12
1PB 2-1980, f. & ef. 4-3-80
1PB 3-1979(Temp), f. & ef. 10-31-79

Or. Admin. R. 855-041-7050 Definitions - Long Term Care Pharmacy

As used in OAR 855-041-7000 through 855-041-7080:

(1) "Long term care facility" means a facility with permanent facilities that include inpatient beds, providing medical services, including nursing services but excluding surgical procedures except as may be permitted by the rules of the director, to provide treatment for two or more unrelated patients. "Long Term Care facility" includes skilled nursing facilities and intermediate care facilities but may not be construed to include facilities licensed and operated pursuant to ORS 443.400 to 443.455.

(2) For the purposes of Schedule II prescriptions in 21 CFR 1306.11 (v. 04/01/2025), 21 CFR 1306.12 (v. 04/01/2025), 21 CFR 1306.13 (v. 04/01/2025), 21 CFR 1306.14 (v. 04/01/2025), and 21 CFR 1306.15 (v. 04/01/2025), the DEA definition of "long term care facility" as defined in 21 CFR 1300.01 (v. 04/01/2025) includes "community-based care facilities."

(3) "Community Based Care Facility" means a home, facility or supervised living environment licensed or certified or otherwise recognized by an agency of the state of Oregon which provides 24-hour care, supervision, and assistance with medication administration. These include but are not limited to Adult Foster Homes, Residential Care Facilities (RCF), Assisted Living Facilities (ALF), Intermediate Care Facilities for Individuals with Intellectual Disabilities and Inpatient Hospice.

(4) "Pharmaceutical Care" means the responsible provision of any or all of the following services by the pharmacist:

(a) Develop and maintain policies and procedures for pharmaceutical services;

(b) Provide direction and oversight regarding all aspects of the acquisition, disposition, handling, storage, and administration of drugs including but not limited to the following:

(A) Receipt and interpretation of physician's orders;

(B) Ordering and receiving of medications;

(D) Labeling of all drugs;

(E) Selection of drug delivery systems;

(F) Development of systems to provide timely delivery of drugs and supplies;

(G) Monitoring of drug storage conditions and expiration dates;

(H) Monitoring accuracy and efficiency of medication administration and compliance with physician's orders;

(I) Establishing and monitoring of appropriate record keeping;

(J) Accountability of controlled substances;

(K) Return, release, and/or destruction of discontinued or outdated drugs; and

(L) Compliance with state and federal laws and regulations related to pharmaceutical services and medication management.

(d) Perform drug regimen review for each resident on a regularly scheduled basis for the purpose of promoting therapeutic appropriateness and achieving the desired drug therapy outcomes by identifying issues such as:

(A) Over-utilization or underutilization;

(B) Therapeutic duplication;

(D) Drug-drug interactions;

(E) Incorrect drug, drug dosage or duration of drug treatment;

(F) Drug-allergy interaction;

(G) Clinical abuse/misuse;

(H) Untreated indication;

(I) Monitoring and assessing of drug therapy outcomes;

(e) Communicate effectively with residents' physicians and facility staff; and

(f) Participate in resident care planning.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 18-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0145, BP 7-2012, f. & cert. ef. 12-17-12
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
PB 8-1990, f. & cert. ef. 12-5-90
1PB 2-1980, f. & ef. 4-3-80

Or. Admin. R. 855-041-7060 Long Term Care Pharmacy - Drug Distribution and Control

(1) Pharmacies or pharmacists that supply emergency drug kits to and/or accept returned medications from long term care facilities or community based care facilities must:

(a) Assist in the establishment and supervision of:

(A) The policies and procedures for the safe storage, distribution, administration, and disposition of drugs;

(B) The maintenance of controlled drug accountability records; and

(b) Have some pharmacists visit and provide consultant services on a regular basis; and

(c) Supervise the implementation of the policies and procedures involving the security, storage, stocking, labeling, and notification of use of emergency drugs kits and supplemental drug supplies.

(2) Arrangements can be made in advance by a provider pharmacy with a long term care facility or a community based care facility to:

(a) Provide emergency drug kits to those facilities permitted by their license to have them; and

(b) Allow only a designated licensed nurse present in the facility access to the emergency drug kit or the on-site pharmacy pursuant to OAR 855-041-6310.

(3) An emergency drug kit consists of those drugs that may be required and are authorized by a practitioner to meet the immediate therapeutic needs of patients, when medication is not readily available directly from a pharmacy.

(4) The emergency drug kit inventory is the property of the provider pharmacy, and the provider pharmacy consultant is responsible for developing the policy and procedures for storing and stocking the emergency drug kit.

(5) Medication(s) can only be removed from the emergency drug kit or the on-site pharmacy by a designated licensed nurse pursuant to a practitioner's order.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 16-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0160, BP 7-2012, f. & cert. ef. 12-17-12
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
PB 8-1990, f. & cert. ef. 12-5-90
PB 1-1990, f. & cert. ef. 1-23-90
1PB 2-1981, f. & ef. 8-20-81
1PB 1-1981(Temp), f. & ef. 4-1-81
1PB 2-1980, f. & ef. 4-3-80

Or. Admin. R. 855-041-7070 Long Term Care Pharmacy - Labeling and Distribution

(1) Except as provided in subsection (2) of this section, all drugs dispensed for individual patients must be labeled as required by OAR 855-041- 1120, or administered by health care professionals from a unit dose system as defined in OAR 855-041- 6050(j).

(2) Pharmacies that provide long term care facilities or community based care facilities with pharmaceuticals can supply, on the order of a practitioner, and consistent with the policy and procedures of the pharmacy or pharmacist providing consultant services:

(a) Injectables for immunization and screening;

(b) Irrigation solutions; and

(3) Institutional pharmacies that dispense medications to patients in long term care facilities and community based care facilities must maintain for three years the records required by OAR 855-041-1120, and comply with the patient counseling requirements of OAR 855-115-0145.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 46-2024, minor correction filed 04/11/2024, effective 04/11/2024
BP 14-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0162, BP 7-2012, f. & cert. ef. 12-17-12
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02

Or. Admin. R. 855-041-7080 Pharmaceutical Care in Community Based Care Facilities

When a pharmacist provides pharmaceutical care to patients in a Community Based Care facility under an arrangement with the facility, the pharmacist may provide the following services:

(1) Assist facilities in establishing the appropriate policies and procedures for distribution, storage, documentation and disposal of drugs;

(2) Assist facilities in establishing and maintaining proper record keeping related to medication administration;

(3) Visit the facility on a regularly scheduled basis;

(4) Supervise the distribution and storage of drugs;

(5) Assist in providing appropriate training, in-service education, and clinical support to facility staff; and

(6) Communicate with physicians and other practitioners as needed.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
Renumbered from 855-041-0164, BP 7-2012, f. & cert. ef. 12-17-12
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02

Or. Admin. R. 855-041-8050 Emergency Drug Supply in Home Health Care Agencies

Pharmacists serving home health care agencies may provide for an emergency supply of drugs to be made available to registered nurses to treat immediate therapeutic needs of their patients or clients during such time as the pharmacy services are not available. Arrangements shall be made in advance by the provider pharmacist for provision of the emergency drug supply:

(1) Emergency drugs defined. Emergency drugs are those non-controlled substances which may be required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in a timely manner;

(2) Portable Container. Subject to all provisions of this section, a licensed pharmacy may furnish to a home health agency licensed by the State an emergency drug supply in a portable container for emergency in home treatment or adjustment of drug therapy by the home health agency nurse;

(3) Drugs included. The pharmacist(s) and the practitioner(s) who represent the agency shall jointly determine and review annually a list of items and quantities to be included in the emergency supply. Drugs shall only be available therein, in amounts sufficient for immediate therapeutic requirements. The selected list shall include only drugs to treat the following specific conditions:

(a) Allergic reactions;

(b) Diabetic emergencies;

(d) Pulmonary congestion or congestive heart failure;

(e) Local or topical anesthetics for catheter and needle placement;

(f) Hydration due to hypovolemia or shock;

(g) Routine catheter maintenance; and

(h) Narcotic analgesic overdose.

(4) Security. The emergency drug supply shall be stored in a manner to prevent loss of drugs, and available only to authorized licensed personnel. It may be kept in a room adjacent to the locked pharmacy, or in a secure area in the Home Health/Home I.V. nursing office;

(5) Storage. The emergency drug supply shall be stored in areas suitable to prevent unauthorized access and to insure a proper environment for preservation of the drugs as required in official compendia;

(6) Labeling-Exterior. The exterior of the emergency drug supply shall be labeled to clearly indicate it as an emergency supply. Labeling shall also include the expiration date of the drug supply. A complete listing of the contents of the supply shall be readily available;

(7) Labeling-Interior. All drugs contained in the emergency medication supply shall in the manufacturer's container or be labeled in accordance with OAR 855-041-1135;

(8) Drugs added to parenteral solutions. Whenever any drug is added to a parenteral solution, whether within or outside the direct personal supervision of a pharmacist, such admixtures shall be labeled with a distinctive supplementary label indicating the name and amount of the drug added, date and time of addition, expiration date, administration time and infusion rate when applicable, and name or initials of person so adding. This excludes any single dose medication prepared and totally administered immediately;

(9) Removal of drugs. Emergency drugs shall be removed for administration only by authorized licensed personnel pursuant to a prescriber's order. A copy of this order shall be forwarded to the provider pharmacist within 72 hours to be reviewed and filed in the pharmacy. Verification of this review shall be a hand written initial of the reviewing pharmacist on that copy of the order;

(10) Expiration Date. The expiration date of the emergency drug supply shall indicate the month and year, and shall be the earliest expiration date of any drug in the supply. The provider pharmacist shall examine the supply and replace drugs prior to their expiration.

History

Statutory/Other Authority: ORS 475.035 & 689.205
Statutes/Other Implemented: ORS 689.225
BP 7-2012, f. & cert. ef. 12-17-12
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02, Renumbered from 855-041-0165
PB 1-1996, f. & cert. ef. 4-5-96, Renumbered from 855-041-0183

Division 42 NUCLEAR PHARMACIES AND PHARMACISTS

Or. Admin. R. 855-042-0005 Purpose and Scope

(1) Any person who provides radiopharmaceutical services shall be a nuclear pharmacist or working under the supervision of a nuclear pharmacist and shall act in accordance with the State Board of Pharmacy and State Radiation Control Agency rules.

(2) These rules shall not apply to anyone who is an “authorized practitioner” as that term is defined in these rules.

(3) The requirements imposed by these nuclear pharmacy rules shall apply in addition to, and not in place of, any other requirements contained in rules of the State Board of Pharmacy, the State Radiation Control Agency, or any other state or federal agency.

History

Statutory/Other Authority: ORS 689
PB 7-1987, f. & ef. 7-8-87

Or. Admin. R. 855-042-0010 Definitions

(1) A “Nuclear Pharmacy” is a pharmacy providing radiopharmaceutical services.

(2) “Nuclear Pharmacist” means a licensed pharmacist who has met the requirements of these rules regarding training, education, and experience, and has received a letter of notification from the board indicating the board recognizes the pharmacist, based on evidence submitted, as qualified to provide radiopharmaceutical services.

(3) “Radiopharmaceutical Services” shall mean, but shall not be limited to, the compounding, dispensing, labeling and delivery or radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation management and control of a nuclear pharmacy.

(4) A “Radiopharmaceutical” is any substance defined as a drug in Section 201(g)(1) of the federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive. This definition includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.

(5) “Radiopharmaceutical Quality Assurance” means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records.

(6) “Internal Test Assessment” means, but is not limited to, conducting those tests of quality assurance necessary to insure the integrity of the test.

(7) “Authentication of Product History” means, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical.

(8) “Authorized Practitioner” means a practitioner duly authorized by law to possess, use, and administer radiopharmaceuticals.

History

Statutory/Other Authority: ORS 689
PB 7-1987, f. & ef. 7-8-87

Or. Admin. R. 855-042-0015 Nuclear Pharmacies

(1) Every nuclear pharmacy shall have a nuclear pharmacist designated on the nuclear pharmacy registration as the pharmacist-in-charge who shall be responsible for the nuclear pharmacy’s compliance with laws and rules, both state and federal, pertaining to the practice of nuclear pharmacy. All personnel performing tasks in the preparation and distribution of radiopharmaceuticals shall be under the supervision of a nuclear pharmacist. The nuclear pharmacy pharmacist-in-charge shall see that directives from the board are communicated to the owner(s), management, other pharmacists, and interns of the nuclear pharmacy. A pharmacist may be pharmacist-in-charge for no more than one nuclear pharmacy at any one given time.

(2) Nuclear pharmacies shall have adequate space, commensurate with the scope of services to be provided. The nuclear pharmacy area shall be separate from the pharmacy areas for nonradio-pharmaceuticals and shall be secured from access by unauthorized personnel. Detailed floor plans shall be submitted to the State Board of Pharmacy and the State Radiation Control Agency before approval of the registration.

(3) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with accepted professional standards of radiopharmaceutical quality assurance.

(4) Nuclear pharmacies shall maintain records of acquisition and disposition of all radiopharmaceuticals in accordance with applicable rules of the state Board of Pharmacy, the State Radiation Control Agency and other state and federal agencies.

(5) For nuclear pharmacies handling radiopharmaceuticals exclusively, the State Board of Pharmacy may waive regulations pertaining to the pharmacy registration for nonradiopharmaceuticals for requirements that do not pertain to the practice of nuclear pharmacy.

(6) Radiopharmaceuticals are to be dispensed only upon a prescription from a practitioner authorized to possess, use and administer radiopharmaceuticals. A nuclear pharmacy may also furnish radiopharmaceuticals for office use to these practitioners.

(7) A nuclear pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with regulations of the state radiation control agency.

(8) Prescriptions or medication orders for radiopharmaceuticals shall include:

(a) The name of the practitioner and/or institution;

(b) The name of the radiopharmaceutical;

(d) The date and time of calibration, and volume.

(9) In addition to any labeling requirements of the state Board of Pharmacy for nonradiopharmaceuticals, the outer container of any radiopharmaceutical to be dispensed shall also be labeled with:

(a) The prescription number and the patient’s name (of the words “Physician Use Only” in the absence of the name of the patient);

(b) The standard radiation symbol;

(d) The name of the radiopharmaceutical;

(e) The lot number;

(f) The amount of radioactive material contained in millicuries, microcuries, or their SI equivalent;

(g) If a liquid, the volume in milliliters;

(h) The requested calibration date and time; and

(i) Expiration date and/or time, if applicable;

(j) Specific concentration of radioactivity;

(k) The name and address of the practitioner and/or institution that ordered the radiopharmaceuticals.

(10) The immediate inner container of a radiopharmaceutical shall be labeled with:

(a) Standard radiation symbol;

(b) The words “Caution — Radioactive Material”; and

(d) The prescription number;

(e) The name of the nuclear pharmacy;

(f) The date; and

(g) The amount of radioactive material in millicuries, microcuries, or their SI equivalent.

(11) The amount of radioactivity shall be determined by radiometric methods for each individual preparation immediately prior to dispensing.

(12) Nuclear pharmacies may redistribute NDA (New Drug Application) approved radiopharmaceuticals to authorized persons if the pharmacy does not process the radiopharmaceuticals in any manner or violate the product packaging.

(13) The nuclear pharmacy shall have the current revisions of state laws and rules of the State Board of Pharmacy and State Radiation Control Agency.

(14) The nuclear pharmacy shall maintain a reference library commensurate with the level of radiopharmaceutical service to be provided and shall include, in addition to the requirements listed in OAR 855-041-0040;

(a) Oregon radiation control regulations;

(b) CFR Title 10, Parts 0–199, with current amendments; and

History

Statutory/Other Authority: ORS 475.035 & 689.205
PB 1-1994, f. & cert. ef. 2-2-94
PB 7-1987, f. & ef. 7-8-87

Or. Admin. R. 855-042-0025 Minimum Equipment Requirements

(1) Nuclear pharmacies shall have adequate equipment commensurate with the scope of radiopharmaceutical services to be provided. A detailed list of equipment and description of use must be submitted to the State Board of Pharmacy and Radiation Control Agency before approval of the license.

(2) The State Board of Pharmacy may, for good cause shown, waive rules pertaining to the equipment and supplies required for nuclear pharmacies handling radiopharmaceuticals exclusively.

History

Statutory/Other Authority: ORS 689
PB 7-1987, f. & ef. 7-8-87

Division 43 PRACTITIONER DISPENSING

Or. Admin. R. 855-043-0002 Definitions

In this division of rules:

(1) "Administer" means the direct application of a drug or device whether by injection, inhalation, ingestion, or any other means, to the body of a patient by:

(a) A practitioner or the practitioner’s authorized agent; or

(b) The patient at the direction of the practitioner.

(2) "Counseling" means an oral or other appropriate communication process between a practitioner and a patient or a patient's agent in which the practitioner obtains information from the patient or patient's agent, and, where appropriate, the patient's medical records, assesses that information and provides the patient or patient's agent with professional advice regarding the safe and effective use of the drug or device for the purpose of assuring therapeutic appropriateness.

(3) "Dispense" or "Dispensing" means the preparation and delivery of a prescription drug pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.

(4) “Expedited Partner Therapy (EPT)” means the practice of prescribing or dispensing an antibiotic drug for the treatment of a sexually transmitted disease to the partner of a patient without first examining that partner.

(5) "Formulary" means a list of drugs or classes of drugs, or a list of disease states, health conditions or preventative measures such as immunization or birth control approved by the board or by the Oregon Health Authority (OHA).

(6) "Health Officer" means a physician licensed by the Oregon Medical Board or the Oregon Board of Naturopathic Medicine and employed by or under contract with a county or district health department or OHA.

(7) “Supervising Physician Dispensing Outlet” (SPDO) means any clinic, office, health care center, treatment center, or other establishment from which a physician assistant dispenses drugs, but that is not otherwise registered with the Board in the category of Retail Drug Outlet.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 3-2012, f. & cert. ef. 6-19-12
Renumbered from 855-043-0120, BP 1-2010, f. & cert. ef. 2-8-10
PB 4-1992, f. & cert. ef. 8-25-92
PB 2-1992, f. & cert. ef. 3-26-92

Or. Admin. R. 855-043-0003 Expedited Partner Therapy

(3) The law specifies that a prescription issued in the practice of Expedited Partner Therapy is valid, even if the name of the patient the prescription is intended for is not on the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 1-2010, f. & cert. ef. 2-8-10

Or. Admin. R. 855-043-0004 Expedited Partner Therapy (EPT) - Procedures

(1) Notwithstanding any other rules in this division that mandate requirements for a valid prescription and for labeling, when a prescription is marked EPT or a similar notation by the prescribing practitioner, this rule governs.

(2) An EPT prescription may only be dispensed for a drug that has been determined by the Oregon Health Authority to be appropriately used for EPT.

Prescription

(3) An EPT treatment protocol must conform to the following:

(a) It must include a prescription for each named or unnamed partner of the patient;

(b) It must contain a hand written or electronic signature of the prescribing practitioner;

(A) Write “for EPT,” or a similar notation, on the face of the prescription;

(B) For a verbal order, the practitioner must identify the prescription as an “EPT Prescription,” or similar identification;

(d) An EPT Prescription expires 30 days after the date written;

(e) An EPT Prescription may not be refilled;

(f) If any component of the prescription is missing, the DPDO must contact the prescriber or the prescriber’s agent and must record the additional information on the prescription.

(4) A patient may give the prescription to each unnamed partner for that person to fill at a pharmacy of their choice; or the patient may elect for a DPDO to dispense all prescriptions and then give the dispensed drugs to each unnamed partner.

Labeling

(5) The DPDO must label the drug for the named patient in accordance with normal procedures as specified in the other rules of this division, however when either the patient or partner is unnamed, the DPDO may create a unique identifier and use that instead of a name for both labeling and record keeping purposes.

(6) The DPDO must assign a separate and unique identifier to each prescription and clearly identity this number on each corresponding prescription label.

Counseling

(7) The DPDO is not required to obtain an EPT patient’s or partner’s name, address, or demographics; however, the DPDO must:

(a) Provide counseling in the form of written patient information to accompany each prescription for each partner and ask the patient about any known allergies or other drugs being taken by each partner. The DPDO should advise the patient to encourage each partner to call the DPDO before taking the drug if they have experienced any adverse effect from a drug in the past or if they are taking other drugs;

(b) Document counseling.

Records

(8) All documentation required by this rule must be attached to the prescription and must be referenced to each partner’s prescription. Such documentation must be retained in accordance with the other rules in this division and must be made available to the board upon request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505
BP 40-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-043-0505 Dispensing Practitioner Drug Outlets - Purpose

Unless subject to an exemption in OAR 855-043-0510(2), a practitioner that engages in dispensing human prescription drug therapies must register their dispensing site with the board as a Dispensing Practitioner Drug Outlet (DPDO).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0510 Temporary rule language in effect until 12/13/2026. Dispensing Practitioner Drug Outlets - Registration

(1) Unless subject to an exemption in OAR 855-043-0510(2), a practitioner that engages in dispensing human prescription drug therapies must register the dispensing site with the board as a DPDO on a form prescribed by the board, and must renew its registration annually on a renewal form prescribed by the board.

(2) A practitioner’s facility is exempt from this registration requirement if the practitioner and facility only engages in:

(A) Dispensing FDA approved drug samples; or

(B) Dispensing Medication Assistance Program (MAP) drugs; or

(D) Dispensing natural thyroid supplemental products; or

(E) Dispensing a small amount of drugs to start therapy or incidental to a procedure or office visit, up to a 72 hour supply; or

(F) An amount greater than a 72 hour supply if the drug is:

(i) A drug in the manufacturer’s original unit-of-use packaging, such as a metered-dose-inhaler or bottle of fluoride rinse; or

(ii) A full course of therapy, if in the professional judgment of the practitioner would be in the patient’s best interest, such as a course of antibiotic therapy.

(3) The initial and renewal applications must state the location of the DPDO and the name of the person applying for registration. When the person applying for registration is not the owner of the dispensing site, the application must disclose the name and address of the owner and the applicant’s affiliation with the owner.

(a) If more than one individual owns the dispensing site, the names and addresses of the partners or persons holding the three largest ownership interests in the dispensing site must be disclosed on the application.

(b) If the owner is a corporation, the application must state the name of the corporation as filed with the Corporation Division of the Oregon Secretary of State, including the names of the corporation’s officers.

(4) Upon request by the board the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

(5) An initial and renewal applications must be accompanied by the fee established OAR 855-110.

(6) A certificate of registration will be issued upon board approval of the application.

(7) The DPDO registration expires March 31, annually. If the annual renewal fee is not paid by March 31 of the current year, the applicant for renewal must submit the late renewal fee established in OAR 855-110 with the renewal application.

(8) The registration is not transferable and the registration fee cannot be prorated.

(9) The registrant must notify the board 15 days prior to any substantial change to the information provided on the registration application. Substantial change includes but is not limited to: change of ownership; change of business name; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, or officers.

(10) A new registration form is required for a change of ownership or location and must be submitted to the board with the fees as specified in OAR 855-110 15 days prior to the change.

(11) The board may grant a time-limited waiver exempting DPDO registration when a practitioner licensing board submits a request to the board with a plan to inspect the dispensing facility as approved by the board.

(12) All Supervising Physician Dispensing Outlet registrations expire on March 31, 2022. Outlets that utilize dispensing Physician Assistants must apply for and be granted registration as a Dispensing Practitioner Drug Outlet upon the expiration of the Supervising Physician Dispensing Outlet Registration unless subject to an exemption in OAR 855-043-0510(2).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.125, ORS 689.155 & ORS 689.305
BP 9-2026, temporary amend filed 06/17/2026, effective 06/17/2026 through 12/13/2026
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0520 Dispensing Practitioner Drug Outlets - Policies and Procedures

The registered DPDO must maintain written policies and procedures for the management of drugs intended for dispensing, to include security, acquisition, storage, dispensing and drug delivery, disposal and record keeping.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 24-2021, minor correction filed 10/21/2021, effective 10/21/2021
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0525 Dispensing Practitioner Drug Outlets - Security

(1) All drugs must be kept in a locked drug cabinet or designated drug storage area that is sufficiently secure to deny access to unauthorized persons. The drug cabinet or designated drug storage area must remain locked and secured when not in use.

(2) A drug dispensing machine cannot be placed in a waiting room or an area that is accessible by the public.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 25-2021, minor correction filed 10/21/2021, effective 10/21/2021
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0530 Dispensing Practitioner Drug Outlets - Drug Procurement

The registered DPDO may only receive drugs from an Oregon Registered Drug Outlet (e.g. Wholesaler, Manufacturer or Pharmacy).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0535 Dispensing Practitioner Drug Outlets - Drug Storage

All drugs must be stored according to manufacturer’s published guidelines and be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 26-2021, minor correction filed 10/21/2021, effective 10/21/2021
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0540 Dispensing Practitioner Drug Outlet - Labeling

(1) Except as described in SB 450 (2023), a prescription must be labeled with the following information:

(a) Name of patient;

(b) Name of prescriber;

(d) Date of dispensing;

(e) Name and strength of the drug. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated;

(f) Quantity dispensed;

(g) Directions for use;

(h) Cautionary statements, if any, as required by law; and

(i) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must be the same as that on the original container or one year from the date the drug was originally dispensed and placed in the new container, whichever date is earlier. Any drug expiring before the expected length of time for course of therapy must not be dispensed.

(j) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules.

(2) Not withstanding any other requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, as described in OAR 855-043-0004, the name of the patient may be omitted.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & 2023 SB 450
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0541 Dispensing Practitioner Drug Outlet - Limited English Proficiency and Accessibility

(1) Upon request of a patient or a patient's agent, each drug dispensed by a drug outlet for a patient's self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

(2) When dispensing a drug under (1), a drug outlet must provide labels and informational inserts in both English and one of the following languages:

(a) Spanish;

(b) Russian;

(d) Arabic;

(e) Chinese (simplified);

(f) Vietnamese;

(g) Farsi;

(h) Korean;

(i) Romanian;

(j) Swahili;

(k) Burmese;

(l) Nepali;

(m) Amharic; and

(n) Pashtu.

(3) The board must reassess and update (2) as necessary and at least every ten years.

History

Statutory/Other Authority: ORS 689.564
Statutes/Other Implemented: ORS 689.205
BP 98-2020, adopt filed 12/23/2020, effective 01/01/2021

Or. Admin. R. 855-043-0545 Dispensing Practitioner Drug Outlets - Dispensing and Drug Delivery

(1) Prescription drugs must be personally dispensed by the practitioner unless otherwise authorized by the practitioner's licensing board.

(2) Drugs dispensed from the DPDO must be dispensed in compliance with the requirements of the practitioner's licensing board.

(3) A DPDO must comply with all requirements of State or federal law.

(4) A DPDO must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2025), 16 CFR 1701 (v. 01/01/2025) and 16 CFR 1702 (v. 01/01/2025).

(5) Dispensed drugs must be packaged by the DPDO, a pharmacy, or a manufacturer registered with the board.

(6) A DPDO may not accept the return of drugs from a previously dispensed prescription and must maintain a list of sites in Oregon where drugs may be disposed.

(7) A DPDO may deliver or mail prescription to the patient if:

(a) Proper drug storage conditions are maintained; and

(b) The DPDO offers in writing, to provide direct counseling, information on how to contact the practitioner, and information about the drug, including, but not limited to:

(A) Drug name, class and indications;

(B) Proper use and storage;

(D) Precautions and contraindications; and

(E) Significant drug interactions.

(8) The DPDO must ensure that all prescriptions, prescription refills, and drug orders are correctly dispensed in accordance with the prescribing practitioner's authorization and any other requirement of State or federal law.

(9) Unless an exemption applies, each authorized dispenser of a prescription drug product for which a Medication Guide is required must provide the Medication Guide directly to each patient or patient's agent when the product is dispensed.

(10) The DPDO must ensure that compounded preparations are dispensed in compliance with OAR 855-183.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 8-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0550 Dispensing Practitioner Drug Outlets - Disposal of Drugs

Drugs that are recalled, outdated, damaged, deteriorated, misbranded, adulterated, or identified as suspect or illegitimate must be documented, quarantined and physically separated from other drugs until they are destroyed or returned to the supplier.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 27-2021, minor correction filed 10/21/2021, effective 10/21/2021
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0555 Dispensing Practitioner Drug Outlets - Records

(1) A unique dispensing record must be maintained, be readily retrievable, and kept for a minimum of three years. The record must show, at a minimum, the following:

(a) Name of patient;

(b) Dose, dosage form, quantity dispensed and either the brand name of drug, or generic name and name of manufacturer or distributor;

(d) Date of dispensing; and

(e) Initials of person dispensing the prescription.

(2) All records of receipt and disposal of drugs must be kept for a minimum of three years.

(3) All records and documents required by ORS 475, ORS 689, and OAR 855:

(a) Must be stored on-site for 12 months and must be provided to the board immediately upon request at the time of inspection;

(b) May be stored in a secured off-site location after 12 months of on-site storage and must be provided to the board upon request within three business days; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0560 Temporary rule language in effect until 12/13/2026. Dispensing Practitioner Drug Outlets - Inspections

(1) The DPDO must annually complete a self-inspection using the board's DPDO Self-Inspection Form by July1 and retain for board inspection.

(2) Each DPDO will be inspected on a routine basis and must be scheduled in advance with the DPDO, to occur during normal business hours.

(3) The inspection must focus on the acquisition, storage, labeling and recordkeeping of drugs intended for dispensing and any violation will apply to the DPDO registration and not to the practitioner.

(4) The Board of Pharmacy must notify the practitioner’s licensing board of any disciplinary action taken against a DPDO.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 9-2026, temporary amend filed 06/17/2026, effective 06/17/2026 through 12/13/2026
BP 12-2023, amend filed 06/13/2023, effective 08/01/2023
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2017, adopt filed 11/30/2017, effective 12/01/2017

Or. Admin. R. 855-043-0600 Correctional Facility - Purpose and Scope

A correctional facility is defined as an institutional drug outlet and as such is subject to the rules of the State Board of Pharmacy. Drug dispensing in a correctional facility shall be from a pharmacy or from a drug room. The facility shall have a pharmacist who acts as a consultant to the institution, develops policies and procedures on drug distribution, procurement and management, monitors for compliance, performs drug utilization reviews, and may delegate registered nurses to withdraw drugs for administration to patient/inmates.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.005, ORS 689.155 & ORS 689.605
BP 39-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0170, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1996, f. & cert. ef. 4-5-96

Or. Admin. R. 855-043-0610 Correctional Facility - Definitions

(1) “Administer” means the direct application of a drug or device whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by:

(a) A practitioner or the authorized agent thereof; or

(b) The patient or research subject at the direction of the practitioner.

(2) “Bulk Drug Container” means a bottle or package of medication, other than unit dose, labeled by a manufacturer or pharmacist.

(3) “Container” is the device that holds the medication and that is or may be in direct contact with the medication.

(4) “Correctional Facility” means any prison, jail, or detention facility for the confinement of juveniles or adults.

(5) “Dispense” or “Dispensing” means the preparation and delivery of a prescription drug pursuant to the lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug.

(6) “Drug Room” means a secure and lockable location within an inpatient care facility that does not have a licensed pharmacy.

(7) “Institutional Drug Outlet” means hospitals and inpatient care facilities where medications are dispensed to another health care professional for administration to patients served by the hospitals or facilities.

(8) “Medication card” means a medication container, labeled as required in OAR 855-041-0177(4), which provides multiple doses of a single medication with each dose contained in a separate, tamper-evident, sealed compartment.

(9) “Practitioner” means a person licensed and operating within the scope of such license to prescribe and dispense, conduct research with respect to or administer drugs in the course of professional practice or research:

(a) In this state; or

(b) In another state or territory of the United States not residing in Oregon and registered under the Federal Controlled Substances Act.

(10) “Unit dose” means a sealed, single-unit container so designed that the contents are administered to the patient as a single dose, direct from the container and which bears a separate label showing the name and strength of the medication, the name of the manufacturer or distributor, an identifying lot number and, if applicable, the expiration date of the medication.

(11) “Unit Dose Dispensing System” means a system which utilizes unit dose as its principle means of distributing drugs within a correctional facility.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.005 & ORS 689.155
BP 35-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0173, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1996, f. & cert. ef. 4-5-96

Or. Admin. R. 855-043-0620 Correctional Facility - Duties of the Pharmacist

(1) May delegate to a registered nurse the authority to withdraw prescription drugs from a unit dose system or from a manufacturer’s or pharmacist’s labeled container for administration to persons confined in the facility;

(2) Develop written policies and procedures with the practitioner representing the facility regarding medication management;

(3) Monitor the facility’s compliance with policies and procedures regarding medication management;

(4) Perform drug utilization review including timely, routine prospective review of specific individual therapies as well as retrospective drug regimen reviews, and drug use review and evaluation.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.605 & ORS 689.155
BP 34-2020, minor correction filed 08/06/2020, effective 08/06/2020
Renumbered from 855-041-0175, BP 7-2012, f. & cert. ef. 12-17-12
PB 1-1996, f. & cert. ef. 4-5-96

Or. Admin. R. 855-043-0630 Correctional Facility (CF) - Drug Delivery and Control

(1) Policies and Procedures: The Pharmacist and the practitioner representing the facility are responsible for establishing written policies and procedures for medication management including, but not limited to, drug procurement, dispensing, administration, labeling, medication counseling, drug utilization review, medication records, parenterals, emergency and nonroutine dispensing procedures, stop orders, over-the-counter drugs, security, storage and disposal of drugs within the facility. Policies and procedures must be reviewed and updated annually by the Pharmacist and the practitioner, maintained in the facility; and be made available to the board for inspection. The facility must submit to the board for approval, the name of any employee Pharmacist or a written agreement between the Pharmacist and the facility regarding drug policies and procedures. The facility must notify the board of any change of Pharmacist within 15 days of the change.

(2) Dispensing: Prescription drugs must be dispensed by a Pharmacist or by a practitioner authorized to dispense in either an individual container, medication card, or in a unit dose system. The Correctional Facility (CF) must ensure that compounded preparations are dispensed in compliance with OAR 855-183.

(3) Unit Dose Dispensing System. The “Unit Dose Dispensing System” is that drug distribution system which is pharmacy based and which uses unit dose packaging in a manner which removes traditional drug stock from patient care areas and enables the selection and distribution of unit dose packaging to be pharmacy based and controlled:

(a) A unit dose dispensing system must:

(A) By nature of the system;

(i) Provide for separation of medications by patient name and location; and

(ii) Provide for separating medications by day of administration.

(B) By means of an individual patient medication record:

(i) Record the drug and dosing regimen of those drugs dispensed by the pharmacy;

(ii) Record the actual doses dispensed and returned to the pharmacy;

(iii) Record the date of the original order and the date the order is discontinued;

(iv) Provide a means for the Pharmacist to verify the prescriber's original order;

(v) Provide a means for the Pharmacist to certify the accuracy of the selected medication before the dose is delivered for administration to the patient; and

(vi) Provide a mechanism to easily identify those drugs dispensed by pharmacy that are controlled substances.

(b) Each CF utilizing a unit dose dispensing system must establish written policies specifying the categories of drugs which will or will not be dispensed under the unit dose distribution system. Such policies must be available in the pharmacy for inspection by the board:

(A) Proper utilization of the unit dose system requires that, in as far as is practicable, all medications be in unit dose packaging when dispensed.

(B) Controlled substances may be included in the unit dose system if the methods of including such drugs in the system are in compliance with applicable federal and state laws and rules.

(c) The Pharmacist must certify the accuracy of the selected unit dose packages before the dose is delivered for administration to the patient.

(d) All medication must be stored in a locked area or locked cart.

(4) Labeling: Except as described in ORS 689.813, prescription drugs dispensed in individual containers or medication cards must be labeled with the following information:

(a) Name and identifying number of the patient/inmate;

(b) Name, strength, and quantity of the drug dispensed. If the drug does not have a brand name, then the generic name of the drug and the drug manufacturer must be stated;

(d) Initials of the dispenser and the date of dispensing;

(e) Directions for use;

(f) Auxiliary labels and cautionary statements as required;

(g) Manufacturer's expiration date, or an earlier date if preferable; and

(h) Name of the pharmacy.

(5) Patient counseling:

(a) Upon receipt of a prescription drug order and following review by the Pharmacist of the patient's record, the Pharmacist must initiate and provide oral counseling to the patient or to the patient's agent or care giver in all ambulatory care settings and for discharge medications in institutions:

(A) Upon request; or

(B) On matters which a reasonable and prudent Pharmacist would deem significant; or

(D) Whenever the patient's medication record shows the drug has not been previously dispensed to the patient in the same dosage, form, strength or with the same written directions.

(b) When counseling is provided it must include information that a reasonable and prudent Pharmacist would deem necessary to provide for the safe and effective use of the drug. Such information may include the following:

(A) The name and description of the drug;

(B) The dosage form, dose, route of administration, and duration of drug therapy;

(D) Special directions and precautions for preparation, administration, and use by the patient;

(E) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(F) The possible dangers of taking the drug with alcohol, or taking the drug and then operating a motor vehicle or other hazardous machinery;

(G) Techniques for self-monitoring drug therapy;

(H) Proper storage;

(I) Prescription refill information;

(J) Action to be taken in the event of a missed dose; and

(K) Pharmacist comments relevant to the patient's drug therapy, including any other information peculiar to the specific patient or drug.

(c) Patient counseling must be in person whenever practicable. Whenever the prescription is delivered outside the confines of the pharmacy by mail or other third party delivery, counseling must be in writing and by free access to the Pharmacist by phone.

(d) Subsections (a) and (b) of this section must not apply to those prescription drug orders for inpatients in hospitals or institutions where the drug is to be administered by a nurse or other individual authorized to administer drugs.

(e) Notwithstanding the requirements set forth in subsection (a), a Pharmacist is not required to provide oral counseling when a patient refuses the Pharmacist 's attempt to counsel, or when the Pharmacist, on a case by case basis and in the exercise of professional judgment, determines that another form of counseling would be more effective.

(f) Board rules for patient counseling must be observed for each inmate/patient who self-administers or who is dispensed prescription drugs when they are released from the CF.

(6) Administration: Drugs must be administered to each inmate/patient by a practitioner or nurse, or by an unlicensed person who has been trained to administer drugs as defined by the Oregon State Board of Nursing in OAR 851-045-0060. Drugs selected by a registered nurse from a bulk drug container as defined in OAR 855-043-0610 must not be administered by an unlicensed person, except under certain emergency and nonroutine situations as described in the facility’s policies and procedures.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.813
BP 8-2026, amend filed 06/17/2026, effective 06/17/2026
BP 1-2025, minor correction filed 01/10/2025, effective 01/10/2025
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
Renumbered from 855-041-0177, BP 7-2012, f. & cert. ef. 12-17-12
BP 33-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
PB 1-1996, f. & cert. ef. 4-5-96

Or. Admin. R. 855-043-0700 Community Health Clinic (CHC) - Purpose and Scope

(1) The purpose of 855-043-0700 to 855-043-0750 is to provide minimum requirements of operation for a Community Health Clinic (CHC) to utilize a Registered Nurse to dispense medications. A Community Health Clinic Drug Outlet registration replaces a Family Planning or County Health Drug Outlet registration. A legend or non-prescription drug may be dispensed to a client for the purpose of birth control, caries prevention, the treatment of amenorrhea, the treatment of a communicable disease, hormone deficiencies, urinary tract infections or sexually transmitted diseases by a practitioner who has been given dispensing privileges by their licensing Board, or a Registered Nurse, who is an employee of a clinic or local public health authority (LPHA), and is recognized by the Oregon Public Health Division for the purposes of providing public health services.

(2) Dispensing must be pursuant to the order or prescription of a person authorized by their Board to prescribe a drug or established by the Medical Director or clinic practitioner with prescriptive and dispensing authority.

(3) Family Planning or County Health Clinic registrations that expire March 31, 2017 will be converted to the CHC category upon renewal in 2017. However, rules take effect on July 1, 2016.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 32-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0705 Community Health Clinic (CHC) - Registration

(1) A Community Health Clinic Drug Outlet must register with the board on a form prescribed by the board, and must renew its registration annually on a renewal form prescribed by the board.

(2) An initial application and renewal application must be accompanied by the fee established in OAR 855-110.

(3) A certificate of registration will be issued upon board approval of the application.

(4) The CHC Drug Outlet registration expires March 31, annually. If the annual renewal fee is not paid by March 31 of the current year, the applicant for renewal must submit the late renewal fee established in OAR 855-110 with the renewal application.

(5) The registration is not transferable and the registration fee cannot be prorated.

(6) The registrant must notify the board, within 15 days, of any substantial change to the information provided on the registration application. A substantial change shall include but not be limited to: a change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, or Medical Director.

(7) A new registration form is required for a change of ownership or location and must be submitted to the board with the fees as specified in OAR 855-110 within 15 days of the change.

(8) A CHC Drug Outlet may be inspected by the board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 31-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0710 Community Health Clinic (CHC) - Personnel

(1) A Community Health Clinic Drug Outlet must employ a Medical Director who is an Oregon practitioner with prescriptive and dispensing authority. The Medical Director shall establish and enforce policies and procedures, drug dispensing formulary, and protocols for the dispensing of drugs by authorized persons in the CHC.

(2) A CHC Drug Outlet must designate a representative employee who will act as the contact person for the Oregon Board of Pharmacy. The designated representative must be onsite the majority of the CHC’s normal operating hours.

(a) The Medical Director or designated representative must conduct and document an annual review of the outlet on a form provided by the Board. The completed report must be filed in the outlet, retained on file for three years and be available to the Board for inspection.

(b) The Medical Director shall develop policies and procedures for the outlet in collaboration with the designated representative.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 29-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0715 Community Health Clinic (CHC) - Policies and Procedures

The Community Health Clinic must:

(1) Maintain written policies and procedures for drug management, including security, acquisition, storage, dispensing and drug delivery, disposal, and record keeping.

(2) Establish procedures to train a Registered Nurse employed by the CHC to ensure continued competence in the dispensing of drugs.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 26-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0720 Community Health Clinic (CHC) - Security

(2) Only a Physician, Clinical Nurse Specialist, Nurse Practitioner, or Registered Nurse shall have a key to the drug cabinet or drug room. In their absence, the drug cabinet or drug room must remain locked.

(3) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety or the health and safety of a patient. A waiver granted under this section shall only be effective when it is issued by the Board in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 24-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0725 Community Health Clinic (CHC) - Drug Acquisition

The CHC must verify that all drugs are acquired from a registrant of the Board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 22-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0730 Community Health Clinic (CHC) - Storage of Drugs

All drugs, including drug samples, must be stored according to the manufacturer’s published guidelines and be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 21-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0735 Community Health Clinic (CHC) - Labeling

(1) Except as described in SB 450 (2023), a prescription must be labeled with the following information:

(a) Unique identifier (i.e. prescription number);

(b) Name of patient;

(d) Name, address, and phone number of the clinic;

(e) Date of dispensing;

(f) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(g) Quantity dispensed;

(h) Directions for use;

(i) Initials of the practitioner who has been given dispensing privileges by their licensing Board or the Registered Nurse;

(j) Cautionary statements, if any, as required by law; and

(k) Manufacturer's expiration date, or an earlier date if preferable, after which the patient should not use the drug.

(2) Notwithstanding any other requirements in this rule, when a drug is dispensed in the practice of an Expedited Partner Therapy treatment protocol, the name of the patient may be omitted from the label, the patient’s name may be omitted from the records and a drug may be dispensed to the patient to be given to the patient’s partner even if the partner has not been examined by a licensed health care provider acting within their scope of practice.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305 & 2023 SB 450
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
BP 19-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0736 Community Health Clinic (CHC) - Limited English Proficiency and Accessibility

(1) Upon request of a patient or a patient's agent, each drug dispensed by a drug outlet for a patient's selfadministration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

(2) When dispensing a drug under (1), a drug outlet must provide labels and informational inserts in both English and one of the following languages:

(a) Spanish;

(b) Russian;

(d) Arabic;

(e) Chinese (simplified);

(f) Vietnamese;

(g) Farsi;

(h) Korean;

(i) Romanian;

(j) Swahili;

(k) Burmese;

(l) Nepali;

(m) Amharic; and

(n) Pashtu.

(3) The board must reassess and update (2) as necessary and at least every ten years.

History

Statutory/Other Authority: ORS 689.564
Statutes/Other Implemented: ORS 689.205
BP 98-2020, adopt filed 12/23/2020, effective 01/01/2021

Or. Admin. R. 855-043-0740 Community Health Clinic (CHC) - Dispensing and Drug Delivery

(1) A drug may only be dispensed by a practitioner who has been given dispensing privileges by their licensing Board or by a Registered Nurse.

(2) A Registered Nurse may only provide over-the-counter drugs pursuant to established CHC protocols.

(3) A Registered Nurse may only dispense a drug listed in, or for a condition listed in, the formulary.

(4) Nonjudgmental dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by a practitioner who has been given dispensing privileges by their licensing Board, or by a Registered Nurse, prior to being delivered or transferred to the patient.

(5) The CHC will provide appropriate drug information for medications dispensed to a patient, which can be provided by the Registered Nurse or practitioner at the time of dispensing.

(6) A CHC must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2025), 16 CFR 1701 (v. 01/01/2025) and 16 CFR 1702 (v. 01/01/2025).

(7) Dispensed drugs must be packaged by the practitioner, Registered Nurse, a pharmacy; or a manufacturer registered with the board.

(8) A CHC may not accept the return of drugs from a previously dispensed prescription and must maintain a list of sites in Oregon where drugs may be disposed.

(9) A CHC must have access to the most current issue of at least one pharmaceutical reference with current, properly filed supplements and updates appropriate to and based on the standards of practice for the setting.

(10) A CHC may deliver or mail prescription to the patient if:

(a) Proper drug storage conditions are maintained; and

(b) The CHC offers in writing, to provide direct counseling, information on how to contact the practitioner, and information about the drug, including, but not limited to:

(A) Drug name, class and indications;

(B) Proper use and storage;

(D) Precautions and contraindications; and

(E) Significant drug interactions.

(11) The CHC must ensure that all prescriptions, prescription refills, and drug orders are correctly dispensed in accordance with the prescribing practitioner's authorization and any other requirement of State or federal law.

(12) The CHC must ensure that compounded preparations are dispensed in compliance with OAR 855-183.

(13) Unless an exemption applies, each authorized dispenser of a prescription drug product for which a Medication Guide is required must provide the Medication Guide directly to each patient or patient’s agent when the product is dispensed.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 8-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 40-2021, amend filed 12/16/2021, effective 01/01/2022
BP 17-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0745 Community Health Clinic (CHC) - Disposal of Drugs

Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or identified as suspect or illegitimate must be documented, quarantined and physically separated from other drugs until they are destroyed or returned to the supplier.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 15-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Or. Admin. R. 855-043-0750 Community Health Clinic (CHC) - Record Keeping

(1) A dispensing record must be maintained separately from the patient chart and kept for a minimum of three years. The record must show, at a minimum, the following:

(a) Name of patient;

(b) Unique identifier (i.e. prescription number);

(c) Dose, dosage form, quantity dispensed and either the brand name of drug, or generic name and name of manufacturer or distributor;

(d) Directions for use;

(e) Date of dispensing; and

(f) Initials of person dispensing the prescription.

(2) All records of receipt and disposal of drugs must be kept for a minimum of three years.

(3) All records required by these rules or by other State and federal law must be readily retrievable and available for inspection by the Board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 13-2020, minor correction filed 08/06/2020, effective 08/06/2020
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16

Division 44 CHARITABLE PHARMACIES

Or. Admin. R. 855-044-0001 Purpose

The purpose of the program is to provide a process to make donated prescription drugs available to needy or uninsured individuals and those with limited access to pharmaceuticals. Under the rules in this Division, a Charitable Pharmacy that is registered with the Oregon Board of Pharmacy (Board) may accept drugs for donation and distribution within this state when the pharmacist can reasonably be assured of the purity and integrity of the drug. The program may not include categories of drugs specified by the Board as excluded from the program.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.772 & 689.774
BP 1-2017, f. & cert. ef. 2-23-17
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0005 Definitions

(1) “Charitable Pharmacy” means a facility registered with the Oregon Board of Pharmacy for the purpose of receiving and distributing donated drugs.

(2) “Point-of-Contact” means an individual designated by a charitable pharmacy who serves as the primary contact person for the charitable pharmacy and who is responsible for managing the charitable pharmacy at that location.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.772 & 689.774
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0010 Registration

(1) A facility may not operate as a charitable pharmacy unless it is registered as such with the Board and has paid the fee specified in Division 110 of these rules.

(2) The application for registration must be on a form provided by the Board and must include proposed policies and procedures and a description of the organization.

(3) Each location must be registered separately.

(4) An applicant for registration as a charitable pharmacy must name a point-of-contact for each registered location.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.774
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0020 Personnel

(1) A charitable pharmacy must have a licensed pharmacist. The pharmacist may also be the Point-of-Contact.

(2) A charitable pharmacy that is co-located with an existing registered pharmacy may name a pharmacist employed by the existing pharmacy as its pharmacist.

(3) A charitable pharmacy that is not co-located with an existing registered pharmacy and does not have a pharmacist on staff must employ a consultant pharmacist.

(4) The pharmacist must develop policies and procedures for:

(a) Receiving donated drugs;

(b) Security;

(d) Distribution of drugs;

(e) Record keeping;

(f) Disposal of unusable drugs; and

(g) Staff training.

(5) The pharmacist must conduct a visual inspection of each donated drug to ensure that the drug has not expired, been adulterated or misbranded and is in its original, sealed packaging, and that based on this inspection and on the accuracy of the Donor’s Form, the drug is safe to distribute.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.774
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0030 Drug Donation

(1) A charitable pharmacy may not accept:

(a) Any controlled substance or any kit, package or blister pack that contains any controlled substance;

(b) A non-prescription drug;

(c) A drug in a container or package that does not contain a product identification label (PIL), except that a drug in a manufacturer’s original container or a manufacturer’s blister pack does not need to bear a PIL;

(d) An FDA REMS (Risk Evaluation and Mitigation Strategy) drug;

(e) A drug donated from another state.

(2) A charitable pharmacy may accept:

(a) A prescription drug received in original, sealed, tamper-evident packaging that displays the lot number and expiration date of the drug; and

(b) Sealed single unit dose packages received in opened packages containing multiple single unit doses.

(3) The following are examples of acceptable packaging:

(a) Manufacturer’s original container;

(b) Single-dose blister packs in sealed outer package;

(d) Tamper-evident hospice kit containing manufacturer’s original containers.

(4) Donated drugs that do not meet the above criteria or are judged by the pharmacist to be unsafe for re-dispensing must be stored separately from the drug supply until they can be destroyed.

(5) A charitable pharmacy may accept a drug from:

(a) An individual;

(b) A long-term care facility;

(d) A practitioner who has been given dispensing privileges by their licensing board and is acting within their scope of practice;

(e) Another registered charitable pharmacy;

(f) A medical clinic;

(g) A drug manufacturer or wholesaler;

(h) A Medication Assistance Program (MAP) such as those supported by drug manufacturers.

(6) The donor must certify on a Donor Form provided by the Board that the donated drug has been properly stored, in accordance with manufacturer’s recommendations, and has never been opened, used, adulterated or misbranded.

(7) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.772 & 689.774
BP 1-2017, f. & cert. ef. 2-23-17
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0040 Storage and Security

(1) A charitable pharmacy must store all donated drugs securely and physically separate from any existing inventory.

(2) All charitable pharmacy records must be secured to comply with HIPAA and all state and federal regulations.

(3) Outdated and unusable drugs intended for destruction must be quarantined and stored securely.

(4) A charitable pharmacy co-located with an existing pharmacy must use storage and record keeping procedures that maintain separation of charitable pharmacy records and drugs from other pharmacy records and inventory.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.774
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0050 Drug Distribution

(1) A charitable pharmacy may not distribute a donated prescription drug that:

(a) Fails to meet the requirements of the program;

(b) Has not been stored in accordance with manufacturer’s recommendations;

(d) Bears an expiration date that is less than nine months from the date the drug is donated;

(e) Is adulterated or misbranded;

(f) Is a controlled substance;

(g) Is a drug that requires a special registration for dispensing;

(h) Is an over-the-counter drug;

(i) Requires specialty storage or handling;

(j) Requires refrigeration;

(k) Is a compounded drug; or

(L) In the pharmacist’s professional judgment, may be unfit for dispensing.

(2) A charitable pharmacy may only dispense a drug to a person who:

(a) Has a valid prescription for the drug; and

(b) Is a resident of Oregon; and

(d) Is enrolled in a program of public assistance as defined in ORS 411.010;

(3) A drug may only be dispensed by a pharmacist or by a practitioner who has been given dispensing privileges by their licensing board and is acting within their scope of practice, or by a registered nurse subject to the following:

(a) A registered nurse who is an employee of a charitable pharmacy may dispense a drug to a client of the charitable pharmacy; and

(b) Such dispensing by a registered nurse shall be pursuant to the order of a person authorized to prescribe the drug.

(4) The dispensing practitioner must provide the patient with appropriate counseling on the use of the drug and any potential side effects, and may provide written drug information;

(5) A recipient of a drug under this program must sign a Recipient Form, provided by the Board, that attests that the recipient has been notified that:

(a) The prescription drug was donated to the program;

(b) A visual inspection was conducted by a pharmacist to ensure that the drug has not expired, been adulterated or misbranded, and is in its original, sealed packaging;

(c) A pharmacist has determined that the drug is safe to distribute based on the accuracy of the Donor’s Form and the visual inspection by the pharmacist;

(d) Participants in the program are immune from liability as provided in ORS 689.780; and

(e) That they are qualified to receive the drug as specified in section (2) of this rule.

(6) Upon written request the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.772 & 689.774
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0060 Labeling

(1) Except as defined in SB 450 (2023), the label on a drug dispensed or distributed from a charitable pharmacy must meet all federal rules and laws and must contain:

(a) The name, address and telephone number of the pharmacy;

(b) The name of the prescribing practitioner;

(d) Date dispensed;

(e) The name of the patient;

(f) Name and manufacturer of drug, drug strength, the quantity dispensed;

(g) Directions for use;

(h) The expiration date;

(i) A unique identifier; and

(j) Any further cautionary information required for patient safety.

(2) All original patient identification must be removed.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.774 & 2023 SB 450
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
BP 92-2020, minor correction filed 10/22/2020, effective 10/22/2020
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0061 Charitable Pharmacies - Limited English Proficiency and Accessibility

(1) Upon request of a prescriber, patient or a patient's agent, each drug dispensed by a pharmacy for a patient's self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

(2) When dispensing a drug under (1), a pharmacy must provide labels and informational inserts in both English and one of the following languages:

(a) Spanish;

(b) Russian;

(d) Arabic;

(e) Chinese (simplified);

(f) Vietnamese;

(g) Farsi;

(h) Korean;

(i) Romanian;

(j) Swahili;

(k) Burmese;

(l) Nepali;

(m) Amharic; and

(n) Pashtu.

(3) The board must reassess and update (2) as necessary and at least every ten years.

(4) A pharmacy that dispenses prescriptions for a patient's self-administration must post signage to provide notification of the right to free, competent oral interpretation and translation services for patients who are of limited English proficiency, in compliance with federal and state regulations.

History

Statutory/Other Authority: ORS 689.564
Statutes/Other Implemented: ORS 689.205
BP 97-2020, adopt filed 12/23/2020, effective 01/01/2021

Or. Admin. R. 855-044-0070 Records

(1) A charitable pharmacy must maintain a donation record of all drugs received that includes:

(a) Donor’s name and address;

(b) Drug manufacturer, lot number, name and strength;

(d) Expiration date of the drug;

(e) Date donated; and

(f) The unique identifier.

(2) A charitable pharmacy must maintain a distribution and dispensing record that includes:

(a) Drug name and strength;

(b) Quantity distributed;

(d) Lot number and expiration date;

(e) Date of distribution or dispensing;

(f) Name and address of recipient.

(3) A charitable pharmacy must maintain a record of all drugs that are destroyed.

(4) In addition to the above records, a charitable pharmacy must cross-reference the donation record and the distribution and dispensing record with the appropriate donor and recipient forms.

(5) A charitable pharmacy must make an annual report to the Board by completing a form provided by the Board and submitting it with their application for renewal of registration.

(6) All records required by these rules must be retained for three years and made available to the Board upon request.

(7) Upon written request the Board may waive any of the requirements of this rule if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.774
BP 9-2014, f. & cert. ef. 12-4-14
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0080 Fees

(1) A charitable pharmacy may not charge a fee for accepting a donation.

(2) A charitable pharmacy may not sell a donated drug.

(3) A charitable pharmacy may charge a dispensing fee that does not exceed two and a half times Oregon’s current Medicaid dispensing fee.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.772 & 689.774
BP 6-2010, f. & cert. ef. 6-29-10

Or. Admin. R. 855-044-0090 Liability

In accordance with ORS 689.780, a person who accepts or distributes donated prescription drugs through the charitable pharmacy program is not subject to criminal prosecution or civil liability for any injury, death or loss of or damage to person or property that results from the acceptance or distribution of the donated prescription drugs if the participant accepts or distributes the donated prescription drugs in good faith.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.774 & 689.780
BP 6-2010, f. & cert. ef. 6-29-10

Division 60 PHARMACEUTICAL MANUFACTURERS

Or. Admin. R. 855-060-0001 Application

No place of manufacturing, wholesaling or repackaging of drugs or medicines, as defined in ORS 689.005(20), (35), and (36) may be conducted or operated until it has been registered by the State Board of Pharmacy.

(1) All applications for registration of a new or relocated manufacturer shall be accompanied by the required fees as set forth in OAR 855-110.

(2) Application must specify the location of the manufacturer premises. When the applicant is not the owner of the business, the application shall indicate the owner and the applicant's affiliation with the owner;

(a) If the owner is a partnership or other multiple owner, the names of the partners or person holding the five largest interests shall be indicated on the application.

(c) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

(3) All registration renewal applications must be accompanied by the annual fee and contain the same information required in subsection (2)(a), (b), and (c) of this rule.

(4) A change of ownership or location requires a new application, fee and registration within 15 days.

(5) The registration certificate is issued to a person or firm and is non-transferable. Additions or deletions of a partner/partners must be considered as a change of ownership.

(6) Manufacturer registration expires September 30th annually. The registration cannot be prorated.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305, ORS 689.315 & ORS 689.325
BP 12-2006, f. & cert. ef. 12-19-06
BP 38-2021, amend filed 12/16/2021, effective 01/01/2022
BP 1-2002, f. & cert. ef. 1-8-02
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80

Or. Admin. R. 855-060-0002 Definitions

(1) “Affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly:

(a) One business entity controls, or has the power to control, the other business entity; or

(b) A third party controls, or has the power to control, both of the business entities.

(2) "Co-Manufacturing Partner" means a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

(3) “Illegitimate Product” means a product for which credible evidence shows that the product is:

(a) Counterfeit, diverted, or stolen;

(b) Intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(d) Otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death.

(4) "Manufacturer" means anyone, including a manufacturer's co-manufacturing partner, who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.

(5)"Pedigree" for the purpose of this Division consists of:

(a) “Transaction History” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

(b) “Transaction Information” must include but is not limited to:

(A) The proprietary or established name or names of the product;

(B) The strength and dosage form of the product;

(D) The container size;

(E) The number of containers;

(F) The lot number of the product;

(G) The date of the transaction;

(H) The date of the shipment, if more than 24 hours after the date of the transaction;

(I) The business name and address of the person from whom ownership is being transferred; and

(J) The business name and address of the person to whom ownership is being transferred.

(c) “Transaction Statement” is a statement, in paper or electronic form, that the entity transferring ownership in a transaction is compliant with Food and Drug Administration (FDA) regulations set forth by the Drug Quality and Security Act and includes but is not limited to:

(A) Confirmation that the entity is authorized or registered as required under the Drug Supply Chain Security Act;

(B) Acknowledgement that product is received from an authorized or registered entity, as required under the Drug Supply Chain Security Act;

(C) Confirmation of receipt of transaction information and of transaction statement from the prior owner of the product, as required under the Drug Supply Chain Security Act;

(D) Verification that a suspect or illegitimate product was not knowingly shipped;

(E) Confirmation that systems and processes are in place to comply with verification requirements under the Drug Supply Chain Security Act;

(F) Confirmation that false transaction information was not knowingly provided; and

(G) Confirmation that transaction history was not knowingly altered.

(6) “Suspect Product” means a product for which there is reason to believe that such product is:

(a) Potentially counterfeit, diverted, or stolen;

(b) Potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(d) Otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15

Or. Admin. R. 855-060-0004 Registration

(1) Any person that manufactures, or contracts for the manufacture of a drug or prescription device that is intended for sale, distribution, dispensing or administration in Oregon must register with the Oregon Board of Pharmacy.

(2) Any person that holds one or more of the following registrations with the Food and Drug Administration (FDA) must register as a Manufacturer.

(a) A New Drug Application number (NDA);

(b) An Abbreviated New Drug Application number (ANDA);

(d) An FDA Central File Number (CFN);

(e) An FDA Establishment Identifier number (FEI);

(f) A Biologic License Application (BLA);

(g) An Outsourcing Facility Registration.

(3) A person that is registered with the FDA as a repackager must register as a Manufacturer.

(4) A person who is a third-party logistics provider as defined in Division 62 or whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a manufacturer must register as a Drug Distribution Agent under Division 62.

(5) A person who is registered with the FDA as the agent for a foreign manufacturer must register as a Drug Distribution Agent under Division 62.

(6) An applicant for a new or renewal of registration must provide all information specified on the form provided by the Board, and pay the fee as specified in OAR 855-110-0007. The applicant must also provide any additional information requested by the Board. An application that does not contain all required information is incomplete and will not be processed.

(7) The registration is non-transferable. Addition or deletion of an owner shall be considered as a change of ownership except where the registrant is a publicly held corporation. A new application for registration and payment of a new registration fee is required when a registrant changes ownership or location. This new application must be submitted to the Board at least 15 days prior to the change.

(8) A person who compounds a drug that is distributed in Oregon not based on a patient specific prescription must register with the Board as a Manufacturer, unless done so pursuant to a Shared Pharmacy Services agreement, as defined in OAR 855-006-0005, between two in-state entities.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & 689.305
BP 4-2015, f. & cert. ef. 7-1-15
BP 5-2013, f. & cert. ef. 8-29-13
BP 1-2013(Temp), f. 3-6-13, cert. ef. 3-7-13 thru 9-3-13
BP 9-2011, f. 12-30-11, cert. ef. 1-1-12

Or. Admin. R. 855-060-0005 General Provisions and Minimum Standards

In order to qualify for a manufacturing registration, the applicant shall meet certain minimum standards:

(1) Organization: The physical plant of the manufacturer shall be properly organized with adequate facilities and qualified personnel to operate the same under the direction of a technically trained or professionally competent supervisor:

(a) The production supervisor in charge shall be responsible to the proper administrative authority of the manufacturer for the developing, supervising, and coordinating of all the activities of the manufacturing plant so far as production techniques are involved;

(b) Departmentalization shall follow good administrative procedure integrated with the administration of the manufacturing firm in general;

(c) The organizational structure of the manufacturing operation may vary depending upon the size and character of the particular products manufactured. (It is not the intent of the minimum standard requirements set out in the rules herein provided to cast all manufacturers in the same mold, although it is their intent to assure the establishment of fundamental principles which will enable competent production with sufficient freedom to supply the demand for adequate pharmaceutical products.)

(2) Policies: The production supervisor in charge, with approval of the director or other proper administrative or executive authority of the manufacturer, shall initiate and develop rules and regulations pertaining to the manufacturing procedures of the firm or producer. Such policies and procedures established by rule and regulation shall conform with techniques currently practiced in the other pharmaceutical industries of a similar kind. (The spirit of the minimum standard requirements for licensees is one of helpful cooperation.)

(3) Personnel: The production supervisor in charge shall be a person adequately trained in the specialized functions required for manufacturing of pharmaceutical products and may be required to submit properly attested documents of proof of formal education qualifying him for this position. He shall have such assistants as the volume of work in the plant may dictate. The personnel shall also include such additional technically trained persons as the activities of the manufacturer may require to supply pharmaceutical service of the highest quality. The adequacy of the personnel will be determined by the size and scope of the manufacturing operation.

(4) Facilities: Adequate pharmaceutical and administrative facilities shall be provided including particularly:

(a) Essential manufacturing equipment to process properly the products to be manufactured;

(b) An adequate, up-to-date library for information concerning drugs and pharmaceutical products;

(d) Adequate floor space;

(e) Sanitary facilities, lighting, ventilation, and plant safety as prescribed by the Workers Compensation Department, the Occupational Safety and Health Division.

(5) Products Control: Pharmaceutical manufacturing operations require facilities for chemical, physical and usually biological and bacteriological testing. The extent of laboratory facilities required for products control depends upon the products to be manufactured, the specifications and standards they are required to meet, and the raw materials involved in their production. If the manufacturing process is not large enough to justify the maintenance of a products control staff, the manufacturer’s samples or products shall be sent to a competent laboratory for control checking of the manufactured product.

(6) Manufacturing of drug substances shall be separated from manufacturing of food substances.

History

Statutory/Other Authority: ORS 689
1PB 2-1980, f. & ef. 4-3-80
Reverted to 1PB 23, f. 2-14-74, ef. 3-11-74
1PB 2-1979(Temp), f. & ef. 10-3-79
1PB 23, f. 2-14-74, ef. 3-11-74
1PB 18, f. & ef. 10-14-64

Or. Admin. R. 855-060-0010 Sanitation and Plant Safety

(1) The manufacturing plant, its equipment and facilities, shall be maintained in a clean and orderly condition.

(2) The physical facilities of the manufacturing plant, shall be maintained so as to conform with the laws of this state and the rules and regulations of the Workers Compensation Department, the Occupational Safety and Health Division, relating to sanitation and safety. (The provisions of this section shall be applicable to storerooms, toilets, washrooms, basements, and all other portions of the plant wherein business is conducted.)

(3) Toilet and washroom accommodations shall be maintained separately and distinct from the manufacturing facilities. The doors to toilet and washroom accommodations shall at all times remain closed, except as a means of ingress or egress.

(4) The walls, ceilings, windows, and floors of the manufacturing plant shall be clean and maintained in good repair.

(5) The manufacturing plant shall be well lighted, ventilated, and kept free of obnoxious odors.

(6) No waste materials shall be permitted to collect upon the floors, counters, or other portions of the manufacturing plant. Waste receptacles shall be placed in convenient places for disposal of waste materials.

(7) No merchandise shall be stored in toilets or washrooms or be permitted to stand or to be stored or placed in any portion of the manufacturing plant except in a storeroom. Storerooms shall be maintained at a cool temperature, shall be dry and ventilated, free from rodents, insects, obnoxious odors, and shall be equipped with adequate lighting facilities. Merchandise shall be arranged in an orderly manner.

(8) The plumbing of the manufacturing plant shall be maintained in good repair.

(9) Equipment and materials necessary for processing or producing items to be manufactured shall be maintained in an orderly and clean condition. All instruments and equipment shall be thoroughly cleansed following use.

History

Statutory/Other Authority: ORS 689
1PB 2-1980, f. & ef. 4-3-80
Reverted to 1PB 33, f. 2-14-74, ef. 3-11-74
1PB 2-1979(Temp), f. & ef. 10-3-79
1PB 33, f. 2-14-74, ef. 3-11-74
1PB 18, f. & ef. 10-14-64

Or. Admin. R. 855-060-0015 Classification of Manufacturers

(1) Class I. A Class I manufacturer is required to employ an Oregon licensed pharmacist or a person approved by the Board who by experience and education possesses the necessary qualifications to supervise manufacturing procedures for United States Pharmacopeia, National Formulary, Accepted Dental Remedies products and including the manufacture of other internal medicines, controlled substances, dangerous external preparations, injectables, products requiring the prescription legend, poisons, and pure (U.S.P. and N.F. chemicals).

(2) Class II. A Class II manufacturer is required to employ personnel with a Bachelor of Science degree or equivalent, but not necessarily a licensed pharmacist to supervise manufacturing procedures and must comply with 503B manufacturing requirements of 21 USC 353 and is exempted from labeling and research requirements.

(3) Class III. Repackagers or distributors of non-legend drugs will not be required to have a licensed pharmacist but is required to have competent supervisory personnel.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
1PB 2-1980, f. & ef. 4-3-80
Reverted to 1PB 8-1978, f. & ef. 10-17-78
1PB 2-1979(Temp), f. & ef. 10-3-79
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78
1PB 33, f. 2-14-74, ef. 3-11-74
1PB 18, f. & ef. 10-14-64

Or. Admin. R. 855-060-0020 Qualifications of Manufacturing and Wholesaling Personnel

(1) Only qualified personnel shall be employed to manufacture products.

(2) No drugs or medical supplies shall be manufactured in this state except under the personal supervision of a licensed pharmacist, chemist, or other person qualified by scientific or technical training or experience to perform such duties of supervision, as may be necessary, to protect the public health and safety. The manufacture of drugs and medicines shall be limited to persons having the necessary professional and/or technical qualifications and such persons may be required to submit properly attested documents of proof of formal education qualifying them for these positions.

History

Statutory/Other Authority: ORS 689
1PB 2-1980, f. & ef. 4-3-80
Reverted to 1PB 33, f. 2-14-74, ef. 3-11-74
1PB 2-1979(Temp), f. & ef. 10-3-79
1PB 33, f. 2-14-74, ef. 3-11-74
1PB 18, f. & ef. 10-14-64

Or. Admin. R. 855-060-0025 Labeling

(1) All stocks and materials, as well as products produced, shall be labeled and conform to the strength and purity as required by law.

(2) A sample label of each product manufactured shall be supplied to the State Board of Pharmacy upon request.

History

Statutory/Other Authority: ORS 689
1PB 2-1980, f. & ef. 4-3-80
Reverted to 1PB 33, f. 2-14-74, ef. 3-11-74
1PB 2-1979(Temp), f. & ef. 10-3-79
1PB 33, f. 2-14-74, ef. 3-11-74
1PB 18, f. & ef. 10-14-64

Or. Admin. R. 855-060-0027 Identification of Prescription Drugs

(1) All prescription drug products in tablet or capsule form intended for oral administration will be required to be specifically identified. These drug products, when sold or distributed in Oregon, must be marked by the manufacturer with a code imprint identifying the drug product and the manufacturer or distributor of the drug product.

(2) "Code imprint" means an individual symbol, number, company name, words, letters, marking, National Drug Code, or any combination thereof, identifying the drug product and the manufacturer or distributor of the drug product.

(3) Exceptions to the requirement are:

(a) Drug products which are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and which are to be used solely by the patient for whom prescribed;

(b) Drug products which are used for experimentation or research purposes.

(4) The Board of Pharmacy, upon application of a manufacturer or distributor, may also exempt a particular drug product from the requirements of this regulation on the grounds that imprinting is not feasible because of such drug product's size, texture, or other unique characteristics.

History

Statutory/Other Authority: ORS 475 & 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
1PB 2-1981, f. & ef. 8-20-81

Or. Admin. R. 855-060-0029 Disposal of Drugs

Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or illegitimate shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

History

Statutory/Other Authority: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
PB 1-1992, f. & cert. ef. 1-31-92
1PB 2-1984, f. & ef. 3-7-84

Or. Admin. R. 855-060-0035 Registration of Mobile Manufacturers

(1) A mobile manufacturer means a manufacturer who manufactures within a vehicle equipped to provide unit dose packaging and repackage capabilities operated by a currently licensed pharmacist in this state.

(2) Stock medication for packaging and repacking will be furnished by the purchaser and shall exclude controlled substances.

(3) The vehicle shall be secure against pilferage, maintained and operated in accordance with good manufacturing practices standards in this division.

(4) All unit dose packages must be labeled in conformity with ORS 689.005.

(5) Records shall be maintained of all package operations of receipt and disposition of drugs.

(6) The building in which this vehicle is stored shall be its permanent address and shall maintain security of vehicle.

(7) Vehicle shall be registered annually; registration shall expire annually on July 1, of each year.

(8) Applicant must show to the Board that he will be actively in charge of equipment in this vehicle at all times it is in operation.

(9) If so required, the vehicle shall be registered with the federal Food and Drug Administration.

(10) The vehicle shall not display insignia or device to indicate that drugs are stored within or represent it as a pharmacy.

History

Statutory/Other Authority: ORS 475.035 & 689.205
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80

Division 62 DRUG DISTRIBUTION AGENT

Or. Admin. R. 855-062-0003 Application

(1) The following persons must register as a Drug Distribution Agent under this Division of rules:

(a) A broker;

(b) An import broker;

(d) Sales and marketing office for a drug;

(e) A Drug Order Contractor;

(f) A Third-Party Logistics Provider; and

(g) A person registered with the FDA as the holder of a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) that contracts with a third-party for the manufacture of a drug but does not take physical possession of the drug, does not have its name on the label and is not accountable to the FDA for the purity and integrity of the drug.

(2) Any person who would otherwise be required to register as a Wholesaler under Division 65 of this Chapter of rules but who does not at any time have possession of a drug intended for distribution must register as a Drug Distribution Agent under this Division of rules.

(3) A person whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a registered manufacturer, but does not take physical possession of a product must register as a Drug Distribution Agent.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Or. Admin. R. 855-062-0005 Definitions

(1) "Broker" means a person engaged in the marketing, offering, or contracting for wholesale distribution and sale of a drug into, within, or out of Oregon and who does not take physical possession of the drug.

(2) "Closed Door Pharmacy" means a pharmacy that provides pharmaceutical services to a defined and exclusive group of patients and is not open for dispensing to the general patient population and cannot be registered as a wholesale distributor.

(3) "Co-Manufacturing Partner" means a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

(4)"Common Carrier" means an organization that is available to the public to transport a product or service using its facilities, or those of other carriers.

(5) “Drug”: In this Division of rules, the term “drug” shall mean any drug and any prescription device as these terms are defined in ORS 689.005.

(6) “Illegitimate Product” means a product for which credible evidence shows that the product is:

(a) Counterfeit, diverted, or stolen;

(b) Intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(d) Otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death.

(7) “Manufacturer” means any person, including a manufacturer's co-manufacturing partner, that is engaged in the manufacture of a drug, is responsible or otherwise accountable to the Food and Drug Administration (FDA) for the manufacture of the drug, or is the private label manufacturer or distributor of product bearing its NDC number that is intended for sale, distribution, dispensing or administration in Oregon, and who holds one or more of the following registrations or licenses with the FDA:

(a) A New Drug Application number (NDA);

(b) An Abbreviated New Drug application number (ANDA);

(d) An FDA Central File Number (CFN);

(e) An FDA Establishment Identifier number (FEI);

(f) A Biologic License Application (BLA);

(g) An Outsourcing Facility.

(8) “Manufacture” means the preparation, propagation, compounding, or processing of a drug or device intended for human or animal use. Manufacture includes repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.

(9)"Pedigree" for the purpose of this Division consists of:

(a) “Transaction History” means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

(b) “Transaction Information” must include, but is not limited to:

(A) The proprietary or established name or names of the product;

(B) The strength and dosage form of the product;

(D) The container size;

(E) The number of containers;

(F) The lot number of the product;

(G) The date of the transaction;

(H) The date of the shipment, if more than 24 hours after the date of the transaction;

(I) The business name and address of the person from whom ownership is being transferred; and

(J) The business name and address of the person to whom ownership is being transferred.

(c) “Transaction Statement” is a statement, in paper or electronic form, that the entity transferring ownership in a transaction is compliant with FDA regulations set forth by the Drug Quality and Security Act and includes, but is not limited to:

(A) Confirmation that the entity is authorized or registered as required under the Drug Supply Chain Security Act;

(B) Acknowledgement that product is received from an authorized or registered entity, as required under the Drug Supply Chain Security Act;

(C) Confirmation of receipt of transaction information and of transaction statement from the prior owner of the product, as required under the Drug Supply Chain Security Act;

(D) Verification that a suspect or illegitimate product was not knowingly shipped;

(E) Confirmation that systems and processes are in place to comply with verification requirements under the Drug Supply Chain Security Act;

(F) Confirmation that false transaction information was not knowingly provided; and

(G) Confirmation that transaction history was not knowingly altered.

(10) “Person” means individual, corporation, partnership, association, joint-stock company, business trust or unincorporated organization.

(11) “Suspect Product” means a product for which there is reason to believe that such product is:

(a) Potentially counterfeit, diverted, or stolen;

(b) Potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(d) Otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

(12) “Third-Party Logistics Provider” means an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, and not have responsibility to direct the sale or disposition of the product.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Or. Admin. R. 855-062-0020 Registration

(1) Any person engaged in any part of the process of manufacture or wholesale distribution of a drug into, out of, or within Oregon must be registered with the board. A person must register as either:

(a) A manufacturer under Division 60 of this chapter of rules; or

(b) A wholesaler under Division 65 of this chapter of rules; or

(2) A person that is required to register as a Drug Distribution Agent must be registered before commencing business in Oregon and before any drug for which they provide a manufacturing, marketing or distribution service, may be sold, distributed, dispensed or administered in Oregon.

(3) A person that is required to register as a Drug Distribution Agent must apply for registration on a form provided by the board and must provide information required by the board that includes but is not limited to:

(a) The name, business address, social security number or federal tax identification number of each owner, officer, and stockholder owning more than 10 per cent of the stock of the company, unless the stock of the company is publicly traded;

(b) Every trade or business name used by the applicant;

(c) Any disciplinary action taken by any state or federal authority against the applicant or any other distributor under common ownership or control, or any owner, principal or designated representative of the applicant, in connection with the drug laws or regulations of any state or the federal government.

(4) An applicant for renewal must complete the form provided by the board and submit it to the board with the appropriate fee by September 30 annually.

(5) An applicant that provides a manufacturing or distribution service in respect of a controlled substance as defined in Division 80 of this chapter of rules must also complete and submit the Controlled Substance registration form provided by the board, with the appropriate fee.

(6) The board may require a criminal history and financial background check of each principal, owner or officer of the applicant prior to initial registration and prior to any renewal unless the applicant is publicly traded. Any such checks will be at the applicant's expense.

(7) The board may require a physical inspection of each facility prior to initial registration and prior to any renewal.

(8) Each separate business entity and each location that does business in Oregon must be separately registered by the board.

(9) The registrant must notify the board, within 15 days, of any substantial change to the information provided on the registration application. Substantial change includes but is not limited to:

(a) Change of ownership;

(b) Change of business address;

(c) Any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers.

(10) The registration certificate is issued to a specific person and is non-transferable. Any addition or deletion of an owner or partner constitutes a change of ownership.

(11) The board may waive any requirement of this rule if, in the board's judgment, a waiver will further public health or safety. A waiver granted under this section will only be effective when issued in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 52-2022, amend filed 12/20/2022, effective 12/21/2022
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Or. Admin. R. 855-062-0030 Minimum Qualifications

The Board may deny an application for registration or renewal of registration as a Drug Distribution Agent on any of the following grounds:

(1) The applicant has been found by the Board or by a court to have violated the pharmacy or drug laws or rules of this state or of any other state, or of the federal government;

(2) The applicant has a history of non-compliance with state or federal rules or laws regulating the manufacture, distribution, or dispensing of drugs;

(3) The applicant has made a material misrepresentation to the Board in the course of applying for an initial or renewal of registration;

(4) Disciplinary action has been taken by the federal government or by any state, or local government regarding any license or registration currently or previously held by the applicant for the manufacture, distribution or dispensing of any drugs;

(5) The applicant has engaged in any conduct involving moral turpitude;

(6) The Board determines that granting the registration is not consistent with the public health or safety or is otherwise not in the public interest.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Or. Admin. R. 855-062-0040 Record Keeping

(1) A Drug Distribution Agent must establish and maintain records regarding the distribution or other disposition of a drug.

(a) If a Drug Distribution Agent distributes product to a wholesaler or pharmacy, the record must contain, but is not limited to the following:

(A) The source of the drug, including the name and physical address of the seller or transferor and any broker or other person involved in the transaction, the address of the location from which the drug was shipped and the address of the location to which the drug was shipped;

(B) The name, dose and quantity of the drug distributed;

(b) If a Drug Distribution Agent distributes product to another Drug Distribution Agent, the pedigree must be maintained and provided to the recipient of the distribution.

(2) Records required by this rule must be made available for inspection and copying by any authorized official of the Drug Enforcement Agency, the Food and Drug Administration, the Department of Agriculture, authorized law enforcement agencies, and this Board.

(3) Records required under these rules must be maintained for three years.

(4) Records required under these rules that are less than 13 months old must be kept at the address of record or be immediately retrievable by computer or other electronic means, and must be immediately available for inspection. All other records required by these rules must be made available for inspection within three business days of a request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2015, f. & cert. ef. 12-23-15
BP 5-2015(Temp), f. & cert. ef. 7-1-15 thru 12-27-15
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Or. Admin. R. 855-062-0050 Prohibited Practices

(1) The following practices are expressly prohibited:

(a) A Drug Distribution Agent may not participate in the purchase of a drug from a closed-door pharmacy;

(b) A Drug Distribution Agent may not participate in any way in the sale, distribution or transfer of a drug to a person who is required by the laws and rules of Oregon to be registered with the Board and who is not appropriately registered. Before authorizing or facilitating the distribution of a drug, a Drug Distribution Agent must verify that the person supplying or receiving the drug is appropriately registered with the Board.

(2) A Drug Distribution Agent may not perform, cause the performance of, or aid the performance of any of the following:

(a) The manufacture, repackaging, sale, delivery, holding, or offering for sale of a drug that is adulterated, misbranded, counterfeit, suspected counterfeit, or is otherwise unfit for distribution;

(b) The adulteration, misbranding, or counterfeiting of a drug;

(c) The receipt of a drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected counterfeit, and the delivery or proffered delivery of the drug for pay or otherwise;

(d) The alteration, mutilation, destruction, obliteration, or removal of the whole or a part of the labeling of a drug or the commission of another act with respect to a drug that results in the drug being misbranded;

(e) The forging, counterfeiting, simulating, or falsely representing a drug using a mark, stamp, tag, label, or other identification device;

(f) The purchase or receipt of a drug from a person that is not registered to distribute drugs to the purchaser or recipient;

(g) The sale or transfer of a drug to a person that is not authorized under the law of the jurisdiction in which the person receives the drug, to purchase or receive drugs from the person selling or transferring the drug;

(h) The failure to maintain or provide records as required under these rules;

(i) Providing the Board, a representative of the Board, or a state or federal official with false or fraudulent records or making false or fraudulent statements regarding a matter related to these rules;

(j) Participating in the wholesale distribution of a drug that was:

(A) Purchased by a public or private hospital or other health care entity under the terms of an "own-use" contract; or

(B) Donated or supplied at a reduced price to a charitable organization; or

(D) Illegally imported into the USA.

(k) Facilitating the distribution or attempting to facilitate the distribution of a drug by fraud, deceit, or misrepresentation;

(l) Facilitating the distribution of a drug that was previously dispensed by a retail pharmacy or a practitioner;

(m) Failing to report an act prohibited by any of the rules in OAR Chapter 855 to the appropriate state or federal authorities.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Division 65 WHOLESALE DRUG OUTLETS

Or. Admin. R. 855-065-0001 Application

(1) These rules (OAR 855-065-0001 to 855-065-0013) apply to any person, including any business entity, located in or outside Oregon that engages in the wholesale distribution of prescription or non-prescription drugs in Oregon except that a manufacturer that is registered under division 60 of this chapter of rules does not also need to register as a wholesale distributor under these rules if they only distribute their own products or those manufactured by a Co-Manufacturing Partner as defined in OAR 855-065-0005.

(2) Any person who is a Third-Party Logistics Provider as defined in division 62 or whose sole purpose is the marketing, brokering or arranging the distribution of drugs manufactured by a manufacturer must register as a Drug Distribution Agent in accordance with division 62 of this chapter of rules.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 4-2015, f. & cert. ef. 7-1-15
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
BP 12-2006, f. & cert. ef. 12-19-06
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
PB 1-1994, f. & cert. ef. 2-2-94
PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-065-0005 Definitions

(1) “Affiliate” means a business entity that has a relationship, or is an authorized trading partner, with a second business entity if, directly or indirectly:

(a) One business entity controls, or has the power to control, the other business entity; or

(b) A third party controls, or has the power to control, both of the business entities.

(2) "Authorized Distributor of Record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. An ongoing relationship is deemed to exist between such wholesale distributor and a manufacturer when the wholesale distributor, including any affiliated group of the wholesale distributor, as defined in Section 1504 of the Internal Revenue Code, complies with either or both of the following:

(a) The wholesale distributor has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship; or

(b) The wholesale distributor is listed on the manufacturer's current list of authorized distributors of record, which is updated by the manufacturer no less than monthly.

(3) "Broker" means a person engaged in the marketing, offering, or contracting for wholesale distribution and sale of a drug into, within, or out of Oregon and who does not take physical possession of the brokered substance.

(4) "Chain Pharmacy Warehouse" means a physical location for drugs that acts as a central warehouse and performs intra company sales or transfers of drugs to a group of chain pharmacies that have the same common ownership and control.

(5) "Closed Door Pharmacy" means a pharmacy that provides pharmaceutical services to a defined and exclusive group of patients and is not open for dispensing to the general patient population and cannot be registered as a wholesale distributor.

(6) "Co-Manufacturing Partner" means a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

(7) "Designated Representative" means an individual designated by each wholesale distributor registered by the board who will serve as the primary contact person for the wholesale distributor with the board and who is responsible for managing the company's operations at that registered location.

(8) "Drug Sample" means a unit of a drug that is intended to promote the sale of the drug, but which is not itself for sale.

(9) “Illegitimate Product” means a product for which credible evidence shows that the product is:

(a) Counterfeit, diverted, or stolen;

(b) Intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(d) Otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death.

(10) "Intra Company Transfer" means the transfer of any drug between a division, subsidiary, parent, and an affiliated or related company under the common ownership and control of a corporate entity.

(11) "Manufacturer" means anyone, including a manufacturer's co-manufacturing partner, who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.

(12) "Pedigree" for the purpose of this Division consists of:

(a) “Transaction History,” which means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

(b) “Transaction Information,” which must include, but is not limited to:

(A) The proprietary or established name or names of the product;

(B) The strength and dosage form of the product;

(D) The container size;

(E) The number of containers;

(F) The lot number of the product;

(G) The date of the transaction;

(H) The date of the shipment, if more than 24 hours after the date of the transaction;

(I) The business name and address of the person from whom ownership is being transferred; and

(J) The business name and address of the person to whom ownership is being transferred.

(c) “Transaction Statement,” which is a statement, in paper or electronic form, that the entity transferring ownership in a transaction is compliant with Food and Drug Administration (FDA) regulations set forth by the Drug Quality and Security Act and includes but is not limited to:

(A) Confirmation that the entity is authorized or registered as required under the Drug Supply Chain Security Act;

(B) Acknowledgement that product is received from an authorized or registered entity, as required under the Drug Supply Chain Security Act;

(C) Confirmation of receipt of transaction information and of transaction statement from the prior owner of the product, as required under the Drug Supply Chain Security Act;

(D) Verification that a suspect or illegitimate product was not knowingly shipped;

(E) Confirmation that systems and processes are in place to comply with verification requirements under the Drug Supply Chain Security Act;

(F) Confirmation that false transaction information was not knowingly provided; and

(G) Confirmation that transaction history was not knowingly altered.

(13) "Prescription Drug" means any drug required by law to be dispensed only by a prescription.

(14) “Quarantine” means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.

(15) "Suspect Product" means a product for which there is no reason to believe that such product is:

(a) Potentially counterfeit, diverted, or stolen;

(b) Potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(d) Otherwise unfit for distribution such that the product would result in serious adverse health consequences or death.

(16) “Trading Partner” means:

(a) A manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or

(b) A third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.

(17) “Validate” means to verify that each transaction listed on the pedigree and other accompanying documentation has occurred and is accurately recorded.

(18) "Wholesale Distribution" means distribution of a drug to a person other than a consumer or patient, but does not include:

(a) Delivery by a retail pharmacy of a prescription drug to a patient or patient's agent pursuant to the lawful order of a licensed practitioner.

(b) The sale of minimal quantities of a prescription drug by retail or institutional pharmacies to licensed practitioners for office use.

(A) Emergency medical reasons;

(B) Drug or devices used during a federal or state declared emergency; or

(d) Intra company transfer of drugs as defined in these rules.

(e) The lawful distribution of a drug sample by a manufacturer's or a distributor's representative.

(f) The distribution of a drug or an offer to distribute a drug by a charitable organization to a non-profit affiliate of the organization to the extent permitted by law.

(g) The purchase or acquisition of a drug by a hospital or other health care entity that is a member of a group purchasing organization, for the hospital's or health care entity's own use, from the group purchasing organization or from other hospitals or health care entities that are members of the organization or under common control.

(h) The transfer of a prescription drug between pharmacies pursuant to a shared pharmacy service agreement as defined in OAR 855-006-0005.

(i) The distribution by a manufacturer, as part of a prescription assistance program, of a drug intended for a specific patient, to a person authorized to prescribe, administer or dispense prescription drugs.

(j) The sale, purchase, or trade of blood and blood components intended for transfusion.

(k) Drug returns, when conducted in accordance with state and federal laws and regulations. A drug return includes the sale or transfer from a dispenser, retail pharmacy, or chain pharmacy warehouse of expired, damaged, returned or recalled drugs to the original manufacturer, wholesale distributor, or to a reverse wholesaler, and the returns of saleable drugs to the original manufacturer or wholesaler.

(l) The sale, transfer, merger or consolidation of all or part of the business of a pharmacy from or with another pharmacy.

(m) The distribution of drugs by a manufacturer registered under OAR 855-065 division of this chapter of rules of its own products to a person other than a patient.

(19) "Wholesale Distributor" means any entity engaged in the wholesale distribution of drugs. The term "Wholesale Distributor" includes but is not limited to, own-label distributors; private-label distributors; warehouses, including manufacturers' and distributors' warehouses; drug wholesalers or distributors; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.

(20) "Wholesaler" means any wholesale distributor:

(a) "Class I Wholesaler" for the purpose of these rules means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which prescription drugs, including controlled drugs, devices containing prescription drugs, medicinal chemicals, or poisons are sold, dispensed, stocked, exposed or offered for sale at wholesale to a pharmacy or other legally licensed drug outlets or persons and is required to comply with all pedigree requirements;

(b) "Class II Wholesaler" means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which any non-prescription drugs are stored, or offered for sale or distribution at wholesale to a drug outlet or practitioner legally authorized to resell, distribute, dispense or administer.

(c) “Class III Wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which any of the products in paragraphs (A)-(F) below are stored, or offered for sale or distribution at wholesale to a drug outlet or practitioner legally authorized to resell, distribute, dispense or administer and is exempted from Federal recordkeeping requirements:

(A) Drugs distributed exclusively for veterinary use. If any prescription drugs not intended for veterinary use are offered for sale, the wholesaler must register as a Class I wholesaler;

(B) Prescription devices that do not contain a prescription drug;

(C) Drugs or devices possessed by a state or local government agency, or non-profit relief organization approved by the board;

(D) Oxygen USP and medical gases;

(E) Intravenous drugs; by which formulation, are intended for the replenishment of fluids, electrolytes or calories;

(F) Medical convenience kits which includes any non-controlled drug product or biological product, assembled in kit form.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 45-2021, amend filed 12/16/2021, effective 12/16/2021
BP 4-2015, f. & cert. ef. 7-1-15
BP 6-2012, f. & cert. ef. 12-13-12
BP 4-2012(Temp), f. & cert. ef. 6-19-12 thru 12-16-12
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
BP 12-2006, f. & cert. ef. 12-19-06
PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-065-0006 Registration Requirements

(1) Every wholesale distributor, wherever located, that engages in wholesale distribution into, out of, or within Oregon must be registered with the Board in accordance with the laws and regulations of Oregon before engaging in wholesale distribution of drugs. Every applicant for registration or renewal of registration must pay the appropriate fee in accordance with OAR 855-110-0007 and 855-110-0010. An applicant must register as a Class I Wholesaler or a Class II Wholesaler unless the applicant qualifies for registration as a Drug Distribution Agent under Division 62 of this chapter of rules.

(2) Application for registration must be on a form approved by the Board and must include, but not be limited to, the following information:

(a) The name, business address, social security number and federal tax identification number of each owner, officer, and stockholder owning more than 10 per cent of the stock of the company, unless the stock of the company is publicly traded;

(b) All trade or business names used by the applicant including any businesses outside Oregon;

(c) The names, addresses and telephone numbers of the designated representatives for all facilities used by the applicant that engage in wholesale distribution into, out of, or within Oregon;

(d) The normal business hours for the applicant; and

(e) Any disciplinary action taken by any state or federal authority against the applicant or any other wholesale distributor under common ownership or control, or any owner, principal or designated representative of the applicant, in connection with the drug laws or regulations of any state or the federal government.

(3) The Board may require a criminal history and financial background check of each principal, owner, officer and designated representative of the applicant prior to initial registration and prior to any renewal. Any such checks shall be at the applicant's expense.

(4) The Board may require a physical inspection of each facility prior to initial registration and prior to any renewal.

(5) Any wholesale distributor located outside the boundaries of Oregon, applying for registration or re-registration, as a Class I Wholesaler, must provide evidence of one of the following:

(a) A current license or registration as a wholesale distributor in a state that has a license or registration procedure approved by the Board that included a physical inspection within the past three years; or

(b) A current accreditation by a process approved by the Board such as The National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor (VAWD) program or other nationally recognized accreditation program or contract inspection service.

(6) Any wholesale distributor located inside the boundaries of Oregon, applying for registration or re-registration, as a Class I Wholesaler, must provide evidence of one of the following:

(a) A current accreditation by a process approved by the Board such as The National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor (VAWD) program or other nationally recognized accreditation program or contract inspection service; or

(b) That it is a small business as defined in ORS 183.310(10); and

(A) The applicant has no affiliation with any out-of-state pharmaceutical company; and

(B) All owners and principals of the applicant are Oregon residents; and

(C) No owner or principal, or close family member of an owner or principal, has a controlling or business interest in any other pharmaceutical company; and

(D) Neither the applicant, nor any of its owners or principals, has ever been found to be in violation of any drug law or regulation in this or any other state.

(7) In addition to the above registration requirements, an applicant for registration as a Class I wholesaler under this rule, that has not received VAWD accreditation, must provide evidence that it has obtained a bond or equivalent means of security of at least $100,000 that provides direct access to the Oregon Board of Pharmacy as a beneficiary to secure payment of any administrative penalties that may be imposed by the Board and any fees and costs that may be incurred by the Board and that:

(a) Are related to a registration held by the wholesale distributor; and

(b) Are authorized under Oregon law; and

(8) The Board may make a claim against a bond or security posted under section (7) of this rule within one year after the wholesale distributor's registration is no longer valid or sixty days after the conclusion of whichever occurs later:

(a) An administrative or legal proceeding before or on behalf of the Board that involves the wholesale distributor and results in penalties, fees or costs; or

(b) An appeal of such a proceeding.

(9) Where operations are conducted at more than one location by a single wholesale drug outlet, each such location that does business in Oregon must be registered by the Board.

(10) The registrant must notify the Board, within 15 days, of any substantial change to the information provided on the registration application. Substantial change shall include but not be limited to: change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, or designated representatives.

(11) The registration certificate is issued to a specific person and is non-transferable. Additions or deletions of an owner or partner shall be considered as a change of ownership.

(12) A new registration form is required for a change of ownership or location and must be submitted to the Board with the fees as specified in OAR 855-110-0007 within 15 days of the change.

(13) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety. A waiver granted under this section shall only be effective when it is issued in writing.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
BP 12-2006, f. & cert. ef. 12-19-06

Or. Admin. R. 855-065-0007 Minimum Qualifications

The Board may deny an application for an initial registration or renewal of registration as a wholesale distributor on any of the following grounds:

(1) The applicant has been found by the Board or by a court to have violated the pharmacy or drug laws or rules of this state or of any other state or of the federal government.

(2) The applicant has been convicted of any offence under federal, state, or local laws.

(3) The applicant has a history of non-compliance with state or federal rules or laws regulating the manufacture, distribution, or dispensing of drugs.

(4) The applicant has made a material misrepresentation to the Board in the course of applying for an initial or renewal of registration.

(5) Disciplinary action has been taken by the federal government or by any state, or local government regarding any license or registration currently or previously held by the applicant for the manufacture, distribution or dispensing of any drugs.

(6) The applicant has engaged in any conduct involving moral turpitude.

(7) The Board determines that granting the registration is not consistent with the public health or safety or is otherwise not in the public interest.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.135, 689.155, 689.305, 689.315 & 689.405
BP 12-2006, f. & cert. ef. 12-19-06
PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)

Or. Admin. R. 855-065-0009 Personnel

As a part of the registration or re-registration application, an applicant for registration as a Class I Wholesaler must name a Designated Representative (DR) for each wholesale distributor registered under these rules. The DR must:

(1) Be employed in a full-time managerial position by the wholesale distributor and may not be listed as the DR for more than one registrant without the specific written authority of the Board.

(2) Have at least two years verifiable full-time managerial or supervisory experience in a pharmacy or with a wholesale distributor registered under these rules or with another state.

(3) Have verifiable experience in record keeping and storage of prescription drugs.

(4) Be actively involved in and aware of the daily operations of the wholesale distributor.

(5) Be knowledgeable about all policies and procedures of the wholesale distributor.

(6) Be physically present at the wholesale distributor during normal business hours, which must be posted to be visible to the public, except when absent due to emergency, authorized absence or legitimate business reason (as used in this rule, “normal business hours” means at least six hours between 6.00 am and 7.00 pm on at least five days between Monday and Saturday every week, excluding national and local holidays). Class I wholesalers located within Oregon must designate a replacement DR and notify the Board accordingly, when any absence of the DR exceeds 15 days.

(7) The DR must conduct a self-inspection of the facility by September 1 each year, and document the results of this self-inspection on Oregon Wholesaler Self-Inspection Form provided by the Board. The DR must certify in writing, under penalties of perjury, that the information recorded on the Oregon Wholesaler Self-Inspection Form is correct. This form must be retained for three years and must be made available to the Board within two days upon request.

(8) The DR must ensure that the wholesale drug outlet has policies and procedures in effect and implemented to ensure that the outlet employs adequate personnel with the education and experience necessary to engage in the wholesale distribution of drugs safely and lawfully.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.135, 689.305 & 689.315
BP 12-2006, f. & cert. ef. 12-19-06
PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)

Or. Admin. R. 855-065-0010 Minimum Requirements for Reporting, Record Keeping and Inventory Management

(1) A Wholesale distributor must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records must comply with all federal drug laws and regulations unless exempted.

(2) Inventories and records required by this rule must be made available for inspection and copying by any authorized official of the Drug Enforcement Agency, the Food and Drug Administration, the Department of Agriculture, law enforcement agencies, and this Board.

(3) Inventories and records required under these rules must be maintained for a minimum of three years following disposition of the drugs.

(4) Records described in this section that are less than 13 months old must be kept at the inspection site or be immediately retrievable by computer or other electronic means, and must be immediately available for inspection. All other records required by this rule must be made available for inspection within three business days of a request.

(5) A wholesale distributor must establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory, transport, shipping and distribution of drugs, including policies and procedures for identifying, recording, and reporting any loss, theft, counterfeiting or diversion of any drug and for correcting all errors and inaccuracies in inventories. A wholesale distributor must include in its written policies and procedures the following:

(a) A procedure whereby the oldest approved stock of a drug is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.

(b) A procedure to be followed for handling a recall or withdrawal of a drug. Such procedure must be adequate to deal with a recall or withdrawal due to:

(A) Any action initiated at the request of the Food and Drug Administration or other federal, state, or local law enforcement or other government agency, including the Board;

(B) Any voluntary action by the manufacturer to remove a defective or potentially defective drug from the market; or

(C) Any action undertaken to promote public health and safety by replacing an existing drug with an improved product or new package design.

(c) A procedure to prepare for, protect against, and handle any crisis that affects the security or operation of the facility in the event of strike, fire, flood, or other natural disaster, or other local, state, or national emergencies.

(d) A procedure to ensure that any outdated drug is segregated from other drugs and either returned to the manufacturer or destroyed. This procedure must provide for written documentation of the disposition of an outdated drug. This documentation must be maintained for three years after disposition of the outdated drug.

(e) Disposition and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging are not used in counterfeiting activities, including necessary documentation and witnessing in accordance with state and federal law.

(f) Investigation of discrepancies in the inventory involving counterfeit, suspected counterfeit, contraband, or suspected contraband drugs and reporting of discrepancies within three business days to the Board and any other appropriate state or federal agency.

(g) Reporting of criminal or suspected criminal activities involving the inventory of drugs to the Board within three business days.

(h) Conducting for cause authentication as required under section (7) of this rule.

(i) Procedures for accurately documenting the temperature and humidity conditions of the storage facility.

(6) A wholesale distributor must maintain and adhere to written policies and procedures for all incoming and outgoing product shipments, including but not limited to the following:

(a) Upon receipt, visual examination of each shipping container sufficient to identify the drugs in the container and to determine whether the drugs may be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution.

(b) Upon receipt, review of records for accuracy and completeness, considering the:

(A) Total facts and circumstances surrounding each transaction involving the drugs; and

(B) Wholesale distributors involved.

(c) Quarantine of a drug considered to be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution until:

(A) Examination and a determination is made that the drug is fit for distribution; or

(B) The drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired.

(d) If the wholesale distributor identifies a suspect product, the wholesale distributor must quarantine the product and promptly conduct an investigation to determine whether the suspect product is illegitimate. If it is determined to be an illegitimate product the wholesale distributor must provide notice to the Board, the Food and Drug Administration, and the trading partners involved in the transaction, within 24 hours.

(e) If the immediate or sealed outer or secondary container or labeling of a drug is adulterated, misbranded, counterfeit, or suspected counterfeit, the wholesale distributor must:

(A) Quarantine the drug until the drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired; and

(B) Provide notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting to the Board, the Food and Drug Administration, and the manufacturer or wholesale distributor from which the drug was acquired, within 24 hours.

(f) A drug that is not adulterated, misbranded, counterfeit, or suspected counterfeit, but has been opened or used, is identified as such and quarantined until the drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired.

(g) A drug that will be returned to a manufacturer or wholesale distributor is stored, handled and transported under proper conditions before the return, and documentation showing that proper conditions were maintained must be provided to the manufacturer or wholesale distributor to which the drug is returned.

(h) Inspection of each outgoing shipment to verify the identity of each drug and to ensure that each drug has not been damaged in storage or held under improper conditions.

(i) Contraband, counterfeit, or suspected counterfeit drugs, other evidence of criminal activity, and accompanying documentation are retained until a disposition is authorized by the Board or the Food and Drug Administration.

(j) Any sealed outer or secondary shipping container or labeling, and accompanying documentation, for a drug that is suspected to be counterfeit or fraudulent, is retained until a disposition is authorized by the Board and the Food and Drug Administration.

(k) Operations comply with all state and federal laws, rules and regulations applicable to wholesale drug distribution.

(l) All confidential information is stored in an area with restricted access and in such a way as to protect the integrity and confidentiality of the information.

(7) A wholesale distributor must maintain pedigree records for a minimum of three years.

(8) If the wholesale distributor is involved in the distribution of controlled substances, the distributor must register with the Drug Enforcement Administration and the Board, and comply with all laws related to the storage, handling, transport, shipment, and distribution of controlled substances including, but not limited to, the isolation of controlled substances from non-controlled substances and storage of the controlled substances in a secure area in accordance with Drug Enforcement Administration security requirements and standards.

(9) A wholesale distributer must notify the Board in writing of suspicious orders of controlled substances to be distributed within Oregon upon discovery. Suspicious orders include, but are not limited to orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, 689.315, 689.325 & 689.765
BP 2-2017, f. 6-30-17, cert. ef. 7-1-17
BP 4-2015, f. & cert. ef. 7-1-15
BP 12-2006, f. & cert. ef. 12-19-06
PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-065-0012 Storage of Drugs

(1) As a condition for receiving and retaining a wholesale distributor registration issued under these rules, an applicant must satisfy the Board that the applicant has and will continuously maintain acceptable storage and handling conditions and facilities standards for each facility at which drugs are received, stored, warehoused, handled, held, offered, marketed, or displayed, or from which drugs are transported, including:

(a) Suitable construction of the facility and appropriate monitoring equipment to ensure that drugs in the facility are maintained in accordance with labeling or in compliance with official compendium standards.

(b) Suitable size and construction to facilitate cleaning, maintenance, and proper wholesale distribution operations.

(c) Adequate storage areas to provide appropriate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions.

(d) A quarantine area for the separate storage of drugs that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, suspected counterfeit, otherwise unfit for distribution, or contained in immediate or sealed secondary containers that have been opened.

(e) Maintenance of the facility in a clean and orderly condition.

(f) Maintenance of the facility in a commercial, nonresidential building.

(g) Freedom of the facility from infestation by insects, rodents, birds or vermin of any kind.

(2) The facility must be equipped with appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs to document proper storage of drugs.

(3) The facility must meet security standards including but not limited to:

(a) An entry system that restricts access to areas where drugs are held, to authorized personnel.

(b) An after-hours central alarm system or a comparable entry detection system.

(d) Safeguards against theft and diversion, including employee theft and theft or diversion facilitated or hidden by tampering with computers or electronic records.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.305
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 12-2006, f. & cert. ef. 12-19-06

Or. Admin. R. 855-065-0013 Prohibited Practices

(1) The following practices are expressly prohibited:

(a) A wholesale distributor may not purchase drugs from a closed-door pharmacy.

(b) A wholesale distributor may not sell, distribute or transfer a drug to a person who is required by the laws and rules of Oregon to be registered with the Oregon Board of Pharmacy and who is not appropriately registered by the Board. Before furnishing a drug to any person not known to the wholesale distributor, the wholesale distributor must verify that the person is legally authorized to receive the drug.

(c) A wholesale distributor may not purchase any drug from a person who is required by the laws and rules of Oregon to be registered with the Oregon Board of Pharmacy and who is not appropriately registered by the Board. Before purchasing a drug from any person not known to the wholesale distributor, the wholesale distributor must verify that the person is legally authorized to sell the drug.

(d) A Class 1 Wholesaler who is classified as a "Specialty Wholesaler Distributor" as defined in OAR 855-065-005(20) may not:

(A) Sell, distribute or transfer a prescription drug to a pharmacy or to a practitioner who is licensed to prescribe the prescription drug, without providing a complete pedigree for the prescription drug, unless the prescription drug was purchased directly from the manufacturer or from the manufacturer's authorized distributor of record.

(B) Sell, distribute or transfer a prescription drug to a wholesale distributor, without providing a complete pedigree for the prescription drug.

(2) A wholesaler may not perform, cause the performance of, or aid the performance of any of the following:

(a) The manufacture, repackaging, sale, delivery, holding, or offering for sale of a drug that is adulterated, misbranded, counterfeit, suspected counterfeit, or is otherwise unfit for distribution.

(b) The adulteration, misbranding, or counterfeiting of a drug.

(c) The intentional receipt of a drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected product, and the delivery or proffered delivery of the drug for pay or otherwise.

(e) The forging, counterfeiting, simulating, or falsely representing a drug using a mark, stamp, tag, label, or other identification device without the authorization of the manufacturer.

(f) The purchase or receipt of a drug from a person that is not registered to distribute drugs to the purchaser or recipient.

(h) The failure to maintain or provide records as required under these rules.

(j) Participating in the wholesale distribution of a drug that was:

(A) Purchased by a public or private hospital or other health care entity under the terms of an "own-use" contract; or

(B) Donated or supplied at a reduced price to a charitable organization; or

(D) Illegally imported into the USA.

(k) Obtaining or attempting to obtain a drug by fraud, deceit, misrepresentation, or engaging in fraud, deceit, or misrepresentation in the distribution of a drug.

(l) Failing to maintain required pedigree records.

(m) Receiving a prescription drug through wholesale distribution without receiving a required pedigree attested to as accurate and complete by the wholesale distributor.

(n) Distributing a drug that was previously dispensed by a retail pharmacy or a practitioner.

(o) Failing to report an act prohibited by any of the rules in OAR 855.065 to the appropriate state or federal authorities.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, 689.305, 689.315 & 689.527
BP 4-2015, f. & cert. ef. 7-1-15
BP 12-2006, f. & cert. ef. 12-19-06

Division 70 PROPHYLACTICS AND CONTRACEPTIVES

Or. Admin. R. 855-070-0001 Definitions

(1) Prophylactic means a drug, device or medical preparation intended for or having special utility in the prevention of a sexually transmitted disease, or in the prevention of conception.

(2) Contraceptive means a drug, device or medical preparation intended for the prevention of conception.

(3) Male condom means a prophylactic or contraceptive device in the form of a sheath which completely covers the penis with a closely fitting membrane.

(4) Female condom means a prophylactic or contraceptive device in the form of an intravaginal pouch that consists of a sheath with a flexible ring on each end.

History

Statutory/Other Authority: ORS 689.155 & 689.205
PB 1-1995, f. & cert. ef. 4-27-95

Or. Admin. R. 855-070-0005 Applications, Fees, and Licenses to Sell Prophylactics and Contraceptives

(1) Every wholesaler or manufacturer of prophylactics or contraceptives who distributes in Oregon goods of the class specified in ORS 435.010 shall annually submit an application for a license issued by the Board of Pharmacy:

(a) The application shall be made in writing on a form prepared by the Board and be accompanied by the fee listed in division 110;

(b) One such application shall be submitted and license obtained for each location or separate address from which goods are distributed;

(c) Licenses shall be issued upon receipt of the fee listed in division 110 and shall be in effect for one year from January 1 of each year. Licenses are not transferable;

(d) Licenses shall be publicly or conspicuously displayed and the wholesaler or manufacturer to whom they are issued shall be open to inspection by the Board or other authorized persons designated by the Board;

(e) Each application for a license shall include a list of all products or brands of prophylactics and contraceptives the applicant wishes to have approved for sale in the state.

(2) Before any condom product can be distributed in Oregon, it must be approved by the Oregon Board of Pharmacy. Every manufacturer or wholesaler that intends to distribute either male or female condoms shall furnish to the Board the names of such products.

(3) The Board may require proof to be furnished by the manufacturer or wholesaler that these products have received approval in accordance with the Federal Food, Drug and Cosmetic Act and regulations thereunder (Title 21 U.S.C. and CFR);

(4) The requirements under the Federal Food, Drug and Cosmetic Act and regulations thereunder (Title 21 U.S.C. and CFR) relating to prophylactics and contraceptives are adopted by reference and made a part hereof.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 435.010, 435.080, 435.100 & 689.155
BP 10-2006, f. and cert. ef. 12-19-06
PB 1-1995, f. & cert. ef. 4-27-95
PB 10-1987, f. & ef. 12-8-87
1PB 39, f. & ef. 1-8-76
1PB 36, f. 7-1-74, ef. 7-25-74
1PB 35(Temp), f. & ef. 3-26-74
1PB 32, f. 1-31-74, ef. 2-25-74
Reverted to 1PB 18, f. & ef. 10-14-64
1PB 29(Temp), f. & ef. 9-6-73
1PB 18, f. & ef. 10-14-64

Or. Admin. R. 855-070-0010 Labeling and Storage of Prophylactics and Contraceptives

(1) The use of detachable slip labels or removable ink stamps listing names and addresses of manufacturer, brand name, and expiration date do not meet the labeling requirements of ORS 435.090.

(2) As of December 31, 1994, all prophylactics and contraceptives shall bear an expiration date. Prophylactics and contraceptives bearing an expiration date shall not be sold or otherwise distributed beyond that date.

(3) Prophylactics and contraceptives shall be stored, displayed, or sold from an area removed from excessive extremes of temperatures which may affect the quality of the products.

History

Statutory/Other Authority: ORS 689.155 & 689.205
PB 1-1995, f. & cert. ef. 4-27-95
1PB 1-1984, f. & ef. 2-16-84
1PB 39, f. & ef. 1-8-76
1PB 32, f. 1-31-74, ef. 2-25-74
Reverted to 1PB 18, f. & ef. 10-14-64
1PB 29(Temp), f. & ef. 9-6-73 thru 1-3-74
1PB 18, f. & ef. 10-14-64

Division 80 SCHEDULE OF CONTROLLED SUBSTANCES

Or. Admin. R. 855-080-0015 Definitions

As used in these rules:

(1) "Act" means the Uniform Controlled Substances Act, ORS Chapter 475, and rules thereunder;

(2) "CFR" means Code of Federal Regulations;

(3) "USC" means United States Code;

(4) "Emergency Situations" means those situations in which the prescribing practitioner who authorizes an oral prescription of a controlled substance listed in schedule II of the Federal Controlled Substances Act determines that:

(a) Immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and

(b) No appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under schedule II of the Act, and

(c) It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance prior to the dispensing.

(5) Terms not defined in this rule have the definitions set forth in ORS 475.005.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.035, ORS 475.940 & ORS 475.185
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
BP 3-2002(Temp), f. & cert. ef. 3-1-02 thru 8-23-02
PB 5-1991, f. & cert. ef. 9-19-91
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0020 Schedules

Pursuant to ORS 475.005(6) those drugs and their immediate precursors classified in Schedules I through V under the Federal Controlled Substances Act, 21 USC 811 (v. 02/26/2026), 21 USC 812 (v. 02/26/2026) and as amended by the board pursuant to ORS 475.035 are the controlled substances for purposes of regulation and control under the Act. Those schedules are set out in OAR 855-080-0021 through 855-080-0026.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.035
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 8-2010, f. & cert. ef. 6-29-10
PB 5-1991, f. & cert. ef. 9-19-91
PB 4-1987, f. & ef. 3-30-87
1PB 2-1986, f. & ef. 7-10-86
1PB 4-1985, f. & ef. 12-2-85
1PB 2-1985, f. & ef. 7-24-85
1PB 1-1985, f. & ef. 2-27-85
1PB 4-1984(Temp), f. & ef. 9-17-84
1PB 2-1984, f. & ef. 3-7-84
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0021 Schedule I

(1) Schedule I consists of the drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR 1308.11 (v. 04/01/2025), and unless specifically exempt or unless listed in another schedule, any quantity of the following substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

(a) 1,4-butanediol;

(b) Gamma-butyrolactone

(d) Dichloro-N-(2-(dimethylamino)cyclohexyl)-N-methylbenzamide (U-47700)

(e) 4-chloro-N-[1-[2-(4-nitrophenyl)ethyl]piperidin-2-ylidene]benzenesulfonamide (W-18) and positional isomers thereof, and any substituted derivative of W-18 and its positional isomers, and their salts, by any substitution on the piperidine ring (including replacement of all or part of the nitrophenylethyl group), any substitution on or replacement of the sulfonamide, or any combination of the above that are not FDA approved drugs, unless specifically excepted or when in the possession of an FDA registered manufacturer or a registered research facility, or a person for the purpose of sale to an FDA registered manufacturer or a registered research facility.

(f) Substituted derivatives of cathinone and methcathinone that are not listed in OARs 855-080-0022 through 0026 (Schedules II through V) or are not FDA approved drugs, including but not limited to,

(A) Methylmethcathinone (Mephedrone);

(B) Methylenedioxypyrovalerone (MDPV);

(D) 2-Methylamino-3’,4’-(methylenedioxy)-butyrophenone (Butylone);

(E) Fluoromethcathinone (Flephedrone);

(F) 4-Methoxymethcathinone (Methedrone).

(2) Schedule I also includes any compounds in the following structural classes (2a–2k) and their salts, that are not FDA approved drugs, unless specifically excepted or when in the possession of an FDA registered manufacturer or a registered research facility, or a person for the purpose of sale to an FDA registered manufacturer or a registered research facility:

(a) Naphthoylindoles: Any compound containing a 3-(1-naphthoyl)indole structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent. Examples of this structural class include but are not limited to: JWH-015, JWH-018, JWH-019, JWH-073, JWH-081, JWH-122, JWH-200, JWH-210, AM-1220, MAM-2201 and AM-2201;

(b) Phenylacetylindoles: Any compound containing a 3-phenylacetylindole structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent, whether or not substituted in the phenyl ring to any extent. Examples of this structural class include but are not limited to: JWH-167, JWH -201, JWH-203, JWH-250, JWH-251, JWH-302 and RCS-8;

(c) Benzoylindoles: Any compound containing a 3-(benzoyl)indole structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent. Examples of this structural class include but are not limited to: RCS-4, AM-694, AM-1241, and AM-2233;

(d) Cyclohexylphenols: Any compound containing a 2-(3-hydroxycyclohexyl)phenol structure with substitution at the 5-position of the phenolic ring whether or not substituted in the cyclohexyl ring to any extent. Examples of this structural class include but are not limited to: CP 47,497 and its C8 homologue (cannabicyclohexanol);

(e) Naphthylmethylindoles: Any compound containing a 1H-indol-3-yl-(1-naphthyl)methane structure with substitution at the nitrogen atom of the indole ring whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent;

(f) Naphthoylpyrroles: Any compound containing a 3-(1-naphthoyl)pyrrole structure with substitution at the nitrogen atom of the pyrrole ring whether or not further substituted in the pyrrole ring to any extent and whether or not substituted in the naphthyl ring to any extent;

(g) Naphthylmethylindenes: Any compound containing a 1-(1-naphthylmethyl) indene structure with substitution at the 3-position of the indene ring whether or not further substituted in the indene ring to any extent and whether or not substituted in the naphthyl ring to any extent;

(h) Cyclopropanoylindoles: Any compound containing an 3-(cyclopropylmethanoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent and whether or not substituted in the cyclopropyl ring to any extent. Examples of this structural class include but are not limited to: UR-144, XLR-11 and A-796,260;

(i) Adamantoylindoles: Any compound containing a 3-(1-adamantoyl)indole structure with substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent and whether or not substituted in the adamantyl ring to any extent. Examples of this structural class include but are not limited to: AM-1248 and AB-001;

(j) Adamantylindolecarboxamides: Any compound containing an N-adamantyl-1-indole-3-carboxamide with substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent and whether or not substituted in the adamantyl ring to any extent. Examples of this structural class include but are not limited to: STS-135 and 2NE1; and

(k) Adamantylindazolecarboxamides: Any compound containing an N-adamantyl-1-indazole-3-carboxamide with substitution at the nitrogen atom of the indazole ring, whether or not further substituted in the indazole ring to any extent and whether or not substituted in the adamantyl ring to any extent. Examples of this structural class include but are not limited to: AKB48.

(3) Schedule I also includes any other cannabinoid receptor agonist that is not listed in OARs 855-080-0022 through 0026 (Schedules II through V) is not an FDA approved drug or is exempted from the definition of controlled substance in ORS 475.005(6)(b)(A)-(E).

(4) Schedule I also includes any substituted derivatives of fentanyl that are not listed in OARs 855-080-0022 through 0026 (Schedules II through V) or are not FDA approved drugs, and are derived from fentanyl by any substitution on or replacement of the phenethyl group, any substitution on the piperidine ring, any substitution on or replacement of the propanamide group, any substitution on the phenyl group, or any combination of the above.

(5) Schedule I also includes any compounds in the following structural classes (a – b), and their salts, that are not listed in OARs 855-080-0022 through 0026 (Schedules II through V) or FDA approved drugs, unless specifically excepted or when in the possession of an FDA registered manufacturer or a registered research facility, or a person for the purpose of sale to an FDA registered manufacturer or a registered research facility:

(a) Benzodiazepine class: A fused 1,4-diazepine and benzene ring structure with a phenyl connected to the diazepine ring, with any substitution(s) or replacement(s) on the 1,4-diazepine or benzene ring, any substitution(s) on the phenyl ring, or any combination thereof. Examples of this structural class include but are not limited to: Clonazolam, Flualprazolam

(b) Thienodiazepine class: A fused 1,4-diazepine and thiophene ring structure with a phenyl connected to the 1,-4-diazepine ring, with any substitution(s) or replacement(s) on the 1,4-diazepine or thiophene ring, any substitution(s) on the phenyl ring, or any combination thereof. Examples of this structural class include but are not limited to: Etizolam

(6) Exceptions. The following are exceptions to subsection (1) of this rule:

(a) 1, 4-butanediol and gamma-butyrolactone when in the possession of a person for the purpose of its sale to a legitimate manufacturer of industrial products and the person is in compliance with the Drug Enforcement Administration requirements for List I Chemicals;

(b) 1, 4-butanediol and gamma-butyrolactone when in the possession of a person for the purpose of the legitimate manufacture of industrial products;

(A) The plant Cannabis family Cannabaceae;

(B) Any part of the plant Cannabis family Cannabaceae, whether growing or not;

(D) The seeds of the plant Cannabis family Cannabaceae; or

(E) Any compound, manufacture, salt, derivative, mixture or preparation of a plant, part of a plant, resin or seed described in this paragraph.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.005, ORS 475.035, ORS 475.055 & ORS 475.065
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2022, amend filed 04/20/2022, effective 04/20/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 8-2020, amend filed 06/22/2020, effective 06/23/2020
BP 6-2016, f. & cert. ef. 12-14-16
BP 3-2016(Temp), f. & cert. ef. 8-22-16 thru 2-17-17
BP 7-2014, f. & cert. ef. 6-18-14
BP 5-2014(Temp), f. & cert. ef. 4-15-14 thru 8-27-14
BP 4-2014(Temp), f. 2-27-14, cert. ef. 2-28-14 thru 8-27-14
BP 11-2013(Temp), f. & cert. ef. 12-20-13 thru 6-18-14
BP 9-2013, f. & cert. ef. 10-28-13
BP 2-2011, f. & cert. ef. 4-11-11
BP 10-2010(Temp), f. & cert. ef. 10-15-10 thru 4-11-11
BP 8-2010, f. & cert. ef. 6-29-10
BP 1-2007, f. & cert. ef. 6-29-07
BP 1-2003, f. & cert. ef. 1-14-03
BP 5-2002, f. & cert. ef. 11-14-02
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
BP 3-2002(Temp), f. & cert. ef. 3-1-02 thru 8-23-02
BP 2-2002(Temp), f. & cert. ef. 2-4-02 thru 7-31-02
BP 9-2000, f. & cert. ef. 6-29-00
BP 4-2000, f. & cert. ef. 2-16-00
PB 1-1997, f. & cert. ef. 9-22-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1994, f. & cert. ef. 2-2-94
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 5-1991, f. & cert. ef. 9-19-91
PB 9-1990, f. & cert. ef. 12-5-90
PB 15-1989, f. & cert. ef. 12-26-89
PB 10-1987, f. & ef. 12-8-87
PB 8-1987, f. & ef. 9-30-87
PB 4-1987, f. & ef. 3-30-87

Or. Admin. R. 855-080-0022 Schedule II

Schedule II consists of the drugs and other substances by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR 1308.12 (v. 04/01/2025) and any quantity of methamphetamine, when in the form of a FDA approved product containing methamphetamine, its salts, isomers, and salts of its isomers as an active ingredient for the purposes of currently accepted medical use.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.005, ORS 475.035, ORS 475.055 & ORS 475.065
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 10-2017, amend filed 12/22/2017, effective 12/26/2017
BP 10-2014, f. 12-30-14, cert. ef. 1-1-15
BP 8-2010, f. & cert. ef. 6-29-10
BP 1-2007, f. & cert. ef. 6-29-07
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
BP 4-2000, f. & cert. ef. 2-16-00
Reverted to PB 1-1997, f. & cert. ef. 9-22-97
BP 3-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00
PB 1-1997, f. & cert. ef. 9-22-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1994, f. & cert. ef. 2-2-94
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 5-1991, f. & cert. ef. 9-19-91
PB 9-1990, f. & cert. ef. 12-5-90
PB 15-1989, f. & cert. ef. 12-26-89
PB 10-1987, f. & ef. 12-8-87
PB 8-1987, f. & ef. 9-30-87
PB 4-1987, f. & ef. 3-30-87

Or. Admin. R. 855-080-0023 Schedule III

Schedule III consists of the drugs and other substances by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR 1308.13 (v. 04/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205 & ORS 475.973
Statutes/Other Implemented: ORS 475.035
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
BP 9-2000, f. & cert. ef. 6-29-00
BP 4-2000, f. & cert. ef. 2-16-00
Reverted to PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
BP 3-1999(Temp), f. & cert. ef. 8-9-99 thru 1-17-00
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 5-1991, f. & cert. ef. 9-19-91
PB 11-1989, f. & cert. ef. 7-20-89
PB 4-1987, f. & ef. 3-30-87

Or. Admin. R. 855-080-0024 Schedule IV

Schedule IV consists of the drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR 1308.14 (v. 04/01/2025), unless specifically excepted or listed in another schedule.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.035
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
BP 9-2000, f. & cert. ef. 6-29-00
BP 4-2000, f. & cert. ef. 2-16-00
PB 1-1997, f. & cert. ef. 9-22-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1995, f. & cert. ef. 4-27-95
PB 1-1992, f. & cert. ef. 1-31-92 (and corrected 2-7-92)
PB 5-1991, f. & cert. ef. 9-19-91
PB 4-1987, f. & ef. 3-30-87

Or. Admin. R. 855-080-0026 Schedule V

Schedule V consists of the drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR 1308.15 (v. 04/01/2025); and

(1) Products containing pseudoephedrine or the salts of pseudoephedrine as an active ingredient.

(2) Products containing ephedrine or the salts of ephedrine as an active ingredient.

(3) Products containing phenylpropanolamine or the salts of phenylpropanolamine as an active ingredient.

(4) In order to provide non-prescription pseudoephedrine or ephedrine to a purchaser, a pharmacy must:

(a) Store all pseudoephedrine and ephedrine behind the pharmacy counter in an area that is inaccessible to the public;

(b) Utilize an electronic system meeting the requirements under ORS 475.230;

(c) Train individuals who are responsible for providing pseudoephedrine or ephedrine to purchasers on the requirements of the Combat Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005, P.L. 109-177), the Combat Methamphetamine Enhancement Act of 2010, P.L. 111-268, and use of the electronic system as described in ORS 475.230;

(d) Ensure that only a Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician provides pseudoephedrine or ephedrine to the purchaser after:

(A) Verifying that the purchaser is 18 years of age or older;

(B) Verifying the identity of the purchaser with valid government-issued photo identification; and

(e) Maintain an electronic log for at least three years from the date of the transaction that documents the following elements:

(A) Date and time of the purchase;

(B) Name, address and date of birth of the purchaser;

(C) Form of government-issued photo identification and the identification number used to verify the identity of the purchaser;

(D) Name of the government agency that issued the photo identification in (C);

(E) Name of product purchased;

(F) Quantity in grams of product purchased;

(G) Name or initials of Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician who provides the drug; and

(H) Signature of the purchaser. The signature of the purchaser may be recorded on a written log that also contains the transaction ID generated by the electronic system.

(5) All sales of pseudoephedrine or ephedrine are subject to the following quantity limits and restrictions:

(a) No more than 3.6 grams in a 24-hour period, no more than 9 grams in a 30-day period without regard to the number of transactions; and

(b) For non-liquids, product packaging is limited to blister packs containing no more than 2 dosage units per blister. Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches.

(6) Sections (4) and (5) do not apply to a pseudoephedrine or ephedrine when the drug is dispensed pursuant to a prescription.

(7) Each pharmacy, Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician involved in the provision of pseudoephedrine or ephedrine to a purchaser must comply with the provisions of 21 CFR 1314.01 (v. 04/01/2025), 21 CFR 1314.02 (v. 04/01/2025), 21 CFR 1314.03 (v. 04/01/2025), 21 CFR 1314.05 (v. 04/01/2025), 21 CFR 1314.10 (v. 04/01/2025), 21 CFR 1314.15 (v. 04/01/2025), 21 CFR 1314.20 (v. 04/01/2025), 21 CFR 1314.25, (v. 04/01/2025); 21 CFR 1314.30 (v. 04/01/2025), 21 CFR 1314.35 (v. 04/01/2025), 21 CFR 1314.40 (v. 04/01/2025), 21 CFR 1314.42 (v. 04/01/2025), 21 CFR 1314.45 (v. 04/01/2025); and 21 CFR 1314.50 (v. 04/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205 & ORS 475.230
Statutes/Other Implemented: ORS 475.035 & ORS 475.230
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 34-2022, amend filed 06/15/2022, effective 06/16/2022
BP 23-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
PB 5-1991, f. & cert. ef. 9-19-91
PB 4-1987, f. & ef. 3-30-87

Or. Admin. R. 855-080-0028 Excluded or Exempted Substances

(1) The board adopts the excluded substances list found in 21 CFR 1308.22 (v. 04/01/2025).

(2) The board adopts the exempt chemical preparations list found in 21 CFR 1308.24 (v. 04/01/2025).

(3) The board adopts the exempted prescription products list in the Table of Exempted Prescription Products (v. 12/03/2025) pursuant to 21 CFR 1308.32 (v. 04/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205 & ORS 475.035
Statutes/Other Implemented: ORS 689.155 & ORS 475.035
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 8-2010, f. & cert. ef. 6-29-10
BP 8-2006, f. & cert. ef. 12-19-06
BP 6-2006(Temp), f. & cert. ef. 8-25-06 thru 1-31-07
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
PB 1-1995, f. & cert. ef. 4-27-95
PB 5-1991, f. & cert. ef. 9-19-91
PB 4-1987, f. & ef. 3-30-87, Renumbered from 855-080-0025
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0029 Acceptable Subpoenas for Law Enforcement Agencies to Obtain Pseudoephedrine or Ephedrine Log Information

(1) “Law Enforcement Agency” includes the following:

(a) County sheriffs, municipal police departments, police departments established by a university under ORS 352.121 or 353.125 and state police;

(b) Other police officers of this state or another state, including humane special agents as defined in ORS 181A.345;

(d) A tribal government as defined in ORS 181A.680 that employs authorized tribal police officers as defined in ORS 181A.680; and

(e) Law enforcement agencies of the federal government.

(2) Acceptable subpoenas for a law enforcement agency to obtain information in a pseudoephedrine or ephedrine log are subpoenas lawfully issued by:

(a) A grand jury under ORS 136.563;

(b) A district attorney under ORS 136.565;

(d) A law enforcement agency of a tribal government under tribal subpoena authority; and

(e) A federal law enforcement agency under federal subpoena power.

(3) Subpoenas that meet the criteria in (2) are accepted by the Board under ORS 475.230. The Board does not act as a decisionmaker as to a subpoena issued for pseudoephedrine or ephedrine logs under this rule. The Board is not a party to a subpoena for information contained in a pseudoephedrine or ephedrine log under this rule.

History

Statutory/Other Authority: ORS 689.205 & ORs 475.230
Statutes/Other Implemented: ORS 475.035 & ORs 475.230
BP 5-2026, minor correction filed 03/06/2026, effective 03/06/2026
BP 42-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-080-0031 Registration Requirements

(1) Every person who manufactures, delivers, or dispenses any controlled substance within this state or who proposes to engage in the manufacture, delivery or dispensing of any controlled substance within this state must obtain a controlled substance registration annually issued by the State Board of Pharmacy.

(2) The board adopts the exceptions to registration for distribution by dispenser to another practitioner pursuant to 21 CFR 1307.11 (v. 04/01/2025).

(3) The board adopts the exceptions to registration for the incidental manufacture of controlled substances pursuant to 21 CFR 1307.13 (v. 04/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.155 & ORS 689.205
Statutes/Other Implemented: ORS 475.125
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
1PB 6-1982, f. & ef. 8-6-82

Or. Admin. R. 855-080-0041 Exemption to Registration

The following persons are not required to register to manufacture, dispense or deliver controlled substances and may lawfully possess controlled substances under ORS 475.005 to ORS 475.285 and ORS 475.752 to ORS 475.980:

(1) An agent or employee of any registered manufacturer, distributor or dispenser of any controlled substance if the agent or employee is acting in the usual course of business or employment.

(2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance is in the usual course of business or employment.

(3) An ultimate user or a person in possession of any controlled substance pursuant to a lawful order of a practitioner or in lawful possession of a Schedule V substance, unless otherwise prohibited.

(4) A practitioner otherwise licensed under the laws of this state and authorized to dispense or administer a controlled substance by the licensing authority.

(5) A person providing proof of a valid DEA registration certificate pursuant to ORS 475.135(3) conducting research with controlled substances in Sections I through V within this state.

History

Statutory/Other Authority: ORS 689.155 & ORS 689.205
Statutes/Other Implemented: ORS 475.125 & ORS 475.135
BP 20-2021, adopt filed 06/15/2021, effective 06/15/2021

Or. Admin. R. 855-080-0065 Security

(1) All applicants and registrants as applicable to the registration classification must comply with the security requirements of 21 CFR 1301.01 (v. 04/01/2025), 21 CFR 1301.02 (v. 04/01/2025), 21 CFR 1301.71 (v. 04/01/2025), 21 CFR 1301.72 (v. 04/01/2025), 21 CFR 1301.73 (v. 04/01/2025), 21 CFR 1301.74 (v. 04/01/2025), 21 CFR 1301.75 (v. 04/01/2025), 21 CFR 1301.76 (v. 04/01/2025), 21 CFR 1301.77 (v. 04/01/2025), 21 CFR 1301.90 (v. 04/01/2025), 21 CFR 1301.91 (v. 04/01/2025), 21 CFR 1301.92 (v. 04/01/2025), and 21 CFR 1301.93 (v. 04/01/2025).

(2) The security requirements of (1) of this rule apply to all controlled substances, as defined in these rules, including ephedrine, pseudoephedrine, and phenylpropanolamine.

(3) Applicants and registrants must guard against theft and diversion of ephedrine, pseudoephedrine, and phenylpropanolamine.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.135 & ORS 475.125
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
PB 5-1991, f. & cert. ef. 9-19-91
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0070 Records and Inventory

(1) All registrants must, as applicable to the registration classification, keep records and maintain inventories in compliance with 21 USC 827 (v. 02/26/2026); 21 CFR 1304.01 (v. 04/01/2025), 21 CFR 1304.02 (v. 04/01/2025), 21 CFR 1304.03 (v. 04/01/2025), 21 CFR 1304.04 (v. 04/01/2025), 21 CFR 1304.05 (v. 04/01/2025), 21 CFR 1304.06 (v. 04/01/2025); 21 CFR 1304.11 (v. 04/01/2025); 21 CFR 1304.21 (v. 04/01/2025), 21 CFR 1304.22 (v. 04/01/2025), 21 CFR 1304.23 (v. 04/01/2025), 21 CFR 1304.24 (v. 04/01/2025), 21 CFR 1304.25 (v. 04/01/2025), 21 CFR 1304.26 (v. 04/01/2025); 21 CFR 1304.31 (v. 04/01/2025), 21 CFR 1304.32 (v. 04/01/2025), 21 CFR 1304.33 (v. 04/01/2025).

(2) A written inventory of all controlled substances must be taken by registrants annually within 367 days of the last written inventory.

(3) All such records must be maintained for a period of three years.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 475.165
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 1-2007, f. & cert. ef. 6-29-07
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
PB 1-1994, f. & cert. ef. 2-2-94
PB 5-1991, f. & cert. ef. 9-19-91
PB 10-1987, f. & ef. 12-8-87
1PB 1-1986, f. & ef. 6-5-86
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0075 Orders for Schedule I and II Controlled Substances

Controlled substances in Schedules I and II must be distributed by a registrant to another registrant only pursuant to an order form or electronic order in compliance with 21 USC 828 (v. 02/26/2026) and 21 CFR 1305.01 (v. 04/01/2025), 21 CFR 1305.02 (v. 04/01/2025), 21 CFR 1305.03 (v. 04/01/2025), 21 CFR 1305.04 (v. 04/01/2025), 21 CFR 1305.05 (v. 04/01/2025), 21 CFR 1305.06 (v. 04/01/2025), 21 CFR 1305.07 (v. 04/01/2025); 21 CFR 1305.11 (v. 04/01/2025), 21 CFR 1305.12 (v. 04/01/2025), 21 CFR 1305.13 (v. 04/01/2025), 21 CFR 1305.14 (v. 04/01/2025), 21 CFR 1305.15 (v. 04/01/2025), 21 CFR 1305.16 (v. 04/01/2025), 21 CFR 1305.17 (v. 04/01/2025), 21 CFR 1305.18 (v. 04/01/2025), 21 CFR 1305.19 (v. 04/01/2025), 21 CFR 1305.20 (v. 04/01/2025); 21 CFR 1305.21 (v. 04/01/2025), 21 CFR 1305.22 (v. 04/01/2025), 21 CFR 1305.23 (v. 04/01/2025), 21 CFR 1305.24 (v. 04/01/2025), 21 CFR 1305.25 (v. 04/01/2025), 21 CFR 1305.26 (v. 04/01/2025), 21 CFR 1305.27 (v. 04/01/2025), 21 CFR 1305.28 (v. 04/01/2025), and 21 CFR 1305.29 (v. 04/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.175
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 4-2006, f. 6-9-06, cert. ef. 7-1-06
PB 5-1991, f. & cert. ef. 9-19-91
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0085 Prescription Requirements

(1) Registrants, practitioners and Pharmacists as specified therein in the issuance, preparation, labeling, dispensing, recordkeeping and filing of prescriptions for controlled substances must comply with the provisions of 21 CFR 1306.01 (v. 04/01/2025), 21 CFR 1306.02 (v. 04/01/2025), 21 CFR 1306.03 (v. 04/01/2025), 21 CFR 1306.04 (v. 04/01/2025), 21 CFR 1306.05 (v. 04/01/2025), 21 CFR 1306.06 (v. 04/01/2025), 21 CFR 1306.07 (v. 04/01/2025), 21 CFR 1306.08 (v. 04/01/2025), 21 CFR 1306.09 (v. 04/01/2025); 21 CFR 1306.11 (v. 04/01/2025), 21 CFR 1306.12 (v. 04/01/2025), 21 CFR 1306.13 (v. 04/01/2025), 21 CFR 1306.14 (v. 04/01/2025), 21 CFR 1306.15 (v. 04/01/2025); 21 CFR 1306.21 (v. 04/01/2025), 21 CFR 1306.22 (v. 04/01/2025); 21 CFR 1306.23 (v. 04/01/2025), 21 CFR 1306.24 (v. 04/01/2025), 21 CFR 1306.25 (v. 04/01/2025), 21 CFR 1306.27 (v. 04/01/2025); and 21 CFR 1304.03(d) (v. 04/01/2025).

(2) Controlled substances listed in 21 CFR 1308.15 (v. 04/01/2025) as Schedule V are prescription drugs.

(3) Pseudoephedrine and ephedrine may be:

(a) Provided to a patient without a prescription under ORS 475.230.

(b) Dispensed to patient pursuant to a prescription which must follow the provisions of 21 CFR 1306.21 (v. 04/01/2025), 21 CFR 1306.22 (v. 04/01/2025); 21 CFR 1306.23 (v. 04/01/2025), 21 CFR 1306.24 (v. 04/01/2025), 21 CFR 1306.25 (v. 04/01/2025), and 21 CFR 1306.27 (v. 04/01/2025).

(4) For a Schedule II controlled substance prescription, a Pharmacist may:

(a) Add the patient’s address based on information provided by the patient or patient's agent with appropriate verification;

(b) Amend or add the following information after consultation with and agreement of the prescriber:

(A) Drug strength;

(B) Dosage form;

(D) Directions for use;

(E) Prescriber's address; and

(F) Prescriber’s DEA registration number.

(A) Date the prescription was issued; and

(B) Date the prescription can be filled.

(d) For (b) and (c), the Pharmacist must document on the prescription the date of the prescriber’s authorization, the amendment or addition authorized, and the Pharmacist’s identity.

(5) For a Schedule II controlled substance prescription, a Pharmacist must not change the patient's name, the controlled substance prescribed except for generic substitution, and the name or signature of the prescriber.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.185 & ORS 475.188
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 29-2023, amend filed 12/19/2023, effective 12/19/2023
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 41-2022, minor correction filed 07/20/2022, effective 07/20/2022
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 8-2010, f. & cert. ef. 6-29-10
BP 1-2007, f. & cert. ef. 6-29-07
PB 5-1991, f. & cert. ef. 9-19-91
PB 15-1989, f. & cert. ef. 12-26-89
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78

Or. Admin. R. 855-080-0100 Animal Euthanasia

(1) The following requirements shall be met in order for a humane society or animal control agency to be registered or registration renewed to allow the purchase, possession and administration of sodium pentobarbital and sedative and analgesic medications for euthanizing injured, sick, homeless or unwanted domestic pets and other animals:

(a) Registration. Registration as an animal euthanasia drug outlet is limited to animal control agencies and humane societies for the purpose of purchasing, possessing, or administering sodium pentobarbital and sedative and analgesic medications to euthanize animals. The outlet must identify and provide to the Oregon Board of Pharmacy via application, a designated representative who will serve as the primary contact person responsible for managing the outlet operations. The outlet shall notify the Board within 15 days of any change in designated representative. Registration requires submission of an application, and a certificate of registration will be issued upon approval. All registrations and renewals shall be accompanied by an annual fee defined in Division 110 of this Chapter.

(b) Drug Storage. All supplies of sodium pentobarbital and sedative and analgesic medications shall be acquired from an Oregon registered distributor and kept in a locked cabinet. An assigned person designated in writing shall be responsible for the security of the sodium pentobarbital and sedative and analgesic medications. Such designated person shall allow access to and withdrawal of the drug only to a person certified by the Oregon State Veterinary Medical Examining Board to administer sodium pentobarbital and sedative and analgesic medications;

(c) Records. The following records shall be made at the time of the occurrence and shall be maintained for a minimum of three years, available for inspection by the Board of Pharmacy and its agents:

(A) A record of the withdrawal of sodium pentobarbital and sedative and analgesic medications, signed by the person who takes possession of the sodium pentobarbital and sedative and analgesic medications for administration;

(B) A record of the weight, species of animal and dosage of each drug administered for euthanasia signed by the person who administers the drug and by the designated person responsible for security;

(C) A record of all wastage of each drug signed by the person administering each drug and the designated person responsible for security; and

(D) A weekly record of verification of the amount of each drug on hand, minus the amounts withdrawn for administration, signed by the designated person responsible for security;

(E) A record of disposal of any expired or unwanted sodium pentobarbital and sedative and analgesic medications. Disposal shall be in conformance with federal regulations.

(F) Annually complete a self-inspection using the board's Animal Euthanasia Self-Inspection Form by July 1 and retain for board inspection.

(d) Audits. The registrant shall submit to random audits of records and analysis of prepared solutions by the Drug Enforcement Administration (DEA), and Board of Pharmacy or its agents.

(2) The outlet shall notify the Board of Pharmacy in the event of a significant drug loss or violation related to drug theft within one (1) business day.

(3) At the time a Report of Theft or Loss of Controlled Substances (DEA Form 106) is sent to the DEA, a copy shall be sent to the Board of Pharmacy.

(4) The Board of Pharmacy will suspend or revoke the registration of an animal euthanasia drug outlet which allows a person to administer sodium pentobarbital or sedative and analgesic medications who is not certified by the Oregon State Veterinary Medical Examining Board to administer such drug.

History

Statutory/Other Authority: ORS 475.095, ORS 475.190 & ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 12-2023, amend filed 06/13/2023, effective 08/01/2023
BP 9-2019, amend filed 12/17/2019, effective 01/01/2020
BP 3-2012, f. & cert. ef. 6-19-12
Reverted to PB 5-1991, f. & cert. ef. 9-19-91
BP 7-2011(Temp), f. & cert. ef. 12-15-11 thru 4-27-12
BP 6-2011(Temp), f. 10-20-11, cert. ef. 10-31-11 thru 4-27-12
PB 5-1991, f. & cert. ef. 9-19-91
PB 9-1990, f. & cert. ef. 12-5-90
1PB 2-1984, f. & ef. 3-7-84

Division 102 BOARD ADMINISTRATION

Or. Admin. R. 855-102-0010 Board Meetings

(1) Board meetings must be held not less than once every three months as designated by the board.

(2) The President of the board has the power to call special meetings, subject to ORS 689.185, when it may be deemed necessary or upon request of a majority of members.

(3) The board must hold an annual meeting each year for the election of officers, the reorganization of the board and the transaction of other business.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.135 & ORS 689.185
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0015 Public Health and Pharmacy Formulary Advisory Committee (PHPFAC) Meetings

(1) A PHPFAC meeting must be held not less than once every six months.

(2) The PHPFAC must periodically review the formulary and protocol compendium and recommend the revisions to the board for adoption by rule.

(3) The PHPFAC must recommend to the board, for adoption by rule, a formulary of drugs and devices from which a Pharmacist can prescribe and dispense to a patient pursuant to a diagnosis by a qualified healthcare practitioner or a protocol from which a Pharmacist can prescribe and dispense.

History

Statutory/Other Authority: ORS 689.649
Statutes/Other Implemented: ORS 689.645 & ORS 689.649
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0020 Board and PHPFAC Member Compliance

Board members and PHPFAC members must comply with the requirements of all Oregon public records and public meeting laws.

History

Statutory/Other Authority: ORS 192.001 & ORS 192.620
Statutes/Other Implemented: ORS 192.630
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0030 Board and PHPFAC Member Compensation

(1) A board member and Public Health and Pharmacy Formulary Advisory Committee (PHPFAC) member of the Oregon Board of Pharmacy who is entitled to compensation under ORS 292.495 is eligible to receive an amount equal to the per diem amount paid to members of the Legislative Assembly under ORS 171.072 when engaged in the performance of official duties for each day or portion thereof.

(2) For the purpose of compensation, a board member or PHPFAC member is considered engaged in the performance of official duties when:

(a) The activity furthers the board’s mission, such as attending a board meeting;

(b) Engaged in an activity at the request of the board chair or authorized by a vote of the board in advance of the activity; or

(3) Except as otherwise provided by law, all members, including those employed in full-time public service, may receive actual and necessary travel or other expenses actually incurred in the performance of their official duties within the limits provided by law or by the Oregon Department of Administrative services under ORS 292.210, ORS 292.220, ORS 292.230, and ORS 292.250.

(4) A board member or PHPFAC member is not required to accept compensation or reimbursement of travel expenses while performing their official duties as a board or appointed committee member.

History

Statutory/Other Authority: ORS 689.115 & ORS 689.205
Statutes/Other Implemented: ORS 171.072, ORS 292.495, ORS 689.115, ORS 689.175, ORS 689.645 & ORS 689.649
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0040 Adoption by Reference - General

(1) The board adopts standards and other publications by reference, as necessary, through administrative rule. When a matter is included in a referenced publication that is in conflict with Oregon Revised Statutes or Oregon Administrative Rules, the statute or rule applies and the standard provision does not. All remaining parts or application of the standard remain in effect.

(2) All outside standards, statutes, rules and publications referred to in any rules adopted by the board are by those references made a part of those rules as though fully set forth. Copies are available for inspection in the office of the Board of Pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.205
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0045 Adoption by Reference - Model Rules of Procedure

Pursuant to the provisions of ORS 183.341, the Board of Pharmacy adopts the Attorney General’s Uniform and Model Rules of Procedure under the Administrative Procedures Act effective 07/2019. These rules must be controlling except as otherwise required by statute or rule.

[ED. NOTE: The full text of the Attorney General’s Model Rules of Procedure is available from the office of the Attorney General or Board of Pharmacy.]

History

Statutory/Other Authority: ORS 183.341
Statutes/Other Implemented: ORS 183.341 & ORS 689.205
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0050 Coaching from Board Members and Staff

A board member or board staff must not:

(1) Discuss the contents of an examination, its preparation or use with any candidate or other person;

(2) Coach a candidate or any other person on materials that may be used in the examination; or

(3) Accept any fees for any act of assistance that would bear on the examination.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.195
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0055 Board Compliance Director and Officers

The board’s Compliance Director and Compliance Officers:

(1) Must be Pharmacists licensed in the State of Oregon; and

(2) Are authorized to provide appropriate deadline extensions.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.195
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0060 License Verification

For purposes of license verification, a person may rely upon the licensing information as it is displayed on the board's website that includes the issuance and expiration dates of any license issued by the board.

History

Statutory/Other Authority: ORS 689.151 & ORS 689.490
Statutes/Other Implemented: ORS 689.151, ORS 689.205 & ORS 689.490
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0100 State and National Criminal Background Checks for Licensure and Registration

(1) The purpose of this rule is to provide for the reasonable screening of applicants for licensure and individuals subject to investigation by the board, in order to determine if they have a history of criminal behavior such that they are not fit to be granted or retain a license or registration issued by the board.

(2) "Subject individual" means a person from whom the board may require legible fingerprints for the purpose of a state or nationwide criminal records check and fitness determination. In this rule, subject individual means applicants for licensure or renewal of a license and individuals subject to an investigation by the board.

(3) Criminal records checks and fitness determinations are conducted according to ORS 181A.170, ORS 181A.190, ORS 181A.195, ORS 670.280, ORS 676.303, OAR 125-007-0210, OAR 125-007-0220, OAR 125-007-0250, OAR 125-007-0260, OAR 125-007-0270, OAR 125-007-0300, OAR 125-007-0310, and OAR 125-007-0330.

(a) The board will request that the Oregon Department of State Police conduct a state and nationwide criminal records check, using fingerprint identification of subject individuals. The board may conduct state criminal records checks on subject individuals and any licensee through the Law Enforcement Data System maintained by the Oregon Department of State Police in accordance with rules adopted, and procedures established, by the Oregon Department of State Police. Criminal history information obtained from the Law Enforcement Data System must be handled in accordance with ORS Chapter 181A, OAR 257-010 and OAR 257-015 and applicable Oregon Department of State Police procedures.

(b) The applicant or licensee must disclose all arrests, charges, and convictions regardless of the outcome or date of occurrence. Disclosure includes any military or criminal records.

(c) The board may require additional information from the applicant or licensee, such as, but not limited to, proof of identity, previous names, residential history or additional criminal, judicial or other background information.

(4) In making licensing fitness determinations subject to the requirements of ORS 670.280, the board will consider the following:

(a) The nature of any criminal record that reflects:

(A) Drug or alcohol offense;

(B) Felony;

(D) U.S. military or international crime;

(E) Offense involving fraud, theft, identity theft or other instance of dishonesty;

(F) Offense involving violation of federal importation or customs laws or rules;

(G) Offense requiring registration as a sex offender;

(H) Condition of parole, probation, or diversion program, or

(I) Unresolved arrest, charge, pending indictment or outstanding warrant.

(b) Intervening circumstances relevant to the responsibilities and circumstances of the license or registration. Intervening circumstances include but are not limited to:

(A) The passage of time since the commission of the crime;

(B) The age of the subject individual at the time of the crime;

(D) The subsequent commission of another relevant crime;

(E) Whether the conviction was set aside and the legal effect of setting aside the conviction; and

(F) A recommendation of an employer.

(d) The relevancy, if any, of the crime or the false statement to the specific requirements of the subject individual's license or registration; and

(e) Any false statement or omission made to the board regarding the individual’s criminal history.

(f) Any refusal to submit or consent to a criminal record check including a refusal to provide fingerprint identification;

(g) Any other pertinent information obtained as part of an investigation.

(h) The board must evaluate a crime or offense on the basis of the law of the jurisdiction in which the crime or offense occurred.

(i) Under no circumstances must an applicant be denied under these rules because of a juvenile record that has been expunged or set aside pursuant to ORS 419A.260 and ORS 419A.262.

(j) Under no circumstances must an applicant be denied under these rules due to the existence or contents of an adult record that has been set aside pursuant to ORS 137.225.

(5) Criminal offender information is confidential. Dissemination of information received under this rule may only be made to people with a demonstrated and legitimate need to know the information. When the information is part of the investigation of an applicant or licensee, it is confidential pursuant to ORS 676.175. Any fingerprint cards used to conduct a check must be destroyed by either the Federal Bureau of Investigation or the Oregon Department of State Police as specified in ORS 181A.195.

(6) The board will permit the subject individual for whom a fingerprint-based criminal records check was conducted to inspect the individual's own state and national criminal offender records and, if requested by the subject individual, provide the individual with a copy of the individual's own state and national criminal offender records.

(7) If an applicant, licensee or registrant is denied a license, they are entitled to a contested case hearing pursuant to ORS chapter 183.

(8) A challenge to the accuracy or completeness of information provided by the Oregon Department of State Police, Federal Bureau of Investigation and agencies reporting information must be made through the Oregon Department of State Police, Federal Bureau of Investigation or reporting agency and not through the contested case process.

(9) Request for re-evaluation following correction. If the subject individual successfully contests the accuracy or completeness of information provided by the Oregon Department of State Police, the Federal Bureau of Investigation or other agency reporting information to the board, the board will conduct a new criminal history check and re-evaluate the criminal history upon submission of a new criminal history request form.

(10) The applicant or licensee must pay a criminal records check fee for the actual cost of acquiring and furnishing the criminal offender information.

History

Statutory/Other Authority: ORS 181A.195, ORS 676.303 & ORS 689.205
Statutes/Other Implemented: ORS 181A.170, ORS 181A.195, ORS 181A.215, ORS 676.175 & ORS 676.303
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0105 State and National Criminal Background Checks for Employees, Volunteers and Employment Applicants

(1) The board requires a criminal records check and fitness determination for board employees, volunteers or applicants for employment with the board.

(2) Criminal records checks and fitness determinations are conducted pursuant to ORS 181A.170, ORS 181A.190, ORS 181A.195, ORS 670.280, ORS 676.303, OAR 125-007-0210, OAR 125-007-0220, OAR 125-007-0250, OAR 125-007-0260, OAR 125-007-0270, OAR 125-007-0300, OAR 125-007-0310 and OAR 125-007-0330.

(a) To complete the criminal records check and fitness determination, the board may require additional information from the employee, volunteer or applicant, such as, but not limited to, proof of identity or additional criminal, judicial or other background information.

(b) If the employee, volunteer or applicant has potentially disqualifying criminal offender information, the board will consider factors listed in ORS 181A.195 before making a fitness determination.

(d) An incomplete fitness determination does not entitle the employee, volunteer or applicant the right to appeal under OAR 125-007-0300.

(3) Pursuant to ORS 181A.195, and OAR 125-007-0310, information obtained in the criminal records check is confidential and will not be disseminated by the board except to persons with a demonstrated and legitimate need to know the information.

History

Statutory/Other Authority: ORS 181A.195, ORS 676.303 & ORS 689.205
Statutes/Other Implemented: ORS 181A.170, ORS 181A.195 & ORS 676.303
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0110 Criminal Background Checks – Costs

The applicant or licensee must pay the board the cost of acquiring and furnishing the criminal offender information. The amount will not exceed the cost to the board to obtain such information on behalf of the applicant or licensee, including fees charged to the board by the Oregon Department of State Police and the Federal Bureau of Investigation.

History

Statutory/Other Authority: ORS 676.303 & ORS 689.205
Statutes/Other Implemented: ORS 181A.195, ORS 676.303 & ORS 689.207
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0125 Notice of Proposed Rule

(1) Prior to the permanent adoption, amendment, or repeal of any rule, the State Board of Pharmacy must give notice of its intended action as required in ORS 183.335;

(2) The board will notify and provide a reasonable opportunity for interested persons to be notified of the agency's proposed action in the following ways:

(a) In the bulletin referred to in ORS 183.360 at least 21 days prior to the effective date;

(b) To persons who have requested notice pursuant to ORS 183.335(8) at least 28 days before the effective date;

(d) To persons or organizations the board's Executive Director determines, pursuant to ORS 183.335, are interested persons in the subject matter of the proposed rule, or would be likely to notify interested persons of the proposal:

(A) Oregon State Pharmacy Association; and

(B) Oregon Society of Health System Pharmacists.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 183.335 & ORS 183.341
BP 14-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-102-0130 Amendment of Vaccine Protocol Rules to Adopt ACIP Recommendations

Pursuant to ORS 689.645(5), the board delegates to the Board President the limited authority to amend the board’s vaccine protocols in OAR 855-115-0345 to adopt recommendations issued by the Advisory Committee on Immunization Practices (ACIP) adopted by the Centers for Disease Control and Prevention (CDC) except for vaccine protocols excluded by the Board. The Board President may further delegate this authority to board staff. ORS 689.649 does not apply to rule amendments made pursuant to the delegation of authority in this rule because those amendments are required and the board’s only course of action.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.645
Statutes/Other Implemented: ORS 689.205 & ORS 689.645
BP 1-2026, amend filed 01/23/2026, effective 01/23/2026
BP 14-2025, temporary amend filed 09/17/2025, effective 09/17/2025 through 03/15/2026
BP 5-2025, adopt filed 08/08/2025, effective 08/08/2025

Division 104 UNIVERSAL RULES

Or. Admin. R. 855-104-0005 Duty to Cooperate

(1) Applicants, licensees, and registrants must timely comply with all board requests, including responding accurately, fully and truthfully to inquiries and providing requested materials within the time allowed by the board and complying with a subpoena.

(2) Applicants, licensees, and registrants must comply with the terms of board orders and agreements.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.612
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0010 Responsibilities: Duty to Report

(1) Unless state or federal laws relating to confidentiality or the protection of health information prohibit disclosure, each licensee must report to the board without undue delay, but within

(a) 10 days if they:

(A) Are convicted of a misdemeanor or a felony; or

(B) Are arrested for a felony; or

(b) 10 working days if they have reasonable cause to believe that another licensee (of the board or any other Health Professional Regulatory Board) has engaged in prohibited or unprofessional conduct to that licensee’s board; or

(A) Legal name;

(B) For Pharmacists and Interns, name used when engaging in the practice of pharmacy and for Certified Oregon Pharmacy Technicians and Pharmacy Technicians, name used when assisting in the practice of pharmacy.

(D) Personal phone number;

(E) Personal physical address;

(F) Personal mailing address; and

(G) Employer.

(2) A licensee who reports to a board in good faith as required by ORS 676.150 is immune from civil liability for making the report.

(3) A Pharmacist, Certified Oregon Pharmacy Technician or Pharmacy Technician who reports to a board in good faith as required by ORS 689.455 is not subject to an action for civil damages as a result thereof.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.150, ORS 689.155, ORS 689.455 & ORS 689.486
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0015 Responsibilities: Confidentiality

(1) No licensee or registrant of the board who obtains any patient information may disclose that information to a third-party without the consent of the patient except as provided in (2)(a)-(e) of this rule.

(2) A licensee or registrant may disclose patient information:

(a) To the board;

(b) To a practitioner, Pharmacist, Intern, Certified Oregon Pharmacy Technician, Pharmacy Technician or registrant, if disclosure is authorized by a Pharmacist and disclosure is necessary to protect the patient’s health or well-being; or

(d) As permitted pursuant to federal and state patient confidentiality laws; or

(e) To the patient or to persons as authorized by the patient.

(3) A licensee or registrant of the board may not access or obtain any patient information unless it is accessed or obtained for the purpose of patient care or as allowed in (2)(a)-(e) of this rule.

History

Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0050 Patients Access to Pharmacy Records

(1) Licensees and registrants of the board must make health information in the pharmacy record available to the patient or the patient’s representative upon their request, to inspect and obtain a copy of health information about the individual, except as provided by law and this rule. The patient may request all or part of the record. A summary may substitute for the actual record only if the patient agrees to the substitution. Board licensees and registrants are encouraged to use the written authorization form provided by ORS 192.566.

(2) For the purpose of this rule, “health information in the pharmacy record” means any oral, written or electronic information in any form or medium that is created or received and relates to:

(a) The past, present, or future physical or mental health of the patient.

(b) The provision of healthcare to the patient.

(a) Information which was obtained from someone other than a healthcare provider under a promise of confidentiality and access to the information would likely reveal the source of the information;

(b) Psychotherapy notes;

(c) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding; and

(d) Other reasons specified by federal regulation.

(4) Registrants who have permanently closed must notify patients according to OAR 855-041-1092.

(5) A reasonable cost may be imposed for the costs incurred in complying with the patient’s request for health information pursuant to ORS 192.563.

(6) A patient may not be denied summaries or copies of pharmacy records because of inability to pay.

(7) Requests for pharmacy records must be complied with within a reasonable amount of time not to exceed 30 days from the receipt of the request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 192.553, ORS 192.556, ORS 192.558, ORS 192.563 & ORS 192.566
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0055 Record and Document Retention

(1) Each licensee and registrant must create documents and retain records required by ORS 475, ORS 689, and OAR 855. Documents and records:

(a) May be in written or electronic format;

(b) Must be stored securely;

(d) Must be retained for 3 years except that:

(A) Clinical pharmacy records must be retained for 7 years; and

(B) Training records for immunization administration and protocol and formulary prescribing, must be retained or uploaded into the licensee’s electronic licensing record with the board;

(2) Records generated by a registrant:

(a) Must be stored on-site by the registrant for at least 12 months and must be provided to the board immediately upon request at the time of inspection;

(b) May be stored in a secured off-site location after 12 months of storage at the registrant and must be provided to the board upon request within 3 business days;

(3) Records generated in the practice of pharmacy that do not belong to a registrant must be stored by a Pharmacist in a secure manner and provided to the board upon request within 3 business days; and

(4) Records must be retained for longer periods of time than required under this rule if:

(a) Federal law provides for a longer retention schedule; or

(b) Licensee or registrant has received notice of a Board investigation to which the records would be relevant;

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.508
BP 6-2025, amend filed 08/08/2025, effective 08/08/2025
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0060 Public Records Request to the Board

Placeholder

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 192.440
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0100 Time for Requesting a Contested Case Hearing

A request for a contested case hearing must be in writing and must be received by the board within 21 days from the date the contested case notice was served. When the board has issued a denial of a license, a request for a contested case hearing must be in writing and must be received by the board within 60 days from the date the licensure denial was served.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 183.435
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0105 Filing Exceptions and Argument to the Board

After a proposed order has been served on a party, the party has 30 days to file written exceptions with the board from receipt of the proposed order.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0110 Petition for Reconsideration or Rehearing as Condition for Judicial Review

All parties, including limited parties, must file a petition for reconsideration or rehearing with the board as a condition for obtaining judicial review of any order of the board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0115 Inspections

(1) A Compliance Officer is a board authorized representative and must be permitted entry to any drug outlet to conduct inspections at all reasonable hours.

(2) The Compliance Officer is authorized and must be permitted to perform the following to determine compliance with ORS 475, ORS 689, and OAR 855 and board orders including but not limited to:

(a) Inspecting conditions, structures, equipment, materials, and methods for compliance;

(b) Inspecting all drugs and devices;

(d) Reviewing, verifying and making copies of records and documents.

(3) All licensees and employees must fully comply and cooperate with all questions and requests made by the Compliance Officer at the time of inspection.

(4) Refusal to allow inspection is grounds for discipline.

History

Statutory/Other Authority: ORS 475.125 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0150 Military Spouse or Domestic Partner Licensure Process

(1) “Military spouse or domestic partner” means a spouse or domestic partner of an active member of the Armed Forces of the United States who is the subject of a military transfer to Oregon.

(2) To qualify for licensure under this rule, the military spouse or domestic partner must meet the following requirements:

(a) Meet the qualifications for licensure as stated in OAR 855-115, OAR 855-120 or OAR 855-125.

(b) Be married to, or in a domestic partnership with, a member of the Armed Forces of the United States who is assigned to a duty station located in Oregon by official active duty military order;

(c) Applicant must complete an application for licensure, provide the board with a valid email address, and complete and pass a national fingerprint-based criminal background check ;

(d) Provide evidence of current licensure as a pharmacist, intern or pharmacy technician issued by another state;

(e) Provide to the board, in a manner determined by the board, sufficient proof that the person is in good standing with the issuing out-of-state professional licensing board; and

(f) Demonstrate competency as a pharmacist, intern or pharmacy technician by having at least one year of active practice during the three years immediately preceding the application.

(3) A temporary authorization under this section is valid until the earliest of the following:

(a) Two years after the date of issuance;

(b) The date the spouse or domestic partner of the person to whom the authorization was issued completes the spouse’s term of service in this state; or

(4) A temporary authorization issued under this section is not renewable.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.265, ORS 670.400 & ORS 670.403
BP 15-2023, adopt filed 08/15/2023, effective 03/01/2024

Or. Admin. R. 855-104-0155 Criminal Conviction Determination Process

(1) Prior to beginning required education or training, a person who was convicted of a crime may petition the Board for a determination as to whether a criminal conviction will prevent the person from receiving a license issued by the Board.

(2) To be complete, a petition must include the following:

(a) A complete and signed determination request form;

(b) The required fee of $100;

(A) A certified copy of the judgment of criminal conviction;

(B) Any charging document(s);

(D) Probation and parole records, if they exist;

(d) A written statement from the petitioner regarding the facts underlying the criminal conviction, and any intervening circumstances.

(e) A written statement or other document listing all criminal convictions, including dates of conviction and a summary of the facts, if the petitioner has more than one.

(3) If any of the records in (2)(c) no longer exist, have been sealed or are otherwise unavailable to the petitioner, petitioner must provide evidence from the agency that held the record that the record no longer exists.

(4) A petition is incomplete when it is missing one or more of the items required in this rule. An incomplete petition will expire 60 days from the date the petition form was submitted to the Board. Petitioners who allow their petition to expire must file a new complete petition, including the required fee.

(5) The petition and the Board’s determination are subject to Oregon’s public records laws, and unless an exemption applies, the information in the petition and determination are subject to public disclosure.

(6) The Board will reconsider a determination that a criminal conviction prevents the person from obtaining a license when the person submits a completed application for a license.

(7) Upon reconsideration, the Board may rescind a previous determination that a criminal conviction does not prevent the person from obtaining a license if the applicant:

(a) Has allegations or charges pending in criminal court;

(b) Has failed to disclose a previous criminal conviction;

(c) Has been convicted of another crime during the period between the determination and the person’s submission of a completed application for an occupational or professional license; or

(d) Has been convicted of a crime that, during the period between the determination and the person’s submission of a completed application for an occupational or professional license, became subject to a change in state or federal law that prohibits licensure for an occupational or professional license because of a conviction of that crime.

(8) Failure to disclose a previous criminal conviction includes any misrepresentation or a prior criminal conviction, any concealment or failure to disclose a material fact about a prior criminal conviction, or any other misinformation regarding a prior criminal conviction.

(9) Nothing in this rule prohibits the Board from denying licensure when the person submits a completed application for a reason other than conviction of a crime.

(10) A determination under this rule is not considered a final determination of the Board.

History

Statutory/Other Authority: ORS 689.205 & 2024 SB 1552
Statutes/Other Implemented: ORS 689.135 & 2024 SB 1552
BP 17-2025, adopt filed 12/16/2025, effective 12/16/2025

Division 110 FEES

Or. Admin. R. 855-110-0003 General

(1) All fees paid under these rules are non-refundable.

(2) Fees cannot be prorated.

(3) Fees for initial licensure as a Pharmacist, Pharmacy Technician or Certified Oregon Pharmacy Technician will be reduced to one-half of a biennial rate, if the application is received within 180 days of expiration.

(4) A late fee must be paid:

(a) When a renewal application is received after the date specified in these rules; or

(b) When the board requests additional information from an applicant and this information is not provided within 30 days.

(5) A fee may be assessed when an application is submitted incomplete and the board requests the missing information.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.135
BP 18-2022, amend filed 04/20/2022, effective 04/20/2022
BP 11-2022, temporary amend filed 02/16/2022, effective 02/16/2022 through 08/14/2022
BP 38-2021, amend filed 12/16/2021, effective 01/01/2022
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
BP 13-2014, f. 12-30-14, cert. ef. 4-1-15
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09

Or. Admin. R. 855-110-0005 Temporary rule language in effect until 02/09/2027. Licensing Fees

(1) Pharmacist initial license NAPLEX examination board processing fee - $50.

(2) Pharmacist licensing by reciprocity fee - $100.

(3) Pharmacist licensing by score transfer fee - $50.

(4) Intern license fee. Expires November 30 every two years - $140.

(5) Pharmacist license fee:

(a) Expires June 30 each odd numbered year. The biennial license fee is - $350. Late renewal fee (received after June 30) - $50.

(b) Electronic Prescription Monitoring Fund fee. Due by June 30 biennially - $70. (This is a mandatory fee, required by ORS 431A.880 that must be paid with the pharmacist license renewal fee).

(c) Workforce Data Collection fee. Due by June 30 biennially - $8. (This is a mandatory fee as required by OAR 409-026-0130 that must be paid with the Pharmacist license renewal fee.)

(6) Certification of approved provider of continuing education course fee, none at this time.

(7) Pharmacy Technician license fee:

(a) Expires June 30 each even numbered year. The biennial license fee is - $140. Late renewal fee (received after June 30) - $20.

(b) Workforce Data Collection fee. Due by June 30 biennially - $8. (This is a mandatory fee as required by OAR 409-026-0130 that must be paid with the Pharmacy Technician license renewal fee.)

(8) Certified Oregon Pharmacy Technician license fee:

(a) Expires June 30 each even numbered year. The biennial license fee is - $140. Late renewal fee (received after June 30) - $20.

(b) Workforce Data Collection fee. Due by June 30 biennially - $8. (This is a mandatory fee as required by OAR 409-026-0130 that must be paid with the Certified Oregon Pharmacy Technician license renewal fee.)

History

Statutory/Other Authority: ORS 689.205, ORS 291.055 & ORS 183.705
Statutes/Other Implemented: ORS 689.135, ORS 676.410 & ORS 431A.880
BP 16-2026, temporary amend filed 08/14/2026, effective 08/14/2026 through 02/09/2027
BP 15-2025, amend filed 10/13/2025, effective 10/13/2025
BP 4-2025, temporary amend filed 07/16/2025, effective 07/16/2025 through 01/11/2026
BP 18-2022, amend filed 04/20/2022, effective 04/20/2022
BP 11-2022, temporary amend filed 02/16/2022, effective 02/16/2022 through 08/14/2022
BP 38-2021, amend filed 12/16/2021, effective 01/01/2022
BP 19-2021, amend filed 06/15/2021, effective 06/15/2021
BP 4-2021, temporary amend filed 02/13/2021, effective 02/13/2021 through 08/11/2021
BP 4-2019, amend filed 06/24/2019, effective 07/01/2019
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
BP 4-2015, f. & cert. ef. 7-1-15
BP 13-2014, f. 12-30-14, cert. ef. 4-1-15
BP 1-2014, f. & cert. ef. 1-3-14
BP 7-2013, f. & cert. ef. 9-23-13
BP 4-2013(Temp), f. & cert. ef. 7-9-13 thru 1-5-14
BP 3-2013(Temp), f. 6-27-13, cert. ef. 7-1-13 thru 12-28-13
BP 2-2013(Temp), f. 4-4-13, cert. ef. 4-5-13 thru 9-28-13
BP 8-2011, f. & cert. ef. 12-15-11
BP 5-2011(Temp), f. 6-24-11, cert. ef. 7-1-11 thru 12-27-11
BP 6-2010, f. & cert. ef. 6-29-10
BP 5-2010(Temp), f. 5-3-10, cert. ef. 5-4-10 thru 10-30-10
BP 5-2009, f. & cert. ef. 12-24-09
BP 9-2006, f. & cert. ef. 12-19-06
BP 5-2006(Temp), f. & cert. ef. 8-25-06 thru 1-20-07
BP 1-2006, f. & cert. ef. 6-9-06
BP 1-2003, f. & cert. ef. 1-14-03
BP 1-2002, f. & cert. ef. 1-8-02
BP 2-2001(Temp), f. & cert. ef. 7-26-01 thru 1-22-02
BP 1-2001, f. & cert. ef. 3-5-01
BP 2-1998, f. & cert. ef. 3-23-98
PB 2-1997(Temp), f. 10-2-97, cert. ef. 10-4-97
PB 1-1996, f. & cert. ef. 4-5-96
PB 1-1994, f. & cert. ef. 2-2-94
PB 4-1992, f. & cert. ef. 8-25-92
PB 1-1992, f. & cert. ef. 1-31-92
PB 3-1991, f. & cert. ef. 9-19-91
PB 10-1990, f. & cert. ef. 12-5-90
PB 15-1989, f. & cert. ef. 12-26-89
PB 7-1989, f. & cert. ef. 5-1-89
PB 3-1988, f. & cert. ef. 5-23-88
1PB 3-1985, f. & cert. ef. 12-2-85
1PB 1-1984, f. & cert. ef. 2-16-84
1PB 2-1982, f. 3-8-82, cert. ef. 4-1-82
1PB 3-1980, f. 5-3-80, cert. ef. 7-1-80
1PB 2-1980, f. & cert. ef. 4-3-80
1PB 2-1979(Temp), f. & cert. ef. 10-3-79

Or. Admin. R. 855-110-0006 Pharmacist Examination Fees Paid to NABP

(1) Pharmacist examination fees to be paid to the National Association of Boards of Pharmacy (NABP) for NAPLEX exam:

(a) NAPLEX Examination fee - $520

(b) NAPLEX Reexamination fee - $520

(2) Pharmacist jurisprudence examination fees to be paid to NABP for MPJE exam:

(a) MPJE Examination fee - $170

(b) MPJE Reexamination fee - $170

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.135
BP 15-2025, adopt filed 10/13/2025, effective 10/13/2025
BP 4-2025, temporary adopt filed 07/16/2025, effective 07/16/2025 through 01/11/2026

Or. Admin. R. 855-110-0007 Fees for Registration, Renewal, and Reinspection of Drug Outlets

(1) Drug Distribution Agent. Expires September 30 annually - $560. Late renewal fee (received after September 30) - $100.

(2) Drug Room (including Correctional Facility). Expires March 31 annually - $140. Late renewal fee (received after March 31) - $75.

(3) Manufacturer (including Manufacturer Class I, Manufacturer Class II and Manufacturer Class III). Expires September 30 annually - $735. Late renewal fee (received after September 30) - $100.

(4) Nonprescription Drug Outlet. Expires January 31 annually - $105. Late renewal fee (received after January 31) - $25.

(a) This includes the following categories of registration:

(A) Nonprescription Class A.

(B) Medical Device, Equipment & Gas Class C.

(b) Other nonprescription Drug Outlet registration category fees are as follows:

(A) Nonprescription Class D. Expires January 31 annually - $140. Late renewal fee (received after January 31) - $25.

(B) Nonprescription Class E. Expires January 31 annually - $0. Late renewal fee (received after January 31) - $0.

(5) Prophylactic and/or Contraceptive Wholesaler and/or Manufacturer - $70. Expires December 31 annually.

(6) Re-inspection fee - $100. Applies to any re-inspection of a drug outlet occasioned to verify corrections of violations found in an initial inspection.

(7) Retail or Institutional Drug Outlet Pharmacy. Expires March 31 annually - $315. Late renewal fee (received after March 31) - $75.

(a) This includes the following categories of registration:

(A) Home Dialysis Retail Drug Outlet Pharmacy

(B) Institutional Drug Outlet Pharmacy

(D) Retail Drug Outlet Pharmacy

(b) Other Retail/Institutional Drug Outlet registration category fees are as follows:

(A) Charitable Retail Drug Outlet Pharmacy. Expires March 31 annually - $105. Late renewal fee (received after March 31) - $25.

(B) Community Health Clinic (CHC) Retail Drug Outlet Pharmacy. Expires March 31 annually - $140. Late renewal fee (received after March 31) - $25.

(C) Dispensing Practitioner Drug Outlet (DPDO) Retail Drug Outlet Pharmacy. Expires March 31 annually - $140. Late renewal fee (received after March 31) - $25.

(D) Prescription Kiosk Retail Drug Outlet Pharmacy. Expires March 31 annually - $168. Due by March 31 annually.

(E) Prescription Locker Retail Drug Outlet Pharmacy. Expires March 31 annually - $168. Due by March 31 annually.

(F) Remote Dispensing Machine Institutional Drug Outlet Pharmacy. Expires March 31 annually - $168. Due by March 31 annually.

(G) Remote Distribution Facility Institutional Drug Outlet Pharmacy. Expires March 31 annually - $168. Due by March 31 annually.

(8) Wholesaler (including Wholesaler Class I, Wholesaler Class II and Wholesaler Class III). Expires September 30 annually - $735. Late renewal fee (received after September 30) - $100.

History

Statutory/Other Authority: ORS 689.205 & ORS 291.055
Statutes/Other Implemented: ORS 689.135, ORS 689.774 & ORS 689.305
BP 15-2025, amend filed 10/13/2025, effective 10/13/2025
BP 4-2025, temporary amend filed 07/16/2025, effective 07/16/2025 through 01/11/2026
BP 6-2024, amend filed 02/15/2024, effective 02/29/2024
BP 6-2023, amend filed 02/14/2023, effective 02/15/2023
BP 35-2022, amend filed 06/15/2022, effective 06/16/2022
BP 12-2022, amend filed 03/21/2022, effective 03/31/2022
BP 35-2021, minor correction filed 12/16/2021, effective 12/16/2021
BP 19-2021, amend filed 06/15/2021, effective 06/15/2021
BP 4-2021, temporary amend filed 02/13/2021, effective 02/13/2021 through 08/11/2021
BP 4-2019, amend filed 06/24/2019, effective 07/01/2019
BP 4-2017, amend filed 11/30/2017, effective 12/01/2017
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
BP 4-2015, f. & cert. ef. 7-1-15
BP 1-2014, f. & cert. ef. 1-3-14
BP 7-2013, f. & cert. ef. 9-23-13
BP 4-2013(Temp), f. & cert. ef. 7-9-13 thru 1-5-14
BP 3-2013(Temp), f. 6-27-13, cert. ef. 7-1-13 thru 12-28-13
BP 6-2012, f. & cert. ef. 12-13-12
BP 5-2012(Temp), f. & cert. ef. 6-19-12 thru 12-16-12
BP 8-2011, f. & cert. ef. 12-15-11
BP 5-2011(Temp), f. 6-24-11, cert. ef. 7-1-11 thru 12-27-11
BP 6-2010, f. & cert. ef. 6-29-10
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
BP 2-2005, f. 2-14-05, cert. ef. 3-1-05
BP 4-2002, f. 6-27-02, cert. ef. 7-1-02
BP 1-2002, f. & cert. ef. 1-8-02
BP 2-2001(Temp), f. & cert. ef. 7-26-01 thru 1-22-02
BP 3-1998, f. & cert. ef. 3-23-98
PB 1-1997, f. & cert. ef. 9-22-97
PB 1-1996, f. & cert. ef. 4-5-96

Or. Admin. R. 855-110-0010 Fees for Registration for Controlled Substances

(1) Animal Euthanasia controlled substance registration fee - $105 annually.

(2) Drug Distribution Agent controlled substance registration fee - $140 annually.

(3) Drug Room (including Correctional Facility) controlled substance registration fee - $140 annually.

(4) Manufacturer controlled substance registration fee - $140 annually.

(5) Retail or Institutional Drug Outlet controlled substance registration fee - $140 annually.

(6) Schedule II Precursor registration fee - $105 annually.

(7) Wholesaler controlled substance registration fee - $140 annually.

(8) Remote Distribution Facility controlled substance registration fee - $140 annually.

History

Statutory/Other Authority: ORS 689.205, ORS 291.055 & ORS 475.095
Statutes/Other Implemented: ORS 689.135
BP 15-2025, amend filed 10/13/2025, effective 10/13/2025
BP 4-2025, temporary amend filed 07/16/2025, effective 07/16/2025 through 01/11/2026
BP 38-2021, amend filed 12/16/2021, effective 01/01/2022
BP 4-2019, amend filed 06/24/2019, effective 07/01/2019
BP 2-2016, f. 6-30-16, cert. ef. 7-1-16
BP 7-2013, f. & cert. ef. 9-23-13
BP 4-2013(Temp), f. & cert. ef. 7-9-13 thru 1-5-14
BP 3-2013(Temp), f. 6-27-13, cert. ef. 7-1-13 thru 12-28-13
BP 8-2011, f. & cert. ef. 12-15-11
BP 5-2011(Temp), f. 6-24-11, cert. ef. 7-1-11 thru 12-27-11
BP 5-2009, f. & cert. ef. 12-24-09
BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
BP 2-2005, f. 2-14-05, cert. ef. 3-1-05
PB 1-1996, f. & cert. ef. 4-5-96
PB 3-1991, f. & cert. ef. 9-19-91
PB 10-1990, f. & cert. ef. 12-5-90
PB 15-1989, f. & cert. ef. 12-26-89
1PB 2-1984, f. & ef. 3-7-84
1PB 6-1982, f. & ef. 8-6-82
1PB 2-1980, f. & ef. 4-3-80
1PB 2-1979(Temp), f. & ef. 10-3-79

Or. Admin. R. 855-110-0015 Administrative Fees

(1) The Board of Pharmacy may charge a fee reasonably calculated to reimburse the agency for costs of providing and conveying copies of public records, and other administrative services.

(2) All fees and charges must be paid before public records will be available for inspection or copies provided.

(3) Costs include but are not limited to:

(a) The services and supplies used in making the records available;

(b) The time spent locating the requested records, reviewing the records, and redacting or separating material exempt from disclosure;

(d) Copying records;

(e) Certified copies of records and licenses;

(f) Summarizing, compiling or organizing the public records to meet the person’s request;

(g) Searching for and reviewing records even if the records subsequently are determined to be exempt from disclosure;

(h) Postal and freight charges for shipping the copies of the public records sent first class or bulk rate based on weight;

(i) Indirect costs or third party charges associated with copying and preparing the public records;

(j) Costs associated with electronic retrieval of records;

(k) Actual costs charged by the Attorney General’s office for attorney’s time spent in reviewing and redacting material from the records, and in separating material into exempt and nonexempt records. A fee may not be charged for the cost of time spent by an attorney in determining the application of the provisions of ORS 192.410 to 192.505;

(l) Staff time for performing the work;

(m) The cost of publications will be based on the actual costs of development, printing and distribution as determined by the Board;

(4) The Board shall establish and publish a list of fees used to charge requestors for the costs of preparing and making available the following and shall review the schedule at least once a biennium and any time an increase is proposed, to assure that the fees reflect current Board costs:

(a) Photocopies;

(b) Facsimile copies. The Board may limit the transmission to twenty pages;

(c) Electronic copies, CDs, DVDs, and other electronically generated materials including lists electronically mailed from the Board database. The Board shall determine what electronic media for reproduction of computer records may be used and whether the electronic media is to be provided by the Board or the requestor;

(d) Manual license verification;

(e) Publications including but not limited to:

(A) Copies of Laws and Rules;

(B) The newsletter.

(f) Licensee duplicate wall certificates;

(g) Duplicate renewal forms;

(h) Re-mailing of returned mail when a licensee or registrant has failed to notify the Board of a change of address.

(5) No additional fee may be charged for providing records or documents in an alternative format when required by the Americans with Disabilities Act.

(6) The Board shall notify requestors of the estimated fees for making the public records available for inspection or for providing copies to the requestor. If the estimated fees exceed $25, the Board shall provide written notice and may not act further to respond to the request until the requestor notifies the Board, in writing, to proceed with making the records available.

(7) The Board or its designee may reduce or waive any of the above administrative fees when a determination is made that the waiver or reduction of fees is in the public interest. Factors that may be taken into account in making such a determination include, but are not limited to:

(a) The overall costs incurred by the Board are negligible; or

(b) Providing the requested records or documents is within the normal scope of the Board’s activity; or

(d) The request is a discovery request made as part of pending administrative, judicial or arbitration proceedings.

(8) If the Board denies an application for waiver or reduction of fees, the requestor may petition the Attorney General under the provisions of ORS 192.440(5) and 192.450.

(9) The Board establishes the following fees for inspection of out-of-state registrants. When an applicant for registration or renewal of registration requests an inspection, the Board shall execute an agreement with the applicant that must specify that the applicant shall pay:

(a) The travel expenses of each Board staff person (inspector) by coach-class commercial air or by rental car;

(b) The hotel costs of the inspector, subject to the applicant arranging accommodation in a hotel that is, whenever possible, on the federal per-diem list;

(d) The per-diem expenses of the inspector;

(e) A fee for the Board’s time and expenses calculated as:

(A) The daily compensation of the inspector, plus the costs of any fringe benefits charged to the Board, multiplied by: one plus the number of days or partial days the inspector is away from their normal workplace; plus

(B) An administrative fee of $750.

(10) In addition to the reinspection fee specified in OAR 855-110-0007, the Board establishes the following administrative fees for a re-inspection of any Oregon drug outlet that is necessary to verify corrections of violations found on an initial inspection:

(a) The travel, hotel and per-diem costs for the inspector; and

(b) The hourly compensation of the inspector plus the cost of any fringe benefits charged to the Board multiplied by the number of hours necessary for the reinspection.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 192.430 & 192.440
BP 2-2010, f. 2-12-10, cert. ef. 3-1-10
PB 1-1996, f. & cert. ef. 4-5-96
PB 10-1990, f. & cert. ef. 12-5-90

Division 115 PHARMACISTS

Or. Admin. R. 855-115-0001 Applicability

(1) This Division applies to any Pharmacist who engages in the practice of pharmacy.

(2) Only persons licensed with the board as a Pharmacist may practice pharmacy and must act in compliance with statutes and rules unless exempt under ORS 689.225.

(3) A pharmacist who is located in another state and who engages in the practice of pharmacy for a patient, drug outlet or healthcare facility in Oregon, must be licensed by the board in accordance with the following rules, except that a pharmacist working for an out-of-state pharmacy, who only performs the professional tasks of interpretation, evaluation, DUR, counseling and verification associated with their dispensing of a drug to a patient in Oregon, is not required to be licensed by the board unless they are the pharmacist-in-charge (PIC).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.255
BP 4-2024, adopt filed 02/15/2024, effective 03/01/2024

Or. Admin. R. 855-115-0010 Licensure: Qualifications - General

(1) Before licensure as a Pharmacist, an applicant must meet the qualifications required that are applicable to their method of licensure:

(a) Examination or Score Transfer in OAR 855-115-0020; or

(b) Reciprocity in OAR 855-115-0025.

(2) If residing in the United States, proof of citizenship, legal permanent residency or qualifying visa, as required by 8 USC 1621.

(3) Foreign pharmacy graduates must also meet the requirements of OAR 855-115-0015 prior to applying for a Pharmacist license.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.285
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0015 Licensure: Qualifications - Foreign Pharmacy Graduate Education

(1) An applicant for pharmacist licensure who graduated from a foreign school, college, or program of pharmacy must meet the following educational requirements:

(a) Obtain certification from the Foreign Pharmacy Graduate Examination Committee (FPGEC); and

(b) Submit evidence of 1440 hours in pharmacy practice as an intern or pharmacist in the United States or its jurisdiction.

(2) (1)(a) is not required for graduates of:

(a) A Canadian Council for Accreditation of Pharmacy Programs (CCAPP) accredited pharmacy program located in Canada or its jurisdiction with a curriculum taught in English and who graduated between 1993 and June 30, 2004.

(b) The ACPE-accredited program at the Lebanese American University in Byblos, Lebanon with a Doctor of Pharmacy degree and graduated after 2002.

(3) If (1)(a) is required, an applicant must not count internship hours or practice as a pharmacist towards the requirement in (1)(b) that was completed before achieving the FPGEC certification.

(4) Once the educational qualifications in this rule are met, an applicant must also comply with the requirements for licensure in OAR 855-115-0020 for examination or score transfer or OAR 855-115-0025 for reciprocity.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.255
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0020 Licensure: Qualifications - Examination or Score Transfer

(1) To receive licensure as a Pharmacist by examination or score transfer, an applicant must meet the following requirements:

(a) Provide evidence in the form of an official transcript from an Accreditation Council for Pharmacy Education (ACPE) accredited college or school of pharmacy or compliance with OAR 855-115-0015 that:

(A) A degree has been conferred; and

(B) The applicant has completed a minimum of 1440 hours in an Internship Program as that term is defined in OAR 855-120-0005.

(b) Pass the North American Pharmacist Licensure Examination (NAPLEX) exam. A passing result is valid for 12 months. A candidate who does not pass may retake the exam after a minimum of 45 days with a limit of three attempts in a 12-month period, not to exceed a lifetime maximum of 5 failed attempts;

(c) Pass the Oregon Multistate Pharmacy Jurisprudence Examination (MPJE) exam. A passing result is valid for 12 months. A candidate who does not pass may retake the exam after a minimum of 30 days with a limit of three attempts in a 12-month period, not to exceed a lifetime maximum of 5 failed attempts; and

(d) Complete one hour of continuing pharmacy education in pain management, provided by the Pain Management Commission of the Oregon Health Authority.

(2) An applicant who has obtained their professional degree outside the United States is not eligible for licensure via examination or score transfer until they have met the requirements of OAR 855-115-0015.

(3) An applicant applying via score transfer must request the National Association of Boards of Pharmacy to transfer their NAPLEX score to Oregon.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 413.590, ORS 689.151 & ORS 689.285
BP 19-2024, minor correction filed 03/01/2024, effective 03/01/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0025 Licensure: Qualifications - Reciprocity

(1) An applicant for licensure as a Pharmacist by reciprocity must meet the requirements of ORS 689.265 and provide evidence of the following requirements:

(a) Be a graduate, as shown by an official transcript, of an ACPE accredited college or school of pharmacy or compliance with OAR 855-115-0015;

(b) Have passed the NAPLEX;

(c) Have passed the Oregon MPJE. A passing result is valid for 12 months. A candidate who does not pass may retake the exam after a minimum of 30 days with a limit of three attempts in a 12-month period, not to exceed a lifetime maximum of 5 failed attempts;

(d) Proof that each pharmacist license granted to the applicant is not suspended, revoked, canceled or otherwise completely restricted from the practice of pharmacy for any reason except nonrenewal or the failure to obtain required continuing education credits in any state where the applicant is licensed but not engaged in the practice of pharmacy; and

(e) Have either:

(A) Been engaged in the practice of pharmacy for period of at least 12 months including a minimum of 1440 hours of work experience as a licensed Pharmacist. Evidence supporting this work experience must be provided at time of application; or

(B) Completed 1440 hours in an Internship Program as that term is defined in OAR 855-120-0190

within the 12-month period immediately before the date of application. Evidence must be provided at time of application.

(2) An applicant who has obtained their professional degree outside the United States and jurisdiction is not eligible for licensure by reciprocity until they have met the requirements of OAR 855-115-0015.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.265 & ORS 689.405
BP 15-2026, minor correction filed 07/13/2026, effective 07/13/2026
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0030 Licensure: Application

(1) An application for licensure as a Pharmacist may be accessed on the board website.

(2) The board may issue a license to a qualified applicant after the receipt of:

(a) Evidence of compliance with OAR 855-115-0020 or 855-115-0025;

(b) A completed application including:

(A) Payment of the fee prescribed in OAR 855-110;

(B) A current, passport regulation size photograph (full front, head to shoulders);

(D) Certificate of completion for the one hour of continuing pharmacy education in pain management, provided by the Pain Management Commission of the Oregon Health Authority;

(d) A completed moral turpitude statement or a written description and documentation regarding all conduct that is required to be disclosed.

(3) Penalties may be imposed for:

(a) Failure to completely and accurately answer each question on the application for licensure or renewal of licensure;

(b) Failure to disclose any requested information on the application;

(d) Any other grounds found in ORS 689.405.

(4) An application submitted to the board that is not complete within 90 days from applicant submission will be expired. Once expired, an applicant who wishes to continue with the application process must reapply by submitting a new application, along with all documentation, and all fees. While a new application and documentation is required, the board may still consider information that was provided in previous applications.

(5) The license of a Pharmacist expires June 30 in odd numbered years and may be renewed biennially.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.225 & ORS 689.285
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0035 Licensure: Renewal or Reinstatement

(1) An applicant for renewal of a Pharmacist license must:

(a) Pay the biennial license fee required in OAR 855-110;

(b) Complete the continuing pharmacy education requirements as outlined in OAR 855-135;

(d) Provide a written description and documentation regarding all conduct that is required to be disclosed.

(2) A Pharmacist who fails to renew their license by the expiration date and whose license has been lapsed for 12 months or less may apply to renew their license and must pay a late fee required in OAR 855-110.

(3) A person who fails to renew their license by the expiration date and whose license has been lapsed for greater than 12 months may apply to reinstate their Pharmacist license as follows:

(a) Apply per OAR 855-115-0030;

(b) Provide certification of completion of the continuing pharmacy education requirement in OAR 855-135 for all years in which the license was lapsed; and

(4) A person must take and pass the Oregon MPJE if their pharmacist license has been lapsed for more than three years. A passing result is valid for 12 months. A candidate who does not pass may retake the exam after a minimum of 30 days with a limit of three attempts in a 12- month period, not to exceed a lifetime maximum of 5 failed attempts.

(5) If the Pharmacist license has been lapsed for more than five years and the person has not maintained an active pharmacist license in another US state or jurisdiction, a person must comply with (4) and take and pass the NAPLEX. A passing result is valid for 12 months. A candidate who does not pass may retake the exam after a minimum of 45 days with a limit of three attempts in a 12 month period, not to exceed a lifetime maximum of 5 failed attempts.

(6) In lieu of reinstatement, a person may apply for licensure via reciprocity if the person has maintained an active pharmacist license in good standing in another US state or jurisdiction.

(7) A person whose Pharmacist license has been retired for more than 12 months need only pay the annual license fees for the year in which they seek a license, however they must also complete the requirements in (3).

(8) A person whose Pharmacist license has been suspended, revoked or restricted has the right, at reasonable intervals, to petition to the board for reinstatement of such license pursuant to ORS 689.445 and in conjunction with the application process identified in OAR 855-115-0030.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.275, ORS 689.285 & ORS 689.448
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0040 Licensure: Lapse

(1) A Pharmacist may let their license lapse by failing to renew or request that the board accept the lapse of their license prior to the expiration date.

(a) Lapse of a license is not discipline.

(b) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

(d) A person may apply for renewal or reinstatement of their license according to OAR 855-115-0035.

(2) If a Pharmacist requests to lapse their license prior to the expiration date, the following applies:

(a) The license remains in effect until the board accepts the lapse.

(b) If the board accepts the lapse, the board will notify the licensee of the date the license terminates.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0045 Licensure: Retire

(1) A Pharmacist may request that the board retire their license if the Pharmacist is in good standing, has been licensed as a Pharmacist for at least 20 years and is no longer practicing pharmacy.

(a) A retired license is not considered discipline.

(b) The board has continuing authority under ORS 689.153.

(d) A person may apply for renewal or reinstatement according to OAR 855-115-0035.

(2) If a Pharmacist requests to retire their license prior to the expiration date of the license, the following applies:

(a) The license remains in effect until the board accepts the request to retire the license.

(b) If the board accepts the request to retire the license, the board will notify the licensee of the date the license is no longer active.

(c) The board will not accept the request to retire the license if an investigation of or disciplinary action against the licensee is pending.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0050 Licensure: Voluntary Surrender

A Pharmacist may request that the board accept the voluntary surrender of their license.

(1) A voluntary surrender of a license is discipline.

(2) The license remains in effect until the board accepts the surrender.

(3) If the board accepts a request for voluntary surrender, the board will issue a final order terminating the license, signed by the licensee and a board representative. The termination date is the date the order is signed by all parties and served on the licensee.

(4) The licensee must cease practicing pharmacy from the date the license terminates.

(5) A voluntarily surrendered license cannot be renewed. A former licensee who wants to obtain a license must apply for reinstatement per OAR 855-115-0035 unless the final order prohibits the licensee from doing so.

(6) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0060 Registration: In-State Volunteer

(1) A Pharmacist may register with the board for the limitation on liability provided by ORS 676.340, which provides a licensee with specific exemptions from liability for the provision of pharmacy services without compensation under the terms of the law.

(2) A no cost registration may be issued by the board upon receipt of a completed application. Registration requires submission of a signed form provided by the board in accordance with ORS 676.345(2).

(3) Registration will expire at the licensee’s next license renewal date and may be renewed biennially. It is the licensee’s responsibility to ensure his or her active registration in this program.

(4) Nothing in this section relieves licensee from the responsibility to comply with board regulations and still may be subject to disciplinary actions.

(5) Pharmacists providing care under the provisions of ORS 676.340 and ORS 676.345 remain subject to the board complaint investigation process articulated in ORS 676.175.

History

Statutory/Other Authority: ORS 676.340 & ORS 689.205
Statutes/Other Implemented: ORS 676.340 & ORS 676.345
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0065 Notification: Out-of-State Volunteer

(1) A pharmacist who is not licensed in Oregon may, without compensation and in connection with a coordinating organization or other entity, practice pharmacy for 30 days each calendar year. The pharmacist is not required to apply for licensure or other authorization from the board to practice pharmacy under this section.

(2) To practice pharmacy under this section, the pharmacist who is not licensed in Oregon must submit on a form prescribed by the board, at least 10 days prior to commencing practice in this state, to the board:

(a) Proof that the pharmacist is in good standing and is not the subject of an active disciplinary action in any jurisdiction in which the Pharmacist is authorized to practice;

(b) An acknowledgement that the pharmacist must provide services only within the scope of practice of pharmacy and will provide services pursuant to the scope of practice of this state or the health care practitioner’s licensing agency, whichever is more restrictive;

(d) The name and contact information of the coordinating organization or other entity through which the Pharmacist will practice; and

(e) The dates on which the pharmacist will practice in this state.

(3) Except as otherwise provided, a pharmacist practicing under this section is subject to the laws and rules governing the pharmacy profession that the pharmacist is authorized to practice and to disciplinary action by the appropriate health professional regulatory board.

History

Statutory/Other Authority: ORS 689.205, ORS 689.315 & ORS 676.347
Statutes/Other Implemented: ORS 689.151 & ORS 676.347
BP 62-2024, minor correction filed 09/06/2024, effective 09/06/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0070 Notification: Nuclear Pharmacists

In order to qualify under these rules as a nuclear Pharmacist, a Pharmacist must :

(1) Meet minimum standards of training and experience in the handling of radioactive materials in accordance with the requirements of the Radiation Protection Services of the Department of Human Services; and

(2) Be a Pharmacist licensed to practice in Oregon; and

(3) Submit to the Board of Pharmacy either:

(a) Evidence of current certification in nuclear pharmacy by the Board of Pharmacy Specialties; or

(b) Evidence that they meet both the following:

(A) Certification of a minimum of six-months on-the-job training under the supervision of a qualified nuclear Pharmacist in a nuclear pharmacy providing radiopharmaceutical services; and

(B) Certification of completion of a nuclear pharmacy training program in a college of pharmacy or a nuclear pharmacy training program approved by the board.

(4) Receive a letter of notification from the board that the evidence submitted by the Pharmacist meets the above requirements and has been accepted by the board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0105 Responsibilities: General

When practicing pharmacy per ORS 689, each Pharmacist must:

(1) Use that degree of care, skill, diligence and reasonable professional judgment that is exercised by a careful and prudent Pharmacist in the same or similar circumstances;

(2) Be responsible for their own actions, however, this does not absolve the pharmacy from responsibility for the Pharmacist’s actions;

(3) Be responsible for the actions of each Intern, Certified Oregon Pharmacy Technician, Pharmacy Technician and non-licensed pharmacy personnel under their supervision;

(4) Ensure compliance with all state and federal laws and rules governing the practice of pharmacy;

(5) Control each aspect of the practice of pharmacy;

(6) Perform appropriately the duties of a Pharmacist;

(7) Ensure access to reference material and equipment needed based on the services provided;

(8) Ensure services are provided with required interpretation and translation per ORS 689.564;

(9) Ensure services occur in a sanitary, secure and confidential environment;

(10) Be clearly identified as a Pharmacist in all interactions and communications (e.g., nametag, phone interaction, chart notations);

(11) Display in plain sight the Pharmacist license within the pharmacy or place of business to which it applies;

(12) Engage in a continuous quality improvement program; and

(13) Review, adhere to and enforce written policies and procedures. The review must:

(a) Occur prior to engaging in the practice of pharmacy;

(b) Occur with each update; and

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: 2022 HB 4034, ORS 689.025, ORS 689.151, ORS 689.155, ORS 689.645, ORS 689.682 & OS 689.689
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0110 Responsibilities: Confidentiality

Each Pharmacist must comply with OAR 855-104-0015 regarding confidentiality.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0115 Responsibilities: Duty to Report

Each Pharmacist must report to the board as required by OAR 855-104-0010. In addition, unless state or federal laws relating to confidentiality or the protection of health information prohibit disclosure, a Pharmacist must report to the board without undue delay, but within 1 business day of:

(1) Confirmed significant drug loss; or

(2) Any loss related to suspected drug theft of a controlled substance.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.455
Statutes/Other Implemented: ORS 689.455, ORS 676.150, ORS 689.151 & ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0120 Responsibilities: Personnel

(1) When practicing pharmacy per ORS 689, each Pharmacist must:

(a) Ensure personnel that require licensure have been granted and maintain licensure with the board;

(b) Ensure licensed personnel work within the duties permitted by their licensure;

(d) Know the identity of each Intern under their supervision, and Certified Oregon Pharmacy Technician and Pharmacy Technician under their supervision, direction and control at all times;

(e) Ensure each Intern only practices pharmacy under the supervision of a Pharmacist as outlined in OAR 855-120 including any applicable ratios;

(f) Ensure each Certified Oregon Pharmacy Technician and Pharmacy Technician only assists in the practice of pharmacy under the supervision, direction, and control of a Pharmacist as outlined in OAR 855-125;

(g) Ensure licensed personnel do not engage in prohibited practices as outlined for Interns in OAR 855-120-0150 and for Certified Oregon Pharmacy Technicians and Pharmacy Technicians in OAR 855-125-0150;

(h) Ensure non-licensed personnel do not practice or assist in the practice of pharmacy;

(i) Ensure initial and ongoing training is completed that is commensurate with the tasks that the Pharmacist and persons under their supervision will perform, prior to the performance of those tasks;

(j) Ensure continued competency in tasks that are performed by the Pharmacist and persons under their supervision; and

(k) Ensure that the supervision of non-Pharmacist personnel does not exceed their capacity to safely supervise based on the workload and services being provided.

(2) When engaging in the practice of pharmacy per ORS 689, each Pharmacist may delegate the practice of pharmacy to other health care providers who are appropriately trained and authorized to perform the delegated tasks.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0122 Responsibilities: Supervision

(1) When supervising a Certified Oregon Pharmacy Technician or Pharmacy Technician, each Pharmacist may supervise as many Certified Oregon Pharmacy Technicians or Pharmacy Technicians as they believe in their reasonable professional judgment is appropriate to promote and protect patient health, safety and welfare.

(2) When supervising an Intern, each Pharmacist may supervise:

(a) No more than four Interns participating in direct patient care activities.

(b) As many Interns as they believe in their reasonable professional judgment is appropriate to promote and protect patient health, safety and welfare for Interns participating in non-direct patient care activities such as informational health fairs that provide general information, but not patient-specific information.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 31-2023, adopt filed 12/19/2023, effective 03/01/2024

Or. Admin. R. 855-115-0125 Responsibilities: Drugs, Records and Security

When practicing pharmacy per ORS 689, each Pharmacist must:

(1) Ensure the security of prescription drugs, pharmacy and patient records including:

(a) Provide adequate safeguards against loss, theft, or diversion; and

(b) Ensure only persons authorized by the Pharmacist access the areas where prescription drugs, pharmacy and patient records are stored by restricting access;

(2) Ensure that all records are maintained in accordance with state and federal laws and rules;

(3) Only receive drugs from an Oregon Registered Drug Outlet (e.g., Wholesaler, Manufacturer or Pharmacy);

(4) Comply with the drug storage rules for pharmacies in OAR 855-041-1036;

(5) Ensure drugs and devices that are recalled, outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, or identified as suspect or illegitimate, or otherwise unfit for dispensing or administration must be documented, quarantined and physically separated from other drugs and devices until they are destroyed or returned to the supplier;

(6) Ensure each compounded drug is prepared in compliance with OAR 855-183;

(7) Ensure all computer equipment used for the practice of pharmacy:

(a) Establishes and maintains a secure connection to patient information to which they have access;

(b) Prevents unauthorized access to patient information; and

(c) Is configured so information from any patient records are not duplicated, downloaded, or removed from the electronic database if accessed remotely;

(8) Document accurately and maintain records in the practice of pharmacy including, but not limited to:

(a) Services provided;

(b) The date, time and identification of the licensee and the specific activity or functions performed; and

(c) Maintain records pertaining to the acquisition, storage, dispensing or administration, and disposal of drugs and devices; and

(9) Ensure reporting of data as required by federal and state regulations, including but not limited to:

(a) ALERT Immunization Information System (ALERT-IIS) per ORS 433.090, ORS 433.092, ORS 433.094, ORS 433.095, ORS 433.096, ORS 433.098, ORS 433.100, ORS 433.102, ORS 433.103, and ORS 433.104;

(b) Communicable diseases per ORS 433.004; and

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 11-2026, minor correction filed 07/07/2026, effective 07/07/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0130 Responsibilities: Practicing Pharmacy for a Drug Outlet

(1) When practicing pharmacy per ORS 689 for a Drug Outlet, each Pharmacist must:

(a) Be responsible for the daily conduct, operation, management and control of the Drug Outlet pharmacy;

(b) Ensure that only a Pharmacist has access to the Drug Outlet pharmacy when the pharmacy is closed, except as permitted in OAR 855-041-6310;

(d) Ensure the patient record contains the elements required in OAR 855-041 or OAR 855-139;

(e) Ensure prescriptions, prescription refills, and drug orders are dispensed:

(A) Accurately;

(B) To the correct party;

(D) Pursuant to a valid patient-practitioner relationship; and

(E) For a legitimate medical purpose;

(f) Ensure the Drug Outlet pharmacy is operated in a professional manner at all times;

(g) Ensure the drug outlet reports data as required by federal and state regulations, including but not limited to:

(A) Prescription Drug Monitoring Program (PDMP) per ORS 413A.890, ORS 413A.895, ORS 413A.896, ORS 413A.898, and OAR 333-023;

(B) Death with Dignity per ORS 127.800, ORS 127.805, ORS 127.810, ORS 127.815, ORS 127.820, ORS 127.825, ORS 127.830, ORS 127.835, ORS 127.840, ORS 127.845, ORS 127.850, ORS 127.855, ORS 127.860, ORS 127.865, ORS 127.870, ORS 127.875, ORS 127.880, ORS 127.885, ORS 127.890, ORS 127.892, ORS 127.895, ORS 127.897, and OAR 333-009;

(D) Listed chemicals per 21 CFR 1310.05 (v. 04/01/2025); and

(2) A Pharmacist who utilizes licensees remotely, must comply with OAR 855-041-3200 through OAR 855-041-3250.

(3) When engaging in the practice of pharmacy per ORS 689, each Pharmacist may delegate final verification of drug and drug dosage, device, or product to a Certified Oregon Pharmacy Technician or Pharmacy Technician per ORS 689.703 when the following conditions are met:

(a) The Pharmacist utilizes reasonable professional judgment to determine that a Certified Oregon Pharmacy Technician or Pharmacy Technician may perform final verification;

(b) The Certified Oregon Pharmacy Technician or Pharmacy Technician does not use discretion in conducting final verification;

(c) The Pharmacist delegating final verification is supervising the Certified Oregon Pharmacy Technician or Pharmacy Technician; and

(d) Ensure the Certified Oregon Pharmacy Technician or Pharmacy Technician is performing a physical final verification.

(4) If the patient is relying on a standing order prescription issued by the Public Health Officer appointed under ORS 431.045, or a physician licensed under ORS chapter 677 who is employed by the Oregon Health Authority, to obtain a drug or device, the Pharmacist does not need to ensure that:

(a) There is a patient-practitioner relationship as required in subsection (1)(e)(D) of this rule; and

(b) The prescription contains the name and date of birth of the patient for whom the drug is prescribed.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.703
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2026, minor correction filed 02/18/2026, effective 02/18/2026
BP 16-2025, amend filed 12/16/2025, effective 12/16/2025
BP 7-2025, amend filed 08/08/2025, effective 08/08/2025
BP 52-2024, amend filed 06/18/2024, effective 06/20/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0140 Drug Utilization Review (DUR)

(1) A Pharmacist must complete a drug utilization review (DUR) by reviewing the patient record prior to dispensing each prescription drug or device for the purpose of identifying the following:

(a) Over-utilization or under-utilization;

(b) Therapeutic duplication;

(d) Drug-drug interactions;

(e) Incorrect drug dosage or formulation;

(f) Inappropriate duration of treatment;

(g) Drug-allergy interactions; and

(h) Drug abuse or misuse.

(2) Upon recognizing a concern with any of the items in (1)(a)-(h), the Pharmacist must take steps to mitigate or resolve the problem and document the steps taken and outcome.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0145 Counseling

(1) For each prescription, the pharmacist must determine the manner and amount of counseling that is reasonable and necessary under the circumstance to promote safe and effective use or administration of the drug or device, and to facilitate an appropriate therapeutic outcome for that patient.

(2) Counseling must be provided or offered to be provided to the patient or patient's agent on the use of a drug or device:

(a) When the drug or device has not been previously dispensed to the patient by the Drug Outlet pharmacy;

(b) When there has been a change in the dose, formulation, or directions;

(d) For any refill that the pharmacist deems counseling is necessary.

(3) An offer for the pharmacist to counsel under (1) and (2) must be made by a licensee.

(4) The pharmacist must counsel the patient or patient’s agent on the use of a drug or device upon request.

(5) When communicating (e.g., counseling, patient care services, billing) with a patient who prefers to communicate in a language other than English or who communicates in signed language, the pharmacist must work with a health care interpreter from the health care interpreter registry administered by the Oregon Health Authority under ORS 413.558 unless the pharmacist is proficient in the patient's preferred language.

(6) For a prescription where counseling has only been provided in writing, the pharmacist must provide drug information in a format accessible by the patient, including information on when the pharmacist is available and how the patient or patient’s agent may contact the pharmacist.

(7) A pharmacist is not required to counsel a patient or patient’s agent when the patient or patient’s agent refuses such consultation. If refused:

(a) Only a licensee can accept a patient’s or patient's agent’s request not to be counseled, when counseling is required.

(b) The pharmacist may choose not to release the prescription until counseling has been completed.

(8) Counseling must be provided under conditions that maintain patient privacy and confidentiality.

(9) Counseling, offers to counsel or declinations of counseling regarding prescriptions must be documented with the licensee’s identity.

(10) Additional forms of drug information (e.g., Medication Guide, Patient Package Inserts, Instructions for Use) must be used to supplement counseling when required by federal law or rule.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 31-2023, adopt filed 12/19/2023, effective 03/01/2024

Or. Admin. R. 855-115-0150 Prohibited Practices

Pharmacists must not:

(1) Engage in the dispensing, distribution or delivery of drugs unless working for a registered Drug Outlet pharmacy.

(2) Possess personally or store drugs other than in a registered Drug Outlet pharmacy except for those drugs legally prescribed for the personal use of the Pharmacist or when the Pharmacist possesses or stores the drugs in the usual course of business and within the Pharmacist’s scope of practice.

(3) Engage in any form of discrimination, harassment, intimidation, or assault.

(4) Permit any Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician to perform any task in which the supervising Pharmacist is not trained or qualified to perform.

(5) Permit any non-licensed pharmacy personnel to perform any function that constitutes the practice of pharmacy as defined in ORS 689 or the assistance of the practice of pharmacy. Non-licensed personnel may only perform functions permitted by the Pharmacist providing supervision.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 16-2024, amend filed 03/01/2024, effective 03/01/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0205 Pharmacist-in-Charge: Qualifications and Limitations

(1) In order to be a Pharmacist-in-Charge (PIC), a Pharmacist must have:

(a) Completed at least one year of pharmacy practice; or

(b) Completed a board provided PIC training course either before the appointment or within 90 days after the appointment; and

(2) A Pharmacist must not be designated PIC of more than three pharmacies. The following drug outlet types do not count towards this limit:

(a) Pharmacy Prescription Kiosks in OAR 855-141; and

(b) Pharmacy Prescription Lockers in OAR 855-143.

(3) Effective July 1, 2025, in order to be a Pharmacist-in-Charge (PIC), a Pharmacist must complete a board provided PIC training course at least every five years.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 31-2023, adopt filed 12/19/2023, effective 03/01/2024

Or. Admin. R. 855-115-0210 Pharmacist-in-Charge: Responsibilities

(1) In addition to the responsibilities of a Pharmacist outlined in OAR 855-115, a Pharmacist-in-Charge of a Drug Outlet pharmacy must:

(a) Be actively engaged in pharmacy activities at the Drug Outlet pharmacy;

(b) Be physically present at the Drug Outlet pharmacy on a regular basis for a sufficient amount of time as needed to ensure Drug Outlet pharmacy compliance;

(d) Establish, maintain, and enforce written policies and procedures governing the practice of pharmacy that are compliant with federal and state laws and rules;

(e) Ensure maintenance of complete and accurate records;

(f) Establish, maintain and enforce a continuous quality improvement program;

(g) Develop, implement and submit a plan of correction for observations noted on an inspection within the time allowed by the board;

(h) Complete an annual self-inspection of the pharmacy using the Self-Inspection Form provided by the board, by July 1 each year and within 15 days of becoming PIC. The completed self-inspection forms must be signed and dated by the PIC and retained for three years from the date of completion; and

(i) Ensure a controlled substance inventory with discrepancy reconciliation is accurately completed and documented:

(A) For all controlled drugs either prior to the opening or after the close of business on the inventory date:

(i) Within 15 days of a change in PIC; and

(ii) At least every 367 days; and

(B) For all Schedule II controlled drugs:

(i) At least every 93 days in a Retail Drug Outlet Pharmacy; and

(ii) At least every 31 days in an Institutional Drug Outlet Pharmacy.

(2) The PIC of a Drug Outlet pharmacy affiliated with the following Drug Outlet types must also comply with the PIC responsibilities as outlined in:

(a) Pharmacy Prescription Kiosk in OAR 855-141;

(b) Pharmacy Prescription Locker in OAR 855-143; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0300 Services: Consulting Practice

(1) A Pharmacist who provides services to an Oregon licensed healthcare facility must perform all duties and functions required by the healthcare facility's licensure as well as by any relevant federal and state laws and rules.

(2) A Pharmacist who provides services to a correctional facility, long term care facility, community-based care facility, hospital drug room, or charitable pharmacy that does not have additional Pharmacist service requirements under the terms of its licensure with any other state agency, must provide services that include but are not limited to the following:

(a) Provide the facility with policies and procedures relating to security, storage and distribution of drugs within the facility;

(b) Provide guidance on the proper documentation of drug administration or dispensing; and

(3) A Pharmacist who provides services to an Oregon licensed healthcare provider must follow all state and federal laws and rules related to the practice of pharmacy.

(4) A Pharmacist must maintain appropriate records of their services in (2) - (4) for three years and make them available to the board for inspection.

(5) A Pharmacist may store protected health records outside an Oregon licensed facility as permitted in OAR 855-104-0055.

(6) Records and documents must be retained according to OAR 855-104-0055.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0305 Services: Administration of Vaccines, Drugs, or Devices

(1) In accordance with ORS 689.645 and ORS 689.655, a Pharmacist may administer a vaccine, drug or device as specified in this rule. The Pharmacist must be acting:

(a) Under the direction of or pursuant to a lawful prescription or order issued by a licensed practitioner acting within the scope of the practitioner’s practice; or

(b) In accordance with a statewide drug therapy management protocol per OAR 855-115-0345; or

(c) In accordance with a clinical pharmacy agreement or collaborative drug therapy management agreement per OAR 855-115-0315.

(2) A Pharmacist who administers a vaccine, drug or device must:

(a) Prior to administration of an injectable drug or device, receive practical training on the injection site and administration technique that is utilized. For orally administered drugs, training is not required.

(b) Hold active CPR certification issued by the American Heart Association or the American Red Cross or any other equivalent program intended for a healthcare provider that is specific to the age and population receiving the vaccine, drug or device, contains a hands-on training component, and is valid for not more than three years. The most current CPR certification record must be retained according to OAR 855-104-0055;

(c) Ensure that any drug administered to a patient was stored in accordance with the drug storage rules for pharmacies in OAR 855-041-1036;

(d) Observe, monitor, report, and otherwise take appropriate action regarding desired effect, side effect, interaction, and contraindication associated with administering the vaccine, drug or device;

(e) Ensure that vaccine, drug or device administration is documented in the patient’s permanent record; and

(f) Ensure records and documents are retained according to OAR 855-104-0055. Records of administration must include but are not limited to:

(A) Patient identifier;

(B) Vaccine, drug or device and strength;

(D) Date and time of administration; and

(E) Pharmacist identifier.

(3) For vaccines only, the requirements in (2) and the following apply, and the Pharmacist who administers or supervises each administration of a vaccine to a patient must:

(a) Complete training that includes hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines. The training may include programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college or school of pharmacy, state or local health department programs, training by an appropriately qualified practitioner, or programs approved by the board; and

(b) Make vaccine recommendations;

(d) Ensure compliance with (1);

(e) Ensure the appropriate Vaccine Information Statement (VIS) is provided to the patient or patient’s agent prior to each dose of vaccine.

(f) Perform verification prior to administration that includes but is not limited to:

(A) Prescription order accuracy verification; and

(B) Vaccine product accuracy review;

(g) Advise or counsel on therapeutic values, content, hazards and use of each vaccine;

(h) Manage adverse events;

(i) Report adverse events as required by the Vaccine Adverse Events Reporting System (VAERS) and to the primary care provider as identified by the patient;

(j) Verify accuracy and completeness of documentation for vaccine administration;

(k) Ensure all persons administering vaccines under their supervision are appropriately trained and qualified;

(l) Follow the guidance in the Centers for Disease Control and Prevention (CDC) Vaccine Storage and Handling Toolkit (v. 4/12/2022); and

(m) Have access to a current edition of the CDC reference, "Epidemiology and Prevention of Vaccine-Preventable Diseases" (v. 8/2021);

(4) The Pharmacist may administer a drug or device in conjunction with training the patient or the patient’s agent on how to administer or self-administer the drug or device.

(5) Records and documents must be retained according to OAR 855-104-0055.

(6) An appropriately trained and qualified Pharmacist may permit an appropriately trained and qualified:

(a) Intern to perform the same duties as a Pharmacist except as prohibited in OAR 855-120-0150.

(b) Certified Oregon Pharmacy Technician or Pharmacy Technician to conduct the physical act of administering a vaccine in accordance with OAR 855-125-0305.

(7) The appropriately trained and qualified Pharmacist who is supervising an Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician in administering a vaccine must be immediately available to the vaccinator to respond in the case of an adverse reaction and any other issue that may arise.

History

Statutory/Other Authority: ORS 689.205, 2023 HB 2486 & 2023 HB 2278
Statutes/Other Implemented: ORS 689.655, 2023 HB 2486 & 2023 HB 2278
BP 18-2024, minor correction filed 03/01/2024, effective 03/01/2024
BP 30-2023, adopt filed 12/19/2023, effective 03/01/2024

Or. Admin. R. 855-115-0310 Services: Laboratory

(1) A Pharmacist must only order and receive laboratory test when:

(a) Managing drug therapy pursuant to the terms of a clinical pharmacy agreement or collaborative drug therapy management agreement with a provider under OAR 855-115-0315;

(b) Providing patient care services pursuant to the terms of the post diagnostic formulary listed in OAR 855-115-0340 that is developed under ORS 689.645 and adopted by the board under ORS 689.649;

(c) Providing patient care services pursuant to and as allowed by the terms of a protocol listed in OAR 855-115-0345 that is developed under ORS 689.645 and adopted by the board under ORS 689.649;

(d) Permitted under a Health Screen Testing Permit pursuant to ORS 438.010(8); ORS 438.060; ORS 438.130(2); ORS 438.150(5), (6) and (7); OAR 333-024-0370, OAR 333-024-0375, OAR 333-024-0380, OAR 333-024-0385, OAR 333-024-0390, OAR 333-024-0395 and OAR 333-024-0400; or

(e) Monitoring a therapeutic response or adverse effect to drug therapy under ORS 689.005.

(2) A pharmacy may perform a laboratory test as permitted under ORS 689.661.

(3) Records and documents must be retained according to OAR 855-104-0055.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0315 Collaborative Drug Therapy Management

(1) As used in this rule "Collaborative Drug Therapy Management" (CDTM) means the participation by a practitioner and a pharmacist in the management of drug therapy pursuant to a written agreement that includes information on the dosage, frequency, duration and route of administration of the drug, authorized by a practitioner and initiated upon a prescription order for an individual patient and:

(a) Is agreed to by one practitioner and one pharmacist; or

(b) Is agreed to by one or more practitioners in a single organized medical group, such as a hospital medical staff, clinic or group practice, including but not limited to organized medical groups using a pharmacy and therapeutics committee, and one or more pharmacists.

(2) A pharmacist shall engage in collaborative drug therapy management with a practitioner only under a written arrangement that includes:

(a) The identification, either by name or by description, of each of the participating pharmacists;

(b) The identification, by name or description, of each of the participating practitioners or group of practitioners;

(c) The name of the principal pharmacist and practitioner who are responsible for development, training, administration, and quality assurance of the arrangement;

(d) The types of decisions that the pharmacist is allowed to make, which may include:

(A) A detailed description of the types of diseases, drugs, or drug categories involved, and the activities allowed in each case;

(B) A detailed description of the methods, procedures, decision criteria, and plan the pharmacist is to follow when conducting allowed activities;

(C) A detailed description of the activities the pharmacist is to follow including documentation of decisions made and a plan or appropriate mechanism for communication, feedback, and reporting to the practitioner concerning specific decisions made. In addition to the agreement, documentation shall occur on the prescription record, patient profile, a separate log book, or in some other appropriate system;

(D) Circumstances which will cause the pharmacist to initiate communication with the practitioner, including but not limited to the need for a new prescription order and a report of a patient's therapeutic response or any adverse effect.

(e) Training requirement for pharmacist participation and ongoing assessment of competency, if necessary;

(f) Quality assurance and periodic review by a panel of the participating pharmacists and practitioners;

(g) Authorization by the practitioner for the pharmacist to participate in collaborative drug therapy; and

(h) A requirement for the collaborative drug therapy arrangement to be reviewed and updated, or discontinued at least every two years.

(3) The collaborative drug therapy arrangement and associated records must be kept on file in the pharmacy and made available to any appropriate health licensing board upon request.

(4) Nothing in this rule shall be construed to allow therapeutic substitution outside of the CDTM agreement.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 3-2024, adopt filed 02/15/2024, effective 03/01/2024

Or. Admin. R. 855-115-0320 Services: Medication Therapy Management

(1) Medication Therapy Management (MTM) is a distinct service or group of services that is intended to optimize the therapeutic outcomes of a patient. Medication Therapy Management can be an independent service provided by a Pharmacist or can be in conjunction with the provision of a medication product with the objectives of:

(a) Enhancing appropriate medication use;

(b) Improving medication adherence;

(d) Improving collaboration between practitioner and Pharmacist; and

(e) Improving outcomes.

(2) A Pharmacist that provides MTM services must ensure that they are provided according to the individual needs of the patient and may include but are not limited to the following:

(a) Performing or otherwise obtaining the patient’s health status assessment;

(b) Developing a medication treatment plan for monitoring and evaluating the patient’s response to therapy;

(d) Selecting, initiating, modifying or administering medication therapy in consultation with the practitioner where appropriate;

(e) Performing a medication review to identify, prevent or resolve medication related problems;

(f) Monitoring the patient for adverse drug events;

(g) Providing education and training to the patient or the patient’s agent on the use or administration of the medication where appropriate;

(h) Documenting the delivery of care, communications with other involved healthcare providers and other appropriate documentation and records as required. Such records must:

(A) Be accurate;

(B) Identify the person who completed each action;

(i) Providing necessary services to enhance the patient’s adherence with the therapeutic regimen; and

(j) Integrating the medication therapy management services within the overall health management plan for the patient.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0330 Services: Prescribing - Formulary or Protocol

(1) A Pharmacist located and licensed in Oregon may prescribe and dispense an FDA-approved drug and device included on either the Formulary or pursuant to a statewide drug therapy protocol (Protocol), set forth in this Division.

(2) A Pharmacist may submit a concept, on a form prescribed by the board to the Public Health and Pharmacy Formulary Advisory Committee for consideration, for the addition of a drug or device to the Formulary or for the development of a Protocol. A Pharmacist may provide feedback on the Formulary or Protocols on a board prescribed form and located on the board website.

(3) A Pharmacist must only prescribe a drug or device consistent with the parameters of the Formulary or Protocol, and in accordance with federal and state regulations.

(4) The Pharmacist is responsible for recognizing limits of knowledge and experience and for resolving situations beyond their expertise by consulting with or referring patients to another health care provider.

(5) For each drug or device the Pharmacist prescribes via Protocol, the Pharmacist must:

(a) Ensure training and education requirements have been met prior to engaging in prescribing activities. A copy of all required training and education must be retained according to OAR 855-104-0055;

(b) Collect subjective and objective information about the patient’s health history and clinical status. If prescribing pursuant to the Formulary in OAR 855-115-0340, a diagnosis from the patient’s healthcare provider is required.

(c) Assess the information collected in (b). Any physical assessment must be performed in a face-to-face, in-person interaction and not through electronic means.

(d) Create an individualized patient-centered care plan that utilizes information obtained in the assessment to evaluate and develop a care plan;

(e) Implement the care plan, to include:

(A) Addressing medication and health-related problems and engaging in preventive care strategies;

(B) Initiating, modifying, discontinuing, or administering medication therapy as permitted by the Formulary or Protocol;

(D) Contributing to coordination of care, including the referral or transition of the patient to another health care professional; and

(E) Scheduling follow-up care as needed to achieve goals of therapy;and

(f) Monitor and evaluate the effectiveness of the care plan and make modifications to the plan.

(6) For each drug or device the Pharmacist prescribes via Formulary, the Pharmacist must:

(a) Ensure training and education requirements have been met prior to engaging in prescribing activities. A copy of all required training and education must be retained according to OAR 855-104-0055; and

(b) Ensure prescribing is pursuant to a diagnosis by a health care practitioner who has prescriptive authority and who is qualified to make the diagnosis.

(7) Provide notification to the patient’s identified primary care provider or other care providers when applicable within five business days following the prescribing of a Formulary or Protocol Compendia drug or device.

(8) All records and documents must be retained according to OAR 855-104-0055 and must be made available to the patient and provider upon request.

(9) Pharmacists must report the prescription and administration of vaccines to a patient’s primary health care provider if identified and to the Oregon Health Authority pursuant to ORS 689.645(4). The reporting of the prescription and administration of vaccines to a patient’s primary health care provider and to the Oregon Health Authority can be accomplished by reporting to the ALERT Immunization Information System (ALERT-IIS) per ORS 433.090, ORS 433.092, ORS 433.094, ORS 433.095, ORS 433.096, ORS 433.098, ORS 433.100, ORS 433.102, ORS 433.103, and ORS 433.104.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.645 & ORS 689.649
BP 6-2025, amend filed 08/08/2025, effective 08/08/2025
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0335 Services: Prescribing - Prohibited Practices

(1) A Pharmacist must not prescribe a drug or device via Formulary or Protocol:

(a) To self; or

(b) When the Formulary or Protocol requires referral to a non-Pharmacist provider.

(2) A Pharmacist must not require, but may allow, a patient to schedule an appointment with the Pharmacist for the prescribing or administering of an injectable hormonal contraceptive or the prescribing or dispensing of a self-administered hormonal contraceptive.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.645 & ORS 689.649
BP 6-2025, amend filed 08/08/2025, effective 08/08/2025
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0340 Services: Prescribing - Formulary

A Pharmacist may prescribe, according to OAR 855-115-0330 and OAR 855-115-0335, an FDA-approved drug and device listed in the Formulary, pursuant to a diagnosis by a health care practitioner who has prescriptive authority and who is qualified to make the diagnosis. Formulary devices and supplies:

(1) Diabetic blood sugar testing supplies;

(2) Injection supplies;

(3) Nebulizers and associated supplies;

(4) Inhalation spacers;

(5) Peak flow meters;

(6) International Normalized Ratio (INR) testing supplies;

(7) Enteral nutrition supplies;

(8) Ostomy products and supplies; and

(9) Non-invasive blood pressure monitors; and

(10) Continuous glucose monitors and associated supplies; and

(11) Epinephrine.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.645 & ORS 689.649
BP 2-2026, amend filed 01/23/2026, effective 01/23/2026
BP 11-2025, minor correction filed 09/05/2025, effective 09/05/2025
BP 6-2025, amend filed 08/08/2025, effective 08/08/2025
BP 54-2024, amend filed 06/18/2024, effective 06/20/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0345 Temporary rule language in effect until 02/09/2027. Services: Prescribing Pursuant to - Protocol

A Pharmacist may prescribe, according to OAR 855-115-0330 and OAR 855-115-0335, FDA-approved drugs and devices pursuant to a Protocol. Protocols in their entirety are adopted by the board by this rule pursuant to the respective effective date referenced and can be found on the board website at https://www.oregon.gov/pharmacy/Pages/PFAC.aspx. Pharmacists can prescribe pursuant to the protocols listed below.

(1) Continuation of Therapy Protocol including emergency refills of insulin (v. 02/2026).

(2) Conditions Protocols:

(a) Cough and cold symptom management:

(A) Benzonatate (v. 06/2021);

(B) Short-acting beta agonists (v. 06/2021);

(b) COVID-19 Antigen Self-Test (v. 12/2021);

(3) Preventative Care Protocols:

(a) Emergency Contraception (v. 06/2021);

(b) Male and female condoms (v. 06/2021);

(d) Travel Medications (v. 06/2024);

(e) HIV Post-exposure Prophylaxis (PEP) (v. 01/2026);

(f) HIV Pre-exposure Prophylaxis (PrEP) (v. 01/2026);

(g) Contraception (v. 06/2025);

(h) Sexually Transmitted Infections Post-exposure Prophylaxis (STI PEP) (v. 06/2024);

(i) Short-acting Opioid Antagonists (v. 06/2024);

(j) Medications for Opioid Use Disorder - Initiation of Care (v. 02/2026); and

(k) Medications for Opioid Use Disorder - Continuation/Modification of Care (v. 02/2026).

(4) Vaccine Protocols:

(a) Vaccination Protocol for Adults 18 Years of Age and Older (v. 01/2026);

(b) Vaccination Protocol for Ages 7 through 17 Years (v. 01/2026); and

(5) Board Excluded Vaccine Protocols:

(a) Coronavirus 19 (v. 01/2026);

(b) Influenza (v. 08/2026); and

[Publications: Publications referenced are available from the agency.]

History

Statutory/Other Authority: ORS 689.205, ORS 689.005 & ORS 689.698
Statutes/Other Implemented: ORS 689.645, ORS 689.649, ORS 689.689, ORS 689.005 & ORS 689.698
BP 17-2026, temporary amend filed 08/14/2026, effective 08/14/2026 through 02/09/2027
BP 7-2026, amend filed 06/17/2026, effective 06/17/2026
BP 4-2026, temporary amend filed 02/25/2026, effective 02/25/2026 through 08/23/2026
BP 2-2026, amend filed 01/23/2026, effective 01/23/2026
BP 13-2025, temporary amend filed 09/17/2025, effective 09/17/2025 through 02/08/2026
BP 12-2025, temporary suspends temporary BP 10-2025, filed 09/17/2025, effective 09/17/2025 through 02/08/2026
BP 10-2025, temporary amend filed 08/29/2025, effective 08/29/2025 through 02/08/2026
BP 9-2025, temporary suspends temporary BP 8-2025, filed 08/29/2025, effective 08/29/2025 through 02/08/2026
BP 8-2025, temporary amend filed 08/13/2025, effective 08/13/2025 through 02/08/2026
BP 6-2025, amend filed 08/08/2025, effective 08/08/2025
BP 2-2025, amend filed 06/12/2025, effective 06/13/2025
BP 66-2024, temporary amend filed 12/17/2024, effective 12/17/2024 through 06/14/2025
BP 64-2024, amend filed 12/17/2024, effective 12/17/2024
BP 61-2024, temporary amend filed 08/09/2024, effective 08/09/2024 through 02/04/2025
BP 59-2024, amend filed 08/09/2024, effective 08/09/2024
BP 54-2024, amend filed 06/18/2024, effective 06/20/2024
BP 25-2024, temporary amend filed 03/04/2024, effective 03/04/2024 through 08/30/2024
BP 14-2024, temporary amend filed 03/01/2024, effective 03/01/2024 through 08/27/2024
BP 16-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-115-0350 Services: Prescribing Practices - Short-acting Opioid Antagonists

(1) A Pharmacist may prescribe any FDA approved short-acting opioid antagonist (e.g., naloxone, nalmefene) and the necessary medical supplies to administer a short-acting opioid antagonist for opiate overdose:

(a) When dispensing any opiate or opioid prescription in excess of 50 morphine milligram equivalents (MME);

(b) To an individual seeking a short-acting opioid antagonist;

(2) A Pharmacist is not required to label the prescription according to OAR 855-041-1130 if dispensing a FDA approved short-acting opioid antagonist in the form of a nasal spray.

(3) The Pharmacist must document the encounter, the prescription and maintain records according to OAR 855-104-0055.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305, ORS 689.681, ORS 689.682 & ORS 689.684
BP 55-2024, amend filed 06/18/2024, effective 06/20/2024
BP 26-2023, adopt filed 10/16/2023, effective 03/01/2024

Division 120 INTERNS AND PRECEPTORS

Or. Admin. R. 855-120-0001 Applicability

This Division applies to any individual who is:

(1) Enrolled in or has completed a Bachelor or Doctor of Pharmacy at a College of Pharmacy or School of Pharmacy (COP or SOP) or is certified by the Foreign Pharmacy Graduate Examination Committee (FPGEC), and who acts as Intern; or

(2) Licensed by the board as a Preceptor to supervise an Intern.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.225
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0005 Definitions

(1) “ACPE accredited” means a college or school of pharmacy that is accredited, accredited with probation, pre-candidate or candidate status by Accreditation Council for Pharmacy Education (v. 02/27/2026) including the Lebanese American University school in Byblos, Lebanon after 2002.

(2) “College of Pharmacy or School of Pharmacy (COP or SOP)” means an ACPE accredited college or school of pharmacy.

(3) “Healthcare Preceptor” means a pharmacist, or person with an active healthcare license in good standing that can independently practice pharmacy within the scope of their licensure and is licensed by the board to supervise the internship training of a licensed Intern.

(4) “Intern” means a person who is enrolled in or has completed a course of study at a board approved college or school of pharmacy and who is licensed with the board as an Intern.

(5) “Internship Program” means a professional experiential program that is approved by the board.

(6) “Internship Program Supervisor” is a Pharmacist licensed with the board as a Preceptor who supervises the Internship Program for a COP or SOP located in Oregon.

(7) “Other Preceptor” means a person who is not licensed as a pharmacist or other healthcare provider in Oregon and is licensed by the board to supervise the internship training of a licensed Intern.

(8) “Preceptor” means a Pharmacist or a person licensed by the board to supervise the internship training of a licensed Intern.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 15-2024, minor correction filed 03/01/2024, effective 03/01/2024
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0010 Licensure: Qualifications - Intern

(1) To qualify for licensure as an Intern, an applicant must provide proof that they:

(a) Are enrolled in a Doctor of Pharmacy program at a COP or SOP; or

(b) Have graduated with a Bachelor or Doctor of Pharmacy degree from a COP or SOP for the purpose of obtaining the qualifications to apply for a Pharmacist license; or

(c) Have graduated with a Bachelor, Master or Doctor of Pharmacy degree from a foreign college or school of pharmacy and are:

(A) Pursuing an Intern license for the purpose of obtaining the qualifications to apply for a Pharmacist license; and

(B) Certified by the Foreign Pharmacy Graduate Examination Committee (FPGEC). Graduates between 1993 and June 30, 2004 of a Canadian Council for Accreditation of Pharmacy Programs (CCAPP) accredited pharmacy program located in Canada or its jurisdiction with a curriculum taught in English do not have to submit certification from the FPGEC but must meet all other requirements under this rule for an FPGEC certified intern.

(2) If residing in the United States, an applicant must provide proof of citizenship, legal permanent residency or qualifying visa as required by 8 USC 1621.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.255
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0030 Licensure: Application - Intern

(1) An application for licensure as an Intern may be accessed on the board website.

(2) The board may issue a license to a qualified applicant after the receipt of:

(a) Documentation required in OAR 855-120-0030 and for FPGEC certified documentation required in OAR 855-115-0015; and

(b) A completed application including:

(A) Payment of the fee prescribed in OAR 855-110;

(B) A current, passport regulation size photograph (full front, head to shoulders);

(D) A completed national fingerprint-based background check; and

(E) A completed moral turpitude statement or a written description and documentation regarding all conduct that is required to be disclosed.

(3) Penalties may be imposed for:

(a) Failure to completely and accurately answer each question on the application for licensure or renewal of licensure;

(b) Failure to disclose any requested information on the application;

(d) Any other grounds found in ORS 689.405.

(5) The license of an Intern expires November 30 and may be renewed as follows:

(a) Biennially prior to graduation from a COP or SOP.

(b) Once after graduation from a COP or SOP.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 20-2024, minor correction filed 03/03/2024, effective 03/03/2024
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0035 Licensure: Renewal or Reinstatement - Intern

(1) When applying for renewal of an Intern license, an applicant must:

(a) Pay the biennial license fee required in OAR 855-110;

(b) Complete the continuing pharmacy education requirements as directed in OAR 855-135;

(d) Provide a written description and documentation regarding all conduct that is required to be disclosed.

(2) An Intern who fails to renew their license by the expiration date and whose license has been lapsed for one year or less may apply to renew their license.

(3) An Intern or who fails to renew their license by the expiration date and whose license has been lapsed for greater than one year may apply to reinstate per OAR 855-120-0030; and

(4) A person whose Intern license has been suspended, revoked or restricted has the right, at reasonable intervals, to petition to the board in writing for reinstatement of such license pursuant to ORS 689.445 may apply to reinstate per OAR 855-120-0030.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.275 & ORS 689.445
BP 21-2024, minor correction filed 03/03/2024, effective 03/03/2024
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0040 Licensure: Lapse - Intern

(1) An Intern may let their license lapse by failing to renew or request that the board accept the lapse of their license prior to the expiration date:

(a) Lapse of a license is not discipline.

(b) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

(d) A person may apply for renewal according to OAR 855-120-0035.

(2) If a person requests lapse prior to the expiration date of the license, the following applies:

(a) The license remains in effect until the board accepts the lapse.

(b) If the board accepts the lapse, the board will notify the licensee of the date the license terminates.

(d) The licensee must return the license to the board within 10 days of the board accepting the lapse.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0050 Licensure: Voluntary Surrender - Intern

An Intern may request that the board accept the voluntary surrender of their license.

(1) A voluntary surrender of a license is discipline.

(2) The license remains in effect until the board accepts the surrender.

(3) If the board accepts a request for voluntary surrender, the board will issue a final order terminating the license, signed by the licensee and a board representative. The termination date is the date is signed by all parties and served on the licensee.

(4) The licensee must cease practicing as an Intern from the date the license terminates.

(5) A voluntarily surrendered license may not be renewed. A former licensee who wants to obtain a license must apply for a license per OAR 855-120-0030 unless the final order prohibits the licensee from doing so.

(6) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0105 Responsibilities: General - Intern

(1) Each Intern is responsible for their own actions; however, this does not absolve the supervising Pharmacist or Preceptor and the pharmacy from responsibility for the Intern’s actions.

(2) An Intern is responsible for recognizing the limits of their knowledge and experience and for resolving situations beyond their expertise by consulting with the supervising Pharmacist or Preceptor.

(3) An Intern must:

(a) Comply with all state and federal laws and rules governing the practice of pharmacy;

(b) Only engage in the practice of pharmacy under the supervision of a Pharmacist or Healthcare Preceptor:

(A) After successful completion of academic coursework corresponding to those tasks; and

(B) When permitted by the supervising Pharmacist or Healthcare Preceptor;

(c) Only work within the scope of duties permitted by their license and by the supervising Pharmacist or Healthcare Preceptor;

(d) Know the identity of the supervising Pharmacist or Preceptor at all times;

(e) Only perform tasks they are trained and competent to perform;

(f) Appropriately perform the tasks permitted;

(g) Only access the pharmacy area when a Pharmacist is physically present;

(h) Be clearly identified as an Intern in all interactions and communications (e.g., nametag, phone interaction, chart notations);

(i) Display in plain sight the Intern license within the pharmacy or place of business to which it applies;

(j) Review and adhere to written policies and procedures. The review must:

(A) Occur prior to engaging in the practice of pharmacy as an Intern;

(B) Occur with each update to the policies and procedures; and

(k) Dispense and deliver prescriptions accurately and to the correct party; and

(l) For hours earned in an Internship Program, must verify that their Preceptor is currently licensed with the board as a Preceptor.

(4) An Intern may not work more than 50 hours per week in an Internship Program and must comply with all supervision and ratio requirements.

(5) An Intern may perform the duties of a pharmacy technician under the supervision of a Pharmacist so long as they adhere to the rules in OAR 855-125. When solely performing technician duties under the supervision of a Pharmacist the ratios in OAR 855-120-1122 do not apply.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0110 Responsibilities: Confidentiality - Intern

Each Intern must comply with OAR 855-104-0015 regarding confidentiality.

History

Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0115 Responsibilities: Duty to Report - Intern

Each Intern must report to the board as required by OAR 855-104-0010. In addition, unless state or federal laws relating to confidentiality or the protection of health information prohibit disclosure, each Intern must report to the board without undue delay, but within 10 working days if they:

(1) Have been removed from an Internship Program site for reasons including but not limited to patient safety, unprofessional conduct or suspected violation of ORS 475, ORS 689 or OAR 855; or

(2) Have been dismissed from the Doctor of Pharmacy degree program.

(3) For (1) and (2) the Intern must report the date and reason for the removal or dismissal.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.150, ORS 689.151, ORS 689.155 & ORS 689.455
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0135 Responsibilities: Permitted Practices - Intern

Interns must only practice pharmacy as authorized by the rules of the board and as permitted by the supervising Pharmacist or Healthcare Preceptor with the practice of pharmacy in their scope. When practicing pharmacy, an Intern must adhere to all the applicable rules in OAR 855-115 for Pharmacists.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0150 Prohibited Practices - Intern

(1) An Intern must not:

(a) Practice pharmacy as defined in ORS 689.005 except as permitted by the Pharmacist or Healthcare Preceptor who is supervising the Intern;

(b) Engage in any form of discrimination, harassment, intimidation, or assault in the workplace;

(c) Communicate (e.g., counseling, patient care services, billing) with a patient who prefers to communicate in a language other than English or who communicates in signed language, unless the Intern is a health care interpreter registered by the Oregon Health Authority under ORS 413.558 or the supervising Pharmacist or Preceptor is also fluent in the language being interpreted; or

(d) Engage in patient care services when the supervising Pharmacist is not trained and qualified to perform the service.

(2) Until an Intern has successfully completed their first academic year, an Intern may observe, but must not:

(a) Conduct a Drug Utilization Review or Drug Regimen Review;

(b) Counsel a patient or the patient’s agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in the patient’s record or chart;

(d) Conduct Medication Therapy Management;

(e) Practice pursuant to a Clinical Pharmacy Agreement or engage in Collaborative Drug Therapy Management;

(f) Practice pursuant to Statewide Drug Therapy Management Protocols;

(g) Prescribe a vaccine, drug or device; or

(h) Perform verification as defined in OAR 855-006-0005.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 56-2024, amend filed 06/18/2024, effective 06/20/2024
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0155 Grounds for Discipline - Intern

The following are grounds for discipline:

(1) Continuing to practice as an Intern when one of the following has occurred:

(a) Dismissal from the Doctor of Pharmacy degree program enrolled in to obtain the Intern license; or

(b) Failure to maintain an active Intern license; or

(2) Any other grounds found in ORS 689.405.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.405
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0190 Internship Programs

(1) Interns must complete 1440 hours of internship in an Internship Program to qualify for licensure as a Pharmacist in OAR 855-115-0010 and 855-115-0015.

(2) For obtaining internship hours necessary to apply for a Pharmacist license, the board approves programs:

(a) Administered by an COP or SOP;

(b) Administered for a foreign graduate with FPGEC certification by a Pharmacist registered with the board as a Preceptor;

(3) The Internship Program for:

(a) Students enrolled in a COP or SOP located in Oregon must be supervised by an Internship Program Supervisor; or

(b) Foreign graduates with FPGEC certification located in Oregon must be supervised by a licensed Preceptor.

(4) Foreign graduates with FPGEC certification located in Oregon must document the hours obtained on a board approved form.

(5) All Internship Programs must include, but are not limited to:

(a) Direct patient care;

(b) Interprofessional interaction and practice;

(d) Professional development.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-0195 Out-of-State Internship Experience

(1) In order for an Intern to obtain credit for experience obtained outside of Oregon as part of an COP or SOP with an Internship Program based in Oregon, an Intern must be licensed as required by state laws and rules in the state in which they practice.

(2) In order for an out-of-state intern to engage in the practice of pharmacy in the State of Oregon, the intern must:

(a) Be licensed as an Intern by the State of Oregon; and

(b) Comply with ORS 475, ORS 689 and OAR 855.

History

Statutory/Other Authority: ORS 689.151, ORS 689.205 & ORS 689.255
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1010 Licensure: Qualifications - Preceptor

To qualify for licensure as a Preceptor, an applicant who is:

(1) A pharmacist must have been actively practicing as a pharmacist in any state for at least one year immediately prior to applying for a Preceptor license unless the pharmacist has been licensed for at least 6 months and is actively participating in an ASHP-accredited, pre-candidate, candidate or conditional accredited PGY1 residency program. The pharmacist license must be in good standing.

(2) A licensed healthcare professional must possess a license in good standing.

(3) Not a licensed healthcare professional must possess a Master or Doctorate degree in the academic discipline for which they are precepting.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.255
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1030 Licensure: Application - Preceptor

(1) An application for licensure as a Preceptor may be accessed on the board website.

(2) The board may issue a license to a qualified applicant after the receipt of:

(a) Attestation to the requirements in OAR 855-120-1010;

(b) A completed application; and

(3) Penalties may be imposed for:

(a) Failure to completely and accurately answer each question on the application for licensure or renewal of licensure;

(b) Failure to disclose any requested information on the application;

(d) Any other grounds found in ORS 689.405.

(5) The license of a Preceptor expires June 30 in odd numbered years and may be renewed biennially.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1035 Licensure: Renewal or Reinstatement - Preceptor

(1) A Preceptor who holds a Pharmacist license will be automatically renewed with each Pharmacist license renewal unless the Pharmacist requests to lapse their Preceptor license per OAR 855-120-1040.

(2) Each Healthcare Preceptor or Other Preceptor must complete a new Preceptor application for license renewal per OAR 855-120-1010.

(3) A Preceptor who fails to renew their license by the expiration date and whose license has been lapsed for one year or less may apply to renew their license.

(4) A Preceptor or who fails to renew their license by the expiration date and whose license has been lapsed for greater than one year may apply to reinstate per OAR 855-120-1010; and

(5) A person whose Preceptor license has been suspended, revoked or restricted has the right, at reasonable intervals, to petition to the board in writing for reinstatement of such license pursuant to ORS 689.445 and may apply to reinstate per OAR 855-120-1010.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.275 & ORS 689.445
BP 2-2024, adopt filed 02/15/2024, effective 03/01/2024

Or. Admin. R. 855-120-1040 Licensure: Lapse - Preceptor

(1) A Preceptor may let their license lapse by failing to renew or request that the board accept the lapse of their license prior to the expiration date.

(a) Lapse of a license is not discipline.

(b) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

(d) A person may apply to reinstate a Preceptor license according to OAR 855-120-1035.

(2) If a person requests to lapse the license, the following applies:

(a) The license remains in effect until the board accepts the lapse.

(b) If the board accepts the lapse, the board will notify the licensee of the date the license terminates.

(d) The licensee must return the license to the board within 10 days of the board accepting the lapse.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1050 Licensure: Voluntary Surrender - Preceptor

A Preceptor may request that the board accept the voluntary surrender of their license.

(1) A voluntary surrender of a license is discipline.

(2) The license remains in effect until the board accepts the surrender.

(4) The licensee must cease acting as a Preceptor from the date the license terminates.

(5) A voluntarily surrendered license may not be renewed. A former licensee who wants to obtain a license must apply for reinstatement per OAR 855-120-1035 unless the final order prohibits the licensee from doing so.

(6) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1070 Responsibilities: General - Preceptor

(1) Each Preceptor is responsible for their own actions.

(2) Each Preceptor is responsible for supervising the actions of each Intern.

(3) A Preceptor must:

(a) Display in plain sight the Preceptor license within the pharmacy or place of business to which it applies;

(b) Provide the Intern with experiences which, in the Preceptor's judgment, will increase the Intern's competency in the practice of pharmacy or as a member of the healthcare team; and

History

Statutory/Other Authority: ORS 689.151 & ORS 689.205
Statutes/Other Implemented: ORS 689.255
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1110 Responsibilities: Confidentiality - Preceptor

Preceptors must follow all applicable confidentiality laws.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1115 Responsibilities: Duty to Report - Preceptor

Within 10 working days, unless state or federal laws relating to confidentiality or the protection of health information prohibit disclosure, each:

(1) Preceptor at an Internship Program site must report if they have dismissed an Intern from an Internship Program site for reasons including but not limited to patient safety, unprofessional conduct or suspected violation of ORS 475, ORS 689 or OAR 855.

(2) Internship Program Supervisor must report the following on behalf of a COP or SOP if it:

(a) Has removed a Preceptor or Internship Program site from the Internship Program for reasons including but not limited to patient safety, unprofessional conduct or suspected violation of ORS 475, ORS 689 or OAR 855; or

(b) Has dismissed an Intern from a Doctor of Pharmacy degree program.

(3) For (1) and (2) the Preceptor and Internship Program Supervisor must report the date and reason for the removal.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 676.150, ORS 689.151, ORS 689.155 & ORS 689.455
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1122 Responsibilities: Supervision - Preceptor

(1) For direct patient care activities, a Pharmacist or Preceptor may supervise no more than four Interns.

(2) For non-direct patient care activities, a Pharmacist or Preceptor may supervise as many Interns as they believe in their reasonable professional judgment is appropriate to promote and protect patient health, safety and welfare.

(3) The majority of an Intern’s overall experience in an Internship Program must be under the supervision of a licensed Pharmacist Preceptor.

History

Statutory/Other Authority: ORS 689.151 & ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.255
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1150 Prohibited Practices - Preceptor

(1) A Preceptor must not engage in any form of discrimination, harassment, intimidation, or assault in the workplace.

(2) A Preceptor, who is not a Pharmacist, must not supervise an Intern in the practice of pharmacy as defined in ORS 689.005 unless the:

(a) Practice is within the scope of the Healthcare Preceptor’s professional license;

(b) Intern is practicing as a part of an Internship Program at a COP or SOP; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1155 Grounds for Discipline - Preceptor

The board may suspend, revoke, or restrict the license of a Preceptor or may impose a civil penalty upon the Preceptor upon the following grounds:

(1) Continuing to supervise an Intern in an Internship Program when one of the following has occurred:

(a) School has removed the Preceptor or Internship Program site from the Internship Program for reasons including but not limited to patient safety, unprofessional conduct or suspected violation of ORS 475, ORS 689 or OAR 855.

(b) Licensee is not permitted to supervise an Intern per Board order.

(2) Any other grounds found in ORS 689.405.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.405
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-120-1205 Qualifications and Responsibilities: Internship Program Supervisor

(1) The Internship Program Supervisor for a COP or SOP located in Oregon must:

(a) Be licensed as a Pharmacist

(b) Be licensed as a Preceptor;

(c) Maintain a record of each internship completed as part of the Internship Program. This record must be made available to the board upon request;

(d) Submit a report on the Internship Program to the board at the end of each academic year. This report must include the names of students who have:

(A) Successfully completed the degree program including:

(i) Date of graduation; and

(ii) Hours earned in Internship Program; and

(B) Extended their course of study; and

(e) Maintain a list of preceptors and Internship Program sites, in and out-of-state, approved by the school and must make this list available to the board upon request.

(2) The Pharmacist who supervises the Internship Program for a FPGEC certified Intern located in Oregon must:

(a) Be licensed as a Pharmacist;

(b) Be licensed as a Preceptor; and

(c) Certify hours completed for internship credit in the Internship Program on a board-approved form. This record must be made available to the board upon request.

(3) The Internship Program Supervisor in (1) and the supervising Preceptor in (2) must ensure the Internship Program includes the following components:

(a) Direct patient care;

(b) Interprofessional interaction and practice;

(d) Professional development.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 17-2023, adopt filed 08/16/2023, effective 03/01/2024

Division 125 CERTIFIED OREGON PHARMACY TECHNICIANS AND PHARMACY TECHNICIANS

Or. Admin. R. 855-125-0001 Applicability

(1) This Division applies to any individual who assists a Pharmacist in the practice of pharmacy.

(2) Only persons licensed with the board as a Certified Oregon Pharmacy Technician or Pharmacy Technician may assist a Pharmacist in the practice of pharmacy and must act in compliance with statutes and rules under the supervision, direction, and control of a Pharmacist.

(3) Only persons licensed with the board as a Certified Oregon Pharmacy Technician or Pharmacy Technician may perform final verification when delegated to do so by a Pharmacist and done in compliance with all applicable statutes and rules and under the supervision, direction, and control of that Pharmacist.

(4) Only a person licensed as a Certified Oregon Pharmacy Technician may use the titles “Certified Oregon Pharmacy Technician” and “COPT.”

History

Statutory/Other Authority: ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.225 & ORS 689.486
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0005 Definitions

Placeholder

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0010 Licensure: Qualifications – Certified Oregon Pharmacy Technician or Pharmacy Technician

(1) To qualify for licensure as a Certified Oregon Pharmacy Technician or Pharmacy Technician, an applicant must demonstrate that the applicant is at least 18 years of age and has completed high school (or equivalent).

(2) To qualify for licensure as a Certified Oregon Pharmacy Technician, the applicant must also demonstrate that the applicant has taken and passed a national pharmacy technician certification examination offered by:

(a) Pharmacy Technician Certification Board (PTCB); or

(b) National Healthcareer Association (NHA).

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.225 & ORS 689.486
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0030 Licensure: Application - Certified Oregon Pharmacy Technician or Pharmacy Technician

(1) An application for licensure as a Certified Oregon Pharmacy Technician or Pharmacy Technician may be accessed on the board website.

(2) The board may issue a license to a qualified applicant after the receipt of a completed application including:

(a) Payment of the fee prescribed in OAR 855-110;

(b) A current, passport regulation size photograph (full front, head to shoulders);

(d) A completed national fingerprint-based background check; and

(e) A completed moral turpitude statement or a written description and documentation regarding all conduct that is required to be disclosed.

(3) An applicant for a Certified Oregon Pharmacy Technician license, must provide a passing result from PTCB or NHA on a national pharmacy technician certification examination.

(4) Penalties may be imposed for:

(a) Failure to completely and accurately answer each question on the application for licensure or renewal of licensure;

(b) Failure to disclose any requested information on the application or requests resulting from the application;

(d) Any other grounds found in ORS 689.405 or ORS 689.490.

(5) An application submitted to the board that is not complete within 90 days from applicant submission will be expired. Once expired, an applicant who wishes to continue with the application process must reapply by submitting a new application, along with all documentation, and all fees. While a new application and documentation is required, the board may still consider information that was provided in previous applications.

(6) The license of a Certified Oregon Pharmacy Technician or Pharmacy Technician expires June 30 in even numbered years and may be renewed biennially.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.225 & ORS 689.486
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0035 Licensure: Renewal or Reinstatement Applications - Certified Oregon Pharmacy Technician or Pharmacy Technician

(1) An applicant for renewal of a Certified Oregon Pharmacy Technician or Pharmacy Technician license must:

(a) Pay the biennial license fee required in OAR 855-110;

(b) Complete the continuing pharmacy education requirements as directed in OAR 855-135;

(d) Provide a written description and documentation regarding all conduct that is required to be disclosed.

(2) A Certified Oregon Pharmacy Technician or Pharmacy Technician who fails to renew their license by the expiration date and whose license has been lapsed for one year or less may apply to renew their license and must pay a late fee required in OAR 855-110.

(3) A Certified Oregon Pharmacy Technician or Pharmacy Technician or who fails to renew their license by the expiration date and whose license has been lapsed for greater than one year may apply to reinstate their license as follows:

(a) Must apply per OAR 855-125-0030; and

(b) Provide certification of completion of 10 continuing education hours earned in the prior 12 months. These hours may not be counted toward a future renewal; and must include:

(A) One hour of continuing pharmacy education in pharmacy law;

(B) One hour of continuing pharmacy education in patient safety or error prevention;

(C) One hour of continuing pharmacy education in cultural competency either approved by the Oregon Health Authority under ORS 413.450 or any cultural competency CPE; and

(D) Seven other hours of pharmacy technician-specific continuing education.

(4) Penalties may be imposed for:

(a) Failure to completely and accurately answer each question on the application for licensure or renewal of licensure;

(b) Failure to disclose any requested information on the application;

(d) Any other grounds found in ORS 689.405 or ORS 689.490.

(5) Continued national certification is not required to renew a license as a Certified Oregon Pharmacy Technician.

(6) Any person whose Certified Oregon Pharmacy Technician or Pharmacy Technician license has been suspended, revoked or restricted has the right, at reasonable intervals, to petition the board for reinstatement of such license pursuant to ORS 689.445 and in conjunction with the application process identified in OAR 855-125-0030.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 413.450, ORS 689.225, ORS 689.445 & ORS 689.486
BP 49-2024, minor correction filed 04/11/2024, effective 04/11/2024
BP 22-2024, minor correction filed 03/03/2024, effective 03/03/2024
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0040 Licensure: Lapse

(1) A Certified Oregon Pharmacy Technician or Pharmacy Technician may let their license lapse by failing to renew or request that the board accept the lapse of their license prior to the expiration date.

(a) Lapse of a license is not discipline.

(b) The board has jurisdiction to proceed with any investigation or any action or disciplinary proceeding against the licensee.

(d) A person may apply for renewal or reinstatement according to OAR 855-125-0035.

(2) If a person requests lapse prior to the expiration date of the license, the following applies:

(a) The license remains in effect until the board accepts the lapse.

(b) If the board accepts the lapse, the board will notify the licensee of the date the license terminates.

(d) The licensee must return the license to the board within 10 days of the board accepting the lapse.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 23-2024, minor correction filed 03/03/2024, effective 03/03/2024
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0050 Licensure: Voluntary Surrender

A Certified Oregon Pharmacy Technician or Pharmacy Technician may request that the board accept the voluntary surrender of their license.

(1) A voluntary surrender of a license is discipline.

(2) The license remains in effect until the board accepts the surrender.

(3) If the board accepts a request for voluntary surrender, the board will issue a final order terminating the license, signed by the licensee and a board representative. The termination date is the date is the order is signed by all parties and served on the licensee.

(4) The licensee must cease assisting in the practice of pharmacy from the date the license terminates.

(5) A voluntarily surrendered license may not be renewed. A former licensee who wants to obtain a license must apply for reinstatement per OAR 855-125-0035 unless the final order prohibits the licensee from doing so.

(6) The board has jurisdiction to proceed with any investigation, action or disciplinary proceeding against the licensee.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.153
BP 24-2024, minor correction filed 03/03/2024, effective 03/03/2024
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0105 Responsibilities: General - Certified Oregon Pharmacy Technician and Pharmacy Technician

(1) Each Certified Oregon Pharmacy Technician and Pharmacy Technician is responsible for their own actions; however, this does not absolve the Pharmacist and the pharmacy from responsibility for the Certified Oregon Pharmacy Technician or Pharmacy Technician’s actions.

(2) A Certified Oregon Pharmacy Technician or Pharmacy Technician may not engage in the practice of pharmacy as defined in ORS 689.005.

(3) A Certified Oregon Pharmacy Technician and Pharmacy Technician must:

(a) Comply with all state and federal laws and rules governing the practice of pharmacy;

(b) Only assist in the practice of pharmacy under the supervision, direction, and control of a Pharmacist;

(d) Only work within the scope of duties permitted by their license;

(e) Only work within the scope of duties permitted by the Pharmacist providing supervision, direction and control;

(f) Only perform duties they are trained to perform;

(g) Appropriately perform the duties permitted;

(h) Only access the pharmacy area when a Pharmacist is physically present at the Drug Outlet Pharmacy or when the Drug Outlet Pharmacy is operating under a Remote Dispensing Site Pharmacy (RDSP) registration and following the requirements in OAR 855-139;

(i) Be clearly identified as a Certified Oregon Pharmacy Technician or Pharmacy Technician in all interactions and communications (e.g., nametag, phone interaction, chart notations);

(j) Display in plain sight the Certified Oregon Pharmacy Technician or Pharmacy Technician license within the pharmacy or place of business to which it applies;

(k) Ensure initial and ongoing training is completed that is commensurate with the tasks that the Certified Oregon Pharmacy Technician or Pharmacy Technician will perform, prior to the performance of those tasks and with each update to the written policies and procedures;

(l) Review and adhere to written policies and procedures. The review must:

(A) Occur prior to assisting in the practice of pharmacy;

(B) Occur with each update; and

(m) Dispense and deliver prescriptions accurately and to the correct party.

(4) A Certified Oregon Pharmacy Technician or Pharmacy Technician may perform final verification of the drug and dosage, device or product when:

(a) The Pharmacist utilizes reasonable professional judgment to determine that a Certified Oregon Pharmacy Technician or Pharmacy Technician may perform final verification;

(b) No discretion is needed;

(c) The Pharmacist delegating final verification is supervising the Certified Oregon Pharmacy Technician or Pharmacy Technician; and

(d) The Certified Oregon Pharmacy Technician or Pharmacy Technician is performing a physical final verification.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0110 Responsibilities: Confidentiality

Each Certified Oregon Pharmacy Technician and Pharmacy Technician must comply with OAR 855-104-0015 regarding confidentiality.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0115 Responsibilities: Duty to Report

Each Certified Oregon Pharmacy Technician and Pharmacy Technician must comply with OAR 855-104-0010 regarding duty to report.

History

Statutory/Other Authority: ORS 689.455
Statutes/Other Implemented: ORS 689.455
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0135 Responsibilities: Permitted Practices

Certified Oregon Pharmacy Technicians or Pharmacy Technicians:

(1) Must only assist in the practice of pharmacy as authorized by the rules of the board and as permitted by the Pharmacist providing supervision, direction, and control.

(2) Must ensure that work is verified by a Pharmacist if judgment is utilized when assisting in the practice of pharmacy.

(3) May perform final verification as permitted under OAR 855-125-0105(4).

History

Statutory/Other Authority: ORS 689.005 & ORS 689.225
Statutes/Other Implemented: ORS 689.151 & 2022 HB 4034
BP 18-2023, adopt filed 08/16/2023, effective 03/01/2024

Or. Admin. R. 855-125-0150 Prohibited Practices

Each Certified Oregon Pharmacy Technician and Pharmacy Technician must not:

(1) Engage in the practice of pharmacy as defined in ORS 689, except as permitted in OAR 855-125-0105(4), including but not limited to the following tasks:

(a) Evaluate and interpret a prescription;

(b) Conduct a Drug Utilization Review or Drug Regimen Review;

(c) Consult with any prescriber, other healthcare professional or authorized agent regarding a patient and any medical information pertaining to the patient’s prescription that requires judgment;

(d) Counsel a patient or the patient’s agent regarding a prescription;

(e) Advise on therapeutic values, content, hazards and use of drugs and devices;

(f) Interpret the clinical data in a patient record system or patient chart;

(g) Conduct Medication Therapy Management;

(h) Practice pursuant to a Clinical Pharmacy Agreement or Collaborative Drug Therapy Management;

(i) Practice pursuant to Statewide Drug Therapy Management Protocols;

(j) Prescribe a vaccine, drug or device;

(k) Administer a drug or device;

(l) Order, interpret or monitor a laboratory test;

(m) Delegate tasks to healthcare providers; and

(n) Deny the patient or the patient’s agent request to speak to the Pharmacist.

(2) Assist in the practice of pharmacy unless permitted by the Pharmacist who is supervising, directing, and controlling the Certified Oregon Pharmacy Technician or Pharmacy Technician.

(3) Perform any task while assisting in the practice of pharmacy that requires judgment unless it is verified by a Pharmacist.

(4) Engage in any form of discrimination, harassment, intimidation, or assault in the workplace.

(5) Refuse a request from a patient, patient’s agent, or practitioner to interact with a Pharmacist.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.155
BP 32-2023, adopt filed 12/19/2023, effective 03/01/2024

Or. Admin. R. 855-125-0305 Temporary rule language in effect until 12/13/2026. Services: Vaccine Administration

(1) A Certified Oregon Pharmacy Technician or Pharmacy Technician may perform the physical act of administering vaccines under the supervision of an appropriately trained and qualified Pharmacist:

(a) To a person who is seven years of age or older;

(b) To a person who is at least three years of age when; and

(A) The Governor declares a state of public health emergency and authorizes the reduced age limitation; or

(B) The Public Health Director, during a declared disease outbreak, authorizes a reduction in the age limit.

(2) A Certified Oregon Pharmacy Technician or Pharmacy Technician must:

(a) Prior to administration of a vaccine, receive practical training that includes infection control, recognition of anatomical landmarks and competency in hands-on administration technique.

(b) Prior to administration of a vaccine, hold active CPR certification issued by the American Heart Association or the American Red Cross or any other equivalent program that is specific to the age and population receiving the vaccine, contains a hands-on training component, and is valid for not more than three years.

(3) Document the vaccine administration including but not limited to the vaccine administered, dose, expiration date, lot number, and injection site.

(4) Notify the supervising Pharmacist immediately in the event of a suspected adverse reaction to a vaccine.

(5) The training required in (2) may include programs approved by the ACPE, curriculum-based programs from an ACPE-accredited college or school of pharmacy or state or local health department programs, training by an appropriately qualified practitioner, or programs approved by the board.

(6) The records and forms required by this section must be filed in the pharmacy, made available to the board for inspection upon request, and must be retained for three years.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.645
Statutes/Other Implemented: ORS 689.151 & ORS 689.645
BP 10-2026, temporary amend filed 06/17/2026, effective 06/17/2026 through 12/13/2026
BP 30-2023, adopt filed 12/19/2023, effective 03/01/2024

Division 135 CONTINUING PHARMACY EDUCATION

Or. Admin. R. 855-135-0001 Continuing Pharmacy Education: Definitions

(1) "Accredited program" means a structured continuing pharmacy education (CPE) program which has been reviewed and approved by a provider of:

(a) Continuing pharmacy education that is accredited by the Accreditation Council on Pharmaceutical Education (ACPE) (v. 02/27/2026);

(b) Continuing medical education (CME) accredited by the Accreditation Council for Continuing Medical Education (ACCME) or an ACCME-recognized State Medical Society (v. 02/27/2026) as an American Medical Association (AMA) Category 1 CME program; or

(c) Continuing veterinary medical education (CVME) approved by the American Association of Veterinary State Boards Registry of Approved Continuing Education (AAVSB-RACE) as a medical program.

(2) "Board-approved program" means a structured continuing pharmacy education program which has been reviewed and approved by the board.

(3) “Certificate of completion” means a certificate or other official document issued to a participant certifying the successful completion of a continuing pharmacy education program.

(4) “Continuing Pharmacy Education” or “CPE” means an accredited or board-approved program designed to support the continuing development of Pharmacists, Interns, Certified Oregon Pharmacy Technicians or Pharmacy Technicians to maintain and enhance their competence applicable to the practice of pharmacy or the assistance of the practice of pharmacy.

(5) “Contact hour” means sixty minutes of continuing pharmacy education.

(6) “CPE Monitor” means the electronic tracking service of the ACPE and the National Association of Boards of Pharmacy (NABP) for monitoring continuing pharmacy education that Pharmacists, Interns, Certified Oregon Pharmacy Technicians and Pharmacy Technicians receive from participating providers;

(7) “Cultural competence” means the lifelong process of examining the values and beliefs and developing and applying an inclusive approach to health care practice in a manner that recognizes the content and complexities of provider-patient communication and interaction and preserves the dignity of individuals, families, and communities.

(a) Cultural competence applies to all patients.

(b) Culturally competent providers do not make assumptions on the basis of an individual’s actual or perceived abilities, disabilities or traits whether inherent, genetic or developmental including: race, color, spiritual beliefs, creed, age, tribal affiliation, national origin, immigration or refugee status, marital status, socio-economic status, veteran’s status, sexual orientation, gender identity, gender expression, gender transition status, level of formal education, physical or mental disability, medical condition or any consideration recognized under federal, state and local law.

(8) “Medication error prevention” means the prevention of events that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer.

(9) “Patient safety” means the prevention of healthcare related errors or the elimination or mitigation of patient injury caused by healthcare related errors.

(10) "Pain management education program" means a specific one-hour web-based program developed by the Pain Management Commission of the Oregon Health Authority.

(11) “Pharmacy law” means the body of laws relating to pharmacy practice.

(12) “Structured continuing pharmacy education” or “Structured CPE” means education that includes defined learning objectives, qualified instructors, learning assessment, and a program evaluation.

History

Statutory/Other Authority: ORS 689.205 & ORS 676.850
Statutes/Other Implemented: ORS 413.450, ORS 413.590, ORS 689.255, ORS 689.285, ORS 689.486 & ORS 689.490
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 7-2025, amend filed 08/08/2025, effective 08/08/2025
BP 60-2024, amend filed 08/09/2024, effective 08/09/2024
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0010 Continuing Pharmacy Education Programs: General Requirements

(1) CPE programs must consist of subject matter pertinent to pharmacy including:

(a) Socioeconomic aspects of healthcare;

(b) Legal aspects of healthcare;

(d) Etiology, characteristics, therapeutics, and prevention of disease states; or

(e) General topics related to pharmacy.

(2) Time spent in the following activities may be included in the calculation of CPE credit:

(a) A program delivered by an instructor or a panel of instructors;

(b) A structured CPE discussion, workshop or demonstration;

(d) An ACPE accredited program or board-approved program;

(e) An ACCME AMA Category 1 accredited program or AAVSB-RACE approved medical program up to the following limits per renewal cycle:

(A) 10 hours of CPE for Pharmacists;

(B) 6 hours of CPE for Certified Oregon Pharmacy Technicians and Pharmacy Technicians.

(f) A policy discussion at an Oregon Board of Pharmacy meeting up to a maximum of 2 hours of law CPE per renewal cycle.

(3) Time spent in the following activities must not be included in the calculation of CPE credit:

(a) Welcoming remarks;

(b) Meals or social functions;

(d) Unstructured discussion, workshops, and demonstrations;

(e) Unstructured question and answer sessions;

(f) Degree programs;

(g) Non-ACPE approved certificate programs;

(h) Licensing or certification examinations;

(i) Skills training programs;

(j) Software training programs;

(k) Learning assessments;

(l) Program evaluations; and

(m) Attending CPE programs for which credit was not granted by the provider.

(4) For each accredited or board-approved program, the licensee must retain a certificate of completion for each completed program that includes:

(a) Licensee name;

(b) Title, activity date, and activity number of the program;

(d) Name of the program provider;

(e) Number of contact hours earned by topic designation; and

(f) Statement of credit granted to the participant.

(5) For each accredited or board-approved program, the licensee must ensure that licensee program completion CPE credit was recorded in the CPE Monitor or a certificate of completion is uploaded to the licensee’s electronic licensing record with the board prior to submission of the license renewal.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.255, ORS 689.285 & ORS 689.490
BP 60-2024, amend filed 08/09/2024, effective 08/09/2024
BP 50-2024, minor correction filed 05/06/2024, effective 05/06/2024
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0030 Continuing Pharmacy Education Programs: Applications for Approval

(1) An application for approval of a CPE program which is not an accredited program may apply for board approval using a form supplied for this purpose. A complete application includes:

(a) Program provider or sponsor name;

(b) Program name;

(d) Licensee type(s);

(e) Total number of contact hours offered by topic designation;

(f) Description of program goal(s) and learning objective(s);

(g) Program format (e.g. interactive discussion, panel, speaker);

(h) Name and qualification(s) of each instructor;

(i) Date(s) and location(s) of program;

(j) Learning assessment; and

(k) Program evaluation.

(2) The provider must submit an application form a minimum of forty-five days prior to the date the program will be held. Applications submitted less than forty-five days prior to the date the program will be held will not be approved.

(3) Incomplete applications will not be approved.

(4) An application for post-approval of a CPE program will not be approved.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.285
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0040 Continuing Pharmacy Education Programs: Instructors' Credit Toward CPE Hours

(1) Any Pharmacist whose primary responsibility is not the education of health professionals, who instructs a group of health professionals on pharmacy-related topics according to OAR 855-135-0010(1)(a)-(e) in structured CPE may be granted two hours of CPE credit for each hour spent in presenting the course or program which has been approved for CPE credit.

(2) Any Pharmacist whose primary responsibility is the education of health professionals may be granted CPE credit as in (1) when instructing a group of health professionals on pharmacy-related topics unrelated to their formal course responsibilities in a learning institution.

(3) An instructor will only be granted credit for one presentation of the same course or program.

(4) An instructor may earn a maximum of 10 hours of CPE for instruction per renewal cycle.

(5) An instructor must submit an application form a minimum of forty-five days prior to the date the program will be held to apply for instructor credit toward CPE hours using a form provided for this purpose by the board. Applications submitted less than forty-five days prior to the date of the program will not be approved.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.285
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0050 Continuing Pharmacy Education: Requirements for Pharmacist License Renewal

(1) During the period from July 1 through June 30 of each biennial license renewal cycle, a pharmacist must have satisfactorily completed at least 30 hours of CPE. These hours must include at least:

(a) Two hours of CPE in pharmacy law;

(b) Two hours of CPE in patient safety or medication error prevention;

(c) Two hours of CPE in cultural competency either approved by the Oregon Health Authority under ORS 413.450 or any cultural competency CPE; and

(d) One hour of CPE in pain management, provided by the Pain Management Commission of the Oregon Health Authority; and

(e) Twenty-three additional hours of CPE in subjects pertinent to pharmacy per OAR 855-135-0010(1)(a)-(e).

(2) Pharmacists applying for the first renewal of their license if they have been licensed by the board for at least one year prior to July 1 of the renewal period, must complete the requirement listed in (1).

(3) Pharmacists applying for the first renewal of their license if they have not been licensed by the board for at least one year prior to July 1 of the renewal period, must have satisfactorily completed the following hours of CPE in any topic area. If the initial license is issued between:

(a) July 1 to September 30 of an even year, the Pharmacist must complete 16 hours of CPE.

(b) October 1 to December 31 of an even year, the Pharmacist must complete 12 hours of CPE.

(d) April 1 to June 30 of an odd year, the Pharmacist must complete 4 hours of CPE.

(4) A Pharmacist must register with the CPE Monitor for tracking completed ACPE credit hours.

(5) For each ACPE-approved program, the licensee must ensure that licensee program completion CPE credit was recorded in the CPE Monitor.

(6) For each board-approved or ACCME accredited program, the licensee must ensure that licensee program completion CPE credit was recorded in the CPE Monitor or uploaded to the licensee’s electronic licensing record with the board.

(7) A Pharmacist must retain documentation of completed CPE for 6 years and must provide this documentation if requested by the board.

(8) CPE credit accumulated in excess of the required 30 contact hours for biennial license renewal cannot be carried forward.

(9) A Pharmacist who fails to renew their license by the expiration date and whose license has been lapsed for one year or less may apply to renew their license, must complete the CPE requirement in (1) prior to renewal.

(10) A Pharmacist who is applying for reinstatement must provide certification of completion of the continuing pharmacy education requirement in (1) for all licensing cycles in which the license was lapsed, and complete reinstatement requirements listed in OAR 855-115.

History

Statutory/Other Authority: ORS 689.205 & ORS 676.850
Statutes/Other Implemented: ORS 413.450, ORS 413.590, ORS 689.285 & ORS 689.486
BP 30-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0060 Continuing Pharmacy Education: Requirements for Intern License Renewal

(1) During each license renewal cycle, an Intern must have satisfactorily completed 2 contact hours of approved CPE in cultural competency either approved by the Oregon Health Authority under ORS 413.450 or any cultural competency CPE; and

(2) An Intern must retain documentation of completed CPE for 6 years and must provide this documentation if requested by the board.

(3) An Intern must register with the CPE Monitor for tracking completed ACPE credit hours.

(4) For each ACPE-approved program, the licensee must ensure that licensee program completion CPE credit was recorded in the CPE Monitor.

(5) For each board-approved or ACCME accredited program, the licensee must ensure that licensee program completion CPE credit was recorded in the CPE Monitor or uploaded to the licensee’s electronic licensing record with the board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 413.450, ORS 676.850, ORS 689.151, ORS 689.255 & ORS 689.285
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0070 Continuing Pharmacy Education: Requirements for Certified Oregon Pharmacy Technician or Pharmacy Technician License Renewal

(1) During the period from July 1 through June 30 of each biennial license renewal cycle, Certified Oregon Pharmacy Technician or Pharmacy Technician must have satisfactorily completed 20 contact hours of CPE. These hours must include:

(a) Two hours of CPE in pharmacy law;

(b) Two hours of CPE in patient safety or medication error prevention;

(c) Two hours of CPE in cultural competency either approved by the Oregon Health Authority under ORS 413.450 or any cultural competency effective July 1, 2023; and

(d) Fourteen additional hours of CPE in subjects pertinent to pharmacy per OAR 855-135-0010(1)(a)-(e).

(2) Certified Oregon Pharmacy Technicians or Pharmacy Technicians applying for the first renewal of their license, if they have not been licensed by the board for at least one year prior to July 1 of the renewal period, only need to complete cultural competency as required by (1)(c).

(3) Certified Oregon Pharmacy Technicians and Pharmacy Technicians must register with the CPE Monitor for tracking completed ACPE credit hours.

(4) For each ACPE-approved program, the licensee must ensure that licensee program completion CPE credit was recorded in the CPE Monitor.

(6) A Certified Oregon Pharmacy Technician or Pharmacy Technician must retain documentation of completed CPE for 6 years and must provide this documentation if requested by the board.

(7) CPE credit accumulated in excess of the required 20 contact hours for biennial license renewal cannot be carried forward.

(8) A Certified Oregon Pharmacy Technician or Pharmacy Technician who fails to renew their license by the expiration date and whose license has been lapsed for one year or less may apply to renew their license and must complete the CPE requirements in (1) prior to renewal.

(9) Section (1)(a)(b) and (d) do not apply to a Pharmacy Technician applying for the first renewal of their license prior to July 1, 2023. Section (1)(c) is required.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 413.450, ORS 676.850, ORS 689.285 & ORS 689.486
BP 13-2023, minor correction filed 07/07/2023, effective 07/07/2023
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0080 Continuing Pharmacy Education: Requirements for Licensees Licensed in Other Health Professions

A Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician who is licensed to practice another health profession must meet the same CPE requirements in the same manner as all other board licensees and must otherwise comply with this chapter.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.255, ORS 689.285 & ORS 689.490
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0085 Continuing Pharmacy Education: Notification of Biennial License Renewal

The board will send a biennial renewal notice to be issued to all licensed Pharmacists, Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians at least 60 days prior to the license expiration date that states the biennial license fee, CPE requirements and other information necessary for renewal.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.255, ORS 689.275, ORS 689.486 & ORS 689.490
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Or. Admin. R. 855-135-0090 Continuing Pharmacy Education: Audits

(1) The biennial renewal application must be submitted to the board with the appropriate fee and the licensee must attest that they have satisfactorily completed the CPE requirements prior to submission of the license renewal.

(2) The board may select and audit applications for renewal to verify completion of CPE by Pharmacists, Interns, Certified Oregon Pharmacy Technicians, and Pharmacy Technicians reported on the application for renewal.

(3) The board may utilize the National Association of Boards of Pharmacy CPE Monitor service or the licensee’s electronic licensing record with the board when auditing licensees for CPE compliance.

(4) If the board is unable to confirm compliance, the licensee must comply with board requests to provide documentation.

(5) A licensee who fails to provide the requested documentation to the board within the time allowed or who fails to complete the biennial CPE requirement may be disciplined for unprofessional conduct.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.275
BP 51-2022, adopt filed 12/20/2022, effective 07/01/2023

Division 139 REMOTE DISPENSING SITE PHARMACY

Or. Admin. R. 855-139-0001 Purpose and Scope

The purpose of OAR 855-139 is to provide minimum requirements for the locations where telepharmacy services are conducted.

History

Statutory/Other Authority: ORS 689.205 & 2021 SB 629
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0005 Definitions

The following words and terms, when used in OAR 855-139, have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section has the definition set out in OAR 855-006.

(1) “RDSP Affiliated Pharmacy” means a Retail Drug Outlet Pharmacy registered in Oregon where an Oregon licensed Pharmacist provides pharmacy services through a telepharmacy system.

(2) “Remote Dispensing Site Pharmacy” or “RDSP” means an Oregon location registered as a Retail Drug Outlet Remote Dispensing Site Pharmacy staffed by a Certified Oregon Pharmacy Technician or Pharmacy Technician under the supervision, direction and control of an Oregon licensed Pharmacist using a telepharmacy system.

(3) “Telepharmacy” means the delivery of pharmacy services by an Oregon licensed Pharmacist through the use of a telepharmacy system to a patient at a remote location staffed by a Certified Oregon Pharmacy Technician or Pharmacy Technician.

(4) “Telepharmacy system” means a system of telecommunications technologies that enables monitoring, documenting, and recording of the delivery of pharmacy services at a remote location by an electronic method which must include the use of audio and video, still image capture, and store and forward.

History

Statutory/Other Authority: ORS 689.205, ORS 689.522, ORS 689.700 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.522, ORS 689.564, ORS 689.700 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 15-2022, amend filed 04/20/2022, effective 04/20/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0010 Registration: General

(1) A location in Oregon where the practice of pharmacy occurs by an Oregon licensed Pharmacist through the use of a telepharmacy system to a patient at a remote location staffed by a Certified Oregon Pharmacy Technician must be registered by the board in Oregon as a Retail Drug Outlet RDSP.

(2) If controlled substances are stored in the RDSP, the RDSP must have an active Controlled Substance Registration Certificate with the board and Drug Enforcement Administration (DEA).

(3) The Retail Drug Outlet RDSP application must specify the RDSP Affiliated Pharmacy and cannot operate without a RDSP Affiliated Pharmacy that is registered by the board as a Retail Drug Outlet Pharmacy.

(4) All registration renewal applications must be accompanied by the annual fee and must contain the same information required in OAR 855-139-0015(2).

(5) The initial and annual registration fee for pharmacies is set out in OAR 855-110.

(6) The Retail Drug Outlet RDSP registration expires March 31, annually. If the annual registration fee referred to in OAR 855-110 is not paid by March 31 of the current year, a late fee as set out in OAR 855-110 must be included with the application for registration renewal.

(7) The registration is not transferable and the registration fee cannot be prorated.

(8) No RDSP may be operated until a certificate of registration has been issued to the pharmacy by the board.

History

Statutory/Other Authority: ORS 689.205 & 2021 SB 629
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225 & 2021 SB 629
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 9-2022, minor correction filed 01/05/2022, effective 01/05/2022
BP 1-2022, minor correction filed 01/03/2022, effective 01/03/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0015 Registration: Application

(1) An application for registration of a new RDSP must be accompanied by a floor plan drawn to scale and must be approved by the board prior to opening.

(2) The application must specify the location of the RDSP and must indicate the owner, trustee, receiver, or other person applying for the registration. When an applicant is not the owner of the pharmacy, the application must indicate the owner and the applicant's affiliation with the owner:

(a) If the owner is a partnership or other multiple owners, the names of the partners or persons holding the five largest interests must be indicated on the application;

(b) If the owner is a corporation, the name filed must be the same as filed with the Secretary of State. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests must be indicated on the application.

(3) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

(4) A certificate of registration will be issued upon board approval of the application.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0020 Registration: Change of Owner, Location, or RDSP Affiliated Pharmacy

(1) A change of location of the RDSP Affiliated Pharmacy or location of the Retail Drug Outlet RDSP requires:

(a) Submission of a new Retail Drug Outlet RDSP application 15 days prior to occurrence;

(b) Registration fee;

(d) New certificate of registration.

(2) A change in the RDSP Affiliated Pharmacy or ownership of the Retail Drug Outlet RDSP requires:

(a) Submission of a new Retail Drug Outlet RDSP application 15 days prior to occurrence;

(b) Registration fee;

(d) New certificate of registration.

(3) A change of ownership includes any change in the legal form of the business including additions or deletions of partners.

(4) A certificate of registration will be issued upon board approval of the application.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0025 Registration: Change of Business Name

A RDSP Affiliated Pharmacy must notify the board a minimum of 15 days prior to any change of business name of a Retail Drug Outlet RDSP. The change must be reported by filing a new application for which no fee is required.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 32-2022, amend filed 06/15/2022, effective 06/16/2022
BP 10-2022, temporary amend filed 02/16/2022, effective 02/16/2022 through 06/07/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0030 Non-Resident Affiliated Pharmacies

(1) For the purpose of these rules, a non-resident pharmacy includes a RDSP Affiliated Pharmacy located outside of Oregon and providing pharmacy services through a telepharmacy system to a Retail Drug Outlet RDSP located in Oregon.

(2) Each non-resident RDSP Affiliated Pharmacy must be registered with the Oregon Board of Pharmacy.

(3) To qualify for registration under these rules, every non-resident RDSP Affiliated Pharmacy must be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence.

(4) Each out-of-state non-resident RDSP Affiliated Pharmacy must designate an Oregon licensed Pharmacist-in-Charge (PIC), who is responsible for all pharmacy services and to provide supervision and control of the RDSP. To qualify for this designation, the person must:

(a) Hold a license to practice pharmacy in the resident state;

(b) Be normally working for the RDSP Affiliated Pharmacy a minimum of 20 hours per week;

(d) Provide the Self-Inspection Form as requested by the board.

(5) Every non-resident RDSP Affiliated Pharmacy will have a Pharmacist-in-Charge (PIC) who is licensed in Oregon prior to initial registration of the RDSP.

(6) The PIC must comply with the requirements of OAR 855-115-0210.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.225
BP 31-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 12-2023, amend filed 06/13/2023, effective 08/01/2023
BP 6-2022, minor correction filed 01/05/2022, effective 01/05/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0050 Personnel

(1) The Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy is responsible for all operations at the RDSP including responsibility for the telepharmacy system and enforcing policies and procedures.

(2) A RDSP may not utilize Interns. Unlicensed personnel may not perform any pharmacy services.

(3) The Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy who is supervising a RDSP must determine how many licensed individuals the Pharmacist is capable of supervising, directing and controlling based on the services being provided.

(4) The RDSP Affiliated Pharmacy and the Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy are required to comply with the Pharmacist’s determination in (3) and retain records.

(5) The RDSP and RDSP Affiliated Pharmacy must ensure adequate staffing at both the RDSP and RDSP Affiliated Pharmacy.

(6) Prior to working at a RDSP, the RDSP Affiliated Pharmacy, and the Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy are responsible for ensuring the Certified Oregon Pharmacy Technician or Pharmacy Technician and the Oregon licensed Pharmacist supervising the RDSP are adequately trained to perform their duties and have completed a training program on the proper use of the telepharmacy system.

(7) A RDSP Affiliated Pharmacy that terminates or allows a board licensee to resign in lieu of termination must report the termination or resignation to the board within 10 working days.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0100 Security

(1) The area in a registered RDSP where legend and/or controlled substances are stored, possessed, prepared, compounded or repackaged must be restricted in access by utilizing physical barriers to include floor to ceiling walls and a locked separate entrance to ensure the security of those drugs.

(2) The RDSP Affiliated Pharmacy, the RDSP, Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy and each Oregon licensed Pharmacist supervising the RDSP is responsible for the security of the prescription area including provisions for adequate safeguards against loss, theft or diversion of prescription drugs, and records for such drugs.

(3) The RDSP must be locked and the alarm system armed to prevent, deter and detect entry when:

(a) There is no Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy actively supervising the RDSP; or

(b) There is no Certified Oregon Pharmacy Technician or Pharmacy Technician present in the RDSP; or

(4) A record must be maintained with the name and license number of each person entering the pharmacy area of the RDSP.

(5) No one may be in the prescription area of a RDSP unless authorized in real-time by an Oregon licensed Pharmacist who is supervising the RDSP and from the RDSP Affiliated Pharmacy.

(6) Minimum security methods must include a properly functioning:

(a) Alarm system at the RDSP and real-time notification to a designated licensee of the RDSP Affiliated Pharmacy if unauthorized access occurs;

(b) Electronic entry system that is controlled by an Oregon licensed Pharmacist and records the:

(A) Identification of the Oregon licensed Pharmacist authorizing access and securing the RDSP;

(B) Identification of the Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the RDSP; and

(c) Surveillance system that utilizes continuously accessible and recorded video between the RDSP Affiliated Pharmacy and the RDSP. The system must provide a clear view of:

(A) Dispensing site entrances;

(B) Preparation areas;

(D) Pick up areas;

(E) Office areas; and

(F) Publicly accessible areas.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0120 Drug: Procurement

RDSP may only receive drugs from an Oregon Registered Drug Outlet (i.e. Wholesaler, Manufacturer or Pharmacy).

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0125 Drug: Storage

(1) A RDSP must maintain proper storage of all drugs. This includes, but is not limited to the following:

(a) All drugs must be stored according to manufacturer’s published or USP guidelines.

(b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

(d) A RDSP must quarantine drugs which are outdated, adulterated, misbranded or suspect. Cold Storage and Monitoring.

(2) A RDSP must store all drugs at the proper temperature according to manufacturer’s published guidelines (pursuant to FDA package insert or USP guidelines).

(a) All drug refrigeration systems must:

(A) Maintain refrigerated products between 2 to 8 °C (35 to 46 °F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer.

(B) Utilize a centrally placed, accurate, and calibrated thermometer;

(b) A RDSP must adhere to a monitoring plan, which includes, but is not limited to:

(A) Documentation of training of all personnel;

(B) Maintenance of manufacturer recommended calibration of thermometers;

(D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses;

(E) Documentation of action(s) taken, including decision to quarantine product for destruction, or determination by an Oregon licensed Pharmacist that it is safe for continued use. This documentation must include details of the information source;

(F) A written emergency action plan;

(G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment; and

(H) Documentation and review of temperature recordings at least once every 28 days by the Oregon licensed Pharmacist at the time of in person physical inspection.

(3) Vaccine Drug Storage:

(a) A RDSP that stores vaccines must comply with section two of this rule and the following:

(A) Vaccines must be stored in the temperature stable sections of the refrigerator;

(B) A centrally placed and accurate buffered probe thermometer, such as glycol or glass beads, calibrated within a plus or minus 0.5 °C variance must be utilized;

(E) Must adhere to a written quality assurance process to avoid temperature excursions.

(4) A retail drug outlet may store drugs in another location that is registered as a Drug Room and meets all Pharmacy drug storage and security requirements.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.325
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0130 Drug: Loss

A RDSP and its RDSP Affiliated Pharmacy must:

(1) Ensure that disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices are reported to the board immediately.

(2) Ensure that confirmed significant drug loss or any loss related to suspected drug theft of a controlled substance is reported to the board within one business day.

(3) Ensure that a Report of Theft or Loss of Controlled Substances (DEA Form 106) or Report of Theft or Loss of Listed Chemicals (DEA Form 107) is sent to the Drug Enforcement Administration, a copy is sent to the board at the same time.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0145 Outlet: Closure- Temporary, Permanent and Emergency

(1) Temporary Closing. Unless subject to an exemption in OAR 855-139-0145(3), when a RDSP is temporarily closed to the public the RDSP must:

(a) Post notification of closure on each RDSP entrance as soon as the need to deviate from the posted hours is known by the RDSP, but no later than 2 hours after the temporary closure begins. The posting must include:

(A) Estimated period of time the RDSP will be closed; and

(B) Options for prescription pick-up (e.g. another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).

(b) Post notification of closure on each telephone greeting and pharmacy operated internet (e.g. website, social media, mobile applications) as soon as possible. The posting must include:

(A) Estimated period of time the RDSP will be closed; and

(B) Options for prescription pick-up (e.g. another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).

(c) If the RDSP is temporarily closed greater than 2 consecutive business days, notify the board office as soon as possible but no later than 72 hours after the temporary closure begins with the date and time the closure began, anticipated date and time of re-opening, and the reason for the temporary closure.

(d) Federal and state holidays are exempt from the requirements of (1).

(2) Permanent Closing. If a RDSP is permanently closing to the public, the RDSP must:

(a) Prior to closing, the RDSP must comply with the following:

(A) Provide notification to each patient who has filled a prescription within the previous 12 months. This notification must be made a minimum of 15 calendar days prior to closing and must include:

(i) The last day the RDSP will be open;

(ii) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the Oregon licensed Pharmacist who will serve as the custodian of records;

(iii) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(iv) The last day a transfer may be initiated.

(B) The notification must be made via:

(i) Distribution by direct mail or written notification with each prescription dispensed;

(ii) Public notice in a newspaper of general circulation, if available, in the area served by the RDSP; and

(iii) Posting a closing notice at each building and each RDSP entrance, on each telephone greeting, and pharmacy-operated internet (e.g. website, social media, mobile applications).

(iv) In addition to (i), (ii) and (iii), the RDSP may also provide notification via email or text.

(C) Provide any new patients filling prescriptions during the 15-calendar day period prior to the RDSP closing with written notification that includes:

(i) The last day the RDSP will be open;

(ii) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the Oregon licensed Pharmacist who will serve as the custodian of records;

(iii) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(iv) The last day a transfer may be initiated.

(D) Notify DEA of any controlled substances being transferred to another registrant as specified in 21 CFR 1301.52 (v. 04/01/2025).

(b) On the date of closing or up to 24 hours after the permanent closure begins, the pharmacist-in-charge must comply with the following:

(A) Complete and document an inventory of all controlled substances.

(B) If the RDSP dispenses prescriptions:

(ii) Update the RDSP operating status with each electronic prescribing vendor; and

(iii) Remove all signs and symbols indicating the presence of the RDSP including pharmacy-operated internet (e.g. website, social media, mobile applications).

(A) Complete and document an inventory of all non-controlled drugs and devices.

(B) Remove all prescription and non-prescription drugs, devices, and related supplies from the RDSP by one or a combination of the following methods:

(i) Return to manufacturer or supplier (credit or disposal);

(ii) Transfer (sell or give away) to a licensed healthcare professional or outlet who is legally authorized to possess drugs; or

(C) Provide the board a written notice of the closing on a board prescribed form which includes the following information:

(i) Date of closing to the public and discontinuance of the business;

(ii) Date and time the inventory of all prescription drugs and devices was conducted;

(iii) Name, address, phone number and applicable registration number where all legend and controlled substances possessed by the RDSP were transferred or disposed;

(iv) If drugs were destroyed, name and license numbers of individuals who witnessed the destruction;

(v) If the RDSP is registered to possess controlled substances, confirmation that the RDSP complied with all applicable federal requirements in 21 CFR 1301.52 (v. 04/01/2025) for discontinuing operation as a RDSP that dispenses controlled substances.

(vi) If the RDSP dispenses prescriptions, the name, address and phone number of the RDSP or Oregon licensed Pharmacist who will serve as the custodian of records to which the prescriptions, including refill information, and patient medication records were transferred;

(vii) Confirmation all RDSP labels and blank prescriptions were destroyed;

(viii) Confirmation all signs and symbols indicating the presence of the RDSP including pharmacy-operated internet (e.g. website, social media, mobile applications) have been removed; and

(ix) Confirmation that each registration certificate issued to the RDSP by the board has been mailed to the board office.

(D) Once the RDSP has notified the board that the RDSP is permanently closed, the license may not be renewed. The RDSP may apply for a new license as specified in OAR 855-139-0015.

(3) Emergency closing. If the RDSP is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, inclement weather, or other emergency circumstances and the pharmacist-in-charge cannot provide notification as required in (1), the pharmacist-in-charge must comply with the provisions of (1) as far in advance or as soon after the closing as allowed by the circumstances.

(4) The board may conduct an inspection to verify all requirements in subsection (1), (2), and (3) of this section have been completed.

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 475.035, ORS 689.205 & ORS 689.700
Statutes/Other Implemented: ORS 689.155 & ORS 689.700
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 46-2022, minor correction filed 11/17/2022, effective 11/17/2022
BP 32-2022, amend filed 06/15/2022, effective 06/16/2022
BP 19-2022, adopt filed 04/20/2022, effective 04/20/2022
BP 10-2022, temporary adopt filed 02/16/2022, effective 02/16/2022 through 06/07/2022

Or. Admin. R. 855-139-0150 Outlet: Sanitation

A RDSP and its RDSP Affiliated Pharmacy must:

(1) Ensure the RDSP is kept clean.

(2) Ensure the Certified Oregon Pharmacy Technician or Pharmacy Technician working in the RDSP practices appropriate infection control.

History

Statutory/Other Authority: ORS 689.305 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.305 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0155 Outlet: Minimum Equipment Requirements

(1) Each Oregon Retail Drug Outlet RDSP must have the following:

(a) Appropriate and current pharmaceutical references (e.g., pharmacology, injectables, and veterinary drugs) services offered by the outlet;

(c) Access to appropriate electronic reporting databases (e.g., PDMP, NPLEx, OHA ALERT-IIS) based on the services offered by the outlet;

(d) Appropriate equipment to maintain the proper storage of drugs;

(f) A sink with running hot and cold water;

(g) Signage in a location easily seen by the public where prescriptions are dispensed or administered:

(B) Providing notification in each of the languages required in OAR 855-139-0410 of the right to free, competent oral interpretation and translation services, including translated prescription labels, for patients who are of limited English proficiency, in compliance with federal and state regulations if the pharmacy dispenses prescriptions for a patient's self-administration;

(C) Providing written notice in a conspicuous manner that short-acting opioid antagonists (e.g., naloxone, nalmefene) and the necessary medical supplies to administer short-acting opioid antagonists are available at the pharmacy if short-acting opioid antagonist services are provided by the pharmacy;

(D) Stating "This location is a Remote Dispensing Site Pharmacy, supervised by an Oregon licensed Pharmacist from (insert name of RDSP Affiliated Pharmacy, address, and telephone number)." The printing on the sign must be in block letters not less than one inch in height; and

(E) Providing notification of accurate hours of operation at each pharmacy entrance; and

(h) Accurate hours of operation on each telephone greeting and pharmacy-operated internet (e.g. website, social media, mobile applications).

(i) Additional equipment and supplies that are determined as necessary by the Pharmacy or Pharmacist-in-Charge.

(2) Failure to have, use and maintain required equipment constitutes unprofessional conduct under ORS 689.405(1)(a).

History

Statutory/Other Authority: ORS 689.205, ORS 689.686, ORS 689.515 & 2021 SB 629
Statutes/Other Implemented: ORS 689.155 & 2023 HB 2395
BP 27-2023, amend filed 10/16/2023, effective 10/17/2023
BP 19-2022, amend filed 04/20/2022, effective 04/20/2022
BP 8-2022, minor correction filed 01/05/2022, effective 01/05/2022
BP 2-2022, minor correction filed 01/03/2022, effective 01/03/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0200 Outlet: General Requirements

(1) A RDSP Affiliated Pharmacy may not be affiliated with more than two Remote Dispensing Site Pharmacies.

(2) A RDSP and its RDSP Affiliated Pharmacy must:

(a) Have the same owner; or

(b) Have a written contract that specifies:

(A) The services to be provided by each licensee and registrant;

(B) The responsibilities of each licensee and registrant; and

(d) Comply with all applicable federal and state laws and rules;

(e) Designate in writing the Oregon licensed Pharmacists and Certified Oregon Pharmacy Technicians authorized to access the RDSP and operate the telepharmacy system;

(f) Train the Oregon licensed Pharmacists and Certified Oregon Pharmacy Technicians in the operation of the telepharmacy system and RDSP;

(g) Develop, implement and enforce a continuous quality improvement program for dispensing services from a RDSP designed to objectively and systematically:

(A) Monitor, evaluate, document the quality and appropriateness of patient care;

(B) Improve patient care; and

(h) Provide a telephone number that a patient, patient’s agent or prescriber may use to contact the Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy; and

(i) Develop, implement and enforce a process for an in person physical inspection of the RDSP by an Oregon licensed Pharmacist at least once every 28 days or more frequently as deemed necessary by the Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy. The inspection must utilize the RDSP self-inspection form, be documented, and records retained.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.700
Statutes/Other Implemented: ORS 689.155 & ORS 689.700
BP 58-2024, amend filed 08/09/2024, effective 08/09/2024
BP 32-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 7-2022, minor correction filed 01/05/2022, effective 01/05/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0205 Outlet: Technology

A RDSP and its RDSP Affiliated Pharmacy must:

(1) Utilize a shared telepharmacy system and have appropriate technology or interface to allow access to information required to process and fill a prescription drug order;

(2) Use still image capture or store and forward for verification of prescriptions with a camera that is of sufficient quality and resolution so that the Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy can visually identify each:

(a) Source container including manufacturer, name, strength, lot, and expiration;

(b) Source ingredient including the imprint and physical characteristics if compounding;

(d) Completed prescription container including the label; and

(e) Ancillary document provided to patient at the time of dispensing.

(3) Utilize barcode, radio-frequency identification or quick response code technology to record information in (2) if available;

(4) Test the telepharmacy system and document that it operates properly before providing pharmacy services; and

(5) Develop, implement and enforce a plan for routine maintenance of the telepharmacy system.

History

Statutory/Other Authority: ORS 689.205 & 2021 SB 629
Statutes/Other Implemented: 2021 SB 629 & ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0210 Outlet: Supervision

A RDSP and its RDSP Affiliated Pharmacy must:

(1) Ensure prescription drugs are only dispensed at the RDSP if an Oregon licensed Pharmacist is supervising the Certified Oregon Pharmacy Technician or Pharmacy Technician, and the surveillance system is fully operational;

(2) Ensure an Oregon licensed Pharmacist supervises, directs and controls each Certified Oregon Pharmacy Technician or Pharmacy Technician at the RDSP using an audiovisual communication system. All patient interactions must be recorded, reviewed and stored;

(3) The Oregon licensed Pharmacist who is supervising the Certified Oregon Pharmacy Technician or Pharmacy Technician at a RDSP must:

(a) Using reasonable professional judgment, determine the percentage of patient interactions for each licensee that must be reviewed to ensure public health and safety with a minimum of 10% of patient interactions observed or reviewed;

(b) Review patient interactions within 48 hours of the patient interaction to ensure that each licensee is acting within the authority permitted under their license and patients are connected with a Pharmacist upon request;

(A) Number of each licensee’s patient interactions;

(B) Number of each licensee’s patient interactions Pharmacist is reviewing;

(D) Date and time of Pharmacist review of licensee’s patient interaction; and

(E) Pharmacist notes of each interaction reviewed; and

(d) Report any violation of OAR 855 to the RDSP Affiliated Pharmacy within 24 hours of discovery and to the board within 10 days.

(4) The Oregon registered Drug Outlet Pharmacy must comply with the Pharmacist’s determination in (3)(a), employ adequate staff to allow for completion of the review within 48 hours, and retain records.

(5) Ensure telephone audio is recorded, reviewed and stored for all patient interactions completed by the Certified Oregon Pharmacy Technician or Pharmacy Technician.

(6) Develop, implement and enforce a plan for responding to and recovering from an interruption of service which prevents an Oregon licensed Pharmacist from supervising a Certified Oregon Pharmacy Technician or Pharmacy Technician at the RDSP.

History

Statutory/Other Authority: ORS 689.205, ORS 689.225 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0215 Outlet: Pharmacist Utilization

A RDSP and its RDSP Affiliated Pharmacy must:

(1) Utilize an Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy to perform the professional tasks of interpretation, evaluation, DUR, verification and counseling before the prescription is dispensed; and

(2) Utilize an Oregon licensed Pharmacist and an audiovisual communication system to provide counseling or accept the refusal of counseling from the patient or the patient’s agent for each prescription being dispensed when counseling is required under OAR 855-115-0145 and when requested and document the interaction.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 33-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0220 Outlet: Non-Prescription Drugs

If non-prescription drugs are offered for sale at the RDSP, the RDSP and its RDSP Affiliated Pharmacy must:

(1) Ensure that the Certified Oregon Pharmacy Technician or Pharmacy Technician does not provide advice, information that requires judgment, or recommendations involving non-prescription drugs; and

(2) Ensure that an Oregon-licensed Pharmacist is immediately available to provide counseling or

recommendations involving non-prescription drugs.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0225 Outlet: Controlled Substances

If controlled substances are at the RDSP, the RDSP and its RDSP Affiliated Pharmacy must:

(1) Comply with controlled substance regulations;

(2) Store all controlled substances in a secure locked cabinet;

(3) Maintain an accurate controlled substance perpetual inventory; and

(4) Ensure an Oregon licensed Pharmacist conducts a controlled substance inventory at least once every 28 days and reconciles all discrepancies at the time of in person physical inspection.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0230 Outlet: Non-Sterile Compounding

If non-sterile preparations are compounded at the RDSP, the RDSP and its RDSP Affiliated Pharmacy must:

(1) Adhere to the requirements of OAR 855-045;

(2) Ensure an Oregon licensed Pharmacist:

(a) Supervises via an audiovisual communication system all steps of the compounding; and

(b) Documents and visually verifies each item required in OAR 855-139-0205.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 3-2022, minor correction filed 01/03/2022, effective 01/03/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0300 Prescription: General Requirements

(1) Prescriptions, prescription refills, and drug orders must be correctly dispensed in accordance with the prescribing practitioner's authorization. When a prescription is transmitted orally, it must be transmitted to the Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy and both the receiving pharmacist's name or initials and the name of the person transmitting must be noted on the prescription.

(2) Each RDSP must document the following information for each prescription:

(a) The name and date of birth of the patient for whom the drug is prescribed, unless for an animal.

(b) If for an animal, the name of the patient, name the owner and the species of the animal.

(c) The full name, address, and contact phone number of the practitioner. If for a controlled substance, the Drug Enforcement Administration registration number of the practitioner and other number as authorized under rules adopted by reference under rule OAR 855-080-0085;

(d) The name, strength, dosage forms of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed;

(e) The directions for use, if given by the practitioner; and

(f) The date of filling, and the total number of refills authorized by the prescribing practitioner.

(3) In accordance with ORS 689.515(3), a practitioner may specify in writing, by a telephonic communication or by electronic transmission that there may be no substitution for the specified brand name drug in a prescription.

(a) For a hard copy prescription issued in writing or a prescription orally communicated over the telephone, instruction may use any one of the following phrases or notations:

(A) No substitution;

(B) N.S.;

(D) Brand necessary;

(E) Medically necessary;

(F) D.A.W. (Dispense As Written); or

(G) Words with similar meaning.

(4) A RDSP or Oregon licensed Pharmacist filling a prescription or order for a biological product may not substitute a biosimilar product for the prescribed biological product unless:

(a) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;

(b) The prescribing practitioner has not designated on the prescription that substitution is prohibited;

(c) The patient for whom the biological product is prescribed is informed of the substitution prior to dispensing the biosimilar product;

(d) The RDSP or Oregon licensed Pharmacist provides written, electronic or telephonic notification of the substitution to the prescribing practitioner or the prescribing practitioner’s staff within three (3) business days of dispensing the biosimilar product; and

(5) The RDSP must dispense prescriptions accurately and to the correct party.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.522
Statutes/Other Implemented: ORS 689.505, ORS 689.515 & ORS 689.522
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0305 Prescription: Tamper-resistant

When the use of a tamper-resistant prescription is required by any federal or state law or rule, the term “tamper-resistant” has the meaning as defined in OAR 855-006-0005.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 44-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0310 Prescription: Verification of Authenticity

Alteration of a written prescription, other than by an Oregon licensed Pharmacist's or practitioner's authorization, in any manner constitutes an invalid order unless verified with the prescriber.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0315 Prescription: Refills

(1) Where refill authority is given other than by the original prescription, documentation that such refill authorization was given, the date of authorization, and name of the authorizing prescriber or the prescriber's agent must be recorded. This documentation must be readily retrievable. Prescriptions for controlled substances in Schedules III, IV and V are limited to five refills or six months from date of issue, whichever comes first.

(2) If the practitioner is not available and in the reasonable professional judgment of the Oregon licensed Pharmacist an emergency need for the refill of a prescription drug has been demonstrated, the Oregon licensed Pharmacist may authorize the Certified Oregon Pharmacy Technician or Pharmacy Technician to prepare for Pharmacist verification a sufficient quantity of the drug consistent with the dosage regimen, provided it is not a controlled substance, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. The practitioner must be promptly notified of the emergency refill.

(3) Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years. This record must include;

(a) The identity of the Certified Oregon Pharmacy Technician or Pharmacy Technician and responsible Oregon licensed Pharmacist;

(b) Name of the patient;

(d) Date of refill; and

(e) Quantity dispensed.

(4) Refill quantities may be combined into a single filling if the prescription is not for a controlled substance or psychotherapeutic drug and the prescriber is notified of the change.

(6) A prescription must be refilled in context with the approximate dosage schedule unless specifically authorized by the prescriber.

(7) Auto-Refill Programs. A mail order or retail pharmacy, excluding cycle-fill for long term care, may use a program that automatically refills non-controlled prescription medications, that have existing refills available and are consistent with the patient’s current medication therapy only when the following conditions are met:

(a) A patient or patient’s agent must enroll each prescription medication in an auto-refill program before a pharmacy can include the prescription medication as part of the auto-refill program;

(b) The prescription is not a controlled substance;

(d) Pick-up notification to a patient or patient’s agent may be generated upon completion of a prescription refill; and

(e) When an auto-refill prescription is returned to stock or when delivery is refused that prescription medication is removed from the auto-refill program for that patient.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.505, ORS 689.515 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0320 Prescription: Expiration

This section of rule addresses the expiration date of the prescription and not the expiration date of the drug.

(1) After one year from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber.

(2) When used alone as a prescription refill designation the abbreviation, "PRN" for a non-controlled substance means that the medication can be refilled in proper context for a period of one year.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & ORS 689.515
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0325 Prescription: Transfers

(1) Prescriptions may be transferred between pharmacies for the purpose of an initial or refill dispensing provided that:

(a) The prescription is invalidated at the sending pharmacy; and

(b) The receiving pharmacy obtains all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability.

(2) Prescriptions for controlled substances can only be transferred one time.

(3) Pharmacies using the same electronic prescription database are not required to transfer prescriptions for dispensing purposes.

(4) An Oregon licensed Pharmacist from the RDSP Affiliated Pharmacy must transfer a prescription:

(a) To a pharmacy requesting a transfer on behalf of the patient or patient’s agent unless the transfer would compromise patient safety or violate state or federal laws or rules; and

(b) By the end of the next business day of the request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 32-2022, amend filed 06/15/2022, effective 06/16/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0350 Dispensing: Containers

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0355 Dispensing: Customized Patient Medication Packages

In lieu of dispensing two or more prescribed drug products in separate containers, an Oregon licensed Pharmacist may, with the consent of the patient, the patient’s caregiver, or a prescriber, provide a customized patient medication package (patient med pak). A patient med pak is a package prepared by a Certified Oregon Pharmacy Technician and verified by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med pak is so designed for each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken:

(1) Label:

(a) The patient med pak must bear a label stating:

(A) The name of the patient;

(B) A serial number for each patient med pak itself and a separate identifying serial number for each of the prescription orders for each of the drug products contained therein;

(C) The name, strength, physical description or identification, and total quantity of each drug product contained therein;

(D) The directions for use and cautionary statements, if any, contained in the prescription order for each drug product therein;

(E) Any storage instructions or cautionary statements required by the official compendia;

(F) The name of the prescriber of each drug product;

(G) The date of preparation of the patient med pak and the beyond-use date assigned to the patient med pak (such beyond-use date must be no later than 60 days from the date of preparation);

(H) The name, address, and telephone number of the dispenser and the dispenser’s registration number where necessary; and

(I) Any other information, statements, or warnings required for any of the drug products contained therein.

(b) If the patient med pak allows for the removal or separation of the intact containers therefrom, each individual container must bear a label identifying each of the drug products contained therein.

(2) Labeling: The patient med pak must be accompanied by a patient package insert, in the event that any medication therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the RDSP for the total patient med pak.

(3) Packaging:

(a) In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med pak must comply with the moisture permeation requirements for a Class B single-unit or unit-dose container. Each container must be either not reclosable or so designed as to show evidence of having been opened;

(b) There is no special exemption for patient med paks from the requirements of the Poison Prevention Packaging Act. Thus the patient med pak, if it does not meet child-resistant standards must be placed in an outer package that does comply, or the necessary consent of the purchaser or physician, to dispense in a container not intended to be child-resistant, must be obtained.

(5) Recordkeeping: In addition to any individual prescription filing requirements, a record of each patient med pak must be made and filed. Each record must contain, as a minimum:

(a) The name and address of the patient;

(b) The serial number of the prescription order for each drug product contained therein;

(e) The date of preparation of the patient med pak and the beyond-use date that was assigned;

(f) Any special labeling instructions; and

(g) The name or initials of the Certified Oregon Pharmacy Technician who prepared the med pak and the Oregon licensed Pharmacist who verified the patient med pak.

(6) Ensure an Oregon licensed Pharmacist visually verifies and documents each item required in OAR 855-139-0205 for each individual dosage unit in the med pak.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 4-2022, minor correction filed 01/03/2022, effective 01/03/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0360 Dispensing: Interpretation

(1) Except as provided in subsection (2) of this section, a Pharmacist or Intern from the RDSP Affiliated Pharmacy must work with a health care interpreter from the health care interpreter registry administered by the Oregon Health Authority under ORS 413.558 when communicating with a patient who prefers to communicate in a language other than English or who communicates in signed language, unless the Pharmacist is proficient in the preferred language of the person with limited English proficiency. The Pharmacist or drug outlet may not charge for these services.

(b) Has offered the patient the services of a health care interpreter from the health care interpreter registry and the patient declined the offer and chose a different interpreter.

(4) A Pharmacist or Intern must maintain records of:

(a) Each patient encounter in which the Pharmacist or Intern worked with a health care interpreter from the health care interpreter registry; or

(5) The records required in (4) must include:

(a) The full name of the health care interpreter;

(b) The health care interpreter’s registry number, if applicable; and

(6) Pharmacists, Interns, Certified Oregon Pharmacy Technicians, Pharmacy Technicians and Pharmacies are required to comply with ORS 413.559.

History

Statutory/Other Authority: ORS 689.205 & 2021 HB 2359
Statutes/Other Implemented: ORS 689.155 & 2021 HB 2359
BP 29-2022, adopt filed 06/15/2022, effective 09/01/2022

Or. Admin. R. 855-139-0400 Labeling: General Requirements

Prescriptions must be labeled with the following information:

(1) Name, address and telephone number of the RDSP;

(2) Date;

(3) Identifying number;

(4) Name of patient;

(5) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(6) Directions for use by the patient;

(7) Name of practitioner;

(8) Required precautionary information regarding controlled substances;

(9) Such other and further accessory cautionary information as required for patient safety;

(10) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must be the same as that on the original container unless, in the Oregon licensed Pharmacist's professional judgment, a shorter expiration date is warranted. Any drug bearing an expiration date must not be dispensed beyond the said expiration date of the drug;

(11) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules; and

(12) Address and telephone number of the RDSP Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & ORS 689.515
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0405 Labeling: Prescription Reader Accessibility

(1) A pharmacy must notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information.

(2) If a person informs the pharmacy that the person identifies as a person who is blind, the pharmacy must provide to the person a prescription reader that is available to the person for at least the duration of the prescription, must confirm it is appropriate to address the person’s visual impairment, and must ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider.

(3) The pharmacy must ensure an Oregon licensed Pharmacist verifies and documents that the correct electronic label was placed on each prescription container and that the audio information produced by the prescription reader is accurate prior to dispensing the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.561
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0410 Labeling: Limited English Proficiency and Accessibility

Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by a pharmacy for a patient’s self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

(2) When dispensing a drug under (1), a pharmacy must provide labels and informational inserts in both English and one of the following languages:

(a) Spanish;

(b) Russian;

(d) Arabic;

(e) Chinese (simplified);

(f) Vietnamese;

(g) Farsi;

(h) Korean;

(i) Romanian;

(j) Swahili;

(k) Burmese;

(l) Nepali;

(m) Amharic; and

(n) Pashtu.

(3) The board must reassess and update (2) as necessary and at least every ten years.

History

Statutory/Other Authority: ORS 689.564
Statutes/Other Implemented: ORS 689.205
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0450 Drugs and Devices: Disposal

Drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0455 Drugs and Devices: Return

A Certified Oregon Pharmacy Technician or Pharmacy Technician may accept the return of a drug or device as defined by ORS 689.005 once the drug or device have been dispensed from the pharmacy if they were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, or are subject of a drug or device recall only if:

(1) An Oregon licensed Pharmacist has approved the return;

(2) The drugs or devices are accepted for destruction or disposal; and

(3) An Oregon licensed Pharmacist verifies the destruction or disposal.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.305 & 2022 HB 4034
BP 43-2022, minor correction filed 08/23/2022, effective 08/23/2022
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0460 Drugs and Devices: Take-back Program

(1) A RDSP that operates a drug take-back collection program or that participates in a drug take-back program under ORS 459A.200 to ORS 459A.266 as an authorized collector must be registered with the DEA as an authorized collector to collect controlled and non-controlled drugs for destruction.

(2) A RDSP that operates as a Drug Enforcement Agency (DEA) authorized collector must notify the board within 30 days of initiating or terminating the program and must establish and enforce policies and procedures, including but not limited to:

(b) Provision of adequate security measures, including proper installation and maintenance of the collection receptacle, tracking of liners, documentation, and key accountability; and

(3) A RDSP must inform consumers to directly deposit drugs into the collection receptacle. Pharmacy personnel must not count, sort, inventory, or otherwise handle drugs collected.

(4) A RDSP must not dispose of drugs from pharmacy stock in a collection receptacle.

(7) Any tampering with a collection receptacle, liner or theft of deposited drugs must be reported to the board in writing within one day of discovery.

(8) A RDSP must maintain all drug disposal records for a minimum of 3 years.

(9) Authorized collectors are required to comply with the following federal and state laws:

(b) OAR 340-098-0000, OAR 340-098-0010, OAR 340-098-0300, OAR 340-098-0350, OAR 340-098-0370, and OAR 340-098-0390;

(d) 21 USC 822 (v. 02/26/2026) and 21 USC 822a (v. 02/26/2026).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205 & ORS 459A.266
Statutes/Other Implemented: ORS 689.305, ORS 459A.203, ORS 459A.215 & ORS 495A.218
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0500 Policies and Procedures

(1) The Oregon licensed Pharmacist-in-charge of the RDSP Affiliated Pharmacy and the RDSP Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the RDSP. The written policies and procedures must be maintained at the RDSP Affiliated Pharmacy and the RDSP and must be available to the board upon request.

(2) The written policies and procedures must include at a minimum the responsibilities of the RDSP Affiliated Pharmacy and each RDSP including;

(a) Security;

(b) Operation, testing and maintenance of the telepharmacy system;

(d) Storage of drugs;

(e) Dispensing;

(f) Oregon licensed Pharmacist supervision, direction and control of pharmacy technicians;

(g) Documenting the identity, function, location, date and time of the licensees engaging in telepharmacy;

(h) Drug and/or device procurement;

(i) Receiving of drugs and/or devices;

(j) Delivery of drugs and/or devices;

(k) Utilization of Oregon licensed Pharmacist (i.e. DUR, Counseling);

(l) Recordkeeping;

(m) Patient confidentiality;

(n) On-site inspection by an Oregon licensed Pharmacist;

(o) Continuous quality improvement;

(p) Plan for discontinuing and recovering services if telepharmacy system disruption occurs;

(q) Training: initial and ongoing; and

(r) Interpretation, translation and prescription reader services.

(3) If non-prescription drugs are offered for sale at the RDSP, the policies and procedures must outline the process for the Oregon licensed Pharmacist counseling and advice.

(4) If non-sterile preparations are compounded at the RDSP, the policies and procedures must meet the requirements of OAR 855-045.

(5) If controlled substances are stored at the RDSP, the policies and procedures must include the following processes:

(a) Reviewing of controlled substance prescriptions for unauthorized alterations and inspected for legitimacy by the Oregon licensed Pharmacist during inspection visits;

(b) Maintaining an accurate controlled substance perpetual inventory for all controlled substances that are stocked at the RDSP; and

(6) A RDSP Affiliated Pharmacy that provides remote pharmacy services through a telepharmacy system at a RDSP must review its written policies and procedures every 12 months, revise them if necessary, and document the review.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0550 Records: General Requirements

(1) The recordkeeping requirements OAR 855-139 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three years and made available to the board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) The RDSP must maintain all required records unless these records are maintained in the RDSP Affiliated Pharmacy.

(3) Records retained by the Drug Outlet must include, but are not limited to:

(a) Patient profiles and records;

(b) Date, time and identification of each individual and activity or function performed;

(c) If filling prescriptions, date, time and identification of the licensee and the specific activity or function of the person performing each step in the dispensing process;

(d) Controlled substance inventory and reconciliation;

(e) Oregon licensed Pharmacist physical inspection of RDSP;

(f) Audiovisual communication system testing and individual training on use of the audiovisual communication system;

(g) Still image capture and store and forward images must be retained according to (1);

(h) Data, telephone audio and surveillance system data must be retained for 6 months; and

(i) Any errors or irregularities identified by the quality improvement program.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.508
BP 17-2022, amend filed 04/20/2022, effective 04/20/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0555 Records: Patient

A patient record system must be maintained by pharmacies for all patients for whom a prescription drug is dispensed. The patient record system must provide information necessary for the dispensing Oregon licensed Pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing. The Pharmacist must make a reasonable effort to obtain, record, and maintain the following information:

(1) Full name of the patient for whom the drug is intended;

(2) Address and telephone number of the patient;

(3) Patient's date of birth;

(4) Patient's gender;

(5) Patient’s preferred language for communication and prescription labeling;

(6) Chronic medical conditions;

(8) Known allergies, drug reactions, and drug idiosyncrasies; and

(9) If deemed relevant in the Oregon licensed Pharmacist's reasonable professional judgment:

(a) Oregon licensed Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug; and

History

Statutory/Other Authority: ORS 689.205 & 2021 HB 2359
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.508 & 2021 HB 2359
BP 29-2022, amend filed 06/15/2022, effective 09/01/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0560 Patients Access to Pharmacy Records

(2) For the purpose of this rule, “health information in the pharmacy record” means any oral, written or electronic information in any form or medium that is created or received and relates to:

(a) The past, present, or future physical or mental health of the patient.

(b) The provision of healthcare to the patient.

(a) Information which was obtained from someone other than a healthcare provider under a promise of confidentiality and access to the information would likely reveal the source of the information;

(b) Psychotherapy notes;

(c) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding; and

(d) Other reasons specified by federal regulation.

(4) Registrants who have permanently closed must notify patients according to OAR 855-139-0145.

(5) A reasonable cost may be imposed for the costs incurred in complying with the patient’s request for health information pursuant to ORS 192.563.

(6) A patient may not be denied summaries or copies of pharmacy records because of inability to pay.

(7) Requests for pharmacy records must be complied with within a reasonable amount of time not to exceed 30 days from the receipt of the request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 192.553, ORS 192.556, ORS 192.558, ORS 192.563, ORS 192.566 & ORS 689.155
BP 47-2022, minor correction filed 11/17/2022, effective 11/17/2022
BP 32-2022, adopt filed 06/15/2022, effective 06/16/2022

Or. Admin. R. 855-139-0600 Prohibited Practices: General

A Retail Drug Outlet RDSP must not:

(1) Allow a Certified Oregon Pharmacy Technician or Pharmacy Technician to:

(a) Refuse a request from a patient, patient’s agent, or practitioner to interact with a Pharmacist; and

(b) Administer a vaccine.

(2) Advertise or otherwise purport to operate as a pharmacy or to advertise or purport to provide pharmacy services unless the person is registered with the board pursuant to ORS 689.305;

(3) Compound sterile preparations; or

(4) Repackage drugs.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.700
Statutes/Other Implemented: ORS 689.315, ORS 689.155, ORS 689.700 & 2023 HB 2486
BP 28-2023, amend filed 12/19/2023, effective 01/01/2024
BP 54-2022, amend filed 12/20/2022, effective 12/21/2022
BP 38-2022, temporary amend filed 06/22/2022, effective 07/01/2022 through 12/27/2022
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0602 Prohibited Practices: Disclosure of Patient Information

A Retail Drug Outlet RDSP may not:

(1) Allow a licensee or registrant of the board who obtains any patient information to disclose that information to a third party without the consent of the patient except as provided in (2) of this rule.

(2) A licensee may disclose patient information:

(a) To the board;

(b) To a practitioner, Oregon licensed Pharmacist, Intern, Pharmacy Technician, or Certified Oregon Pharmacy Technician, if disclosure is authorized by an Oregon-licensed Pharmacist who reasonably believes that disclosure is necessary to protect the patient’s health or well-being; or

(d) As permitted pursuant to federal and state patient confidentiality laws; or

(e) To the patient or to persons as authorized by the patient.

(3) Allow a licensee or registrant of the board to access or obtain any patient information unless it is accessed or obtained for the purpose of patient care.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0650 Grounds for Discipline

(1) Unprofessional conduct as defined in OAR 855-006-0020;

(2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that:

(a) Is false, fraudulent, deceptive, or misleading; or

(b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee.

(3) Failure to provide a working environment that protects the health, safety and welfare of a patient which includes but is not limited to:

(a) Sufficient personnel to prevent fatigue, distraction or other conditions that interfere with an Oregon licensed Pharmacist’s ability to practice with reasonable competency and safety.

(b) Appropriate opportunities for uninterrupted rest periods and meal breaks.

(c) Adequate time for an Oregon licensed Pharmacist to complete professional duties and responsibilities including, but not limited to:

(A) Drug Utilization Review;

(B) Verification of the accuracy of a prescription;

(D) All other duties and responsibilities of an Oregon licensed Pharmacist as specified in OAR 855-115.

(4) Introducing external factors such as productivity or production quotas or other programs to the extent that they interfere with the ability to provide appropriate professional services to the public.

(5) Incenting or inducing the transfer of a prescription absent professional rationale.

History

Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.155
BP 34-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0710 Service: Epinephrine- Definitions

The following words and terms, when used in OAR 855-139-0710 through OAR 855-139-0715 have the following meanings, unless the context clearly indicates otherwise.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.681
Statutes/Other Implemented: ORS 689.681 & ORS 689.155
BP 5-2022, minor correction filed 01/03/2022, effective 01/03/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0715 Service: Epinephrine- General Requirements

(1) A Certified Oregon Pharmacy Technician or Pharmacy Technician may prepare for Oregon licensed Pharmacist verification an order for epinephrine to be used by trainees to treat an anaphylactic reaction. Trainees must be 18 years of age or older and must have responsibility for or contact with at least one (1) other person as a result of the trainee’s occupation or volunteer status, such as, but not limited to, a camp counselor, scout leader, forest ranger, school employee, tour guide or chaperone.

(a) Statement of Completion; and

(b) Authorization to Obtain Epinephrine.

(3) Acquisition of epinephrine from a pharmacy to be used for the treatment of allergic emergencies may occur in the following manners:

(a) An Oregon licensed Pharmacist may dispense epinephrine to a trainee upon presentation of the Statement of Completion and Authorization to Obtain Epinephrine certificate to a pharmacy when:

(A) An Oregon licensed Pharmacist may generate a prescription for and dispense an emergency supply of epinephrine for not more than one adult and one child dose package, as specified by the supervising professional whose name, signature, and license number appear on the Authorization to Obtain Epinephrine certificate.

(B) The Oregon licensed Pharmacist who generates the hardcopy prescription for epinephrine in this manner must reduce the prescription to writing and file the prescription in a manner appropriate for a non-controlled substance.

(C) Once the Oregon licensed Pharmacist generates the epinephrine prescription, the Certified Oregon Pharmacy Technician or Pharmacy Technician must write in the appropriate space provided on the Authorization to Obtain Epinephrine certificate the date and the number of doses dispensed, the Oregon licensed Pharmacist must verify the accuracy of data written on the certificate and the Certified Oregon Pharmacy Technician or Pharmacy Technician must return the completed certificate to the trainee.

(F) Upon completion of the training, the trainee will receive a new Statement of Completion and Authorization to Obtain Epinephrine certificate, with a valid duration of three (3) years.

(b) A Certified Oregon Pharmacy Technician or Pharmacy Technician may prepare for Oregon licensed Pharmacist verification epinephrine to be dispensed to an entity when:

(A) The epinephrine is acquired by a valid prescription presented to the pharmacy;

(B) The prescription identifies the entity as the patient for the purpose of prescribing and labeling the prescription.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.155, ORS 433.825 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0725 Service: Expedited Partner Therapy (EPT)- Purpose

(3) The law specifies that a prescription issued in the practice of Expedited Partner Therapy is valid, even if the name of the patient the prescription is intended for is not on the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Or. Admin. R. 855-139-0730 Service: Expedited Partner Therapy (EPT) - Procedures

(1) “Expedited Partner Therapy (EPT)” means the practice of prescribing or dispensing an antibiotic drug for the treatment of a sexually transmitted disease to the partner of a patient without first examining that partner.

(3) An EPT prescription may only be dispensed for a drug that has been determined by the Oregon Health Authority (OHA) to be appropriately used for EPT.

(4) Prescription;

(a) An EPT treatment protocol must conform to the following:

(A) It must include a prescription for each named or unnamed partner of the patient;

(B) It must contain a handwritten or electronic signature of the prescribing practitioner;

(i) Write “for EPT,” or a similar notation, on the face of the prescription;

(ii) For a verbal order, the practitioner must identify the prescription as an “EPT Prescription,” or similar identification;

(iii) The practitioner must identify the prescription for each partner either by including the name of the patient, such as “John Doe – Partner 1” or by labeling the prescription as “EPT Partner”.

(b) An EPT Prescription expires 30 days after the date written;

(d) If any component of the prescription is missing, the Oregon licensed Pharmacist must contact the prescriber or the prescriber’s agent and must record the additional information on the prescription.

(e) A patient may give the prescription to each unnamed partner for that person to fill at a pharmacy of their choice; or the patient may give all prescriptions to one pharmacy and then give the dispensed drugs to each unnamed partner.

(5) Labeling;

(a) The Certified Oregon Pharmacy Technician or Pharmacy Technician must label the drug for the named patient in accordance with normal procedures as specified in the other rules of this division, however when either the patient or partner is unnamed, the pharmacy may create a unique identifier and use that instead of a name for both labeling and record keeping purposes.

(b) The Oregon licensed Pharmacist must assign a separate and unique identifier to each prescription and clearly identity this number on each corresponding prescription label.

(6) Counseling; The Oregon licensed Pharmacist is not required to obtain an EPT patient’s or partner’s name, address, or demographics; however, the Oregon licensed Pharmacist must:

(a) Provide counseling in the form of written patient information to accompany each prescription for each partner and ask the patient about any known allergies or other drugs being taken by each partner. The Oregon licensed Pharmacist should advise the patient to encourage each partner to call the Pharmacist before taking the drug if they have experienced any adverse effect from a drug in the past or if they are taking other drugs;

(b) Document counseling.

(7) Records; All documentation required by this rule must be attached to the prescription and must be referenced to each partner’s prescription. Such documentation must be retained in accordance with the other rules in this division and must be made available to the board upon request.

History

Statutory/Other Authority: ORS 689.205 & 2022 HB 4034
Statutes/Other Implemented: ORS 689.505 & 2022 HB 4034
BP 36-2022, amend filed 06/15/2022, effective 06/16/2022
BP 26-2022, temporary amend filed 04/22/2022, effective 04/22/2022 through 10/18/2022
BP 43-2021, adopt filed 12/16/2021, effective 01/01/2022

Division 141 PHARMACY PRESCRIPTION KIOSK

Or. Admin. R. 855-141-0001 Purpose and Scope

The purpose of OAR 855-141 is to provide minimum requirements for the operation of a Pharmacy Prescription Kiosk (PPK) by a PPK Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0005 Definitions

(1) “Pharmacy Prescription Kiosk Affiliated Pharmacy” or “PPK Affiliated Pharmacy” means a Retail Drug Outlet Pharmacy registered in Oregon that operates a Pharmacy Prescription Kiosk.

(2) “Pharmacy Prescription Kiosk” or “PPK” means an Oregon location registered as a Retail Drug Outlet Pharmacy Prescription Kiosk using a mechanical system that stores and dispenses patient-specific prescription and non-prescription drugs, devices, and related supplies.

(3) “Telepharmacy system” means a system of telecommunications technologies that enables documenting and recording of the delivery of pharmacy services at a remote location by an electronic method.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0010 Registration: General

(1) Each PPK located in Oregon must be registered as a Retail Drug Outlet PPK.

(2) A controlled substance registration will not be issued for a Retail Drug Outlet PPK.

(3) A Retail Drug Outlet PPK application must specify the PPK Affiliated Pharmacy and cannot operate without a PPK Affiliated Pharmacy that is registered by the board as a Retail Drug Outlet Pharmacy.

(4) Each registration renewal application must be accompanied by the annual fee and must contain the same information required in OAR 855-141-0015(2) and additional information requested by the board.

(5) The initial and annual registration fee for a PPK is set out in OAR 855-110.

(6) A Retail Drug Outlet PPK registration expires March 31, annually. If the annual registration fee in OAR 855-110 is not paid by March 31 of the current year, a late fee as set out in OAR 855-110 must be included with the application for registration renewal.

(7) The registration is not transferable.

(8) The registration fee cannot be prorated.

(9) A PPK must not operate until a certificate of registration has been issued by the board.

(10) The PPK Affiliated Pharmacy registration and the PPK registration must be on display at both the PPK Affiliated Pharmacy and at the PPK.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225, ORS 689.305 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0015 Registration: Application

(1) An application for registration of a PPK may be accessed on the board website.

(2) The board may issue a license to a qualified applicant after the receipt of:

(a) A completed application including;

(A) Payment of the fee prescribed in OAR 855-110;

(B) A floor plan drawn to scale with the location of the:

(i) PPK within the building;

(ii) Surveillance system cameras; and

(iii) Alarm system panel; and

(C) A detailed explanation and supporting documentation relating to the PPK Affiliated Pharmacy regarding all conduct that is required to be disclosed;

(b) The PPK Affiliated Pharmacy name, Retail Drug Outlet registration number and Pharmacist-in-Charge; and

(c) Indicate the owner, trustee, receiver, or other person applying for the registration. When an applicant is not the owner of the pharmacy, the application must indicate the owner and the applicant's affiliation with the owner:

(A) If the owner is a partnership or other multiple owners, the names of the partners or persons holding the five largest interests must be indicated on the application; and

(B) If the owner is a corporation, the name filed must be the same as filed with the Secretary of State. The name of the corporation, the names of the corporation officers and the names of the stockholders, if applicable, who own the five largest interests must be indicated on the application.

(3) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

(4) A registration may be denied for any of the following:

(a) Failure to completely and accurately answer all questions on the application for registration or renewal of registration;

(b) Failure to disclose any requested information on the application or requests resulting from the application; or

(6) The certificate of registration for a PPK must be issued prior to opening.

(7) The registration for a PPK expires March 31 in each year and may be renewed annually.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0020 Registration: Change of Physical Address or Location

(1) A change of physical address of the PPK requires:

(a) Submission of a new PPK application a minimum of 15 days prior to occurrence;

(b) Registration fee;

(d) Issuance of a new certificate of registration.

(2) A change of location at the same physical address of the PPK requires the submission of an updated floor plan drawn to scale a minimum of 15 days prior to the change with the new location of the:

(a) PPK within the building;

(b) Surveillance system cameras; and

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0030 Non-Resident PPK Affiliated Pharmacies

(1) For the purpose of these rules, a non-resident pharmacy includes a PPK Affiliated Pharmacy located outside of Oregon and providing pharmacy services under OAR 855-141 with a PPK located in Oregon.

(2) Each non-resident PPK Affiliated Pharmacy must be registered with the Oregon Board of Pharmacy as a Retail Drug Outlet Pharmacy.

(3) To qualify for registration under these rules, every non-resident PPK Affiliated Pharmacy must be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence.

(4) The Pharmacist-in-Charge (PIC) of the non-resident PPK Affiliated Pharmacy is the PIC for each PPK.

(5) The PIC is responsible for annually completing a self-inspection using the board's PPK Self-Inspection Form prior to July 1.

(6) The PIC must comply with the requirements of OAR 855-115-0210.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225 & ORS 689.527
BP 35-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 12-2023, amend filed 06/13/2023, effective 08/01/2023
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0050 Personnel

(1) A PPK must have a PIC at all times.

(2) Prior to utilizing a PPK, a Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician must have completed a training program on the proper use of the PPK.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0100 Security

(1) The PPK Affiliated Pharmacy, the PPK, PIC of the PPK Affiliated Pharmacy and each Pharmacist supervising the PPK is responsible for the security of the PPK including provisions for adequate safeguards against loss, theft or diversion of prescription and non-prescription drugs, devices, and related supplies, and records for such drugs, devices and related supplies.

(2) The PPK Affiliated Pharmacy must ensure the PPK:

(a) Is placed in a secure indoor location that is climate controlled and protected from the elements;

(b) Is securely fastened to a permanent structure so that it cannot be removed;

(c) Stores prescription and non-prescription drugs, devices, and related supplies in compliance with the provisions of OAR 855-141-0125;

(3) The PPK must be secured to prevent access when:

(a) There is no Pharmacist supervising and authorizing access in real-time to the PPK; or

(b) There is no Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician employed by the PPK Affiliated Pharmacy present at the PPK; or

(4) A record must be maintained with the name and Oregon license number of each person accessing the PPK.

(5) An Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician must only access the PPK when a Pharmacist is supervising the licensee and has authorized access to the PPK in real-time.

(6) Unlicensed personnel (e.g. service or repair personnel) must only access the PPK when escorted and continuously observed by a licensee who is authorized by the Pharmacist who is supervising and authorizing access to the PPK in real-time.

(7) Minimum security methods must include a properly functioning:

(a) Alarm system at the PPK and real-time notification to a Pharmacist from the PPK Affiliated Pharmacy if unauthorized access occurs;

(b) Electronic entry system that is controlled by a Pharmacist and records the:

(A) Identification of the Pharmacist authorizing each access and securing the PPK;

(B) Identification of the Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the PPK; and

(c) Surveillance system that utilizes continuously accessible and recorded video between the PPK Affiliated Pharmacy and the PPK. The system must provide a clear view of the entire PPK including its access points.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0120 Drug: Procurement

A PPK must only receive prescription and non-prescription drugs, devices, and related supplies from the PPK Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 6879.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0125 Drug: Storage

(1) A PPK must maintain proper storage of all drugs. This includes, but is not limited to the following:

(a) All drugs must be stored according to manufacturer’s published or USP guidelines.

(b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

(d) A PPK must quarantine drugs which are outdated, adulterated, misbranded or suspect.

(2) A PPK must store all drugs at the proper temperature according to manufacturer’s published guidelines (pursuant to FDA package insert or USP guidelines).

(a) All drug refrigeration systems must:

(A) Maintain refrigerated products between 2 to 8 °C (35.6 to 46.4°F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer.

(B) Utilize a centrally placed, accurate, and calibrated thermometer;

(b) A PPK must adhere to a monitoring plan, which includes, but is not limited to:

(A) Documentation of training of all personnel;

(B) Maintenance of manufacturer recommended calibration of thermometers;

(D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses;

(E) Documentation of action(s) taken, including decision to quarantine product for destruction, or determination by a Pharmacist that it is safe for continued use. This documentation must include details of the information source;

(F) A written emergency action plan;

(G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment; and

(H) Documentation and review of temperature recordings at least once every 28 days by the Pharmacist at the time of in person physical inspection.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.325
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0130 Drug: Loss

A PPK and its PPK Affiliated Pharmacy must:

(1) Ensure that disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices are reported to the board immediately.

(2) Ensure that confirmed significant drug loss or any loss related to suspected drug theft is reported to the board within one business day.

History

Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0145 Outlet: Closure

A PPK Affiliated Pharmacy must notify the board a minimum of 15 days prior to discontinuing operation of a PPK. Notification must include the:

(1) Final disposition of drugs stored in the PPK including:

(a) Name and location where the drugs are transferred;

(b) Name and location where destruction occurred; and

(2) Provide the board with:

(a) Oregon Board of Pharmacy state license(s); and

(b) Signed statement giving the effective date of closure.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0150 Outlet: Sanitation

A PPK and its PPK Affiliated Pharmacy must ensure the PPK is kept clean.

History

Statutory/Other Authority: ORS 689.305
Statutes/Other Implemented: ORS 689.305 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0155 Outlet: Minimum Equipment Requirements

(1) Each Oregon PPK must have the following:

(a) Appropriate equipment and supplies as required by Oregon Revised Statutes, Oregon Administrative Rules, United States Code, Code of Federal Regulations, and standards adopted by reference (e.g. USP) based on services offered by the PPK outlet;

(b) Appropriate equipment to maintain the proper storage of drugs;

(c) Signage in a location easily seen by the public at the PPK where prescription and non-prescription drugs, devices, and related supplies are dispensed:

(A) Stating “The (insert name of PPK Affiliated Pharmacy) may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on this sign must be in block letters not less than one inch in height.

(B) Providing notification in each of the languages required in OAR 855-141-0410 of the right to free, competent oral interpretation and translation services, including translated prescription labels, for patients who are of limited English proficiency, in compliance with federal and state regulations if the pharmacy dispenses prescriptions for a patient's self-administration;

(C) Stating "This location is a Pharmacy Prescription Kiosk, supervised by a Pharmacist from (insert name of PPK Affiliated Pharmacy, address, and telephone number)." The printing on the sign must be in block letters not less than one inch in height; and

(D) Providing notification of accurate hours of operation at the PPK; and

(d) Additional equipment and supplies that are determined as necessary by the PPK Affiliated Pharmacy or PIC.

(e) As an alternative to posting the required signage, PPK's that utilize an electronic video monitor that the patient is required to acknowledge prior to retrieving medication from the PPK may display the information required by sub-paragraphs (1)(c)(A) - (D) electronically.

(2) Failure to have, use and maintain required equipment constitutes unprofessional conduct under ORS 689.405(1)(a).

History

Statutory/Other Authority: ORS 689.205 & ORS 689.654
Statutes/Other Implemented: ORS 689.155, ORS 689.515, ORS 689.654 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0200 Outlet: General Requirements

(1) The PPK Affiliated Pharmacy and its PIC are responsible for all operations and enforcing all policies and procedures of the PPK.

(2) A PPK Affiliated Pharmacy may operate more than one PPK.

(3) A PPK Affiliated Pharmacy must be less than 120 miles apart via the shortest surface street route from the PPK.

(4) A PPK and its PPK Affiliated Pharmacy must:

(a) Have the same owner; or

(b) Have a written contract that specifies:

(A) The services to be provided by each licensee and registrant;

(B) The responsibilities of each licensee and registrant; and

(c) Ensure prescription and non-prescription drugs, devices, and related supplies are dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125, and OAR 855-141;

(d) Ensure that the PPK Affiliated Pharmacy prevents duplicate dispensing of a prescription;

(e) Comply with all applicable federal and state laws and rules;

(f) Ensure that there is an PIC who is responsible for all operations and enforcing all policies and procedures of the PPK;

(g) Designate in writing the Pharmacists, Interns, Certified Oregon Pharmacy Technicians and Pharmacy Technicians authorized to access the PPK;

(h) Utilize complete chain of custody tracking;

(i) Train the Pharmacists, Interns, Certified Oregon Pharmacy Technicians and Pharmacy Technicians in the operation of the telepharmacy system and PPK and document the training;

(j) Develop, implement and enforce a continuous quality improvement program for dispensing services from a PPK designed to objectively and systematically:

(A) Monitor, evaluate, document the quality and appropriateness of patient care;

(B) Improve patient care; and

(k) Provide a telephone number that a patient, patient’s agent or prescriber may use to contact the Pharmacist from the PPK Affiliated Pharmacy; and

(l) Develop, implement and enforce a process for an in person physical inspection of the PPK by a Pharmacist at least once every 28 days or more frequently as deemed necessary by the PIC of the PPK Affiliated Pharmacy. The inspection must utilize the PPK self-inspection form, be documented, and records retained.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 36-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0205 Outlet: Technology

A PPK and its PPK Affiliated Pharmacy must:

(1) Utilize a shared telepharmacy system and have appropriate technology or interface to allow access to information required to dispense prescription and non-prescription drugs, devices, and related supplies and counsel the patient or patient’s agent;

(2) Utilize barcode, radio-frequency identification or quick response code technology for stocking, destocking and dispensing at the PPK;

(3) Test the telepharmacy system and PPK and verify the unit is operable and functioning in all aspects in accordance with minimum acceptable system or unit design specifications before dispensing prescription and non-prescription drugs, devices, and related supplies and after an upgrade or change is made to the system. The PPK Affiliated Pharmacy must make the results of such testing available to the board upon request; and

(4) Develop, implement and enforce a plan for routine maintenance of the telepharmacy system and PPK.

(5) Develop, implement and enforce a plan for responding to and recovering from an interruption of service where the PPK is not fully operational and functioning.

(6) For verification of prescriptions, use still image capture or store and forward with a camera that is of sufficient quality and resolution so that the Pharmacist from the PPK Affiliated Pharmacy can visually identify each:

(a) Source container including manufacturer, name, strength, lot, and expiration;

(b) Dispensed product including the imprint and physical characteristics if applicable;

(7) Utilize barcode, radio-frequency identification or quick response code technology to record information in (6) if available.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0210 Outlet: Supervision

A PPK and its PPK Affiliated Pharmacy must:

(1) Ensure prescription and non-prescription drugs, devices, and related supplies are only dispensed at the PPK if a Pharmacist is available for patient consultation and the PPK is fully operational.

(2) Ensure that stocking and destocking of prescription and non-prescription drugs, devices, and related supplies in a PPK is completed under the supervision, direction, and control of a Pharmacist.

(3) Ensure that a Pharmacist verifies and documents that:

(a) All prescription and non-prescription drugs, devices, and related supplies were correctly stocked into the PPK;

(b) All prescription and non-prescription drugs, devices, and related supplies destocked from the PPK were returned to the PPK Affiliated Pharmacy;

(d) Records are maintained per OAR 855-141-0550.

(4) Drugs and devices destocked from a PPK that satisfy the requirements of this section may be returned to stock at the PPK Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0215 Outlet: Pharmacist Utilization

A PPK and its PPK Affiliated Pharmacy must ensure that a prescription drug or device is not released from the PPK until the Pharmacist or Intern has:

(1) Provided counseling when required under OAR 855-115-0145 or when requested by the patient or patient’s agent; and

(2) Documented the interaction.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 37-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0225 Outlet: Controlled Substances

Controlled substances must not be stored in the PPK.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0300 Prescription: General Requirements

(1) Prescriptions, prescription refills, and drug orders must be correctly dispensed in accordance with the prescribing practitioner's authorization.

(2) Each PPK Affiliated Pharmacy must document the following information for each prescription:

(a) The name and date of birth of the patient for whom the drug is prescribed, unless for an animal.

(b) If for an animal, the name of the patient, name the owner and the species of the animal.

(d) The name, strength, dosage forms of the substance, quantity prescribed and, if different from the quantity prescribed, the quantity dispensed;

(e) The directions for use, if given by the practitioner; and

(f) The date of filling, and the total number of refills authorized by the prescribing practitioner.

(a) For a hard copy prescription issued in writing or a prescription orally communicated over the telephone, instruction must use one of the following phrases or notations:

(A) No substitution;

(B) N.S.;

(D) Brand necessary;

(E) Medically necessary;

(F) D.A.W. (Dispense As Written); or

(G) Words with similar meaning.

(4) A PPK or Pharmacist filling a prescription or order for a biological product must not substitute a biosimilar product for the prescribed biological product unless:

(a) The biosimilar product has been determined by the United States Food and Drug Administration to be interchangeable with the prescribed biological product;

(b) The prescribing practitioner has not designated on the prescription that substitution is prohibited;

(c) The patient for whom the biological product is prescribed is informed of the substitution prior to dispensing the biosimilar product;

(d) The PPK Affiliated Pharmacy or Pharmacist provides written, electronic or telephonic notification of the substitution to the prescribing practitioner or the prescribing practitioner’s staff within three business days of dispensing the biosimilar product; and

(5) The PPK must dispense prescriptions accurately and to the correct party.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.522
Statutes/Other Implemented: ORS 689.505, ORS 689.515 & ORS 689.522
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0305 Prescription: Tamper-resistant

When the use of a tamper-resistant prescription is required by any federal or state law or rule, the term “tamper-resistant” has the meaning as defined in OAR 855-006-0005.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 43-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0310 Prescription: Verification of Authenticity

Alteration of a written prescription, other than by a Pharmacist's or practitioner's authorization, in any manner constitutes an invalid order unless verified with the prescriber.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151 & ORS 689.155
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0315 Prescription: Refills

(2) If the practitioner is not available and in the reasonable professional judgment of the Pharmacist from the PPK Affiliated Pharmacy an emergency need for the refill of a prescription drug has been demonstrated, the Pharmacist may authorize the PPK to prepare for Pharmacist verification a sufficient quantity of the drug consistent with the dosage regimen, to last until a practitioner can be contacted for authorization, but not to exceed a 72-hour supply. The practitioner must be promptly notified of the emergency refill.

(3) Each refilling of a prescription must be accurately documented, readily retrievable, and uniformly maintained for three years by the PPK Affiliated Pharmacy. This record must include;

(a) Date, time and identification of each individual and activity or function performed;

(b) Name of the patient;

(d) Date of refill; and

(e) Quantity dispensed.

(4) Refill quantities may be combined into a single filling if the prescription is not for a psychotherapeutic drug and the prescriber is notified of the change.

(5) A PPK may only dispense a prescription refill upon request of the patient or patient’s agent. A request specific to each prescription medication is required.

(6) A prescription must be refilled in context with the approximate dosage schedule unless specifically authorized by the prescriber.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & ORS 689.515
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0320 Prescription: Expiration

This section of rule addresses the expiration date of the prescription and not the expiration date of the drug.

(1) After one year from date of issue, a prescription for a non-controlled substance becomes invalid and must be re-authorized by the prescriber.

(2) When “PRN” is used as a prescription refill designation:

(a) The abbreviation means that the prescription can be refilled in proper context for a period of one year.

(b) In conjunction with a definite time period, or a specific number of refills, the prescription can be refilled in proper context for a period not to exceed one year.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & ORS 689.515
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0325 Prescription: Transfers

(1) Prescriptions may be transferred between pharmacies for the purpose of an initial or refill dispensing provided that:

(a) The prescription is invalidated at the sending pharmacy; and

(b) The receiving pharmacy obtains all the information constituting the prescription and its relevant refill history in a manner that ensures accuracy and accountability.

(2) Prescriptions for controlled substances can only be transferred one time.

(3) Pharmacies using the same electronic prescription database are not required to transfer prescriptions for dispensing purposes.

(4) An Oregon registered pharmacy must transfer a prescription:

(a) To a pharmacy requesting a transfer on behalf of the patient or patient's agent unless the transfer would compromise patient safety or violate state or federal laws or rules; and

(b) By the end of the next business day of the request.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0345 Dispensing: General Requirements

The PPK Affiliated Pharmacy must:

(1) Ensure each prescription, prescription refill, and drug order is correctly dispensed from the PPK in accordance with the prescribing practitioner's authorization; and

(2) Ensure the PPK dispenses prescriptions accurately and to the correct party.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0350 Dispensing: Containers

Each PPK must dispense a drug in a new container that complies with the current provisions of the Poison Prevention Packaging Act in 16 CFR 1700 (v. 01/01/2025), 16 CFR 1701 (v. 01/01/2025), and 16 CFR 1702 (v. 01/01/2025).

[Publications: Publications referenced are available for review at the agency.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0400 Labeling: General Requirements

Prescriptions must be labeled with the following information:

(1) Name and address of the PPK.

(2) Date;

(3) Identifying number;

(4) Name of patient;

(5) Name of drug, strength, and quantity dispensed; when a generic name is used, the label must also contain the identifier of the manufacturer or distributor;

(6) Directions for use by the patient;

(7) Name of practitioner;

(8) Such other and further accessory cautionary information as required for patient safety;

(9) An expiration date after which the patient should not use the drug or medicine. Expiration dates on prescriptions must be the same as that on the original container or one year from the date the drug was originally dispensed and placed in the new container, whichever date is earlier. Any drug expiring before the expected length of time for course of therapy must not be dispensed.

(10) Any dispensed prescription medication, other than those in unit dose or unit of use packaging, must be labeled with its physical description, including any identification code that may appear on tablets and capsules; and

(11) Name, address and telephone number of the PPK Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.505 & ORS 689.515
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0405 Labeling: Prescription Reader Accessibility

(1) A PPK must notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information.

(2) If a person informs the PPK Affiliated Pharmacy that the person identifies as a person who is blind, the pharmacy must provide to the person a prescription reader that is available to the person for at least the duration of the prescription, must confirm it is appropriate to address the person’s visual impairment, and must ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider.

(3) The PPK Affiliated Pharmacy must ensure a Pharmacist verifies and documents that the correct electronic label was placed on each prescription container and that the audio information produced by the prescription reader is accurate prior to dispensing the prescription.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.561
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0410 Labeling: Limited English Proficiency and Accessibility

(1) Upon request of a prescriber, patient or a patient’s agent, each drug dispensed by the PPK for a patient’s self-administration must bear a label in both English and the language requested for an individual with limited English proficiency, defined as a person who is not fluent in the English language. This does not apply to a drug outlet dispensing a drug intended for administration by a healthcare worker.

(2) When dispensing a drug under (1), the PPK must provide labels and informational inserts in both English and one of the following languages:

(a) Spanish;

(b) Russian;

(d) Arabic;

(e) Chinese (simplified);

(f) Vietnamese;

(g) Farsi;

(h) Korean;

(i) Romanian;

(j) Swahili;

(k) Burmese;

(l) Nepali;

(m) Amharic; and

(n) Pashtu.

(3) The board must reassess and update (2) as necessary and at least every ten years.

History

Statutory/Other Authority: ORS 689.564
Statutes/Other Implemented: ORS 689.205
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0450 Drugs and Devices: Disposal

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0455 Drug and Devices: Return

A PPK or PPK Affiliated Pharmacy may accept the return of a drug or device as defined by ORS 689.005 once the drug or device have been dispensed from the PPK if they were dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, or are subject of a drug or device recall only if:

(1) A Pharmacist has approved the return;

(2) The drugs or devices are accepted for destruction or disposal; and

(3) A Pharmacist verifies the destruction or disposal.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.305
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0500 Policies and Procedures

(1) The PIC of the PPK Affiliated Pharmacy and the PPK Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the PPK. The written policies and procedures must be maintained at the PPK Affiliated Pharmacy and must be available to the board upon request.

(2) The written policies and procedures must include at a minimum the responsibilities of the PPK Affiliated Pharmacy and each PPK including;

(a) Security;

(b) Operation, testing and maintenance of the telepharmacy system and the PPK;

(d) Storage of drugs;

(e) Stocking and destocking;

(f) Dispensing;

(g) Preventing duplicate dispensing;

(h) Pharmacist supervision, direction and control of and licensed personnel accessing the PPK;

(i) Documenting the identity, function, location, date and time of licensees engaging in telepharmacy and licensed personnel accessing the PPK;

(j) Utilization of Interns, Certified Oregon Pharmacy Technicians or Pharmacy Technicians;

(k) Utilization of Pharmacist (e.g. Counseling);

(l) Drug and/or device procurement

(m) Receiving of drugs and/or devices;

(n) Delivery of drugs and/or devices;

(o) Recordkeeping;

(p) Patient confidentiality;

(q) On-site inspection by a Pharmacist;

(r) Continuous quality improvement;

(s) Plan for discontinuing and recovering services if PPK disruption occurs;

(t) Training: initial and ongoing; and

(u) Interpretation, translation and prescription reader services.

(3) A PPK Affiliated Pharmacy that provides prescription and non-prescription drugs, devices, and related supplies through a PPK must review its written policies and procedures every 12 months, revise them if necessary, and document the review.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0550 Records: General Requirements

(1) The recordkeeping requirements OAR 855-141 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three years and made available to the board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) All required records for the PPK must be maintained by the PPK Affiliated Pharmacy.

(3) Records retained by the PPK Affiliated Pharmacy must include, but are not limited to:

(a) Date, time and identification of each individual and activity or function performed via the PPK;

(b) Pharmacist physical inspection of the PPK;

(d) Licensee training on the proper use of the PPK;

(e) Still image capture and store and forward images must be retained according to (1);

(f) Data and surveillance system data must be retained for 6 months; and

(g) Any errors or irregularities identified by the quality improvement program.

(4) Records of dispensing from a PPK must include the:

(a) Physical location of the PPK;

(b) Identification of the patient or patient’s agent retrieving the prescription, non-prescription drugs, and supplies;

(d) Date and time of transaction;

(e) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity;

(f) Each non-prescription drug and supply name, UPC or NDC number, and quantity; and

(g) Name of Pharmacist or Intern who provided counseling to the patient or patient’s agent, if required, documentation that the counseling was performed or that the Pharmacist or Intern accepted the patient or patient’s agent request not to be counseled.

(5) Records of stocking and destocking of prescriptions into or from a PPK must include the:

(a) Date and time;

(b) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity;

(d) Name and Oregon license number of the person stocking or destocking prescription, non-prescription drugs and supplies from the system; and

(e) Identity of the Pharmacist who verifies that the system has been accurately stocked or destocked.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.508 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0555 Records: Patient

A patient record system must be maintained by the PPK Affiliated Pharmacy for all patients for whom a prescription drug is dispensed. The patient record system must provide information necessary for the dispensing Pharmacist to identify previously dispensed drugs at the time a prescription is presented for dispensing. The Pharmacist must make a reasonable effort to obtain, record, and maintain the following information:

(1) Full name of the patient for whom the drug is intended;

(2) Address and telephone number of the patient;

(3) Patient’s age or date of birth;

(4) Patient's gender;

(5) Patient's preferred language for communication and prescription labeling;

(6) Chronic medical conditions;

(8) Known allergies, drug reactions, and drug idiosyncrasies; and

(9) If deemed relevant in the Pharmacist’s reasonable professional judgment:

(a) Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug; and

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.508
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0600 Prohibited Practices: General

A PPK must not:

(1) Allow unlicensed personnel, Certified Oregon Pharmacy Technicians or Pharmacy Technicians to ask questions of a patient or patient's agent which screen and/or limit interaction with the Pharmacist;

(2) Utilize a person to dispense or deliver a prescription and non-prescription drug, device, and any related supply directly to the patient from the PPK;

(3) Dispense drugs that require further manipulation prior to administration or dispensing (e.g. reconstitution, compounding, vaccines); and

(4) Store or dispense controlled substances.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0602 Prohibited Practices: Disclosure of Patient Information

A PPK must not:

(a) To the board;

(b) To a practitioner, Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician, if disclosure is authorized by a Pharmacist who reasonably believes that disclosure is necessary to protect the patient's health or wellbeing; or

(d) As permitted pursuant to federal and state patient confidentiality laws; or

(e) To the patient or to persons as authorized by the patient.

(2) Allow a licensee or registrant of the board to access or obtain any patient information unless it is accessed or obtained for the purpose of patient care except as provided in (1)(a)-(e) of this rule.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Or. Admin. R. 855-141-0650 Grounds for Discipline

(1) Any of the grounds listed in ORS 689.405.

(2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that:

(a) Is false, fraudulent, deceptive, or misleading; or

(b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee.

History

Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.155, ORS 689.405 & ORS 689.527
BP 50-2022, adopt filed 12/20/2022, effective 02/15/2023

Division 143 PHARMACY PRESCRIPTION LOCKER

Or. Admin. R. 855-143-0001 Purpose and Scope

The purpose of OAR 855-143 is to provide minimum requirements for the operation of a Pharmacy Prescription Locker (PPL) by a PPL Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0005 Definitions

The following words and terms, when used in OAR 855-143, have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section has the definition set out in OAR 855-006.

(1) “Pharmacy Prescription Locker Affiliated Pharmacy” or “PPL Affiliated Pharmacy” means a Retail Drug Outlet Pharmacy registered in Oregon that operates a Pharmacy Prescription Locker.

(2) “Pharmacy Prescription Locker” or “PPL” means an Oregon location registered as a Retail Drug Outlet Pharmacy Prescription Locker using a mechanical system that securely stores completed patient-specific prescription and non-prescription drugs, devices, and related supplies for pick up.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0010 Registration: General

(1) Each PPL located in Oregon must be registered as a Retail Drug Outlet PPL.

(2) A controlled substance registration will not be issued for a Retail Drug Outlet PPL.

(3) A Retail Drug Outlet PPL application must specify the PPL Affiliated Pharmacy and cannot operate without a PPL Affiliated Pharmacy that is registered by the board as a Retail Drug Outlet Pharmacy.

(4) Each registration renewal application must be accompanied by the annual fee and must contain the same information required in OAR 855-143-0015(2) and additional information requested by the board.

(5) The initial and annual registration fee for pharmacies is set out in OAR 855-110.

(6) A Retail Drug Outlet PPL registration expires March 31, annually. If the annual registration fee referred to in OAR 855-110 is not paid by March 31 of the current year, a late fee as set out in OAR 855-110 must be included with the application for registration renewal.

(7) The registration is not transferable.

(8) The registration fee cannot be prorated.

(9) A PPL may not operate until a certificate of registration has been issued by the board.

(10) The PPL Affiliated Pharmacy registration and PPL registration must be on display at both the PPL Affiliated Pharmacy and at the PPL.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225, ORS 689.305 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0015 Registration: Application

(1) An application for registration of a new PPL must include a floor plan drawn to scale with the location of the:

(a) PPL at the facility;

(b) Surveillance system cameras; and

(2) The certificate of registration for a PPL must be issued prior to opening.

(3) The application must specify the location of the PPL and must indicate the owner, trustee, receiver, or other person applying for the registration. When an applicant is not the owner of the pharmacy, the application must indicate the owner and the applicant's affiliation with the owner:

(a) If the owner is a partnership or other multiple owners, the names of the partners or persons holding the five largest interests must be indicated on the application;

(b) If the owner is a corporation, the name filed must be the same as filed with the Secretary of State. The name of the corporation, the names of the corporation officers and the names of the stockholders, if applicable, who own the five largest interests must be indicated on the application.

(4) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0020 Registration: Change of Owner, Location, or PPL Affiliated Pharmacy

(1) A change of location of the PPL Affiliated Pharmacy or location of the PPL requires:

(a) Submission of a new PPL application a minimum of 15 days prior to occurrence;

(b) Registration fee;

(d) New certificate of registration.

(2) A change in the PPL Affiliated Pharmacy or ownership of the PPL requires:

(a) Submission of a new PPL application a minimum of 15 days prior to occurrence;

(b) Registration fee;

(d) New certificate of registration.

(3) A change of ownership includes any change in the legal form of the business including additions or deletions of partners.

(4) A certificate of registration will be issued upon board approval of the application.

(5) A PPL that has changed location or ownership must not operate until the new certificate of registration has been approved and issued.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0025 Registration: Closure

A PPL Affiliated Pharmacy must notify the board a minimum of 15 days prior to discontinuing operation of a PPL. Notification must include the:

(1) Final disposition of drugs stored in the PPL including:

(a) Name and location where the drugs are transferred;

(b) Name and location where destruction occurred; and

(2) Provide the board with:

(a) Oregon Board of Pharmacy state license(s); and

(b) Signed statement giving the effective date of closure.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.305 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0030 Non-Resident PPL Affiliated Pharmacies

(1) For the purpose of these rules, a non-resident pharmacy includes a PPL Affiliated Pharmacy located outside of Oregon and providing pharmacy services to a PPL located in Oregon.

(2) Each non-resident PPL Affiliated Pharmacy must be registered with the Oregon Board of Pharmacy as a Retail Drug Outlet Pharmacy.

(3) To qualify for registration under these rules, every non-resident PPL Affiliated Pharmacy must be registered and in good standing with the Board of Pharmacy in the pharmacy's state of residence.

(4) The Oregon licensed Pharmacist-in-Charge (PIC) of the non-resident PPL Affiliated Pharmacy is the PIC for each PPL.

(5) The PIC is responsible for annually completing a self-inspection using the board's PPL Self-Inspection Form prior to July 1.

(6) The PIC must comply with the requirements of OAR 855-115-0210.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.225 & ORS 689.527
BP 40-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 12-2023, amend filed 06/13/2023, effective 08/01/2023
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0050 Personnel

(1) A PPL must have an Oregon licensed PIC at all times.

(2) Prior to utilizing a PPL, the Oregon licensed Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician must have completed a training program on the proper use of the PPL.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.151, ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0100 Security

(1) The PPL Affiliated Pharmacy, the PPL, Oregon licensed PIC of the PPL Affiliated Pharmacy and each Oregon licensed Pharmacist supervising the PPL is responsible for the security of the PPL including provisions for adequate safeguards against loss, theft or diversion of prescription and non-prescription drugs, devices, and related supplies, and records for such drugs, devices and related supplies.

(2) The PPL Affiliated Pharmacy must ensure the PPL:

(a) Is placed in a secure indoor location that is climate controlled and protected from the elements;

(b) Is securely fastened to a permanent structure so that it cannot be removed;

(c) Stores prescription and non-prescription drugs, devices, and related supplies in compliance with the provisions of OAR 855-143-0125;

(3) The PPL must be secured to prevent access when:

(a) There is no Oregon licensed Pharmacist supervising and authorizing access in real-time to the PPL; or

(b) There is no Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician employed by the PPL Affiliated Pharmacy present at the PPL; or

(4) A record must be maintained with the name and Oregon license number of each person accessing the PPL.

(5) An Intern, Certified Oregon Pharmacy Technician, and Pharmacy Technician may only access the PPL when an Oregon licensed Pharmacist is supervising the licensee and has authorized access to the PPL in real-time.

(6) Unlicensed personnel (e.g. vendor) may only access the PPL when escorted and continuously observed by a licensee who is authorized by the Oregon licensed Pharmacist who is supervising and authorizing access to the PPL in real-time.

(7) Minimum security methods must include a properly functioning:

(a) Alarm system at the PPL and real-time notification to an Oregon licensed Pharmacist of the PPL Affiliated Pharmacy if unauthorized access occurs;

(b) Electronic entry system that is controlled by an Oregon licensed Pharmacist and records the:

(A) Identification of the Oregon licensed Pharmacist authorizing access and securing the PPL;

(B) Identification of the Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician accessing and securing the PPL; and

(c) Surveillance system that utilizes continuously accessible and recorded video between the PPL Affiliated Pharmacy and the PPL. The system must provide a clear view of the entire PPL including its access points.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0120 Drug: Procurement

A PPL may only receive prescription, non-prescription drugs, devices, and related supplies from the PPL Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 475.035 & ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0125 Drug: Storage

(1) A PPL must maintain proper storage of all drugs. This includes, but is not limited to the following:

(a) All drugs must be stored according to manufacturer’s published or USP guidelines.

(b) All drugs must be stored in appropriate conditions of temperature, light, humidity, sanitation, ventilation, and space.

(d) A PPL must quarantine drugs which are outdated, adulterated, misbranded or suspect.

(2) A PPL must store all drugs at the proper temperature according to manufacturer’s published guidelines (pursuant to FDA package insert or USP guidelines).

(a) All drug refrigeration systems must:

(A) Maintain refrigerated products between 2 to 8 °C (35.6 to 46.4°F); frozen products between -25 to -10 °C (-13 to 14 °F); or as specified by the manufacturer.

(B) Utilize a centrally placed, accurate, and calibrated thermometer;

(b) A PPL must adhere to a monitoring plan, which includes, but is not limited to:

(A) Documentation of training of all personnel;

(B) Maintenance of manufacturer recommended calibration of thermometers;

(D) Documentation of excursion detail, including, but not limited to, event date and name of persons(s) involved in excursion responses;

(F) A written emergency action plan;

(G) Routine preventative maintenance and evaluation of refrigeration equipment and monitoring equipment; and

(H) Documentation and review of temperature recordings at least once every 28 days by the Oregon licensed Pharmacist at the time of in person physical inspection.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.325
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0130 Drug: Loss

A PPL and its PPL Affiliated Pharmacy must:

(1) Ensure that disasters, accidents and emergencies which may affect the strength, purity, or labeling of drugs or devices are reported to the board immediately.

(2) Ensure that confirmed significant drug loss or any loss related to suspected drug theft is reported to the board within one business day.

History

Statutory/Other Authority: ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0150 Outlet: Sanitation

A PPL and its PPL Affiliated Pharmacy must ensure the PPL is kept clean.

History

Statutory/Other Authority: ORS 689.305
Statutes/Other Implemented: ORS 689.305 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0155 Outlet: Minimum Equipment Requirements

(1) Each Oregon PPL must have the following:

(b) Appropriate equipment to maintain the proper storage of drugs;

(c) Signage in a location easily seen by the public at the PPL where prescription and non-prescription drugs, devices, and related supplies are dispensed:

(A) Stating “The (insert name of PPL Affiliated Pharmacy) may be able to substitute a less expensive drug which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve.” The printing on this sign must be in block letters not less than one inch in height.

(B) Providing notification in each of the languages required in OAR 855-143-0410 of the right to free, competent oral interpretation and translation services, including translated prescription labels, for patients who are of limited English proficiency, in compliance with federal and state regulations if the pharmacy dispenses prescriptions for a patient's self-administration;

(C) Stating "This location is a Pharmacy Prescription Locker, supervised by an Oregon licensed Pharmacist from (insert name of PPL Affiliated Pharmacy, address, and telephone number)." The printing on the sign must be in block letters not less than one inch in height; and

(D) Providing notification of accurate hours of operation at the PPL; and

(d) Additional equipment and supplies that are determined as necessary by the PPL Affiliated Pharmacy or PIC.

(e) As an alternative to posting the required signage, PPL’s that utilize an electronic video monitor that the patient is required to acknowledge prior to retrieving medication from the PPL may display the information required by sub-paragraphs (1)(c)(A) – (D) electronically.

(2) Failure to have, use and maintain required equipment constitutes unprofessional conduct under ORS 689.405(1)(a).

History

Statutory/Other Authority: ORS 689.205 & ORS 689.654
Statutes/Other Implemented: ORS 689.155, ORS 689.515, ORS 689.527 & ORS 689.654
BP 30-2022, amend filed 06/15/2022, effective 06/16/2022
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0200 Outlet: General Requirements

(1) The PPL Affiliated Pharmacy and its PIC are responsible for all operations and enforcing all policies and procedures of the PPL.

(2) A PPL Affiliated Pharmacy may operate more than one PPL.

(3) A PPL Affiliated Pharmacy must be less than 120 miles apart via the shortest surface street route from the PPL.

(4) A PPL and its PPL Affiliated Pharmacy must:

(a) Have the same owner; or

(b) Have a written contract that specifies:

(A) The services to be provided by each licensee and registrant;

(B) The responsibilities of each licensee and registrant; and

(c) Ensure each prescription and non-prescription drugs, devices, and related supplies are dispensed in compliance with OAR 855-041, OAR 855-115, OAR 855-120, OAR 855-125 and OAR 855-143;

(d) Ensure that the PPL Affiliated Pharmacy prevents duplicate dispensing of a prescription;

(e) Comply with all applicable federal and state laws and rules;

(f) Ensure that PPL Affiliated Pharmacy has received and documented consent by the patient or patient's agent for the patient’s prescription and non-prescription drugs, devices, and related supplies to be placed in the PPL;

(g) Ensure that there is an Oregon licensed PIC who is responsible for all operations and enforcing all policies and procedures of the PPL;

(h) Designate in writing the Oregon licensed Pharmacists, Interns, Pharmacy Technicians and Certified Oregon Pharmacy Technicians authorized to access the PPL;

(i) Utilize complete chain of custody tracking;

(j) Train the Oregon licensed Pharmacists, Interns, Pharmacy Technicians and Certified Oregon Pharmacy Technicians in the operation of the PPL and document the training;

(k) Develop, implement and enforce a continuous quality improvement program for dispensing services from a PPL designed to objectively and systematically:

(A) Monitor, evaluate, document the quality and appropriateness of patient care;

(B) Improve patient care; and

(l) Provide a telephone number that a patient, patient’s agent or prescriber may use to contact the Oregon licensed Pharmacist from the PPL Affiliated Pharmacy; and

(m) Develop, implement and enforce a process for an in person physical inspection of the PPL by an Oregon licensed Pharmacist at least once every 28 days or more frequently as deemed necessary by the Oregon licensed PIC of the PPL Affiliated Pharmacy. The inspection must utilize the PPL self-inspection form, be documented, and records retained.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 38-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0205 Outlet: Technology

A PPL and its PPL Affiliated Pharmacy must:

(1) Utilize a shared computer system and have appropriate technology or interface to allow access to information required to dispense prescription and non-prescription drugs, devices, and related supplies and counsel the patient or patient’s agent;

(2) Utilize barcode, radio-frequency identification or quick response code technology for stocking, destocking and dispensing at the PPL;

(3) Test the PPL and verify the unit is operable and functioning in all aspects in accordance with minimum acceptable system or unit design specifications before dispensing prescription and non-prescription drugs, devices, and related supplies and after an upgrade or change is made to the system.

The PPL Affiliated Pharmacy must make the results of such testing available to the board upon request; and

(4) Develop, implement and enforce a plan for routine maintenance of the PPL.

(5) Develop, implement and enforce a plan for responding to and recovering from an interruption of service where the PPL is not fully operational and functioning.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0210 Outlet: Supervision

A PPL and its PPL Affiliated Pharmacy must:

(1) Ensure prescription and non-prescription drugs, devices, and related supplies are only dispensed at the PPL if an Oregon licensed Pharmacist is available for patient consultation and the PPL is fully operational.

(2) Ensure that stocking and destocking of prescription and non-prescription drugs, devices, and related supplies in a PPL is completed under the supervision, direction and control of a Pharmacist.

(3) Ensure that an Oregon licensed Pharmacist verifies and documents that:

(a) All prescription and non-prescription drugs, devices, and related supplies were correctly stocked into the PPL;

(b) All prescription and non-prescription drugs, devices, and related supplies destocked from the PPL were returned to the PPL Affiliated Pharmacy;

(d) Records are maintained per OAR 855-143-0550.

(4) Drugs and devices destocked from a PPL that satisfy the requirements of this section may be returned to stock at the PPL Affiliated Pharmacy.

History

Statutory/Other Authority: ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.151, ORS 689.155, ORS 689.305 & ORS 689.527
BP 30-2022, amend filed 06/15/2022, effective 06/16/2022
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0215 Outlet: Pharmacist Utilization

A PPL and its PPL Affiliated Pharmacy must ensure that a prescription drug or device is not released from the PPL until the Oregon licensed Pharmacist or Intern has:

(1) Provided counseling when required under OAR 855-115-0145 or when requested by the patient or patient’s agent; and

(2) Documented the interaction.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 39-2024, minor correction filed 04/10/2024, effective 04/10/2024
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0220 Outlet: Non-Prescription Drugs and Supplies

If non-prescription drugs and related supplies are placed in the PPL, the PPL and its PPL Affiliated Pharmacy must ensure that only an Oregon licensed Pharmacist verifies non-prescription drugs and related supplies that will be placed in the PPL.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0225 Outlet: Controlled Substances

Controlled substances may not be stored in the PPL.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0345 Dispensing: General Requirements

The PPL Affiliated Pharmacy must:

(1) Ensure each prescription, prescription refill, and drug order is correctly dispensed by the PPL in accordance with the prescribing practitioner's authorization; and

(2) Ensure the PPL dispenses prescriptions accurately and to the correct party.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0500 Policies and Procedures

(1) The Oregon licensed PIC of the PPL Affiliated Pharmacy and the PPL Affiliated Pharmacy drug outlet is accountable for establishing, maintaining, and enforcing written policies and procedures for the PPL. The written policies and procedures must be maintained at the PPL Affiliated Pharmacy and must be available to the board upon request.

(2) The written policies and procedures must include at a minimum the responsibilities of the PPL Affiliated Pharmacy and each PPL including;

(a) Security;

(b) Operation, testing and maintenance of the PPL;

(d) Storage of drugs;

(e) Stocking and destocking;

(f) Dispensing;

(g) Preventing duplicate dispensing;

(h) Oregon licensed Pharmacist supervision, direction and control of and licensed personnel accessing the PPL;

(i) Documenting the identity, function, location, date and time of the licensed personnel accessing the PPL;

(j) Utilization of Oregon licensed Pharmacist (i.e. Counseling);

(k) Recordkeeping;

(l) Patient consent and confidentiality;

(m) On-site inspection by an Oregon licensed Pharmacist;

(n) Continuous quality improvement;

(o) Plan for discontinuing and recovering services if PPL disruption occurs;

(p) Training: initial and ongoing; and

(q) Interpretation, translation and prescription reader services.

(3) If compounded preparations are compounded at the PPL Affiliated Pharmacy and placed in the PPL the policies and procedures must meet the requirements of OAR 855-183.

(4) A PPL Affiliated Pharmacy that provides prescription and non-prescription drugs, devices, and related supplies through a PPL must review its written policies and procedures every 12 months, revise them if necessary, and document the review.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 13-2026, minor correction filed 07/09/2026, effective 07/09/2026
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0550 Records: General Requirements

(1) The recordkeeping requirements OAR 855-143 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three years and made available to the board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) All required records for the Drug Outlet PPL must be maintained by the PPL Affiliated Pharmacy.

(3) Records retained by the PPL Affiliated Pharmacy must include, but are not limited to:

(a) Date, time and identification of each individual and activity or function performed on the PPL;

(b) Oregon licensed Pharmacist physical inspection of the PPL;

(d) Licensee training on the proper use of the PPL;

(e) Still image capture and store and forward images must be retained according to (1);

(f) Data and surveillance system data must be retained for 30 days except when a PPL Affiliated Pharmacy becomes aware of an incident that requires review of surveillance data, the PPL Affiliated Pharmacy must retain the data related to that incident for 6 months from the date of review; and

(g) Any errors or irregularities identified by the quality improvement program.

(4) Records of dispensing from a PPL must include the:

(a) Physical location of the PPL;

(b) Identification of the patient or patient’s agent retrieving the prescription, non-prescription drugs, and supplies;

(d) Date and time of transaction;

(e) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity;

(f) Each non-prescription drug and supply name, UPC or NDC number, and quantity; and

(g) Name of Oregon licensed Pharmacist or Oregon licensed Intern who provided counseling to the patient or patient’s agent, if required, documentation that the counseling was performed or that the Pharmacist or Intern accepted the patient or patient’s agent request not to be counseled.

(5) Records of stocking and destocking of prescriptions into or from a PPL must include the:

(a) Date and time;

(b) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity;

(d) Name and Oregon license number of the person stocking or destocking prescription, non-prescription drugs and supplies from the system; and

(e) Identity of the Oregon licensed Pharmacist who verifies that the system has been accurately stocked or destocked.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155, ORS 689.508 & ORS 689.527
BP 30-2022, amend filed 06/15/2022, effective 06/16/2022
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0600 Prohibited Practices: General

A PPL may not:

(1) Allow unlicensed personnel, Oregon licensed Pharmacy Technicians or Certified Oregon Pharmacy Technicians to ask questions of a patient or patient's agent which screen and/or limit interaction with the Oregon licensed Pharmacist;

(2) Utilize a person to dispense or deliver a prescription and non-prescription drugs, devices, and related supplies directly to the patient;

(3) Dispense drugs that require further manipulation prior to administration or dispensing (e.g. reconstitution, compounding, vaccines); and

(4) Store or dispense controlled substances.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0602 Prohibited Practices: Disclosure of Patient Information

A Retail Drug Outlet PPL may not:

(2) A licensee may disclose patient information:

(a) To the board;

(d) As permitted pursuant to federal and state patient confidentiality laws; or

(e) To the patient or to persons as authorized by the patient.

(3) Allow a licensee or registrant of the board to access or obtain any patient information unless it is accessed or obtained for the purpose of patient care.

History

Statutory/Other Authority: ORS 475.035, ORS 689.205, ORS 689.305 & ORS 689.315
Statutes/Other Implemented: ORS 689.155 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Or. Admin. R. 855-143-0650 Grounds for Discipline

(1) Any of the grounds listed in ORS 689.405.

(2) Advertising or soliciting that may jeopardize the health, safety, or welfare of the patient including, but not be limited to, advertising or soliciting that:

(a) Is false, fraudulent, deceptive, or misleading; or

(b) Makes any claim regarding a professional service or product or the cost or price thereof which cannot be substantiated by the licensee.

History

Statutory/Other Authority: ORS 689.151, ORS 689.155, ORS 689.205 & ORS 689.225
Statutes/Other Implemented: ORS 689.155, ORS 689.405 & ORS 689.527
BP 21-2022, adopt filed 04/20/2022, effective 04/20/2022

Division 183 DRUG COMPOUNDING

Or. Admin. R. 855-183-0001 Applicability

(1) All Division 183 rules apply to sterile and non-sterile compounding of a drug for humans and animals.

(2) Entities that are located in or outside Oregon that engage in the practice of compounding a drug for dispensing, delivery or distribution in Oregon must register with the board as a Drug Outlet and comply with board regulations.

(3) Entities that are registered with the FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act in 21 USC 353b (03/05/2026) must register with the board as a Manufacturer in OAR 855-060.

(4) Compounding does not include:

(a) Mixing, reconstituting, or other such acts that are performed in accordance with directions contained in FDA-approved labeling or supplemental materials provided by the product’s manufacturer.

(b) Preparing a conventionally manufactured sterile product in accordance with the directions in the manufacturer’s FDA-approved labeling when the:

(A) Product is prepared as a single dose for an individual patient; and

(B) Labeling includes information for the diluent, the resultant strength, the container closure system and Beyond Use Date.

(c) Docking and activation of a proprietary bag and vial system in accordance with the FDA-approved labeling for immediate administration to an individual patient.

(d) The addition of flavoring to a drug intended for dispensation if the flavoring:

(A) Is inert, nonallergenic and has no effect other than imparting a flavor to the drug or

modifying the flavor of the drug; and

(B) Does not constitute more than five percent of the total volume of the drug.

[Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.]

History

Statutory/Other Authority: ORS 689.205 & ORS 689.608
Statutes/Other Implemented: ORS 689.155 & ORS 689.608
BP 8-2026, adopt filed 06/17/2026, effective 06/17/2026

Or. Admin. R. 855-183-0005 Definitions

(1) Phrases or definitions used in OAR 855-183 are the same as provided in OAR 855-006, or as included in the USP standard adopted by reference unless otherwise specified.

(2) “Compounding Area” means a location designated by the registrant that limits personnel access when activities and items related to compounding may occur.

(3) “Compounding” means the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer's labeling, or otherwise altering a drug product or bulk drug substance in accordance with a licensed practitioner’s prescription drug order for a patient specific prescription. Compounding includes the following:

(a) Preparation of drug dosage forms for both human and animal patients;

(b) Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing or ordering patterns;

(d) Manipulation of commercial products for patient-specific needs beyond FDA-approved labeling.

[Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2026, adopt filed 06/17/2026, effective 06/17/2026

Or. Admin. R. 855-183-0010 Notification Requirements

Each Drug Outlet must notify the board within 15 days of initiation of sterile compounding, non-sterile compounding or both using a form provided by the board.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2026, adopt filed 06/17/2026, effective 06/17/2026

Or. Admin. R. 855-183-0015 Requirements: General

(1) All drug compounding must adhere to the following standards of the United States Pharmacopeia (USP) and the National Formulary (NF) including:

(a) USP <795> Pharmaceutical Compounding- Non-Sterile Preparations (11/01/2023);

(b) USP <797> Pharmaceutical Compounding - Sterile Preparations (02/01/2026);

(d) USP <825> Radiopharmaceuticals - Preparation, Compounding, Dispensing, and Repackaging (01/01/2024).

(2) In addition to completing the appropriate drug outlet self-inspection form by July 1 of each year and within 15 days of becoming the Pharmacist-in-Charge (PIC), the PIC must also complete the Compounding Self-Inspection form provided by the board.

(3) All compounding records must be maintained for 3 years in accordance with OAR 855-104-0055.

(4) A pharmacist for a pharmacy or prescriber with prescribing and dispensing privileges for a Dispensing Practitioner Drug Outlet, Correctional Facility or Community Health Clinic must;

(a) Supervise compounding;

(b) Ensure only authorized personnel are in the compounding area; and

(5) Comply with all state and federal laws and rules.

(6) Effective November 1, 2027, Non-Resident Drug Outlets that prepare compounded products must be inspected and be in compliance with current USP standards. If a Drug Outlet’s home state does not inspect and require compliance with current USP standards, the Drug Outlet, prior to obtaining or renewing a license, must provide evidence to the board that the Drug Outlet is accredited, certified or received an approved inspection within the last two years as follows:

(a) Pharmacy Compounding Accreditation Board (PCAB) provided by the Accreditation Commission for Health Care (ACHC);

(b) Coalition for Compounding Excellence (CCE);

(d) The Joint Commission; or

(e) As otherwise approved by the board.

(7) The following is prohibited in the compounding area:

(a) Animal(s); and

(b) For non-sterile compounding, flooring that is not easily cleanable, is porous or particle generating.

[Publications: Publications referenced are available for review at the agency or from the United States Pharmacopoeia.]

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2026, adopt filed 06/17/2026, effective 06/17/2026

Or. Admin. R. 855-183-0020 Labeling

(1) Labeling requirements for preparation of a compounded product must follow USP <795> (11/01/2023), and USP <797> (02/01/2026).

(2) Labeling requirements for dispensing a compounded product must follow OAR 855-041, OAR 855-043, and OAR 855-139.

(3) The Drug Outlet must maintain policies and procedures in compliance with all labeling requirements referenced in this rule.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2026, adopt filed 06/17/2026, effective 06/17/2026

Or. Admin. R. 855-183-0030 Pharmacy Compounding for a Veterinarian – Non-Food Producing Animals

(1) A patient specific prescription is not required to compound drugs for a licensed veterinarian when:

(a) The request for drug compounding is submitted by a licensed veterinarian; and

(b) The compounded drug will only be dispensed for use by non-food producing animals.

(2) The drug compounded in accordance with section (1) of this rule can only be delivered directly to the licensed veterinarian or their office.

History

Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 689.155
BP 8-2026, adopt filed 06/17/2026, effective 06/17/2026