title-15•Title 15 W. Va. C.S.R.
Pharmacy Pharmacy
Series 01 Licensure and Practice of Pharmacy
W. Va. Code R. § 15-1-1 General
1.1. Scope. -- Licensure and practice of pharmacist care.
1.2. Authority -- W. Va. Code §30-5-7.
1.3. Filing date -- May 4, 2026.
1.4. Effective date -- July 1, 2026.
1.5. Sunset Provision-- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-1-2 Definitions
2.1. The following words and phrases as used in this Rule mean:
2.1.1. "Abortifacient" means any chemical or drug prescribed or dispensed with the intent of causing an abortion.
2.1.2. “Accredited School of Pharmacy" means a school of pharmacy accredited by the American Council on Pharmaceutical Education (ACPE), or a recognized school of pharmacy located outside of the United States or its territories (a foreign school of pharmacy) which pharmacy education is found by the Board to be equivalent to an ACPE accredited school by a graduate from the foreign school of pharmacy obtaining a Foreign Pharmacy Graduate Examination Committee Certificate (FPGEC) from the National Association of Boards of Pharmacy (NABP).
2.1.3. "Act" or "Uniform Controlled Substance Act" means Chapter 60A of the West Virginia Code.
2.1.4. "Administer" means the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion or any other means.
2.1.5. “Automated pharmacy system” means mechanical systems which perform operations or activities, other than compounding or administration, relative to the storage, packaging, dispensing, or distribution of medications, and which collect, control, and maintain all transaction information.
2.1.6. “Beyond-use date” means a date placed on a medication package or prescription label at the time of dispensing or repackaging that is intended to indicate the time beyond which the contents are not recommended to be used.
2.1.7. "Board" means the West Virginia Board of Pharmacy.
2.1.8. “Board authorization” means a license, registration or permit issued under W. Va. Code §30-5-1 et seq. and this rule.
2.1.9. "Compounding" means:
2.1.9.a. The preparation, mixing, assembling, packaging, or labeling of a drug or device:
2.1.9.a.1. As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/ pharmacist relationship in the course of professional practice for sale or dispensing, or
2.1.9.a.2. For the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing, and
2.1.9.b. The preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.
2.1.9.c. The following are not “compounding” and are exempt from USP 795 Compounding Standards:
2.1.9.c.1. The reconstitution of a drug pursuant to a manufacturer’s directions;
2.1.9.c.2. The act of tablet splitting, crushing, or capsule opening; except those prohibited by USP General Chapter 800 Hazardous Drugs;
2.1.9.c.3. Upon the request of the prescribing practitioner and/or the patient for whom the prescription is ordered or such patient’s agent, the addition of therapeutically inert, nonallergenic flavoring agents to a commercially manufactured product, not in excess of five percent (5%) of the preparation’s total volume;
2.1.9.c.4. The combining of commercially manufactured ready to use products under the following conditions:
2.1.9.c.4.A. No more than four (4) commercially manufactured ready-to-use products are combined;
2.1.9.c.4.B. All products combined are FDA approved;
2.1.9.c.4.C. Combining is not done in anticipation of medication orders;
2.1.9.c.4.D. USP 795 beyond use dating (BUDs) is followed;
2.1.9.c.4.E. Combining with hazardous drugs from final dosage forms, listed in NIOSH List Tables 2 and 3 requires assessment of risk, the pharmacist or pharmacy technician should wear personal protective equipment as described in USP Chapter 800 and must use compounding equipment dedicated solely for hazardous drugs;
2.1.9.c.4.F. A valid prescription shall serve as the combining record, including the name and amount or concentration, lot number, and expiration date of each ingredient; and
2.1.9.c.4.G. The prescription label shall comply with the labeling requirements as set forth in 15 C.S.R. 01.
2.1.10. "Confidential information" means patient-identifiable information maintained by any person in connection with the practice of pharmacist care in the patient record or which is communicated to the patient as part of patient counseling, or which is communicated by the patient to the person providing pharmacist care.
2.1.11. "Controlled Substance" means a drug, substance, or immediate precursor in Schedule I through Schedule V of either the Federal Controlled Substances Act, 21 U.S.C § 801 et seq., or the West Virginia Uniform Controlled Substances Act, Chapter 60A of the West Virginia Code.
2.1.12. "Cosmetic" means:
2.1.12.a. Articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body, or any part of the human body for cleansing, beautifying, promoting attractiveness or temporarily altering the appearance;
2.1.12.b. Articles intended for use as a component of those articles, except that the term shall not include soap; and
2.1.12.c. Shall be held to include "dentifrice" and “toilet articles.”
2.1.13. "Deliver" or "delivery" means the actual, constructive or attempted transfer of a drug or device from one person to another, whether or not for a consideration.
2.1.14. "Device" means an instrument, apparatus, implement or machine, contrivance, implant or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, "Caution: Federal or state law requires dispensing by or on the order of a physician" or the language or symbol as determined by the U. S. Food and Drug Administration.
2.1.15. “Direct supervision” means that a licensed pharmacist is physically present in the pharmacy and is available to verify the accuracy of a prescription before it is dispensed.
2.1.16. "Dispense" or "dispensing" means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation, verification and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for subsequent administration to, or use by, a patient.
2.1.17. “Distribute" or "Distribution" means to sell, offer to sell, deliver, offer to deliver, broker, give away, or transfer a drug, whether by passage of title, physical movement, or both. The term does not include:
2.1.17.a. To dispense or administer;
2.1.17.b. Delivering or offering to deliver a drug by a common carrier in the usual course of business as a common carrier; or providing a drug sample to a patient by a practitioner licensed to prescribe such drug;
2.1.17.b.1. A health care professional acting at the direction and under the supervision of a practitioner; or the pharmacy of a hospital or of another health care entity that is acting at the direction of such a practitioner and that received such sample in accordance with the Prescription Drug Marketing Act and regulations to administer or dispense;
2.1.17.b.2. Intracompany sales.
2.1.18. “Distributor" means a person licensed as a wholesaler or third-party logistics provider.
2.1.19. "Drug" means:
2.1.19.a. Articles recognized as drugs by the United States Food and Drug Administration, or in any official compendium, or supplement;
2.1.19.b. An article, designated by the board, for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;
2.1.19.c. Articles, other than food, intended to affect the structure or any function of the body of humans or other animals; and
2.1.19.d. Articles intended for use as a component of any articles specified in paragraph 2.1.19.a., 2.1.19.b., or 2.1.19.c. of this subdivision.
2.1.20. "Drug regimen review" includes, but is not limited to, the following activities:
2.1.20.a. Evaluation of the prescription drug orders and, if available, patient records for:
2.1.20.a.1. Known allergies;
2.1.20.a.2. Rational therapy-contraindications;
2.1.20.a.3. Reasonable dose and route of administration; and
2.1.20.a.4. Reasonable directions for use.
2.1.20.b. Evaluation of the prescription drug orders and patient records for duplication of therapy.
2.1.20.c. Evaluation of the prescription drug for interactions and/or adverse effects which may include, but are not limited to, any of the following:
2.1.20.c.1. Drug-drug;
2.1.20.c.2. Drug-food;
2.1.20.c.3. Drug-disease; and
2.1.20.c.4. Adverse drug reactions.
2.1.20.d. Evaluation of the prescription drug orders and if available, patient records for proper use, including overuse and underuse and optimum therapeutic outcomes.
2.1.21. "Electronic data intermediary" means an entity that provides the infrastructure to connect a computer system, hand-held electronic device or other electronic device used by a prescribing practitioner with a computer system or other electronic device used by a pharmacist to facilitate the secure transmission of:
2.1.21.a. An electronic prescription order;
2.1.21.b. A refill authorization request;
2.1.21.c. A communication; or
2.1.21.d. Other patient care information.
2.1.22. "E-prescribing" means the transmission, using electronic media, of prescription or prescription-related information between a practitioner, pharmacist, pharmacy benefit manager or health plan as defined in 45 CFR §160.103, either directly or through an electronic data intermediary. E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the pharmacist. E-prescribing may also be referenced by the terms "electronic prescription" or "electronic order".
2.1.23. “Electronic supervision” means that a licensed pharmacist provides supervision of the pharmacy through the utilization of audio and visual technology, which may be used with both direct and indirect supervision tasks of a pharmacy technician or pharmacy technician trainee.
2.1.24. “Expiration date” means the time assigned by manufacturers based on analytical and performance testing of the sterility, chemical and physical stability, and packaging integrity of the product during which it can be expected to meet the requirements of a compendial monograph, if one exists, or is guaranteed to be safe and potent provided it is kept under the prescribed storage conditions.
2.1.25. "Gender altering medication" means the prescribing or administering of the following for the purpose of assisting an individual with a gender transition:
2.1.25.a. Gonadotropin-releasing hormone (GnRH) analogues or other puberty blocking medication to stop or delay normal puberty; and
2.1.25.b. Supraphysiologic doses of testosterone, estrogen, or other androgens than would normally be produced endogenously in a healthy individual of the same age and sex.
2.1.26. “Inpatient pharmacy" means the area within a licensed institution; i.e., a hospital, or other place where patients stay at least one night, where drugs are stored and dispensed to other areas of the institution for administration to the patients by other licensed health care providers.
2.1.27. "Inspector" means an agent of the Board, who is a licensed pharmacist, appointed by the Board to conduct periodic inspections of board authorization holders and perform other duties as designated by the Board.
2.1.28. “Institutional facility” means any organization whose primary purpose is to provide a physical environment for patients to obtain health care services, including but not limited to a hospital, convalescent home, nursing home, extended care facility, mental health facility, rehabilitation center, psychiatric center, developmental disability center, drug abuse treatment center, family planning clinic, correctional facility, hospice, public health facility, or athletic facility.
2.1.29. “Institutional pharmacy” means that physical portion of an institutional facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease and which holds a pharmacy license from the Board.
2.1.30. "Intern" or “pharmacy intern” means an individual who is currently licensed by the board to engage in the practice of pharmacist care while under the supervision of a pharmacist.
2.1.31. "Labeling" means the process of preparing and affixing a label to a drug container exclusive, however, of a labeling by a manufacturer, packer or distributor of a nonprescription drug or commercially packaged prescription drug or device.
2.1.32. “Mail order pharmacy" means a pharmacy, regardless of its location, which dispenses greater than twenty-five percent (25%) prescription drugs via the mail or other delivery services.
2.1.33. "Manufacturer" means any person who is engaged in manufacturing, preparing, propagating, processing, packaging, repackaging or labeling of a prescription drug, whether within or outside this state.
2.1.34. "Manufacturing" means the production, preparation, propagation or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes any packaging or repackaging of the substance or substances or labeling or relabeling of its contents and the promotion and marketing of the drugs or devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, practitioners, or other persons.
2.1.35. "Nonprescription drug" means a drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of this state and the federal government.
2.1.36. “Nuclear pharmacist” means a pharmacist who has been certified in the specialty of nuclear pharmacy.
2.1.37. "Nuclear pharmacy" means a place where radioactive drugs are prepared and dispensed and which operates under specialized rules.
2.1.38. "Original License" means a license issued by the Board to an applicant when:
2.1.38.a. The applicant is a new business;
2.1.38.b. The applicant is an established business that is transferred to a successor;
2.1.38.c. The applicant is an established business in which fifty percent (50%) ownership or more is transferred to a new owner;
2.1.38.d. The applicant is an established business in which control of pharmaceutical services is transferred; not including a change in pharmacist-in-charge; or
2.1.38.e. The applicant is an established business which moves to a new location.
2.1.39. "Outpatient pharmacy" means any pharmacy, apothecary, or place within this state where drugs are dispensed and sold at retail or displayed for sale at retail and where the practice of pharmacy is conducted and pharmacist care is provided; and any place outside of this state where drugs are dispensed and the practice of pharmacy and pharmacist care is provided to residents of this state.
2.1.40. "Over-the-counter drug" or "OTC drug” means any drug that is not a prescription drug or prescription drug.
2.1.41. "Patient counseling" means the communication by the pharmacist of information, as prescribed further in the rules of the board, to the patient to improve therapy by aiding in the proper use of drugs and devices.
2.1.42. "Person" means an individual, corporation, partnership, association or any other legal entity, including government.
2.1.43. "Person Addicted" means one who has acquired the habit of using alcoholic beverages or controlled substances or other agents to such an extent as to deprive him or her of reasonable self-control.
2.1.44. "Pharmacist care" means the provision by a pharmacist of patient care activities, with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, the elimination or reduction of a patient’s symptoms, or the arresting or slowing of a disease process, and as provided in W. Va. Code §30-5-10.
2.1.45. "Pharmacist" means an individual currently licensed by this state to engage in the practice of pharmacist care.
2.1.46. "Pharmacist-in-charge" means a pharmacist currently licensed in this state who:
2.1.46.a. Accepts responsibility for the operation of a pharmacy in conformance with all state and federal laws and rules pertinent to the practice of pharmacist care and the distribution of drugs;
2.1.46.b. Has the responsibility for the practice of pharmacist care, as defined in this rule, at the pharmacy for which he or she is pharmacist-in-charge. The pharmacy permit holder has responsibility for all other functions, administrative and operational, of the pharmacy. The pharmacist-in-charge may advise the pharmacy permit holder in writing of administrative and operational matters. The pharmacist-in-charge is not legally responsible if the permit holder does not follow the written advice;
2.1.46.c. Works at least 30 hours a week, with the pharmacist-in-charge working at least three days per week, in that pharmacy, including the use of any accrued annual or sick leave; Provided That, in any pharmacy which is open on average less than 40 hours per week in a calendar year, he or she must work in the pharmacy a majority of the hours that the pharmacy is open (e.g., if open 20 hours per week, the pharmacist-in-charge must work 11 hours per week within the pharmacy); and
2.1.46.d. With regards to a pharmacist-in-charge in a Charitable Clinic Pharmacy, this position may be filled by a committee of up to 3 pharmacists who accept as a group the responsibilities of the required pharmacist-in-charge. Further notwithstanding the requirements of subsection c, above, with regard to a Charitable Clinic Pharmacy, if the pharmacy is open an average of more than 40 hours per week, the pharmacist-in-charge or pharmacist-in-charge committee must work at least eight hours per calendar month; if the pharmacy is open on average at least 30 and up to 40 hours per week, the pharmacist-in-charge or pharmacist-in-charge committee must work in the charitable clinic pharmacy at least six hours per calendar month; if the pharmacy is open on average at least 15 and up to 30 hours per week, the pharmacist-in-charge or pharmacist-in-charge committee must work in the charitable clinic pharmacy at least four hours per calendar month; if the charitable clinic pharmacy is open on average at least five and up to 15 hours per week, the pharmacist-in-charge or pharmacist-in-charge committee must work in the charitable clinic pharmacy at least two hours per calendar month; and, if the charitable clinic pharmacy is open less than five hours per week, the pharmacist-in-charge or pharmacist-in-charge committee must work in the charitable clinic pharmacy the lesser of two hours per month or 50% of the hours the charitable clinic pharmacy is open.
2.1.46.d.1. Charitable Clinic Hours required Pharmacy hours by PIC per week per month More than 40: 8 30 to 40: 6 15 to 30: 4 5 to 15: 2 Less than 5: The lesser of 2 or 50% of hours open
2.1.47. "Pharmacy technician" means registered supportive personnel who work under the direct or electronic supervision of a pharmacist, and who have passed an approved training program; Provided That, in a Charitable Clinic Pharmacy, when no pharmacist is on-site, a pharmacy technician may work under the direct supervision of a prescribing practitioner who is licensed as such in the State of West Virginia.
2.1.48. “Pharmacy technician trainee” means registered supportive personnel currently engaged in a pharmacy technician training program which has been approved by the Board and who is under the direct supervision of a pharmacist.
2.1.49. “Practice of telepharmacy” means the provision of pharmacist care by properly licensed pharmacists located within United States jurisdictions through the use of telecommunications or other technologies to patients or their agents at a different location that are located within United States jurisdictions.
2.1.50. "Practitioner" or “prescribing practitioner” means an individual authorized by a jurisdiction of the United States to prescribe drugs in the course of professional practices, as allowed by law.
2.1.51. "Preceptor" means an individual who is currently licensed as a pharmacist by the board, meets the qualifications as a preceptor under the rules of the board, and participates in the instructional training of pharmacy interns.
2.1.52. "Prescription drug" means any human drug required by federal law or regulation to be dispensed only by prescription, including finished dosage forms and active ingredients subject to section 503(b) of the federal food, drug and cosmetic act.
2.1.53. "Prescription" or "Prescription order" means a lawful order from a practitioner for a drug or device for a specific patient, including orders derived from collaborative pharmacy practice, where a valid patient-practitioner relationship exists, that is communicated to a pharmacist in a pharmacy.
2.1.54. "President" means the President of the West Virginia Board.
2.1.55. “Refill” means a subsequent dispensing of the medicine ordered by the practitioner in the original prescription order, based upon the practitioner’s authorization for the subsequent dispensing in that original prescription order.
2.1.56. “Renewal” means a new prescription drug order for the same medication previously prescribed for a patient, authorized by the practitioner without change or modification from the original prescription order after the authorized number of refills of the original prescription order has been exhausted.
2.1.57. “Sample" means a package of a prescription drug provided by a manufacturer on the request of a practitioner or charitable clinic to be given to a patient without charge in accordance with federal law.
2.1.58. “Secretary" means the Secretary of the West Virginia Board.
2.1.59. “Telehealth services” means the use of synchronous or asynchronous telecommunications technology or audio only telephone calls by a health care practitioner to provide health care services, including, but not limited to, assessment, consultation, treatment, and monitoring of a patient; transfer of medical data; patient and professional health-related education; public health services; and health administration. The term does not include internet questionnaires, e-mail messages, or facsimile transmissions.
2.1.60. "Vendor" means a private vendor which produces or supplies official state prescription paper.
2.1.61. "Vice-President" means the Vice-President of the West Virginia Board.
2.1.62. "West Virginia Official Prescription Paper" means prescription paper which meets the following criteria:
2.1.62.a. Prevention of unauthorized copying;
2.1.62.b. Prevention of erasure or modification; and
2.1.62.c. An ability to prevent counterfeit prescriptions or prescription pads.
2.1.63. "Wholesaler" is a person or entity licensed by the Board to distribute, by sales or otherwise, prescription drugs to persons other than a consumer or patient.
W. Va. Code R. § 15-1-3 General Provisions
3.1. Officers of the Board. – The members of the board shall annually elect as officers of the Board one member to serve as President of the Board, one to serve as Vice-president and one to serve as Secretary, all to serve a one-year term or until their successors are elected. The election is to be held in June each year.
3.2. Official Seal – The Board hereby reaffirms and readopts, as the official seal of the Board the following: The outer circle of the seal has inscribed in it ‘West Virginia Board of Pharmacy’; and the inner circle of the seal consists of a base upon which rests a graduate entwined about which there is an Aesculapius serpent and holding in balance a set of scales, an impression of which is affixed to it.
3.3. Disposition of moneys; report to auditor. – The Secretary shall receive and account for, all moneys derived by virtue of the provisions of W.Va. Code §30-1-1 .et seq. and §30-5-1 et seq, and shall pay such moneys into the State Treasury monthly on or before the 10th day of each month in which the monies are received.
3.4. Record of proceedings; registration of applicant; certified copies of records prima facie evidence, report to governor. – The Secretary of the Board shall keep a record of its proceedings and a register of all applicants for license or registration, showing for each, the date of his or her application, name, age, educational and other qualifications, place of residence, whether an examination was required, whether the applicant was rejected or a certificate of licensure or registration granted, the license or registration number, if required, and any suspension or revocation of any license or registration. The books and register of the Board shall be open to public inspection at all reasonable times, and the books and register, or a copy of any part of them, certified by the Secretary and attested by the seal of the Board, is prima facie evidence of all matters recorded by the Board.
3.5. Roster of licensed or registered persons. – The Secretary shall prepare and maintain a complete roster of all persons, granted a board authorization, alphabetically and by class or type and by whether within or without the state.
3.6. Power of Inspection and Investigation – The authorized agents of the Board may inspect and investigate in a lawful manner and during regular business hours all places or persons holding a board authorization. The investigation may include, but not be limited to, all inventories, invoices for prescription drugs, selling prices, and other records required by law, acts of individuals and facilities, but shall not extend to financial data or sales data other than shipment data or pricing data; unless the owner, operator or agent in charge of the controlled premises consents in writing. The board authorization holder shall allow access to selling prices only when needed for a specific investigation or inquiry by the Board regarding a particular drug.
3.7. During the course of any inspection or investigation by an agent of the Board the agent may temporarily close any holder of a board authorization upon the discovery of any of the following:
3.7.1. The ability of the pharmacist to practice pharmacist care with reasonable skill, competency, or safety to the public is impaired because the board authorization holder’s cognitive, interpersonal, or psychomotor skills are affected by psychiatric, psychological, or emotional problems, or excessive alcohol or drug use or addiction; or
3.7.2. The absence of valid board authorization issued by the Board or by the absence of an available pharmacist to be on duty.
3.8. When a board authorization holder is closed under subsection 3.7.1 of this section they shall remain closed until an unimpaired pharmacist arrives on the premises or when a board authorization holder is closed under subsection 3.7.2 of this section, the permittee shall remain closed until a valid permit is obtained and on display as required by law.
3.9. Agents of the Board when acting in good faith and without malice are immune from individual civil liability while acting within the scope of their duties as such agents of the Board.
W. Va. Code R. § 15-1-4 Internship Requirements
4.1. No person may practice as a pharmacy intern without being licensed by the board.
4.2. To be eligible to practice as a pharmacy intern, an applicant must:
4.2.1. Make application to the board on a form provided by the Board;
4.2.2. Pay the required application fee;
4.2.3. Meet all other requirements for licensure; and
4.2.4. Complete a criminal history records check as prescribed in 15 C.S.R. 01.
4.3. A pharmacy intern license expires on the 30th day of June, six years from the date of issue.
4.4. A legible copy of the original internship certificate of licensure shall be displayed at the place of internship.
4.5. The pharmacy intern must have the original with him or her in a readily retrievable location at any pharmacy or other practice site where he or she is practicing as an intern. An intern shall produce the original intern certificate upon request of an appropriate official or agent of the board or proper law enforcement.
4.6. The Board may certify internship credit for an individual:
4.6.1. When a preceptor holds a current, valid license as a pharmacist from the board and the pharmacy intern has been issued an intern certificate;
4.6.2. When the pharmacy intern has notified the Board within 10 days of the employment as an intern; 4.6.3 When the pharmacy intern notifies the Board within 10 days subsequent to termination of any internship under a specific preceptor; and 4.6.4 When the internship is certified by the submission of a “Certification by Preceptor as to Internship” form immediately after termination of the internship. Forms are available from the board office.
4.7. No pharmacy intern shall be certified by the Board unless the intern is enrolled in or is a graduate of an accredited school of pharmacy or has met the requirements for educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee Certification.
4.8. A pharmacy intern may receive experience credit for any period of time during which he or she is enrolled in an accredited school of pharmacy and the Board may accept and certify up to 1,500 hours of internship credit for interns participating or enrolled in a supervised internship as part of the school of pharmacy experiential education curriculum.
4.9. A pharmacy intern shall earn internship hours only for hours obtained in the practice of pharmacist care in the role of a pharmacist and in a licensed pharmacy. Hours worked in the role of a pharmacy technician will not be certified or accepted.
4.10. The Board may accept internship hours gained outside West Virginia on a letter of credit or certification from the Board of Pharmacy of the state in which the pharmacy intern acquired internship experience or from the recognized school of pharmacy from which the intern acquired internship experience. Up to one third of the internship hours may be fulfilled by an internship in a foreign country either through an accredited school of pharmacy experiential education program or as certified on a letter of credit or certification from the Board of Pharmacy or other regulatory body of the foreign state, province, or country responsible for regulation of the practice of pharmacy in the foreign location.
W. Va. Code R. § 15-1-5 Confidential Information
5.1. All licensees and registrants must comply with the Health Insurance Portability and Accountability Act (“HIPAA”), 45 C.F.R. § 160, 45 C.F.R. § 162, and 45 C.F.R. § 164.
W. Va. Code R. § 15-1-6 Transfer of Prescription Drugs
6.1. No prescription drug may be transferred except by the following methods:
6.1.1. Transfer of drugs without prescription.
6.1.1.a. Prescription drugs without a prescription may be transferred only to a permittee or practitioner and the transaction shall be recorded and the gross dollar value of the transfers shall not exceed five percent of the total prescription drug sales revenue of either the transferor or the transferee pharmacy during any 12 consecutive month period.
6.1.1.b. The record showing transfers of prescription drugs without a prescription shall contain:
6.1.1.b.1. The name of the drug and its quantity;
6.1.1.b.2. The date of transaction;
6.1.1.b.3. The permittee or practitioner to whom the prescription drug was transferred; and
6.1.1.b.4. The selling price.
6.1.1.c. The record of the transfer shall be kept in the pharmacy and be immediately accessible within one year from the date of transfer, and available within 72 hours if between one year and five years from the date of transfer.
6.1.1.d. Any pharmacy with transfers of prescription drugs that exceed the five percent restriction set forth in paragraph 9.6.1.1a of this section shall obtain a permit to be a wholesaler. Intracompany sales and transfers of drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage shall not be included in calculation of the drug sales revenue.
6.1.2. Transfer of drugs with a Prescription.
6.1.2.a. Prescription drugs transferred by a practitioner’s prescription order are dispensed. A prescription shall contain at least the following elements:
6.1.2.a.1. The patient’s name and address and the date the prescription is written, Provided that, if the prescription is for expedited partner therapy as permitted by West Virginia Code Chapter 16, Article 4F, then the words “Expedited Partner Therapy” or the designation “EPT” may be written for the name of the patient;
6.1.2.a.2. The drug’s name and quantity; and
6.1.2.a.3. Directions for use.
6.1.2.a.3.A. If the prescription is written on a practitioner’s date prescription blank, the order shall contain the following:
6.1.2.a.3.A.1. The practitioner’s printed name, address, professional designation and practitioner identifier number; and
6.1.2.a.3.A.2. The practitioner’s signature.
6.1.2.a.3.B. If the prescription is written on an institutional prescription blank, the order shall contain the following:
6.1.2.a.3.B.1. The printed name of the practitioner and DEA number with suffix; and
6.1.2.a.3.B.2. The practitioner’s signature.
6.1.2.a.3.C. No sticker or other substance shall be allowed to obliterate or cover any of the information required by this subdivision.
6.2. Samples.
6.2.1. Pharmacies may not sell, purchase, or trade or offer to sell, purchase, or trade any prescription drug sample.
W. Va. Code R. § 15-1-7 Refilling Prescription Orders
7.1. A pharmacist may not refill any prescription order containing a drug if the label of the original container bears the statement, “CAUTION: Federal Law Prohibits Dispensing Without Prescription”, or “RX Only”, unless the practitioner has authorized the refill by written notation on the original prescription order. Subsequent refill authorization shall be treated as a new prescription order.
7.2. If a prescription order is refillable, the date of the refill and the handwritten initials of the pharmacist shall be recorded upon the original written prescription order; if an Automated Data Processing System is used to document the refill, such documentation shall be completed in accordance with West Virginia Title 15 Code of State Rules Series 4.
7.3. No prescription order may be refilled after 12 months from the date of issuance by the practitioner.
7.4. The refilling of prescription orders for controlled substances is limited by provisions of the Uniform Controlled Substances Act, W. Va. Code §60A-3-308.
W. Va. Code R. § 15-1-8 Transferring Prescription Orders Between Pharmacies
8.1. The pharmacist or pharmacy intern shall, upon the request of the patient, transfer the prescription information to the pharmacy designated by the patient. Pharmacy interns are prohibited from transferring controlled substances.
8.2. The transfer of original prescription order information is permissible between pharmacies if the transfer is communicated directly between pharmacists or pharmacy interns, and the following occurs:
8.2.1. The transferring pharmacist or pharmacy intern:
8.2.1.a. Writes the word “VOID” on the face of the original prescription order; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record;
8.2.1.b. Records on the reverse of the original prescription the name, address, and Drug Enforcement Administration (DEA) registry number of the pharmacy to which the prescription was transferred and the name of the pharmacist or pharmacy intern receiving the prescription information; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record; and
8.2.1.c. Records the date and time of the transfer and his or her first and last name;
8.2.2. The pharmacist or pharmacy intern receiving the transferred prescription order information:
8.2.2.a. Writes the word “TRANSFER” on the face of the transferred prescription; and
8.2.2.b. Provides all the information required to be on a prescription and includes:
8.2.2.b.1. Date of issuance of the original prescription;
8.2.2.b.2. Number of refills on the original prescription;
8.2.2.b.3. The date the original prescription was dispensed;
8.2.2.b.4. The number of valid refills remaining and date of last refill;
8.2.2.b.5. The pharmacy’s name, address, DEA registry number and the original prescription number from which the prescription was transferred; and
8.2.2.b.6. The first and last name of the transferring pharmacist or pharmacy intern;
8.2.3. A pharmacist or pharmacy intern may give a copy of a prescription clearly marked “For Information Only” to a patient; and
8.2.4. A computer record may be used if it reflects the fact that the original prescription order has been voided and shall contain all the other information required in this subsection.
8.3. No pharmacy shall refuse to transfer information about a prescription to another pharmacy when requested by a patient. A pharmacy shall transfer prescription information in accordance with this rule as soon as possible in order to assure that the patient’s drug therapy is not interrupted.
8.4. Information on a prescription is the property of the patient and is intended to authorize the dispensing of a specific amount of medication for the use by the patient. Pharmacies shall maintain original and transferred prescription drug orders for a period of five years from the date of the last refill; maintained on-site for a period of 12 months from last of last refill, and available within 72 hours of request if date of last refill is between one and five years.
8.5. Pharmacies accessing a common electronic file or database used to maintain required dispensing information are not required to transfer prescription drug orders or information for dispensing purposes between or among pharmacies participating in the same common prescription file. Provided, the common electronic file or database shall contain complete records of each prescription drug order and refill dispensed, and the system shall have the capability at the pharmacy refilling the prescription drug order or at the pharmacy where the prescription is transferred to generate a hard copy record of each prescription drug order transferred or accessed for purposes of refilling.
8.6. After direct communication between pharmacists or pharmacy interns or between a pharmacist and pharmacy intern confirming the prescription transfer, the required prescription order information may be transferred via facsimile.
W. Va. Code R. § 15-1-9 Returning Drugs and Devices
9.1. No pharmacist or pharmacy shall accept from a patient or other person, except for the purpose of destruction, any part of any unused prescription drug unless:
9.1.1. The returned drugs are in a manufacturer’s original, sealed and visibly tamperproof container;
9.1.2. The returned drugs are in extemporaneously prepared unit dose packaging, as defined in this rule, and are returned within an institution or by an institution; and
9.1.3. All drugs are identified as to lot and control number and expiration date.
9.2. No controlled substance that has been dispensed may be returned and placed in stock for reuse or resale under any circumstances. However, any entity registered pursuant to 15 C.S.R. 02 which is properly registered with the DEA as an authorized collector to receive the transfer from ultimate users of any unwanted and unused pharmaceutical controlled substances in their lawful possession for safe, secure, and responsible disposal, may receive returns of controlled substances for such disposal.
9.3. Any drugs returned within or by an institution shall be recorded in a log which lists the name of the patient, the name and strength of the drug with the name of its manufacturer, the prescription number (if applicable), the amount of the drug returned and the date of the return. The log shall contain the signatures of the receiving pharmacist and a registered nurse employed by the facility and the log shall be retained for at least two years. 9.4 Drugs must be returned in compliance with a Donated Drug Repository Program as permitted in W. Va. Code §60B-1-1 et seq. and 15 C.S.R. 20.
W. Va. Code R. § 15-1-10 Drug Product Selection and Substitution
10.1. The Board adopts the drug products in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the Food and Drug Administration, Center for Drug Evaluation and Research, (commonly called the “Orange Book”) with “AA”, “AB”, “AN”, “AO”, “AP”, or “AT” ratings and any authorized generics as acceptable products for generic substitution as required by W. Va. Code §30-5-12b. The Board may approve drug products not listed in the Orange Book as acceptable products for generic substitution upon submission of a written request to the Board.
W. Va. Code R. § 15-1-11 Equipment, Facilities and Record Systems
11.1. The Board shall not issue a registration to operate a pharmacy unless the necessary professional, physical, and technical equipment requirements have been fulfilled.
11.1.1. The pharmacy shall have a separate area available for patient counseling which will ensure the privacy and confidentiality of the discussions; and which has adequate space to use any equipment, visual aids, and publications, if necessary, to provide proper counseling. This subdivision does not apply to pharmacies which have been granted a registration prior to the effective date of this provision of May 1, 1999 or inpatient pharmacies.
11.1.2. All standards set by the United States Pharmacopeial Convention (“USP”) are the minimum standards followed by all licensed pharmacists and pharmacies during the course of the professional practice of pharmacist care.
11.2. A pharmacy shall continually possess the following:
11.2.1. A sanitary method of measuring and dispensing between five and 250 milliliters of liquids;
11.2.2. Supplies necessary to ensure the physical, equipment, and environmental requirements established by USP;
11.2.3. For a pharmacy compounding ophthalmic preparations, IV additives, enteral nutritional products or other pharmaceuticals requiring more sophisticated techniques, the proper equipment and facilities to prepare sterile products and meet the requirements of good compounding practice;
11.2.4. Adequate facilities for the proper storage of pharmaceuticals. All areas where drugs and devices are stored shall be dry, well-lighted, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing as stipulated by the USP and/or the manufacturer’s or distributor’s labeling unless otherwise indicated by the Board;
11.2.5. Facilities for the safe storage of controlled substances if the dispersion method is not used;
11.2.6. An acceptable system of keeping records of prescriptions dispensed as required by the Uniform Controlled Substance Act and any Rules and Regulations pertaining to the Act;
11.2.7. A system of keeping patient profiles as required by 15 C.S.R. 04; and
11.2.8. The most currently available Pharmacy Law Book and book of Rules and Regulations published by the Board, provided that a readily retrievable electronic copy may suffice.
W. Va. Code R. § 15-1-12 Sterile Pharmaceutical Compounding
12.1. Permitting and Control.
12.1.1. A pharmacy compounding or mixing prescription orders for sterile solutions or suspensions shall obtain a Sterile Pharmaceutical Compounding Permit from the Board in addition to a pharmacy license. The Board shall issue a permit after a satisfactory inspection of the completed facilities.
12.1.2. The compounding and preparation of sterile prescription orders shall be accomplished in a pharmacy environment subject to the West Virginia Code and the Rules of this Board and all Federal laws and regulations.
12.1.3. Sterile compounding or mixing shall be under the supervision and control of a pharmacist who shall be present on duty during all hours of prescription preparation.
12.2. An applicant for a Sterile Pharmaceutical Compounding Permit shall provide the Board with the following:
12.2.1. A completed Board application form;
12.2.2. A copy of the Policy and Procedure Manual;
12.2.3. Statement and plans showing how the applicant meets the minimum requirements regarding space, equipment, supplies, and publications.
12.3. The compounding environment for this practice shall be separate rooms set apart from all other activities. The environment shall facilitate controlled aseptic conditions and meet all the following standards of:
12.3.1. The 2023 United States Pharmacopeia (USP) Chapter 797 Pharmaceutical Compounding – Sterile Preparations; 12.3.2 The 2023 United States Pharmacopeia (USP) Chapter 800 Hazardous Drugs; and
12.3.3. The Controlled Environment Testing Association’s (CETA) Certification Guide for Sterile Compounding Facilities or a substantially similar standard for certification completed by a qualified independent certifier indicating that the compounding area is meeting its design and air quality specifications.
12.4. General Requirements.
12.4.1. Special handling and packaging shall be available to maintain stability of the prepared prescription orders during delivery to the patient.
12.4.2. All prescriptions shall include labeling, in addition to that required by other state or federal law or rule, showing:
12.4.2.a. The drug’s beyond-use date;
12.4.2.b. The date of preparation; and
12.4.2.c. The drug’s control number.
12.4.3. A pharmacy with a Sterile Pharmaceutical Compounding Permit shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists.
12.5. Reference Works. Minimum reference works required in a pharmacy with a Sterile Pharmaceutical Compounding:
12.5.1. A current edition, in either print or electronic media, of a drug information and reference compendium such as Elsevier Gold Standard/Clinical Pharmacology, Facts & Comparisons, or other appropriate compendium approved by the board; and
12.5.2. Handbook of Injectable Drugs published by the American Society of Health System Pharmacists, or its equivalent.
W. Va. Code R. § 15-1-13 Licensure and Control of Nuclear Pharmacies
13.1. General Requirements.
13.1.1. A pharmacy providing radiopharmaceutical services, and compounding or mixing prescription orders for radiopharmaceuticals shall obtain a Nuclear Pharmacy registration from the Board. The license will be issued after satisfactory inspection of the completed facilities. The license will be issued only when the pharmacist-in-charge is a qualified nuclear pharmacist and the pharmacy has been approved by the appropriate federal agency.
13.1.2. Pharmacies providing regular pharmacist care in addition to radiopharmaceutical services shall comply with all sections of this rule applicable to pharmacies in general.
13.2. Space.
13.2.1. The nuclear pharmacy area shall be separate from all other pharmacy areas for non-radioactive drugs and shall be secured from unauthorized personnel.
13.2.2. A pharmacy handling radiopharmaceuticals shall provide a radioactive storage and product decay area which meets the requirements of the appropriate federal agency and the 2023 United States Pharmacopeia (USP) Chapter 825 Radiopharmaceuticals.
13.3. Dispensing and labeling.
13.3.1. A prescription order for a radiopharmaceutical shall be dispensed in a package that is properly labeled. A pharmacy may furnish radiopharmaceuticals only to practitioners for administration to patients and for the occasional transfer to another pharmacist.
13.3.2. In addition to any label requirements of the Board for nonradioactive drugs, the immediate outside container of a radiopharmaceutical to be dispensed shall also be labeled with:
13.3.2.a. The standard radiation symbol;
13.3.2.b. The words “CAUTION-Radioactive Material”;
13.3.2.c. The name of the radio nucleotide;
13.3.2.d. The chemical form;
13.3.2.e. The amount of radioactive material contained in millicuries or microcuries;
13.3.2.f. The volume in milliliters, if the material is a liquid;
13.3.2.g. The requested calibration time for the amount of radioactivity contained; and
13.3.2.h. The practitioner’s name and the assigned lot number.
13.3.3. The immediate inner container shall be labeled with:
13.3.3.a. The standard radiation symbol;
13.3.3.b. The words “CAUTION-Radioactive Material”; and
13.3.3.c. The prescription number
13.3.4. The amount of radioactivity shall be determined by radiometric methods for each dose immediately prior to dispensing.
13.4. Distribution – Nuclear pharmacies may distribute approved radioactive drugs to any receiving pharmacy if the receiving pharmacy does not process the radioactive drugs in any manner nor violate or change the product packaging except that a licensed pharmacist may divide the product into individual doses.
W. Va. Code R. § 15-1-14 Sanitary Regulation of Pharmacies
14.1. The pharmacy shall have undergone a pharmacy inspection by the Board or authorized agent thereof; and possess the following minimum requirements for a pharmacy:
14.1.1. Each Pharmacy shall be of sufficient size, as determined by the Board, to allow for the safe and proper storage of Prescription Drugs and for the safe and proper Compounding and/or preparation of Prescription Drug Orders.
14.1.2. Each Pharmacy shall maintain an area designated for the provision of Patient Counseling services. This area shall be designed to provide a reasonable expectation of privacy of Protected Health Information.
14.1.3. The prescription counter shall be used for no other purpose than for the compounding and dispensing of prescriptions and shall be maintained free from dust and in an orderly condition.
14.1.4. All pharmacist and pharmacy interns when providing pharmacist care, shall wear a name tag identifying the individual and showing their job designation, and are required to keep themselves and their apparel in clean condition. All pharmacy technicians and pharmacy technician trainees shall wear a name tag identifying the individual and showing their job designation and shall wear clean attire. Provided, that only pharmacists and pharmacy interns may wear a white coat or jacket.
14.1.5. All areas where Drugs and Devices are stored shall be dry, well lighted, well ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures which will ensure the integrity of the Drugs prior to their Dispensing as stipulated by the United States Pharmacopeia–National Formulary (USP-NF) and/or the Manufacturer’s or Distributor’s Product Labeling unless otherwise indicated by the Board.
14.1.6. Each Pharmacy shall have access to a sink with hot and cold running water that is convenient to the prescription preparation, patient care, and compounding area for the purpose of hand scrubs prior to pharmacist care.
14.1.7. The Pharmacy shall carry and utilize the equipment and supplies necessary to conduct a Pharmacy in a manner that is in the best interest of the patients served and to comply with all State and Federal laws.
14.1.8. The Pharmacy shall provide a means for patients to prevent disclosure of Confidential Information or personally identifiable information that was obtained or collected by the Pharmacist or Pharmacy incidental to the Delivery of Pharmacist Care Services other than as authorized by law or rules of the Board.
W. Va. Code R. § 15-1-15 Unprofessional Conduct
The following practices shall constitute unprofessional conduct for W. Va. Code §30-5-7(9):
The illegal use, accessing, or disclosure of protected health information and confidential information;
Failure to maintain adequate records, systems, and security to protect against the illegal use or disclosure of protected health information and confidential information;
Failure to maintain adequate records to account for disclosures of protected health information and confidential information;
Engaging in conduct likely to deceive, defraud, or harm the public;
Demonstrating a willful or careless disregard for the health, welfare, or safety of a patient;
Engaging in conduct, which substantially departs from the standards of care ordinarily exercised by a licensee with proof of actual injury not having to be established;
Providing a drug for which a prescription order from a practitioner is required without having received a prescription drug order for the drug;
Willfully and knowingly failing to maintain complete and accurate records of all drugs received, dispensed, or disposed of in compliance with the federal laws and regulations and state laws and rules;
Obtaining any remuneration by fraud, misrepresentation, or deception, including, but not limited to, receiving remuneration for amending or modifying, or attempting to amend or modify, a patient’s pharmacist care services, absent a clear benefit to the patient, solely in response to promotion or marketing activities;
Willfully and knowingly completing and submitting inaccurate due diligence questionnaires or attestation documents regarding the purchase or receipt of drugs from manufacturers, repackagers, third-party logistics providers, and wholesale distributors;
Knowingly filing a false or fraudulent complaint with the board;
Participation in any plan, agreement, or arrangement which eliminates or detrimentally affects the traditional relationship of physician, patient, pharmacist, and the patient's freedom of choice of professional services;
Committing any act of abuse, misconduct, or exploitation related to a licensee’s practice of pharmacist care.
Consequences of Unprofessional Conduct.
15.14.1. The list of unprofessional conduct in this section is intended to govern all pharmacists, pharmacy interns, pharmacy technicians, pharmacy technician trainees, and pharmacies licensed or registered by the Board and improve the pharmacist care provided to the citizens of West Virginia.
15.14.2. The violation of the provisions of this section by a licensed pharmacist, pharmacy intern, pharmacy technician, pharmacy technician trainees, or person with a permit to operate a pharmacy may result in disciplinary action. To the extent not otherwise provided, pharmacy interns, pharmacy technician trainees, and pharmacy technicians must comply with the requirements of 15 C.S.R. 07 to the extent permitted by his or her scope of practice.
15.14.3. Any pharmacist who knowingly accepts and continues employment with any permittee who violates the rules of the Board is guilty of a violation of the rule the same as if he or she had personally engaged in the violation.
W. Va. Code R. § 15-1-16 Duties and Responsibilities of the Pharmacist-in-Charge
16.1. A pharmacy may not operate without a pharmacist-in-charge (hereinafter “PIC”), who shall be designated on the application for a pharmacy license, and in each license renewal. A pharmacist may not serve as PIC unless he or she is physically present in the pharmacy a sufficient amount of time to provide supervision and control. A pharmacist may not serve as PIC for more than one pharmacy at any one time; Provided that, he or she may volunteer as the pharmacist-in-charge at a charitable clinic pharmacy while serving as a PIC in another pharmacy.
16.2. The pharmacist-in-charge has the following responsibilities:
16.2.1. The pharmacist-in-charge shall be responsible for the practice of pharmacy, as defined in this rule, at the pharmacy for which he or she is the pharmacist-in-charge. The pharmacy permit holder shall be responsible for all other functions, administrative and operational, of the pharmacy. The pharmacist-in-charge may advise the pharmacy permit holder in writing of administrative and operational matters. The pharmacist-in-charge is not legally responsible if the permit holder does not follow the written advice;
16.2.2. The pharmacist-in-charge shall document and notify the pharmacy permit holder of potential violations of any statute, rule or court order existing within the pharmacy. The PIC shall provide the permit holder verbal or electronic mail communication of any violations. Documentation shall be kept on file at the pharmacy. If appropriate action has not been taken within a reasonable amount of time the pharmacist-in-charge shall provide the pharmacy permit holder written notification of the violation(s) and a copy shall be retained in the pharmacy. If appropriate action has not been taken or significant progress achieved within a reasonable amount of time the pharmacist-in-charge shall provide a written notice to the permit holder with a copy submitted to the Chief Compliance Officer at the Board. No pharmacist-in-charge shall be sanctioned by the Board for any violation of any statute, rule or court order if they have previously given documented notice to the pharmacy permit holder as outlined in this section. The pharmacy permit holder shall be responsible for such violations. Nothing precludes the pharmacist-in-charge from immediately notifying the Board of any violations;
16.2.3. Implementing quality assurance programs for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. Quality assurance programs shall be designed to prevent and detect drug diversion;
16.2.4. The PIC shall implement and maintain a Pharmacy Technician Training Manual for the specific practice setting of which he or she is in charge. He or she shall supervise a training program conducted pursuant to the training manual for all individuals employed by the pharmacy who will assist in the practice of pharmacy. The PIC shall maintain a record of all technicians successfully completing the pharmacy’s technician training program and shall attest to the Board, in a timely manner, those persons who, from time to time, have met the training requirements necessary for registration with the Board;
16.2.5. Implementing policies and procedures for the procurement, storage, security, and disposition of drugs and devices;
16.2.6. Assuring that all pharmacists and pharmacy interns employed at the pharmacy are currently licensed and that all pharmacy technicians employed at the pharmacy are currently registered with the board;
16.2.7. Notifying the board immediately of any of the following changes:
16.2.7.a. Change of employment or responsibility as the PIC;
16.2.7.b. Change of ownership of the pharmacy;
16.2.7.c. Change of address of the pharmacy;
16.2.7.d. Permanent closing of the pharmacy which shall be accompanied with a statement of the location where records will be retained for the required time period; or
16.2.7.e. The separation of employment of any pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee for any confirmed drug-related reason, including but not limited to, adulteration, abuse, theft, or diversion.
16.2.7.f. Notification shall include the reason for the termination. If it is the employment of the Pharmacist-in-Charge that is terminated, the owner and/or pharmacy permit holder shall immediately notify the Board of Pharmacy.
16.2.8. Making or filing any reports required by state or federal laws, rules, and regulations;
16.2.9. Responding to the board regarding any warning notice issued by the Board. The Board shall provide notification of the issuance of the warning notice to the pharmacy permit holder;
16.2.10. Implementing policies and procedures for maintaining the integrity and confidentiality of prescription information and patient health care information, or verifying their existence and ensuring that all employees of the pharmacy read, sign, and comply with the established policies and procedures; and
16.2.11. Providing the board with prior written notice of the installation or removal of an Automated Pharmacy System. The notice shall include, but is not limited to:
16.2.11.a. The name and address of the pharmacy;
16.2.11.b. The location of the automated equipment; and
16.2.11.c. The identification of the responsible pharmacist.
16.3. The PIC shall be assisted by a sufficient number of pharmacists and pharmacy technicians as may be required to competently and safely provide pharmacy services.
16.3.1. The PIC shall maintain and file with the Board, on a form provided by the Board, a current list of all pharmacy technicians assisting in the provision of pharmacy services.
16.3.2. The PIC shall implement written policies and procedures to specify the duties to be performed by pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall specify that pharmacy technicians are to be personally and directly supervised by a pharmacist stationed within the same work area who has the ability to control and who is responsible for the activities of pharmacy technicians, and that pharmacy technicians are not assigned duties that may be performed only by a pharmacist.
W. Va. Code R. § 15-1-17 Manner of Issuance of a Prescription
17.1. A prescription to be valid, shall be issued for a legitimate medical purpose by a practitioner acting within the course of legitimate professional practice, and shall bear the preprinted, stamped, typed, or manually printed name, address and telephone number of the prescribing practitioner. If it is a prescription for a controlled substance listed in Schedules II through V, then it shall also contain the prescriber's DEA registration number, including any suffix. The National Provider Identification (NPI) number shall be required on all valid prescriptions beginning January 1, 2012.
17.1.1. A pharmacist shall receive the communication of a prescription. A pharmacist may accept a prescription, including that for a controlled substance listed in Schedules II through V, that is communicated in written form or by E-prescribing. A pharmacist may accept a prescription, including that for a controlled substance listed in Schedules III through V, and, in certain situations, that for a controlled substance listed in Schedule II, that is communicated orally (including telephone voice communication) or by way of electronic transmission other than E-prescribing.
17.1.2. If communicated orally or by way of electronic transmission other than E-prescribing, the pharmacist shall immediately reduce the prescription to a form that may be maintained for the time period required by any applicable federal and State of West Virginia laws and rules.
17.1.3. A prescription blank for a controlled substance shall not contain the preprinted name of a controlled substance or the written, typed or rubber-stamped name of a controlled substance until the prescription blank is signed, dated and issued to a patient.
17.1.4. A prescription for a Schedule II controlled substance may be communicated orally or by way of electronic transmission other than E-prescribing only in the following situations and with the following restrictions. Otherwise, a prescription for a Schedule II controlled substance shall be communicated in written form or by E-prescribing.
17.1.4.a. A prescription for a Schedule II controlled substance may be communicated by the practitioner or the practitioner's agent by way of electronic transmission, provided the original written prescription, signed by the practitioner, is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except the hard copy of the electronic transmission may serve as the original, written prescription in the following instances:
17.1.4.a.1. The prescription for a Schedule II narcotic substance is to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion;
17.1.4.a.2. The prescription for a Schedule II controlled substance is for a resident of a Long Term Care Facility; or
17.1.4.a.3. The prescription for a Schedule II controlled substance is for a patient under the care of a hospice certified by Medicare or licensed by the state. The practitioner or Practitioner's agent shall note on the prescription that the patient is a hospice patient.
17.1.6. In the case of an emergency situation, a prescription for a Schedule II controlled substance may be communicated by the practitioner orally or by way of electronic transmission, provided that if the prescribing practitioner is not known to the pharmacist, he or she shall make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a callback to the practitioner using the practitioner's phone number as listed in the telephone directory and other good faith efforts to insure his identity; and:
17.1.6.a. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing practitioner);
17.1.6.b. The orally communicated prescription is immediately reduced to writing by the pharmacist, or, if necessary, the prescription communicated by way of electronic transmission is immediately reduced to a hard copy;
17.1.6.c. Within seven days after authorizing an emergency oral prescription, the practitioner has a written prescription for the emergency quantity prescribed delivered to the dispensing pharmacist. The prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the orally or electronically transmitted prescription. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven-day period. Upon receipt, the dispensing pharmacist shall attach this written prescription to the emergency oral prescription which had earlier been reduced to writing or to the hard copy of the electronically transmitted prescription. The pharmacist shall notify the nearest office of the U.S. Drug Enforcement Administration if the prescribing practitioner fails to deliver a written prescription.
17.1.7. A prescribing practitioner may authorize his or her agent to communicate a prescription orally or by way of electronic transmission either directly or through an electronic data intermediary to a pharmacist in a licensed pharmacy, provided:
17.1.7.a. The identity of the transmitting agent is included in the order;
17.1.7.b. The prescription is transmitted either directly or through an electronic data intermediary to a pharmacist in a licensed pharmacy of the patient's choice with no unauthorized person having access to the prescription;
17.1.7.c. The prescription identifies the transmitter's phone number for verbal confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law;
17.1.7.d. The pharmacist exercises professional judgment regarding the accuracy, validity, and authenticity of the prescription communicated by way of electronic transmission; and
17.1.7.e. All electronic equipment for receipt of prescriptions communicated by way of electronic transmission is maintained so as to ensure against unauthorized access.
17.1.8. Electronic Data Intermediaries.
17.1.8.a. Electronic data intermediaries may transmit electronic prescriptions, prescription refill authorization requests, communications, and other patient care information using a secure infrastructure between an authorized prescribing practitioner and a pharmacy of the patient’s choice.
17.1.8.b. Electronic data intermediaries shall meet the following requirements for electronically transmitted prescription orders, refill authorization requests, communications and other transmitted patient care information:
17.1.8.b.1. Maintain the confidentiality and security of transmitted information as required by applicable federal and state laws.
17.1.8.b.2. Transmit prescriptions to the pharmacy of the patient’s choice.
17.1.8.b.3. Maintain the integrity, privacy, and security of archived copies of the electronic information related to the transmissions as required by applicable state and federal laws, including maintaining them as confidential information.
W. Va. Code R. § 15-1-18 Labeling
18.1. All drugs dispensed by a licensed pharmacy shall be labeled according to the requirements of this section, and shall include all information required by federal law or regulation or state law or rule.
18.1.1. All drugs dispensed for use by inpatients of a hospital or other health care facility, where the drug is not in the possession of the ultimate user prior to administration, shall meet the following requirements:
18.1.1.a. The label of a single-unit package of an individual-dose or unit-dose system of packaging of drugs shall include:
18.1.1.a.1. The name of the drug;
18.1.1.a.2. The route of administration, if other than oral;
18.1.1.a.3. The strength and volume, where appropriate, expressed in the metric system whenever possible;
18.1.1.a.4. The control number and beyond-use-date;
18.1.1.a.5. Special storage conditions, if required; and
18.1.1.b. Identification of the repackager by name or by license number shall be clearly distinguishable from the rest of the label.
18.1.1.c. When a multiple-dose drug distribution system is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container to which is affixed a label containing the following information:
18.1.1.c.1. Identification of the dispensing pharmacy;
18.1.1.c.2. The patient’s name;
18.1.1.c.3. The date of dispensing;
18.1.1.c.4. Then name of the drug dispensed; and
18.1.1.c.5. The strength, expressed in the metric system whenever possible.
18.1.2. All drugs dispensed to inpatients for self-administering shall be labeled in accordance with subdivision 22.18.1.4 of this section.
18.1.3. Whenever any drugs are added to parental solutions, the admixtures shall bear a distinctive label indicating:
18.1.3.a. The name of the solution, the lot number, and the volume of the solution;
18.1.3.b. The patient’s name;
18.1.3.c. The infusion rate;
18.1.3.d. The bottle sequence number or other system control number;
18.1.3.e. The name and quantity of each additive;
18.1.3.f. The date of the preparation;
18.1.3.g. The beyond-use date and time of parental admixture; and
18.1.3.h. Ancillary precaution labels.
18.1.4. All drugs dispensed to ambulatory or outpatients shall have a label affixed to the container in which the drug is dispensed, including:
18.1.4.a. The name (including store number, if any), address, and telephone number of the pharmacy dispensing the drug;
18.1.4.b. The name of the patient for whom the drug is prescribed; or, if the patient is an animal, the last name of the owner, name and species of the animal; Provided that, if the prescription is for expedited partner therapy as permitted by W. Va. Code §16-4F-1 et seq. , then the words “Expedited Partner Therapy” or the designation “EPT” may be written for the name of the patient;
18.1.4.c. The name of the prescribing practitioner;
18.1.4.d. Directions stated on the prescription order, and medication purpose/indication if included on the prescription order;
18.1.4.e. The date filled;
18.1.4.f. Any cautions which may be required by federal or state law;
18.1.4.g. The prescription number of the prescription drug order;
18.1.4.h. The name or initials of the dispensing pharmacist;
18.1.4.i. The proprietary or generic name of the drug dispensed, and its strength;
18.1.4.i.1. When dispensing an equivalent drug product, the word ‘substitution” or the letters ‘sub” shall appear on the label affixed to the container in which the drug is dispensed, followed by the generic name and manufacturer, or reasonable abbreviation, and/or distributor of the chosen product. This requirement only applies to single-entity, multiple-source drugs;
18.1.4.i.2. When dispensing a single-entity, single-source drug, the trade name of the prescribed drug may also appear on the label, and the generic name of the prescribed drug may also appear on the label;
18.1.4.i.3. When dispensing a fixed combination product, the United States Pharmacopeia’s publication of Pharmacy Equivalent Names (PEN) for fixed combination products is the official list of abbreviations for labeling, and is the approved abbreviation for identifying the combination product dispensed;
18.1.4.j. Drug quantity;
18.1.4.k. Number of remaining refills;
18.1.4.l. Auxiliary information;
18.1.4.m. The name of the manufacturer or distributor of the drug; and
18.1.4.n. The beyond-use date.
18.1.5. No radiopharmaceutical may be dispensed unless a label is affixed to the immediate container bearing the following information:
18.1.5.a. The standard radiation symbol;
18.1.5.b. The words “Caution- Radioactive Material”; and
18.1.5.c. The prescription number.
18.1.6. No radiopharmaceutical may be dispensed unless a label is affixed to the outer or delivery container bearing the following information:
18.1.6.a. The standard radiation symbol;
18.1.6.b. The words “Caution- Radioactive Material”;
18.1.6.c. The radionuclide and chemical form;
18.1.6.d. The activity and date and time of assay;
18.1.6.e. The volume, if in liquid form;
18.1.6.f. The requested activity and the calibrated activity;
18.1.6.g. The prescription number;
18.1.6.h. The patient’s name or space for the patient’s name. When the patient’s name is not available at the time of dispensing, a 72 hour exemption is allowed to obtain the name of the patient. No later than 72 hours after dispensing the radiopharmaceutical, the pharmacist shall obtain the patient’s name and it shall become a part of the prescription to be retained for a period of five years;
18.1.6.i. The name and address of the nuclear pharmacy;
18.1.6.j. The name of the practitioner; and
18.1.6.k. The lot number of the prescription.
W. Va. Code R. § 15-1-19 Pharmacist Consultants
19.1. Locations requiring a pharmacist to serve as a pharmacy consultant:
19.1.1. Hospital or medical clinic without a pharmacy; ;
19.1.2. Weight loss clinic (registered as a facility);
19.1.3. Urgent care clinic;
19.1.4. Long Term Care Facility, including but not limited to, skilled nursing facilities, intermediate nursing facilities, nursing homes, extended care facilities, assisted living facilities, rest homes, and personal care centers;
19.1.5. Opioid Treatment Facility or Medication Assisted Treatment Facility;
19.1.6. Jails and correctional facilities.
19.2. Locations not required to have a pharmacist consultant;
19.2.1. Teaching institutions/researcher;
19.2.2. Emergency services;
19.2.3. Law enforcement;
19.2.4. Veterinary hospital/clinic
19.2.5. Dental practice
19.2.6. Humane society
19.3. Requirements and registration.
19.3.1. A pharmacist providing consulting services shall be registered as a consultant pharmacist with the Board and shall be licensed to practice pharmacy in West Virginia.
19.3.2. Every pharmacist providing pharmacy consulting services shall apply annually on the prescribed form, to register with the Board as follows:
19.3.2.a. The consultant pharmacist shall file an application with the Board for each institution, place or person to whom consulting services are provided;
19.3.2.b. The application shall contain, but is not limited to:
19.3.2.b.1. The name, address and phone number of the applying consultant and his or her license number;
19.3.2.b.2. The name, address, phone number and type of institution, entity or person receiving the consulting services;
19.3.2.b.3. A description of the services to be provided by the consultant; and
19.3.2.b.4. The name and signature of the facility administrator.
19.3.3. The consultant pharmacist shall immediately report to the Board any change in the data previously placed on the application for registration as a consultant. If the consulting arrangement is discontinued the consultant pharmacist shall immediately return the consulting permit to the Board.
19.3.4. The fee for registration as a consultant is $20.00 annually for each registration.
19.4. Responsibilities.
19.4.1. A pharmacist consultant shall document by date and time, in a permanent log book, his or her activities for each place where he or she is registered. This log book shall be present in each facility for which the consultant pharmacist is registered and shall be available for inspection by the Board at any time.
19.4.2. The pharmacist consultant shall initiate and maintain, in each facility, appropriate records and procedures for the receipt, storage and disposition of all drugs including but not limited to:
19.4.2.a. Prescriptions;
19.4.2.b. Floor stock;
19.4.2.c. Emergency boxes or kits;
19.4.2.d. Investigational drugs;
19.4.2.e. Samples; and
19.4.2.f. Outdated or discontinued drugs.
19.4.3. The pharmacist consultant shall maintain a Policy and Procedures Manual for pharmaceutical services. The Manual shall be available to all inspectors and available to patient care providers for their guidance in drug handling. The manual shall include, but not be limited to, provisions for the following:
19.4.3.a. Transcribing drug orders and prescription ordering;
19.4.3.b. Prescription delivery system and in-house verification;
19.4.3.c. Drug recall;
19.4.3.d. Automatic stop orders;
19.4.3.e. Formulary or standards for drug quality;
19.4.3.f. Systematic review of drug orders;
19.4.3.g. Reconciliation of controlled substances;
19.4.3.h. Disposition by the following means of prescriptions not totally consumed by the patient:
19.4.3.h.1. Return to pharmacy for credit; and
19.4.3.h.2. Destruction by the pharmacist in the presence of a registered nurse; and
19.4.3.i. Drug education for other personnel.
19.4.4. The pharmacist consultant shall maintain an appropriate drug reference library for use by other health care personnel.
19.4.5. The pharmacist consultant shall ensure compliance with all applicable laws and regulations, both state and federal.
19.4.6. The pharmacist consultant shall make every effort to separate consulting duties from dispensing duties. Remuneration shall be comparable to that charged by a pharmacist consultant not associated with the supplier of drugs or devices.
19.4.6.a. The pharmacist or his or her employer shall receive remuneration directly from the facility to which he or she is providing the service.
19.4.6.b. If the pharmacist consultant has any financial interest in the pharmacy providing drugs or devices to the facility he or she may not provide consulting service in order to obtain an agreement to be the supplier.
19.4.7. Nothing in this rule precludes a patient in a skilled or intermediate nursing facility, or other voluntarily entered facility, from free choice of pharmacy services.
W. Va. Code R. § 15-1-20 Specialized Dispensing Systems
20.1. Definition.
20.1.1. Specialized dispensing systems are those systems other than traditional bottle systems used to provide controlled administration of drugs, for oral administration, to ambulatory patients, and to patients and residents of health institutions.
20.2. Types.
20.2.1. A unit dose dispensing system is a system in which each individual unit of medication dosage form is in a separate container, which is intended to be placed in a larger prescription container which is complete with prescription labeling and contains several unit doses. Each individual unit-dose container shall be labeled with the following:
20.2.1.a. The name and strength of the drug;
20.2.1.b. The name of the manufacturer or the packager;
20.2.1.c. The lot number; and
20.2.1.d. The beyond-use date.
20.2.2. A unit of use system is a system in which all doses containing different medications to be administered at a given time are placed together in a single package, or packet, which is intended to be placed in a larger prescription container which is complete with prescription labeling and contains several unit of use packets. Each unit of use packet shall be labeled with the following:
20.2.2.a. The name and strength of each drug contained in the unit of use packet;
20.2.2.b. The name of the manufacturer or the packager of each drug in the unit of use packet;
20.2.2.c. The lot number of each drug in the unit of use packet; and
20.2.2.d. The expiration date of each drug in the unit of use packet;
20.2.3. Punch card packaging is a system, which does not constitute unit dose packaging, in which several doses of the same drug are packaged in a card, which is a prescription container, in which each dose has its own space and may be removed without disturbing the packaging for the remaining doses. A punch card shall be labeled with the following:
20.2.3.a. The name and strength of the drug contained in the punch card;
20.2.3.b. The name of the manufacturer or packager of the drug contained in the punch card;
20.2.3.c. The lot number of the drug contained in the punch card;
20.2.3.d. The expiration date of the drug contained in the punch card; and
20.2.3.e. All other information required to be on the label of a completed prescription order.
20.3.1. All extemporaneous unit dose, unit of use, punch card or any other specialized packaging shall be done by pharmacists, pharmacy interns, pharmacy technicians or pharmacy technician trainees under the direct supervision of a pharmacist.
20.3.2. The beyond-use date shall not exceed:
20.3.2.a. Six months from the date of repackaging; or
20.3.2.b. The manufacturer’s expiration date; whichever is earlier.
20.3.2.c. Except as modified in 15 C.S.R. 05.
20.3.3. These specialized packaging systems may not be used without the required prescription labeling being on the package that is intended to hold several doses for an individual patient.
20.4. Methods of supplying drugs and devices.
20.4.1. Institutions may not have drugs supplied in floor stock quantities unless a controlled substance permit is held by the institution.
20.4.2. Drugs may be supplied by prescription for individual patients.
20.4.3. Drugs, other than by prescription, may be stocked in emergency kits when the following conditions are met:
20.4.3.a. Drugs in emergency kits are to be administered only by those persons licensed to administer drugs;
20.4.3.b. The drugs in the emergency kit are of such nature that their absence would threaten the survival of the patients or intended recipients;
20.4.3.c. The contents of the emergency kit are determined by the pharmacist consultant and the medical director and the nursing director;
20.4.3.d. The emergency kit is sealed so that it is obvious if it has been opened and it is stored under secure conditions;
20.4.3.e. Administration of drugs from the kit is ordered by a practitioner and a record kept of administration;
20.4.3.f. Drugs stocked in the emergency kit are unit dose packaged;
20.4.3.g. Any drug used from the kit is replaced only upon a prescription or physician institution order form for the patient to which the dose was administered; and
20.4.3.h. Any emergency kit containing controlled substances is kept only at a facility holding a controlled substance permit from the Board.
W. Va. Code R. § 15-1-21 Institutions and Other Places Needing a Controlled Substance Permit
21.1. Any facility, including any hospital, skilled nursing facility, intermediate nursing facility, personal care home, jail, correctional institution, emergency organization, clinic or any other place which is responsible to administer drugs to in-patients or out-patients which, may or may not, hold a permit from this Board to operate a pharmacy, shall have a permit to handle controlled substances at the facility. A practitioner whose office is his or her primary place of practice is not required to obtain a permit for the office but shall obtain a permit for any satellite offices or clinics with controlled substances on the premises.
21.2. The Board shall issue a controlled substance permit to those persons required by W. Va. Code §60A-3-301 and §60A-3-302 to possess a permit.
21.3. Fees –The fees for a controlled substance permit are as follows unless changed by statute:
21.3.1. Manufacturer and wholesaler . . . . . . . . . . . . . . . . . .$50.00
21.3.2. Hospital or Clinic . . . . . . . . . . . . . . . . . . . . . . . . . . .$50.00
21.3.3. Extended care facility or nursing home . . . . . . . . . .$25.00
21.3.4. Non-government training institution . . . . . . . . . . . .$25.00
21.3.5. Non-government researcher . . . . . . . . . . . . . . . . . . .$25.00
21.3.6. Pharmacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $10.00
21.3.7. Non-government jails and correctional facilities . . ..$25.00
21.3.8. Non-government rescue or emergency squads . . . . .$25.00
21.3.9. Non-government humane societies . . . . . . . . . . . . . .$25.00 21.3.10 All government agencies or employees are exempt from paying the fee.
W. Va. Code R. § 15-1-22 Emergency Dispensing by Pharmacists
22.1. If a pharmacist is unable to obtain a refill authorization from a health care professional who issued the prescription and the pharmacy at which the pharmacist works has a record of the prescription for the drug in the name of the patient who is requesting it, a pharmacist may dispense an emergency supply of a prescription drug of life-sustaining medication or continue therapy for a chronic condition of the patient, when in the professional judgement of the pharmacist, failure to dispense could result in harm to the health of the patient. An amount not to exceed a 30-day supply or the standard unit of dispensing of a non-controlled substance may be provided to the patient as demonstrated by records maintained by the pharmacy. An amount not to exceed a 72-hour supply of a Schedule III, IV or V may be provided to the patient as demonstrated by records maintained by the pharmacy. A pharmacist shall not dispense a particular drug to a patient as an emergency supply more than once in any 12-month period.
22.1.1. A pharmacist who dispenses under 15 C.S.R. 01 shall:
22.1.1.a. Maintain a record of the dispensing for one year from the date of dispensing;
22.1.1.b. Notify the health professional who prescribed the initial professional within 72 hours after the drug is dispensed;
22.1.1.c. If possible, obtain authorization for additional dispensing from one of the health professionals responsible for the patient’s care; and
22.1.1.d. A pharmacist who dispenses under this section may do so once per year for each particular drug.
W. Va. Code R. § 15-1-23 West Virginia Official Prescription Paper Program Rules
23.1. The purpose of this section is to establish rules for the West Virginia official prescription paper program set forth at W. Va. Code §30-5-7(a)(32) for use in writing prescriptions by practitioners.
23.2. Minimum Requirements of West Virginia Official Prescription Paper. The prescription paper shall contain the following security features:
23.2.1. Shall meet all requirements issued by the Center for Medicare and Medicaid Services for a written prescription for controlled substances as required by Section 2002(b) of PL. 110-28 of the Iraq War Supplemental Appropriations Bill enacted by the United States Congress in 2007;
23.2.2. Shall contain six quantity check-off boxes printed on the form and in the following quantities shall appear:
23.2.2.a. 1-24;
23.2.2.b. 25-49;
23.2.2.c. 50-74; 23.2 2.d. 75-100;
23.2.2.e. 101-150; and
23.2.2.f. 151 and over:
Provided That, if the blank has the quantity prescribed electronically printed in both numeric and word format, then the quantity check-off boxes shall not be necessary;
23.2.3. Shall contain space for the prescriber to indicate number of refills, if any, or to indicate no refills;
23.2.4. Shall provide space for the patient’s name and address, the prescribing practitioner’s signature;
23.2.5. Shall provide space for the preprinted, stamped, typed, or manually printed name, address and telephone number of the prescribing practitioner, and the practitioner’s DEA registration number and NPI number; Provided that, if a practitioner does not have authority to prescribe controlled substances, then no DEA number shall be required, and, instead, the following statement shall be printed: “No Controlled Substances Authority”; and, Provided further that, if a practitioner is a veterinarian, no NPI number shall be required;
23.2.6. Shall contain the following statement printed on the bottom of the prescription blank: "This prescription may be filled with a generically equivalent drug product unless the words 'Brand Medically Necessary' are written in the practitioner's own handwriting, on this prescription form.".
23.3. Practitioners licensed to practice in this State may purchase West Virginia Official Prescription Paper as per individual orders from any vendor(s) which produces or supplies compliant West Virginia Official Prescription Paper.
23.4. On and after July 1, 2016, every written prescription written in West Virginia by a practitioner shall be written on West Virginia Official Prescription Paper. A pharmacist may not fill a written prescription from a West Virginia practitioner unless issued upon West Virginia Official Prescription Paper, except that a pharmacist may provide emergency supplies in accordance with the relevant laws and rules for emergency dispensing or other insurance contract requirements. Nothing in this section shall be construed to impact regulations regarding verbal, facsimile, electronic, or out-of-state prescription practices.
23.5. Practitioners; control and reporting of West Virginia Official Prescription Paper.
23.5.1. Adequate safeguards and security measures shall be undertaken by practitioners holding West Virginia Official Prescription Paper to assure against the loss, destruction, theft or unauthorized use of the forms. The forms may be used only by the practitioner to whom they are issued and are not transferable.
23.5.2. The Practitioner must also notify the vendor of any failure to receive West Virginia Official Prescription Paper within a reasonable time after ordering it. Further, practitioners must immediately notify the Board and vendor in writing of the loss through destruction, theft or loss, or unauthorized use of any Official Prescription Paper blanks, including:
23.5.2.a. Estimated number of blanks affected;
23.5.2.b. Control numbers if available; and
23.5.2.c. Suspected reason for destruction, theft, or loss.
23.5.3. West Virginia Official Prescription Paper does not have to come pre-printed from a vendor, but may also be created at the point of prescribing with software-generated prescriptions by printing on plain paper with secure technology accessible only by the prescriber and his or her authorized agent that results in a tamper resistant prescription as required by subsection 23.3 of this section.
W. Va. Code R. § 15-1-24 Practice of Telepharmacy and Telehealth services
24.1. Except as otherwise provided specifically herein, the practice of telepharmacy or telehealth is permitted only as follows:
24.1.1. For a pharmacist to provide direct patient-care activities, when the patient is unable to be present in the pharmacy for a personal, face-to-face interaction, provided the pharmacist is:
24.1.1.a. Licensed to practice pharmacist care in West Virginia; or,
24.1.1.b. Licensed to practice pharmacist care in the state where the mail order pharmacy is located if dispensing prescription drugs to a patient in this State from a non-resident mail order pharmacy properly permitted as a mail order pharmacy to dispense into this State;.
24.1.2. For drug regimen review of prescription orders for a patient in an institutional facility, for the pharmacist to authorize the dispensing and administration, provided the pharmacist is licensed to practice pharmacist care in West Virginia.
24.2. The practice of the health care service occurs where the patient is located at the time the telehealth services are provided;
24.2.1. The health care practitioner-patient relationship is established according to the definition of “valid patient-practitioner relationship” found in W. Va. Code §30-5-4;
24.2.2. The standard of care shall require that with respect to the established patient, the patient shall visit an in-person health care practitioner within 12 months of using the initial telehealth service or the telehealth service shall no longer be available to the patient until an in-person visit is obtained. This requirement may be suspended, in the discretion of the health care practitioner, on a case-by-case basis, and it does not apply to the following services: Acute inpatient care, post-operative follow-up checks, behavioral medicine, addiction medicine, or palliative care;
24.2.3. A prohibition of prescribing any controlled substance listed in Schedule II of the Uniform Controlled Substance Act, unless authorized by another section: Provided, That the prescribing limitations contained in this section do not apply to a physician or a member of the same group practice with an established patient;
24.2.4. A pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee performing telehealth care service is subject to the code of unprofessional conduct in 15 C.S.R. 01;
24.2.5. A pharmacist, pharmacy intern, pharmacy technician or pharmacy technician trainee performing telehealth care service is subject to the Board’s discipline process as specified in 15 C.S.R. 09.
24.2.6. A pharmacist is prohibited from prescribing or dispensing an abortifacient; and
24.2.7. A pharmacist is prohibited from prescribing or dispensing gender altering medication to a person who is under 18 years of age.
24.3. The health care provider by registering to provide interstate telehealth services to patients in this state is subject to:
24.3.1. The laws regarding the profession in this state, including the state judicial system and all professional conduct rules and standards incorporated into the health care practitioner’s practice act and the legislative rules of the registering board; and
24.3.2. The jurisdiction of the board with which he or she registers to provide interstate telehealth services, including such board’s complaint, investigation, and hearing process.
24.3.3. A health care professional who registers to provide interstate telehealth services pursuant to the provisions of or the requirements of this section shall immediately notify the board where he or she is registered in West Virginia and of any restrictions placed on the individual’s license to practice in any state or jurisdiction.
W. Va. Code R. § 15-1-25 Criminal History Record Check. 25.1 Beginning July 1, 2017, and in addition to all the requirements for licensure, an applicant for an initial license to practice as a pharmacist, intern, pharmacy technician, or pharmacy technician trainee in West Virginia shall request and submit to the Board the results of a state and national criminal history record check
25.2. The purpose of the criminal history record check is to assist the Board in obtaining information that may relate to the applicant’s fitness for licensure.
25.3. In addition to the State Police, the Board may contract with and designate a company specializing in the services required by this section instead of requiring the applicant to apply directly to the West Virginia State Police or similar out-of-state agency for the criminal history records checks. Provided that any such company must utilize protocols consistent with standards established by the Federal Bureau of investigation and the National Crime Prevention and Privacy Compact.
25.4. The applicant shall furnish to the State Police, or other organization duly designated by the Board, a full set of fingerprints and any additional information required to complete the criminal history record check.
25.5. The applicant is responsible for any fees required by the State Police, or other organization duly designated by the Board, for the actual costs of the fingerprinting and the actual costs of conducting a complete criminal history record check.
25.6. The Board may require the applicant to obtain a criminal history records check from a similar Board approved agency or organization in the state of the applicant’s residence if outside of West Virginia.
25.7. The applicant shall authorize the release of all records obtained by the criminal history record check to the Board.
25.8. A criminal history record check submitted in support of an application for licensure must have been requested by the applicant no earlier than 12 months immediately prior to the Board’s receipt of the applicant’s application for licensure.
25.9. An initial licensure application is not complete until the Board receives the results of a state and criminal history record check conducted by the State Police or another entity duly authorized by the Board. The Board shall not grant an application for licensure submitted by any applicant who fails or refuses to submit the criminal history record check required by this section.
25.10. Should criminal offenses be reported on an applicant’s criminal history record check, the Board will consider the nature, severity, and recency of offenses, as well as rehabilitation and other factors on a case-by-case basis for licensure. Criminal history record checks shall be verified by a source acceptable to the Board, other than the applicant.
25.11. The results of the state and national criminal history record check may not be released to or by a private entity except:
25.11.1. To the individual who is the subject of the criminal history record check;
25.11.2. With written authorization of the individual who is the subject of the criminal history record check; or
25.11.3. Pursuant to a court order.
25.12. Criminal history record checks and related records are not public records for the purposes of Chapter 29B of the West Virginia Code.
W. Va. Code R. § 15-1-26 Duties and Responsibilities of a Pharmacist It is the duty and responsibility of the pharmacist in every pharmacy to perform, at the minimum, the following duties:
26.1. To accept all new prescription orders from authorized prescribers transmitted by oral communication, immediately reduce them to writing and document the prescription by entering on the prescription order form:
26.1.1. The name of the caller;
26.1.2. The time and date of transmission; and
26.1.3. The handwritten initials of the receiver.
26.2. To dispense, deliver, or distribute a prescription drug order accurately as prescribed. For the purposes of this paragraph “accurately as prescribed” means:
26.2.1. To the correct patient (or agent of the patient) for whom the drug or device was prescribed;
26.2.2. With the correct drug in the correct strength, quantity, and dosage form ordered by the practitioner, unless converting a prescription order in accordance with W. Va. Code §30-5-35; a pharmacist may substitute a generic drug pursuant to W. Va. Code §30-5-12b; and 26.2.3 With correct labeling (including directions for use) as ordered by the practitioner;
26.3. To ensure that his or her initials are on all prescription labels dispensed while he or she is on duty, whether prepared by him or her or prepared by a pharmacy technician under his or her supervision;
26.4. To ensure that his or her initials are on all prescription order forms dispensed while he or she is on duty, whether prepared by him or her or prepared by a pharmacy technician under his or her supervision;
26.5. To counsel or inform patients about their drugs, which may include supplemental media according to the pharmacist’s professional judgment, to the patient, care giver, or agent. An offer to counsel shall be made by the pharmacist or designee in an oral communication with the patient, care giver or agent who presents a new prescription order, unless in the professional judgment of the pharmacist it is permissible for the offer to counsel to be made in a written communication, by telephone, in person, or in a manner determined by the pharmacist to be appropriate. The exercise of and reasons for this judgment shall be documented including the hand-written pharmacist’s initials. An offer to counsel has not been made by a mere question of whether the patient has any questions.
26.5.1. In those cases, when the offer to counsel, as described in this subsection, has been accepted, a pharmacist who provides pharmacist care to patients shall discuss with the patient or care giver or agent who presents a new prescription order, any matter which in the exercise of the pharmacist’s professional judgment he or she considers significant, which may or may not include the following:
26.5.1.a. The name of and a description of the medication;
26.5.1.b. The dosage form, route of administration, degree, and duration of drug therapy;
26.5.1.c. Special directions and precautions for preparation, administration, and use by the patient;
26.5.1.d. Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance and the actions required if they occur;
26.5.1.e. Techniques for self-monitoring drug therapy;
26.5.1.f. Proper storage and handling;
26.5.1.g. Prescription refill information; and
26.5.1.h. Any action to take in the event of a missed dose.
26.5.2. Nothing in this subsection requires a pharmacist to provide consultation if the patient, care giver, or agent does not accept the offer to counsel. If counseling is refused it shall be documented, followed by the initials of the recording pharmacist. Patient counseling is not required for inpatients of a hospital or institution where other licensed health care workers are authorized to administer the drugs;
26.6. To make a reasonable effort to obtain, record, and maintain at least the following information at the individual pharmacy:
26.6.1. The patient’s name, address, telephone number, date of birth or age, and gender;
26.6.2. The patient’s individual history including disease states, known allergies and drug reactions, and a comprehensive list of medications and relevant devices; and
26.6.3. The pharmacist’s comments regarding the patient’s therapy;
26.7. To perform all of the functions in this section;
26.8. To adequately supervise all pharmacy interns, registered pharmacy technicians and pharmacy technician trainees; and
26.9. To perform any other functions of any nature or kind which:
26.9.1. Require the knowledge, ability or skill of a licensed pharmacist; and
26.9.2. Attempt to improve the therapeutic outcome to the patient of the pharmacist care provided by the pharmacist.
26.10. No pharmacist, pharmacy intern, or pharmacy technician shall compound or dispense any prescription order which, in his or her judgment or professional opinion, contains any error, irregularity or ambiguity. The pharmacist shall hold a conference with the prescriber before dispensing, if there is any doubt that the prescription order is not legal or correct or issued for a legitimate medical purpose.
26.11. No person practicing pharmacist care shall engage in conduct, in the practice of pharmacy or in the operation of a pharmacy, which tends to reduce the public confidence in the ability and integrity of the profession of pharmacy, or endangers the public health, safety and welfare; nor shall he or she interfere in the profession of pharmacist care or offer pharmaceutical services under any terms or conditions which tend to impair the free and complete exercise of the professional skill and judgement of another pharmacist. A person practicing pharmacist care shall at all times practice his or her profession in conformity with federal and state laws and regulations and rules of this Board.
26.12. No pharmacist, pharmacy technician, or pharmacy intern shall attempt to diagnose any disease, illness, or disorder except as permitted in §30-5-10(15). This does not preclude evaluation of a patient after a diagnosis is made by a practitioner. The pharmacist may advise on the merits and quality of over-the-counter (OTC) products.
Series 02 Rules of the Board of Pharmacy for the Uniform Controlled Substances Act
W. Va. Code R. § 15-2-1 General
1.1. Scope. -- This rule relates to the registration and control of the manufacture and distribution of controlled substances within this State.
1.2. Authority. -- W. Va. Code §60A-3-301.
1.3. Filing Date. -- May 30, 2025.
1.4. Effective Date. -- July 1, 2025.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect on August 1, 2035.
W. Va. Code R. § 15-2-2 Definitions
2.1. The following words and phrases as used in this Rule mean:
2.1.1. "Act" means the Uniform Controlled Substances Act as provided in W. Va. Code §60A-1-101 et. seq.
2.1.2. “Acute care hospital” means a hospital licensed by the West Virginia Office of Health Facility Licensure and Certification that provides acute hospital care and treatment.
2.1.3. "Analogue" means a substance that, in relation to a controlled substance, has a substantially similar chemical structure. 2.1.4 "Commercial Container" means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. "Commercial Container" does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drug, or other package in which commercial containers are stored or are used for shipment of controlled substances.
2.1.5. "Immediate derivative" means a substance which is the principal compound or any analogue of the parent compound manufactured from a known controlled substance primarily for use and which has equal or similar pharmacologic activity as the parent compound which is necessary to prevent, curtail or limit manufacture.
2.1.6. "Immediate precursor" means a substance which is the principal compound commonly used or produced primarily for use and which is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled substance, the control of which is necessary to prevent, curtail or limit manufacture.
2.1.7. "Individual Practitioner" means a physician, dentist, veterinarian or other individual authorized by the jurisdiction in which he or she practices to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy or an institutional practitioner.
2.1.8. "Institutional Practitioner" means a hospital or other person, not including an individual, authorized by the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.
2.1.9. "Label" means a display of written, printed, or graphic matter upon the immediate container of any drug or device.
2.1.10. "Labeling" means the process of preparing and affixing a label to a drug container exclusive, however, of a labeling by a manufacturer, packer or distributor of a nonprescription drug or commercially packaged prescription drug or device.
2.1.11. "Manufacture" means the producing, preparation, propagation, compounding, conversion or processing of a controlled substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance, or the labeling or relabeling of its container, except that this term does not include the preparation, compounding, packaging or labeling of a controlled substance:
2.1.11.a. By a practitioner as an incident to his or her administering or dispensing of a controlled substance in the course of his or her professional practice; or
2.1.11.b. By a practitioner, or by his or her authorized agent under his or her supervision, for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale.
2.1.12. "Manufacturer" means any person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging or labeling of a prescription drug, whether within or outside this state.
2.1.13. "Perpetual inventory" means an ongoing system for recording quantities of drugs received, dispensed or otherwise distributed by a pharmacy. 2.1.14."Pharmacist" or “registered pharmacist” means an individual currently licensed by the jurisdiction in which he or she practices to engage in the practice of pharmacist care.
2.1.15. "Pharmacist-in-charge" means a pharmacist currently licensed in this state who:
2.1.15.a. Accepts responsibility for the operation of a pharmacy in conformance with all state and federal laws and rules pertinent to the practice of pharmacist care and the distribution of drugs;
2.1.15.b. Has the responsibility for the practice of pharmacist care, as defined in this rule, at the pharmacy for which he or she is pharmacist-in-charge. The pharmacy permit holder has responsibility for all other functions, administrative and operational, of the pharmacy. The pharmacist-in-charge may advise the pharmacy permit holder in writing of administrative and operational matters. The pharmacist-in-charge is not legally responsible if the permit holder does not follow the written advice;
2.1.15.c. Work requirements as required in W.Va. §15 CSR 1.2.42.c-d.
2.1.16. “Pharmacy technician” means a person registered with the board to practice certain tasks related to the practice of pharmacist care as permitted by the board.
2.1.17. "Prescription" means an order for medication which is dispensed to or for an ultimate user but does not include the immediate administration to the ultimate user.
2.1.18. "Readily Retrievable" means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined or in some other manner visually identifiable apart from other items appearing on the records.
2.1.19. “Registered nurse” means an individual granted this licensure by the West Virginia Board of Registered Nurses according to W.Va. Code §30-7-6.
2.1.20. “Registrant” means a person who has obtained a controlled substance registration from the Board.
2.1.21. Any term not defined in this rule has the definition set forth in W. Va. Code §60A-1-101 and 60A-8-5.
W. Va. Code R. § 15-2-3 Adoption of Federal Law
3.1. The requirements of the federal regulations, Drug Enforcement Administration, Department of Justice, 21 CFR Parts 1300-1321 (2020), and the federal Controlled Substances Act, 21 U.S.C. 801, as revised, are adopted by reference.
3.2. The federal regulations are available on the internet at http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.
W. Va. Code R. § 15-2-4 Controlled Substance Registration
4.1. Persons required to register.
4.1.1. A person who manufactures, distributes, reverse distributes, or dispenses any controlled substance or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance shall obtain annually a controlled substance registration unless exempted by law or pursuant to Section 4.2 of this rule. Only persons actually engaged in these activities are required to obtain a registration; related or affiliated persons who are not engaged in these activities are not required to be registered. For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration. A person who has obtained a controlled substance registration from the Board is a “registrant”.
4.2. The Board shall exempt from payment of a fee for a controlled substance registration the following registrants:
4.2.1. An official or agency of the United States Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration or Public Health Service who is authorized to procure or purchase controlled substances for official use; and
4.2.2. An official, employee or other civil officer or agency of the United States, of any state or any political subdivision or agency thereof, who is authorized to purchase controlled substances, to obtain the substances from official stocks, to dispense or administer the substances, to conduct research, instructional activities, or chemical analysis with the substances, or any combination thereof, in the course of his or her official duties or employment.
4.3. In order to claim exemption from payment of a fee, the applicant shall complete the certification on the appropriate application form, in which the registrant's superior certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess or handle controlled substances.
4.4. Exemption from payment of a fee does not relieve the registrant of any other requirements or duties prescribed by law or legislative rule.
4.5. An applicant shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.
4.6. An individual applicant shall sign the application; the partners shall sign the application if the applicant is a partnership; by a partner of the applicant if a partnership; the officers shall sign the application if the applicant is a corporation, corporate division, association, trust or other entity. Another person may be authorized to sign for the applicant, if proof of authority accompanies the application.
4.7. If an applicant is a pharmacy, the pharmacist in charge of the pharmacy shall sign the application. If the owner of the pharmacy is a person, other than the practicing pharmacist, the other person, partnership, or corporation, corporate division, association, trust or other entity, shall sign the application form as provided in subsection 4.6. of this rule in addition to any other persons required to sign the application.
4.8. If the applicant is at a place requiring the use of pharmacist consultants or coordinators of pharmaceutical services, the consultant or coordinator shall sign the application in addition to any other persons required to sign the application.
4.9. Filing of application; joint filings.
4.9.1. An applicant for registration shall submit the application to the office of the Board for filing.
4.9.2. A person required to obtain more than one registration may submit all applications in one package. An application must be complete and should not refer to an accompanying application for required information.
4.10. Acceptance for filing; defective applications.
4.10.1. Upon receipt, the Board shall date the application. If found to be complete, the Board will accept the application for filing. The Board does not accept an application failing to comply with the requirements of this rule. If an application has minor defects as to completeness, the Board may accept the application for filing with a request to the applicant for additional information. The Board shall return a defective application to the applicant within ten days following its receipt with a statement of the reason for not accepting the application for filing. An applicant may correct a defective application and resubmit the application for filing at any time.
4.11. Additional information.
4.11.1. The Board may require an applicant to submit documents or written statements of fact relevant to the application as it considers necessary to determine whether the application should be granted. The failure of the applicant to provide the documents or statements within a reasonable time after being requested to do so is considered a waiver by the applicant of an opportunity to present the documents or facts for consideration by the Board in granting or denying the application.
4.12. Amendments to and withdrawal of applications.
4.12.1. An applicant may amend or withdraw an application without permission of the Board at any time before the date on which the applicant receives an order to show cause, or before the date on which a notice of hearing on the application is published pursuant to W. Va. Code §60A-3-305, whichever is sooner. An applicant may amend or withdraw an application with permission of the Board at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.
4.12.2. After an application has been accepted by the Board for filing, the Board shall consider a request by the applicant that it be returned or failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, as withdrawal of the application.
4.13. Administrative review generally.
4.13.1. The Board may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to W. Va. Code §60A-5-501. The Board shall review the application for registration and other information gathered by the Board regarding an applicant in order to determine whether the applicable standards of W. Va. Code §60A-3-303 have been met by the applicant.
4.14. Applications for research in Schedule I substances.
4.14.1. In the case of an application for registration to conduct research with controlled substances in Schedule I, the Board shall determine the qualifications and competency of the applicant as well as the merits of the research protocol. The Board, in determining the merits of a research protocol, shall confer as to effective procedures to safeguard adequately against diversion of the controlled substances from legitimate medical or scientific use. If the Board finds the applicant qualified and competent and the research protocol meritorious and adequately safeguarded, it shall register the applicant unless it finds registration should be denied for reasons set forth in W. Va. Code §60A-3-303.
4.14.2. If the Board is unable to find the applicant qualified or the Board finds that grounds exist for the denial of the application, it shall issue an order to show cause and, if requested by the applicant, shall hold a hearing on the application.
4.15. The controlled substance registration shall contain the name, address and registration number of the registrant, the activity authorized by the registration, the schedules of the controlled substances which the registrant is authorized to handle, and the expiration date of the registration. The registrant shall prominently display the controlled substance registration at the registered location.
4.16. Registration or any authority conferred may not be assigned or otherwise transferred except upon conditions specifically designated by the Board and then only pursuant to its written consent.
W. Va. Code R. § 15-2-5 Security Requirements
5.1. Security requirements.
5.1.1. A registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Board shall evaluate the overall security system and needs of the applicant or registrant.
5.1.2. Physical security controls shall be commensurate with the schedules and quantity of controlled substances in the possession of the registrant in normal business operations. If a controlled substance is transferred to a different schedule or a noncontrolled substance is listed on any schedule, or the quantity of controlled substances in the possession of the registrant in normal business operations significantly increases, physical security controls shall be expanded and extended accordingly.
5.1.3. A registrant who receives or transfers substantial quantities of controlled substances in normal business operations shall employ security procedures to guard against in-transit losses.
5.2. Before distributing a controlled substance to a person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Board or with the appropriate state controlled substances registration agency, if any, to determine that the person is registered to possess the controlled substance.
5.3. A wholesale drug distributor shall design and operate a system to disclose to the wholesale drug distributor suspicious orders of controlled substances. A wholesale drug distributor shall inform the Office of the Board on the Board supplied form of suspicious orders of controlled substances when discovered by the wholesale drug distributor by providing a copy of the information which the wholesale drug distributor provides to the U.S. Drug Enforcement Administration regarding such suspicious orders. The notification shall include the contact information for the wholesale drug distributor’s department or staff responsible for coordinating with state regulatory or enforcement entities, unless such information has previously been provided in writing, including electronic or internet-based means, to the Office of the Board. If a wholesale distributor detects no suspicious orders in a calendar month, then the wholesale drug distributor shall inform the Office of the Board in writing within fifteen days of the end of such month stating it is reporting no suspicious orders for that month. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. The Board supplied form is available at www.wvbop.com.
5.3.1. A wholesale drug distributor that ceases distribution of Schedule II through V controlled substances to a customer located in West Virginia due to concerns that the customer may be involved in dispensing controlled substances for other than a legitimate medical purpose shall notify the Office of the Board within 5 days of the cessation. The notification shall include the contact information for the wholesale drug distributor’s department or staff responsible for coordinating with state regulatory or enforcement entities, unless such information has previously been provided in writing to the Office of the Board.
5.3.2. A wholesale drug distributor that decides not to commence distribution of Schedule II through V controlled substances to a customer in West Virginia due to a concern that the customer may be involved in dispensing controlled substances for other than a legitimate medical purpose shall notify the Office of the Board within five days of that decision. The notification shall include the contact information for the wholesale drug distributor’s department or staff responsible for coordinating with state regulatory or enforcement entities, unless such information has previously been provided in writing to the Office of the Board.
5.4. The registrant shall notify the Office of the Board of any theft or significant loss of any controlled substances as provided in subsection 9.3.
5.5. Physical security controls
5.5.1. When a pharmacy is closed, controlled substances listed in Schedule II shall be stored in a securely locked narcotic cabinet made of 20 gauge metal or better or may be dispersed throughout the stock of noncontrolled substances in a manner as to obstruct the theft or diversion of the controlled substance. Any other method of storage of controlled substances listed in Schedule II is not allowed unless specifically approved by the Board for that particular pharmacy. Only pharmacists practicing at the pharmacy and authorized by the pharmacist-in-charge may possess any keys or combinations to the narcotic cabinet. Controlled substances listed in Schedule III, IV, or V may be stored in the narcotic cabinet or may be dispersed throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substance. A secure automated distribution system, approved by the Board, may contain controlled substances within an institutional setting in lieu of a narcotic cabinet.
5.5.2. The registrant shall not employ as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration denied, or had his or her registration revoked.
W. Va. Code R. § 15-2-6 Labeling And Packaging Requirements For Controlled Substances. 6.1 Symbol required; exceptions
6.1.1. A commercial container of a controlled substance shall have printed on the label the symbol designating the schedule in which the controlled substance is listed. A commercial container, if it otherwise has no label, shall bear a label complying with the requirement of this section.
6.1.2. A manufacturer shall print upon the labeling of a controlled substance distributed the symbol designating the schedule in which the controlled substance is listed.
6.1.3. The following symbols shall designate the schedule corresponding thereto:
Schedule I CI or C-I.
Schedule II ………CII or C-II.
Schedule III CIII or C-III.
Schedule IV CIV or C-IV.
Schedule V ……….CV or C-V.
The word "Schedule" does not need to be used. There is no distinction made between narcotic and nonnarcotic substances.
6.1.4. The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through the carton or wrapper.
6.1.5. The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.
6.1.6. The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.
6.1.7. The symbol is not required on a commercial container containing, or on the labeling, of a controlled substance intended for export from the United States.
6.2. Location and size of symbol on label.
6.2.1. The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in Schedule I through V. The symbol shall be at least two times as large as the largest type otherwise printed on the label.
6.2.2. In lieu of locating the symbol in the corner of the label, as prescribed in subsection 6.2.1. of this rule, the symbol may be overprinted on the label, in which case the symbol shall be printed at least one half the height of the label and in a contrasting color providing clear visibility against the background color of the label.
6.2.3. The symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.
6.3. Sealing of controlled substances.
6.3.1. On a bottle, multiple dose vial, or other commercial container of a controlled substance, there shall be securely affixed to the stopper, cap, lid, covering or wrapper or other container, a seal to disclose upon inspection any tampering or opening of the container.
W. Va. Code R. § 15-2-7 Records And Reports Of Registrants
7.1. Records required to be kept shall be readily retrievable.
7.2. Maintenance of records and inventories.
7.2.1. Every inventory and other record required to be kept shall be kept by the registrant and be available, for at least five years from the date of the inventory or record, for inspecting and copying by authorized employees of the Board.
7.2.2. A registrant shall maintain inventories and records of controlled substances as follows:
7.2.2.a. Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; and
7.2.2.b. Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the registrant or in a form that the information required is readily retrievable from the ordinary business records of the registrant.
7.2.3. Each registered individual practitioner and institutional practitioner required to keep records shall maintain inventories and records of controlled substances in the manner prescribed in subdivision 7.2.2. of this rule.
7.2.4. Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:
7.2.4.a. Inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for the substances shall be maintained in a separate prescription file. Each pharmacy shall maintain a perpetual inventory of all Schedule II drugs received, dispensed, or otherwise distributed, with reconciliation at least monthly. Electronic monitoring at the pharmacy or by another entity that provides alerts for discrepancies between drugs received, drugs dispensed, or otherwise distributed is acceptable provided such alerts are reviewed at least monthly; and
7.2.4.b. Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the pharmacy or in a form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for the substances shall be maintained either in a separate prescription file for controlled substances listed in Schedules III, IV and V only, or in a form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions shall be considered readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if a pharmacy employs an automated data processing system or other electronic record-keeping system for prescriptions which utilizes identification by prescription number and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red “C” is waived.
7.3. General requirements for inventories.
7.3.1. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances are considered to be "On Hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.
7.3.2. A registrant shall make a separate inventory for each registered location. In the event controlled substances are in the possession or under the control of the registrant at a location for which he or she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location.
7.3.3. A registrant shall make a separate inventory for each independent activity for which he or she is registered, except as provided in subsection 7.10. of this rule.
7.3.4. A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory is taken.
7.3.5. A registrant shall maintain an inventory in a written, typewritten or printed form. An inventory taken by use of an electronic or oral recording device shall be promptly transcribed.
7.4. Initial inventory date.
7.4.1. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he or she first engages in the manufacture, distribution or dispensing of controlled substances, in accordance with subsections 7.4. through 7.7 of this rule, as applicable. In the event a person commences business with no controlled substances on hand, he or she shall record this fact as the initial inventory.
7.5. Biennial inventory date.
7.5.1. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.
7.6. Inventory date for new controlled substances.
7.6.1. On the effective date of a rule or statutory change by the Board or the DEA adding a substance to any schedule of controlled substances, when the substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who is manufacturing, distributing or dispensing that substance, shall take an inventory of all stocks of the substance on hand. Thereafter the substance shall be included in each inventory made by the registrant pursuant to subsection 7.5. of this rule.
7.7. Inventories of manufacturers.
7.7.1. Each registered manufacturer shall include the following information in the inventory:
7.7.1.a. For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or noncontrolled substances in finished form:
7.7.1.a.1. The name of the substance; and
7.7.1.a.2. The total quantity of the substance to the nearest metric unit weight consistent with unit size.
7.7.1.b. For each controlled substance in the process of manufacture on the inventory date:
7.7.1.b.1. The name of the substance;
7.7.1.b.2. The quantity of the substance in each batch and/or stage of manufacture, identified by the batch number or other appropriate identifying number; and
7.7.1.b.3. The physical form which the substance is to take upon completion of the manufacturing process, identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance and the number or volume of the substance.
7.7.1.c. For each controlled substance in finished form:
7.7.1.c.1. The name of the substance;
7.7.1.c.2. Each finished form of the substance;
7.7.1.c.3. The number of units or volume of each finished form in each commercial container; and
7.7.1.c.4. The total quantity of the substance in all forms to the nearest metric unit weight.
7.7.1.d. For each controlled substance not included in Subdivisions (a), (b) or (c) of this subsection:
7.7.1.d.1. The name of the substance;
7.7.1.d.2. The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and
7.7.1.d.3. The reason for the substance being maintained by the registrant and whether the substance is capable of use in the manufacture of any controlled substance in finished form.
7.8. Inventories of distributors.
7.8.1. Each registered distributor shall include in the inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule.
7.9. Inventories of dispensers and researchers.
7.9.1. Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to section 7.4. of this rule, shall include in the inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:
7.9.1.a. If the substance is listed in Schedule I or II, the dispenser shall make an exact count or measure of the content; and
7.9.1.b. If the substance is listed in Schedule III, IV or V, the dispenser shall make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which case the dispenser shall make an exact count of the contents.
7.10. Inventories of importers and exporters.
7.10.1. Each registered importer or exporter shall include in the inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule. Each registered importer and exporter who is also registered as a manufacturer or as a distributor shall include in the inventory as an importer or exporter only those stocks of controlled substances that are actually separated from the stocks as a manufacturer or as a distributor.
7.11. Inventories for chemical analysts.
7.11.1. Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule, as to substances which have been manufactured, imported or received by the laboratory conducting the inventory. If less than one kilogram of any controlled substance, other than a hallucinogenic controlled substance listed in Schedule I, or less than twenty grams of a hallucinogenic substance listed in Schedule I, other than lysergic acid diethylamide, or less than five tenths gram of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. Laboratories of the Board may possess up to one hundred fifty grams of any hallucinogenic substance in Schedule I without regard to a need for an inventory of those substances.
7.12. General requirements for continuing records.
7.12.1. Every registrant required to keep records pursuant to subsection 7.3. of this rule, shall maintain on a current basis a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported or otherwise disposed of by the registrant.
7.12.2. A registrant shall maintain separate records for each registered location. In the event controlled substances are in the possession or under the control of a registrant at a location for which he or she is not registered, the registrant shall include the substances in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.
7.12.3. A registrant shall maintain separate records for each independent activity for which he or she is registered.
7.12.4. In recording dates of receipt, importation, distribution, exportation or other transfer, the registrant shall use the date on which the controlled substances are actually received, imported, distributed, exported or otherwise transferred as the date of receipt or distribution of any documents of transfer.
7.13. Records of manufacturers.
7.13.1. Each registered manufacturer shall maintain records with the following information to account for all controlled substances used in the manufacturing process:
7.13.1.a. For each controlled substance in bulk form to be used, or capable of use in, or being used in, the manufacture of the same or other controlled or noncontrolled substances in finished form:
7.13.1.a.1. The name of the substance;
7.13.1.a.2. The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;
7.13.1.a.3. The quantity received from other persons, including the date and quantity of each delivery and the name, address and registration number of the other person from whom the substance was received;
7.13.1.a.4. The quantity imported directly by the registrant under a registration as an importer for use in manufacture by him or her, including the date, quantity and import permit or declaration number for each importation;
7.13.1.a.5. The quantity used to manufacture the same substance in finished form, including:
7.13.1.a.5.A. The date and batch or other identifying number of each manufacture;
7.13.1.a.5.B. The quantity used in the manufacture;
7.13.1.a.5.C. The finished form;
7.13.1.a.5.D. The number of units of finished form manufactured;
7.13.1.a.5.E. The quantity used in quality control;
7.13.1.a.5.F. The quantity lost during manufacturing and the causes therefore, if known;
7.13.1.a.5.G. The total quantity of the substance contained in the finished form;
7.13.1.a.5.H. The theoretical and actual yields; and
7.13.1.a.5.I. Any other necessary information;
7.13.1.a.6. The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in subdivision 7.13.1.a.5. of this rule;
7.13.1.a.7. The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address and registration number of each person to whom a distribution was made;
7.13.1.a.8. The quantity exported directly by the registrant under a registration as an exporter, including the date, quantity and export permit or declaration number of each exportation; and
7.13.1.a.9. The quantity distributed or disposed of in any other manner by the registrant, for example, by distribution of complimentary samples or by destruction, including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity distributed or disposed.
7.13.1.b. For each controlled substance in finished form:
7.13.1.b.1. The name of the substance;
7.13.1.b.2. Each finished form and the number of units or volume of finished form in each commercial container;
7.13.1.b.3. The number of containers of each commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subdivision 7.13.1.a.5. of this rule;
7.13.1.b.4. The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each delivery and the name, address and registration number of the person from whom the units were received;
7.13.1.b.5. The number of units of finished forms and/or commercial containers imported directly by the registrant under a registration as an importer, including the date of and the number of units and for commercial containers in each importation;
7.13.1.b.6. The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:
7.13.1.b.6.A. The date and batch or other identifying number of each manufacture;
7.13.1.b.6.B. The operation performed;
7.13.1.b.6.C. The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes therefore, if known; and
7.13.1.b.6.D. Any other information necessary to account for all controlled substances used in the manufacturing process;
7.13.1.b.7. The number of commercial containers distributed to other persons, including the date of and number of containers in each distribution, and the name, address and registration number of the person to whom the containers were distributed;
7.13.1.b.8. The number of commercial containers exported directly by the registrant under a registration as an exporter, including the date, number of containers and export permit or declaration number for each exportation; and
7.13.1.b.9. The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant, including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity in finished form distributed or disposed.
7.14. Records for distributors.
7.14.1. Each registered distributor shall maintain records with the following information for each controlled substance:
7.14.1.a. The name of the substance;
7.14.1.b. Each finished form, for example, ten milligram tablet or ten milligram concentration per fluid ounce or milliliter and the number of units or volume of finished form in each commercial container, for example, one hundred tablet bottle or three milliliter vial;
7.14.1.c. The number of commercial containers of each finished form received from other persons, including the date of and number of containers in each delivery and the name, address and registration number of the person from whom the containers were received;
7.14.1.d. The number of commercial containers of each finished form imported directly by the registrant under a registration as an importer, including the date of and the number of containers in each importation;
7.14.1.e. The number of commercial containers of each finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;
7.14.1.f. The number of commercial containers of each finished form exported directly by the registrant under a registration as an exporter, including the date of and the number of containers in each exportation; and
7.14.1.g. The number of units or volume of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant, for example, by distribution as complimentary samples, including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity of the substance in finished form distributed or disposed.
7.15. Records for dispensers and researchers.
7.15.1. Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to section 7.3. of this rule, shall maintain records with the following information for each controlled substance:
7.15.1.a. The name of the substance;
7.15.1.b. Each finished form, for example, ten milligram tablet or ten milligram concentration per fluid ounce or milliliter and the number of units or volume of finished form in each commercial container, for example, one hundred bottle or three milliliter vial;
7.15.1.c. The number of commercial containers of each finished form received from other persons, including the date of and number of containers in each delivery and the name, address and registration number of the person from whom the containers were received;
7.15.1.d. The number of units or volume of each finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser; and
7.15.1.e. The number of units or volume of each finished form and/or commercial container disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity of the substance in finished form disposed.
7.16. Records for importers.
7.16.1. Each registered importer shall maintain records with the following information for each controlled substance:
7.16.1.a. The name of the substance;
7.16.1.b. The quantity or number of units or volume in finished form imported, including the date, quantity or number of units or volume and import permit or declaration number for each importation;
7.1.6.1.c. The quantity or number of units or volume in finished form distributed to other persons, including the date and quantity or number of units or volume of each distribution and the name, address and registration number of each person to whom a distribution was made;
7.16.1.d. The quantity disposed of in any other manner by the registrant except quantities used in manufacturing by an importer under a registration as a manufacturer, which is to be recorded pursuant to subdivision 7.13.1.a.4. or subdivision 7.13.1.b.5. of this rule, including the date and manner of disposal and the quantity disposed.
7.17. Records for chemical analysis.
7.17.1. Each person registered to conduct chemical analysis with controlled substances shall maintain records with the following information, to the extent known and reasonably ascertainable, for each controlled substance:
7.17.1.a. The name of the substance;
7.17.1.b. The form or forms in which the substance is received, imported or manufactured by the registrant, for example, powder, granulation, tablet, capsule or solution and the concentration of the substance in that form, such as C.P., U.S.P., N.F., ten milligram tablet or ten milligram concentration per milliliter;
7.17.1.c. The total number of the forms received, imported or manufactured, for example, one hundred tablets, thirty one milliliter vial, or ten grams of powder, including the date and quantity of each receipt, importation or manufacture and the name, address and registration number, if any, of the person from whom the substance was received; and
7.17.1.d. The quantity distributed, exported or destroyed in any manner by the registrant except quantities used in chemical analysis or other laboratory work, including the date, the manner of distribution, exportation or destruction and the name, address and registration number, if any, of each person to whom the substance was distributed or exported.
7.17.2. Order forms, import and export permits, import invoices and export declarations relating to controlled substances shall be maintained separately from all other records of the registrant.
7.17.3. Records of controlled substances used in chemical analysis are not required.
7.17.4. Records relating to known or suspected controlled substances received as samples for analysis are not required under this section.
W. Va. Code R. § 15-2-8 Prescriptions
8.1. Rules governing the issuance, filling and filing of prescriptions for controlled substances are set forth generally in W. Va. Code §60A-3-308 and West Virginia Code of State Rules § 15-1-21.
8.2. Reserved.
8.3. Persons entitled to issue prescriptions.
8.3.1. A prescription for a controlled substance may be issued only by an individual practitioner who is authorized to prescribe controlled substances in the jurisdiction in which he or she practices, and is strictly limited to the schedule, class or specific substance which he or she is authorized by that jurisdiction to prescribe.
8.3.2. A prescription issued by an individual practitioner except for Schedule II controlled substance, may be communicated to a pharmacist by an employee or agent of the individual practitioner.
8.4. Purpose of issue of prescription.
8.4.1. To be effective, an individual practitioner shall issue a prescription for a controlled substance for a legitimate medical purpose in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Uniform Controlled Substances Act and the person knowingly filling such a purported prescription, as well as the person issuing it, are subject to the penalties provided for violations of the provisions of law relating to controlled substances.
8.4.2. An individual practitioner shall not issue a prescription in order for the individual practitioner to obtain controlled substances for the purpose of general dispensing to patients. A pharmacy may provide controlled substances to a practitioner for office use, but must do so by providing appropriate documentation through the use of an invoice or other federally required documentation or forms.
8.4.3. A practitioner shall not issue a prescription for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs, except in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.
8.5. Manner of issuance of prescriptions.
8.5.1. All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, and the name, address and registration number of the practitioner. If the prescription is transmitted by e-prescribing, the signature may be an electronic signature. All paper prescriptions, including, but not limited to traditional paper prescription blanks, computer generated prescriptions that are printed out or faxed, and prescriptions received by the pharmacy as a fax prescription regardless of the method of transmission by the prescriber, must contain the prescriber’s manual signature; an electronic signature, an electronic reproduction of the signature, signature stamp, or other form of signature is not a valid signature for a paper prescription. A practitioner may sign a prescription in the same manner as he or she would sign a check or legal document, for example, J.H. Smith or John H. Smith. Where an oral order is not authorized, prescriptions shall be written, typed, or computer-generated and printed with ink, and shall be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and legislative rules. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed in this rule, Provided that: a pharmacist may make changes to a prescription order written for a controlled substance in accordance with the following:
8.5.1.a. The pharmacist may add or change the patient's address upon verification;
8.5.1.b. The pharmacist may add or change the dosage form, drug strength, drug quantity, directions for use, or issue date only after consultation with and agreement of the prescribing practitioner.
8.5.1.c. Such consultations and corresponding changes should be noted by the pharmacist on the prescription; and
8.5.1.d. The pharmacist is never authorized to make changes to the patient's name, controlled substance prescribed, except for generic substitution authorized by state law or the prescriber's signature.
8.6. Form of controlled substance prescription.
8.6.1. Each controlled substance prescription shall be written on a separate blank and no non-controlled substance can be ordered on a blank with a controlled substance. This rule does not apply to prescriptions written for patients of an institutional facility as defined by West Virginia Code of State Rules § 15-1-2.1.21, 15 CSR 1. No more than one controlled substance may be written per prescription blank. A controlled substance prescription issued by a practitioner located outside the state of West Virginia that does not comply with this section may be accepted by the pharmacist if it is issued pursuant to the laws in the state in which the practitioner resides.
8.6.2. If a pharmacist receives a prescription with more than one controlled substance on the blank or a non-controlled substance on a blank with a controlled substance, then the pharmacist shall refuse to fill the prescription. If the pharmacist in his or her professional judgment determines the immediate necessity for the patient to receive his or her medication, then the prescriptions may be dispensed and the pharmacist shall document in a log the prescription numbers and drugs dispensed. This log shall be kept in the pharmacy and be available for inspection. The pharmacist shall contact the prescriber as soon as possible to inform them that the prescription was not written according this rule. If the pharmacist continues to receive prescriptions from the same practitioner that do not comply with this rule, then the pharmacist shall inform the Board.
8.6.3. Every controlled substance prescription shall have the name of the practitioner stamped, typed, or printed legibly on the face of the prescription, as well as the signature of the practitioner. Institutional prescription blanks shall include the DEA number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution, in lieu of the individual DEA number of the practitioner. If multiple practitioners are listed on a prescription blank, then the specific name of the prescriber shall be clearly distinguished upon the prescription. If a pharmacist receives a prescription that does not comply with this subsection, then the pharmacist shall refuse to fill the prescription. If the pharmacist in his or her professional judgment determines the immediate necessity for the patient to receive his or her medication, then the prescriptions may be dispensed and the pharmacist shall document in a log the date, patient name, practitioner name, prescription numbers, and drugs dispensed. This log shall be kept in the pharmacy and be available for inspection. The pharmacist shall contact the prescriber as soon as possible to inform them that the prescription was not written according to this rule. If the pharmacist continues to receive prescriptions from the same practitioner that do not comply with this rule, then the pharmacist shall inform the Board.
8.7. Persons entitled to fill prescriptions.
8.7.1. A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his or her professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner, for example, a hospital, nursing home, home for the aged, clinic, orphanage, governmental agency or institution or other place of similar character which dispenses controlled substances.
8.8. Dispensing of narcotic drugs for maintenance purposes.
8.8.1. The administering or dispensing directly, but not prescribing, of narcotic drugs listed in any schedule to a narcotic drug dependent person for “detoxification treatment” or “maintenance treatment” shall be considered to be within the meaning of the term "in the course of his or her professional practice or research." The practitioner shall be separately registered with the U.S. Attorney General as required by section 303(g) of the federal Controlled Substances Act 21 U.S.C. 823(g) and then thereafter comply with the regulatory standards imposed relative to treatment qualification, security, records and unsupervised use of drugs pursuant to the Act.
8.8.2. A physician who is not specifically registered to conduct a narcotic treatment program may administer, but not prescribe, narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. No more than one day’s medication may be administered to the person or for the person’s use at one time. The emergency treatment may be carried out for not more than three days and may not be renewed or extended.
8.8.3. This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.
8.9. Controlled substances listed in Schedule II.
8.9.1. Requirement of prescription.
8.9.1.a. A pharmacist may dispense a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to a paper prescription manually signed by the prescribing individual practitioner, or by electronic prescribing, except as allowed by subdivision 8.9.2. of this rule. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner’s agent to a pharmacy via facsimile equipment or other electronic transmission other than electronic prescribing, provided that the original paper, manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as provided by West Virginia Code of State Rules § 15-1-21, 15 CSR 1. A prescription for a Schedule II controlled substance is valid for ninety days from the date issued. A pharmacist may fill the prescription after ninety days if the prescriber confirms to the pharmacist that he or she still wants the prescription filled and the pharmacist documents upon the prescription that the confirmation was obtained.
8.9.1.b. An individual practitioner may administer or dispense a controlled substance listed in Schedule II in the course of his or her professional practice without a prescription, subject to subsection 8.8.1. of this rule.
8.9.1.c. An institutional practitioner may administer or dispense directly, but not prescribe, a controlled substance listed in Schedule II only pursuant to a paper prescription manually signed by the prescribing individual practitioner, an electronic prescription, or an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.
8.9.2. In the case of an emergency situation, a practitioner may communicate a prescription for a Schedule II controlled substance orally or by way of electronic transmission other than electronic prescribing, provided that if the prescribing practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a call-back to the practitioner using the practitioner’s phone number as listed in the telephone directory and other good faith efforts to insure his or her identity; and:
8.9.2.a. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Dispensing beyond the emergency period shall be pursuant to a prescription issued in the normal course of practice as authorized in subsection 8.9.1. of this rule.
8.9.2.b. The orally communicated prescription is immediately reduced to writing by the pharmacist, or, if necessary, the prescription communicated by way of electronic transmission other than electronic prescribing is immediately reduced to a hard copy;
8.9.2.c. Within seven days after authorizing an emergency oral prescription, the practitioner delivers a valid paper or electronic prescription for the emergency quantity prescribed to the dispensing pharmacist. The prescription shall have written on its face “Authorization for Emergency Dispensing” and the date of the orally or electronically transmitted prescription. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail, it shall be postmarked within the seven day period; if sent by electronic prescription, it must be transmitted by the prescriber within the seven day period. Upon receipt, the dispensing pharmacist shall attach this written prescription to the emergency oral prescription which had earlier been reduced to writing or to the hard copy of the electronically transmitted prescription. The pharmacist shall notify the nearest office of the U.S. Drug Enforcement Administration and the Board if the prescribing practitioner fails to deliver a written prescription.
8.10. Refilling Schedule II prescriptions; issuance of multiple prescriptions.
8.10.1. The refilling of a prescription for a controlled substance listed in Schedule II is prohibited. However, a prescriber may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided each separate prescription provides instructions other than the first prescription if the prescriber intends for that prescription to be filled immediately indicating the earliest date on which each prescription may be dispensed. The signatures on such prescriptions must be dated as of the date they were actually signed, and may provide the instructions for when they may be filled by indicating “do not full until”, “may not be filled before”, or other similar language, followed by the earliest date on which it may be dispensed.
8.11. Partial filling of Schedule II prescriptions.
8.11.1. A pharmacist may dispense a partial filling of a prescription for a controlled substance listed in Schedule II, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of the written prescription or written record of the emergency oral prescription. The remaining portion of the prescription may be filled within 72 hours of the first partial filling, however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity of controlled substances may be supplied beyond seventy-two hours without a new prescription.
8.12. Labeling of Schedule II prescriptions.
8.12.1. The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner and directions for use and cautionary statements, if any, contained in the prescription or required by law.
8.13. Filing of prescriptions.
8.13.1. All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of the Uniform Controlled Substances Act and this rule.
8.14. Controlled substances listed in Schedules III, IV, and V.
8.14.1. Requirement of prescription.
8.14.1.a. A pharmacist may dispense a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, only pursuant to either a paper prescription manually signed by a prescribing individual practitioner, a facsimile of a paper prescription or order for medication, an electronic prescription, or an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required by this rule, except for the signature of the prescribing individual practitioner.
8.14.1.b. An individual practitioner may administer or dispense a controlled substance listed in Schedule III, IV, or V in the course of his or her professional practice without a prescription, subject to the provisions of section 8.8. of this rule.
8.14.1.c. An institutional practitioner may administer or dispense directly, but not prescribe, a controlled substance listed in Schedules III, IV, or V pursuant to a paper prescription signed by a prescribing individual practitioner, an electronic prescription, or an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in section 8.5. of this rule, except for the signature of the prescribing individual practitioner, or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user, subject to section 8.8. of this rule.
8.15. Refilling of Schedule III, IV, or V prescriptions.
8.15.1. A pharmacist shall not fill or refill a prescription for a controlled substance listed in Schedule III, IV, or V more than six months after the date on which the prescription was issued and any prescription authorized to be refilled may not be refilled more than five times. Each refilling of a prescription shall be entered on the back of the prescription, or on another uniformly maintained appropriate record, such as medication records, which indicate prescription refills, initialed, and dated by the pharmacist as of the date of dispensing, and shall state the amount dispensed. If the pharmacist merely initials and dates the back of the prescription, he or she shall be considered to have dispensed a refill for the full face amount of the prescription. Additional quantities of controlled substances listed in Schedule III, IV, or V may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in section 8.14. of this rule, which shall be a new and separate prescription. The number of partial fills may be more than five times as long as the total quantity prescribed is not exceeded. No refill may be provided more than three days prior to the date the prior dispensing would be exhausted unless special circumstances justifying the early refill exist. If an early refill is made, the pharmacist is encouraged to consult with the prescriber, and must document on the prescription record the special circumstances justifying the early dispensing.
8.16. Partial Filling of Schedule III, IV, or V prescriptions.
8.16.1. The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible provided that:
8.16.1.a. Each partial filling is recorded in the same manner as a refilling;
8.16.1.b. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and
8.16.1.c. No dispensing occurs after six months after the date on which the prescription was issued.
8.17. Labeling of Schedule III, IV, or V prescriptions.
8.17.1. The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in the prescription as required by law.
8.18. Filing of Schedule III, IV, or V prescriptions.
8.18.1. All prescriptions for controlled substances listed in Schedules III, IV, or V shall be kept in accordance with section 7.15. of this rule.
8.19. Dispensing without prescription.
8.19.1. A pharmacist may dispense a controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined by the Federal Food, Drug, and Cosmetic Act, without a prescription to a purchaser at retail, unless:
8.19.1.a. The dispensing is made only by a pharmacist and not by a non-pharmacist employee even if under the direct supervision of a pharmacist. After the pharmacist has fulfilled his or her professional and legal responsibilities set forth in this section, the actual cash, credit transaction or delivery, may be completed by a non-pharmacist;
8.19.1.b. Not more than 240 cc. of any controlled substance containing opium, nor more than 120 cc. of any other controlled substance nor more than 48 dosage units of any controlled substance containing opium, nor more than 24 dosage units of any other controlled substance may be dispensed at retail to the same purchaser in any given 48 hour period;
8.19.1.c. The purchaser is at least 18 years of age;
8.19.1.d. The pharmacist requires every purchaser of a controlled substance under this section not known to him or her to furnish suitable identification, including proof of age where appropriate;
8.19.1.e. A bound record book for distributions of controlled substances under this section, other than by prescription, is maintained by the pharmacist. The book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase and the name or initials of the pharmacist who dispensed the substance to the purchaser. The book shall be maintained in accordance with the record keeping requirement of section 7.2. of this rule; and
8.19.1.f. A prescription is not required for distribution or dispensing of the substance pursuant to any other federal, state or local law.
W. Va. Code R. § 15-2-9 Miscellaneous
9.1. Distribution upon discontinuance or transfer of business.
9.1.1. Any registrant desiring to discontinue or transfer business activities altogether or with respect to controlled substances shall notify the Board immediately and shall submit with the notification a complete and detailed closing inventory of all controlled substances in the registrant's possession.
9.2. Disposal of controlled substances.
9.2.1. Compliance with federal law and regulations is considered in compliance with this section. A registrant shall document the destruction or disposal of all controlled substances on the appropriate form approved by the Board. The disposal of excessive amounts of residual and wasted controlled substances accrued by extemporaneous compounding in an institutional setting may be completed by two registered or licensed health care professionals with a record of the destruction indicating the two witnesses with their signatures.
9.2.2. Registrants may become registered with the DEA as an authorized collector to receive the transfer from ultimate users any unwanted and unused pharmaceutical controlled substances in their lawful possession for safe, secure, and responsible disposal. Any authorized collector must comply fully with the DEA requirements for such an authorized collection program. 9.2.3 In acute care hospitals, discontinued individual patient medications not supplied by the hospital should be sent home with the patient. Those that remain in the hospital after discharge may be considered abandoned and shall be destroyed in the following manner and in compliance with federal law:
9.2.3.a. Drugs listed in Schedules I, II, III, IV, V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, or by W.Va. Code §60A-1 et seq. shall be destroyed in the presence of two pharmacists, a pharmacist and pharmacy technician, or a pharmacist and a registered nurse employed by the hospital. The name of patient or patient medical record number, the name and strength of the drug, the amount destroyed, the date of destruction, and documentation of the required witnesses shall be recorded and maintained in the medical record. The destruction should also be recorded without patient specific information and maintained with the pharmacy’s controlled substance records.
9.2.3.b. Drugs not listed in Schedules I, II, III, IV, V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended, or W.Va. Code §60A-1 et seq, shall be destroyed in the presence of a pharmacist.
9.3. Reporting theft or significant loss of drugs.
9.3.1. A registrant shall notify the Board in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant must also file a complete and accurate DEA Form 106 with the Board within 45 days after discovery of the theft or significant loss.
9.3.2. The Pharmacist-in-charge must immediately notify the Board of the separation of employment of any pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee for any confirmed drug-related reason, including but not limited to, adulteration, abuse, theft, or diversion as required in W.Va. CSR §15-1-16.2.7.e-f.
9.4. Ordering of Controlled Substances.
9.4.1. A registrant shall complete DEA Form 222 for each transfer of a Schedule II controlled substance to another registrant without a prescription.
9.4.2. A pharmacist shall verify the receipt within the pharmacy of all controlled substances listed in Schedule II-V by reviewing and countersigning the invoices or packing documents.
Series 03 Continuing Education for Licensure for Pharmacists
W. Va. Code R. § 15-3-1 General
1.1. Scope. -- W. Va. Code §30-5-3A authorizes the Board of Pharmacy to promulgate rules which are necessary to perform the duties and responsibilities of the board as they relate to requiring pharmacists to meet certain continuing education requirements in order to maintain their license to practice pharmacy in the State of West Virginia.
1.2. Authority. -- This legislative rule is issued under the authority of W. Va. Code §30-5-7.
1.3. Filing Date. -- May 3, 2024.
1.4. Effective Date. -- May 3, 2024.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect upon August 1, 2034.
W. Va. Code R. § 15-3-2 Definitions
2.1. “Accreditation Council for Pharmacy Education” (“ACPE”) means the national accreditation organization for continuing pharmacy education.
2.2. “Chronic Pain” means pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months. For purposes of this rule, “chronic pain” does not include pain associated with a terminal condition or illness, or with a progressive disease that, in the normal course of progression, may reasonably be expected to result in a terminal condition or illness.
2.3. “Continuing Pharmacy Education” (“CPE”) means planned and accredited learning experiences beyond a formal degree program designed to promote the continual development of knowledge, skills, and attitudes on the part of the pharmacist or pharmacy technician. which promotes problem-solving and critical thinking and is applicable to the practice of pharmacy.
2.4. “Continuing Pharmacy Education Committee” (“CPE Committee”) means that committee appointed by the board responsible for approval of the content of each CPE activity, which is not otherwise automatically approved by this rule for CPE credit, offered by a non-accredited ACPE provider of CPE.
2.5. “Continuing Pharmacy Education Coordinator” (“CPE Coordinator”) means that individual or organization who may be retained by the board for the purpose of coordinating CPE activities and licensure renewal requirements.
2.6. “Continuing Pharmacy Education Hour” (“CPE Hour”) means one hour of participation in a board accredited continuing pharmacy education activity under responsible providership, capable direction and qualified instruction. For the purposes of this definition, an hour equals sixty minutes of participation and represents 1.0 continuing pharmacy education contact hour, but Continuing Pharmacy Education activities of less than one hour may be approved as Continuing Pharmacy Education activities in fifteen-minute increments worth one quarter contact hour per fifteen-minute period.
2.7. “Continuing Pharmacy Education Number” (Number) means either the ACPE number or board-issued CPE number assigned to identify each approved activity.
2.8. “Continuing Pharmacy Education Provider” (Provider) means an institution, organization, agency, corporation, company, or individual approved by the board for the purpose of direct provision of continuing pharmacy education activities.
2.9. “CPE Monitor” means the electronic CPE monitor created and maintained through the collaborative efforts of National Association of Boards of Pharmacy the Accreditation Council for Pharmacy Education (ACPE) to permit CPE providers, pharmacists, and pharmacy technicians to electronically keep track of CPE credits earned from CPE providers, by acting as a repository of this information maintained on licensees’ behalf and reported by NABP to state boards of pharmacy which request verification of CPE.
2.10. “Reporting Period” means the two-year licensure period beginning on July 1 of a given year through June 30 two years later which coincides with the licensee’s renewal period.
2.11. “West Virginia Pharmacists Association” (Association) means a statewide professional organization whose members are current or former pharmacists duly licensed by the board.
2.12. “West Virginia Society of Health System Pharmacists” means a statewide professional organization representing the interests of current and former pharmacists duly licensed by the board who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems.
W. Va. Code R. § 15-3-3 Purpose
3.1. The purpose of Continuing Pharmacy Education (CPE) is to maintain and enhance the professional proficiency of pharmacists licensed to practice in West Virginia for the benefit and health, safety and welfare of the people served by pharmacists in the State of West Virginia.
W. Va. Code R. § 15-3-4 Continuing Pharmacy Education Requirements
4.1. A licensed pharmacist shall complete a minimum of thirty CPE hours every two years, inclusive of any CPE requirements for consultant pharmacist registration, pharmacist immunization registration, and drug diversion training and best practice prescribing of controlled substances training, in order to renew his or her license to practice pharmacy in West Virginia, and each reporting period thereafter.
4.2. Hours earned may only be used to meet the requirements for one reporting period. Hours in excess of the number required at the end of each reporting period shall not be transferred or applied to future reporting periods to satisfy future CPE requirements. Hours earned in a new reporting period but used to meet the requirements of a prior reporting period may only be used for the prior reporting period.
4.3. Six hours of the thirty CPE hours required every two years shall be obtained through a live presentation requiring the direct presence of the pharmacist at the CPE activity.
4.4. Every pharmacist shall complete a minimum of two hours of drug diversion training and best practice prescribing of controlled substances training within one year of receiving his or her initial license from the Board.
4.4.a. Said two hours of CPE shall be a part of the 30 hours of CPE required and is not two additional hours.
4.4.b. For purposes of this subsection, “drug diversion training and best practice prescribing of controlled substances training” means a training course of at least two CPE hours which includes drug diversion training, best-practice prescribing of controlled substances training, and training on prescribing and administration of an opioid antagonist that has been approved by the Board.
W. Va. Code R. § 15-3-5 Methods of Acquiring Continuing Pharmacy Education
5.1. Continuing pharmacy education hours of credit may be earned by licensed pharmacists in the following manner:
5.1.a. Live Activities, which means CPE activities that provide for a direct interaction between faculty and learners, and may include lectures, symposia, live teleconferences, live webinars, workshops, and other similar venues;
5.1.b. Home study by print, webinar, computer-based training, video, or other non-live approved activities or audio-visual presentations;
5.1.c. Credit earned from a United States accredited college/school or university for post-graduate courses in pharmaceutical sciences or other courses applicable to pharmacy practice;
5.1.d. Continuing pharmacy education activities granted credit by other states; and
5.1.e. Any activity approved by ACPE.
5.2. ACPE approved providers do not have to give a statement of credit to pharmacists. Non-ACPE approved providers shall provide the pharmacist a statement of credit or statement of attendance.
W. Va. Code R. § 15-3-6 Activity Administration
6.1. The board has the statutory responsibility for the oversight of CPE as required for licensure renewal and to appoint a Continuing Pharmacy Education Committee.
W. Va. Code R. § 15-3-7 Continuing Pharmacy Education Committee
7.1. The Continuing Pharmacy Education Committee shall be composed of equal representation from the West Virginia Board of Pharmacy, each accredited school of pharmacy located in the State of West Virginia, the West Virginia Pharmacists Association, and the West Virginia Society of Health System Pharmacists.
7.2. The members of the CPE Committee shall be selected by the board and shall serve for a period of three years and may be reappointed.
7.3. The chairman of the CPE Committee shall be selected by the members of the committee.
7.4. The CPE Committee is responsible for approval of each activity offered by a non-accredited ACPE provider of CPE credit.
7.5. The CPE Committee shall:
7.5.a. perform necessary correspondence and communication with professional groups, organizations, and individuals who have interest in CPE; and
7.5.b. recommend to the board for its approval those providers of continuing pharmacy education activities who have been certified as meeting the criteria established for this purpose. 7.6 In all other matters concerning the approval of Continuing Pharmacy Education providers, the role of the CPE Committee is to advise and submit its recommendations to the board.
W. Va. Code R. § 15-3-8 Responsibilities of Providers
8.1. CPE providers are responsible for submitting CPE activities to the board for approval.
8.2. Providers shall submit an application for approval of any CPE activity in writing to the board at least thirty days prior to their offering in order that potential participants will know whether the activity is approved. The board may approve activities submitted later provided proper cause is shown for late submission.
8.3. The proposed CPE activity shall contain all required information on forms provided by the board, including, but not limited to, the course name, provider name, proposed dates the activity will be offered, agenda, content overview, learning objectives and faculty name with biography.
8.4. The board may revoke or suspend approval of providers for submission of fraudulent information concerning CPE.
8.5. Changes to the content of an ongoing approved activity shall require the provider to submit a new application for the activity.
8.6. Providers shall retain a file of participants of each accredited activity for four years.
8.7. Providers not accredited by ACPE shall provide a statement of credit of participation to each participant or report course completion to the CPE Monitor for each participant who attends and successfully completes an activity. The statement of credit shall include at a minimum, the course name, date completed, total CPE hours earned, and the provider’s name, address, phone number, and board CPE number.
W. Va. Code R. § 15-3-9 Responsibilities of Pharmacists
9.1. Pharmacists shall keep valid records, receipts, and certifications of continuing pharmacy education activities completed for four years and submit certifications of participation and completion to the board upon request. The records may be kept in whole or in part in the pharmacist’s personal account in the CPE Monitor.
9.2. The board may take disciplinary action against a pharmacist for submission of fraudulent statements or certificates concerning CPE.
9.3. A Pharmacist shall submit, on forms provided by the board, a list of accredited CPE activities completed in the preceding reporting period with their renewal license application.
9.4. In the event a pharmacist fails to submit a list of completed CPE activities with his or her renewal application, the board shall notify the pharmacist at his or her last known address that disciplinary action shall be taken for failure to comply with CPE requirements.
9.5. A pharmacist may request a waiver from the board from the CPE requirements for reasons of illness, injury, incapacity, retirement, or other extenuating circumstances.
9.6. A pharmacist shall keep the board informed of his or her current mailing address.
9.7. A pharmacist may only transfer CPE hours from another state if that state accepts the transfer of West Virginia CPE hours to its state.
9.8. A West Virginia licensed pharmacist who resides in another state requiring CPE and who does not practice in West Virginia may renew his or her West Virginia license by certifying on his or her CPE report form that he or she has a current and valid license to practice in the state in which he or she is residing. The following statement shall be placed on the form, and the form signed, dated, notarized, and returned to the West Virginia Board of Pharmacy with the renewal application and fee:
"I declare under penalties of falsification that I hold a current and valid pharmacist license, No. [] in the State of [___], and that I do not presently practice pharmacy in the State of West Virginia. I hereby agree to notify the West Virginia Board of Pharmacy if I return and commence practice in West Virginia."
9.9. A pharmacist may request CPE credit only once in a reporting period for each activity attended or completed.
W. Va. Code R. § 15-3-10 Approval of Continuing Pharmacy Activities
10.1. Providers shall submit all CPE activities for approval by the board except as provided for in subsections 10.2 and 10.3 of this section.
10.2. The board has approved all activities developed and presented by ACPE accredited providers.
10.3. Approval of a CPE activity is valid for a three-year period if the content remains the same.
10.4. All activities shall meet the criteria utilized by ACPE and additionally shall meet the following criteria:
10.4.a. The activity shall be relevant, timely, and applicable to pharmacy practice;
10.4.b. The activity content shall be well organized with stated objectives, and an orderly flow of material, with appropriate examples and/or illustrations; and
10.4.c. The activity shall be appropriately presented, with the mode/method of presentation appropriate to the topic.
W. Va. Code R. § 15-3-11 Activity Evaluation
11.1. The provider or sponsor shall have an evaluation mechanism for the purpose of allowing the participant to assess achievement of personal objectives.
11.2. The provider or sponsor shall develop and employ evaluation techniques that will assess the effectiveness of the CPE activities and the level of fulfillment of the stated objectives, with the goal of CPE improvement by the provider or sponsor.
11.3. The provider or sponsor shall compile the results of participants' evaluations and submit them to the board upon request.
W. Va. Code R. § 15-3-12 Credits and Records
12.1. Credits and records of CPE shall be based on a CPE hour or approved fifteen-minute increments.
12.2. A pharmacist who develops and/or presents an approved CPE activity shall receive credit for the number of continuing pharmacy education hours of that activity for his or her initial presentation.
12.3. All providers and pharmacists shall retain their records for four years in a manner that will enable their ready retrieval upon request of the board, its authorized agent or Committee.
12.4. Graduates providing documentation of enrollment in graduate programs of health-related fields or participation in a residency program in a health-related field are not required to provide additional documentation of participation in CPE. If a graduate discontinues his or her pursuit of graduate study, the prevailing CPE requirements apply for his or her continued licensure.
Series 04 Record Keeping and Automated Data Processing Systems
W. Va. Code R. § 15-4-1 General
1.1. Scope. -- Recordkeeping requirements, and outlining the proper use of an automated Data Processing System.
1.2. Authority. -- W. Va. Code §30-5-7.
1.3. Filing Date. -- April 27, 2020.
1.4. Effective Date. -- April 27, 2020.
1.5. Sunset Provision-- This rule shall terminate and have no further force or effect on April 27, 2030.
W. Va. Code R. § 15-4-2 Use of Automated Data Processing Systems -- General Provisions
2.1. A pharmacy may establish and use an automated data processing system to keep records of prescription drugs which it dispenses.
2.2. Two or more pharmacies may establish and use an automated data processing system as a common data file or database to maintain required or pertinent prescription drug dispensing information. Pharmacies using a common file are not required to transfer prescriptions or information for dispensing purposes between or among the pharmacies participating in the same common prescription file or data base: Provided that any common file must contain complete and adequate records of each prescription and renewal dispensed.
W. Va. Code R. § 15-4-3 Definitions
3.1. Except as otherwise specifically stated in this rule, the definitions set forth in Title 15, Series 1, Section 2 are incorporated by reference, and are fully applicable hereto.
3.2. “Automated Data Processing System (ADP)” means a system utilizing computer software and hardware for the purpose of recordkeeping.
3.3. “Printout” means a readable printed copy of the output of a computer.
3.4. “Common database” means a file or collection of information created by the automated data processing system that enables authorized users to have common access to the file regardless of physical location.
3.5. “On-line retrieval” means the producing of sight-readable documents on a suitable computer screen or monitor.
3.6. “Hardware” is the fixed components of a computer, server, or other such devices used for the electronic storage and retrieval of data.
3.7. “Software” is a computer program used to direct the operation of a computer, as well as the documentation giving instructions on how to use it, and directs the storage of required data on the hardware.
W. Va. Code R. § 15-4-4 Record of Dispensing Prescription Drugs
Records of dispensing of prescription drugs for original and refill prescriptions are to be made and kept by pharmacies for five (5) years. Information must be immediately accessible for a period of not less than one (1) year from the date of last dispensing. Information beyond one (1) year but up to five (5) years from the date of dispensing may be maintained other than on-line, but must be produced within seventy-two (72) hours upon request by proper authorities. The information contained in the records shall include, but not be limited to:
4.1. the information required to be placed upon the label for the dispensed medication as set forth in Title 15, Series 1, Section 18;
4.2. the full name of the pharmacist responsible for dispensing the drug; and
4.3. a record of renewals to date.
W. Va. Code R. § 15-4-5 Record of Retrieval (Documentation of Activity)
5.1. The pharmacy must be able to provide a current history of all authorized prescription activity required to be kept by section 4. In addition, this information must be capable of production on a patient-by-patient basis in the form of patient profiles which allows immediate review of any other data necessary to make rational judgments about pharmacist care.
5.2. An ADP system, if used, must provide this information by a suitable computer screen or monitor display and be capable of providing a printout.
5.3. An ADP system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedule III and IV, subject to the following conditions:
5.3.1. The ADP system shall provide on-line retrieval (via computer screen or monitor display or printout) of the original prescription order information for those prescription orders which are currently authorized for refilling. Order information includes, but is not limited to: the original prescription number, the date of issuance of the original prescription order by the prescribing practitioner, the full name and the address of the patient, the name, the address, and the DEA registration number of the prescribing practitioner, and the name, the strength, the dosage form and quantity of the controlled substance prescribed and the quantity dispensed if different from the quantity prescribed, and the total number of refills authorized by the prescribing practitioner.
5.3.2. The ADP system shall provide on-line retrieval (via computer screen or monitor display or printout) of the current refill history for Schedule III, IV, or V controlled substance prescription order (those authorized for refill during the past six (6) months). This refill history shall include, but not be limited to, the name of the controlled substance, the date of refill, the name of the controlled substance, the date of the refill, the quantity dispensed, the name or initials (or identification code if used) of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.
5.3.3. The ADP system shall contain documentation that an individual pharmacist has taken the responsibility for the accuracy of the information entered into the system for original prescriptions and for refills of the original prescription for a Schedule III, IV, or V Controlled Substance. A verified record of the day's controlled substance prescription order refill data must be retrievable by each pharmacy within seventy-two (72) hours of the date on which the refill was dispensed.
5.3.4. The ADP system shall have the capability of producing a printout of any refill data which the user pharmacy is responsible for maintaining under W. Va. Code §30-5-1 et seq. and its implementing regulations. This includes a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). The printout must include the name of the prescribing practitioner, the name and address of the patient, the quantity dispensed on each refill, the date of dispensing for each refill, the name or identification code of the dispensing pharmacist, and the number of the original prescription order. Any recordkeeping location must be capable of sending the Special Agent or Compliance Investigator a copy of the printout from the user pharmacy if requested to do so by the Agent or Investigator and must verify the printout transmittal capability of its system by documentation. (e.g., postmark).
5.3.5. In the event that pharmacy which employs a computerized system experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III, IV, and V controlled substance prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.
5.3.6. When filing refill information for original prescription orders for Schedule III, IV, or V Controlled Substances, a pharmacy may use the system described in Chapter 11, Drug Enforcement Administration, Department of Justice, as it relates to the Code of Federal Regulations under Section 1306.22, Titled, Refilling of Prescriptions.
W. Va. Code R. § 15-4-6 Auxiliary Recordkeeping System
An auxiliary recordkeeping system shall be established by each pharmacy for the documentation of renewals if the ADP is inoperative. Information regarding prescriptions dispensed and renewed during the inoperative period shall be entered into the automated data processing system within seventy-two (72) hours.
W. Va. Code R. § 15-4-7 Operating the ADP System
Only authorized pharmacy personnel licensed or registered by the Board may have access to the ADP.
W. Va. Code R. § 15-4-8 Records of Provision of Pharmacist Care Outside of a Licensed Pharmacy. 8.1 A pharmacist practicing pharmacist care services outside the premises of a licensed pharmacy shall maintain the records or other patient-specific information used in such activities in a readily retrievable form in a system that is secured and managed by the pharmacy with whom the pharmacist is providing such services; or, if acting independent of a pharmacy without the dispensing of prescription drugs to provide direct patient-care activities of patient counseling and medication therapy management, when the patient is unable to present to the pharmacy for a personal, face-to-face interaction, a secure system maintained by the pharmacist. The records or information shall:
(a) provide accountability and an audit trail;
(b) be provided to the Board upon request;
(c) be preserved for a period of at least five years from the date relied upon or consulted for the purposes of performing any such function; and (d) secure from unauthorized access and use.
15CSR4
Series 05 Licensure of Wholesale Drug Distributors, Third Party Logistics Providers, and Manufacturers
W. Va. Code R. § 15-5-1 General
1.1. Scope. -- To establish rules for the federal Drug Quality and Security Act, and Prescription Drug Marketing Act, as amended, for the licensing by this state of persons who engage in wholesale distributions, provision of third-party logistics, and manufacturing, of prescription drugs in interstate commerce within and into this state.
1.2. Authority. -- W. Va. Code §60A-8-9.
1.3. Filing Date. -- May 11, 2021
1.4. Effective Date. -- June 11, 2021
1.5. Sunset Date -- This rule shall terminate and have no further force or effect upon June 11, 2031.
W. Va. Code R. § 15-5-2 Definitions
2.1. Except as otherwise specifically stated in this rule, the definitions set forth in Title 15, Series 1, Section 2 are incorporated by reference as if set forth fully herein, and are fully applicable hereto.
2.2. “Affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly:
2.2.1. one business entity controls, or has the power to control, the other business entity; or
2.2.2. a third party controls, or has the power to control, both of the business entities.
2.3. “Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing.
2.4. “Blood component” means that part of blood separated by physical or mechanical means.
2.5. “Drug sample” means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
2.6. “Healthcare entity” means any person or entity that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or any wholesale drug distributor. Except as provided in § 203.22(h) and (i) of Chapter 21 of the Code of Federal Regulations (2020), a person cannot simultaneously be a “healthcare entity” and a retail pharmacy or wholesale drug distributor.
2.7. “Manufacturer” means anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.
2.8. “Outsourcing facility” means a facility engaged in manufacturing by compounding of sterile or non-sterile drugs which has registered with the Federal Food and Drug Administration as an outsourcing facility pursuant to Section 503B of the Federal Drug Quality and Security Act.
2.9. “Prescription drug” means any human drug required by Federal Law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug and Cosmetic Act.
2.10. “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, nor have responsibility to direct the sale or disposition of the product.
2.11. “Wholesale distribution” means distribution of prescription drugs, including directly or through the use of a third-party logistics provider or any other situation in which title, ownership, or control over the prescription drug remains with one person or entity but the prescription drug is brought into this state by another entity on their behalf, to persons other than a consumer or patient, but does not include: 2.11.1.. Intracompany sales, (which include but are not limited to a transaction or transfer between any division, subsidiary, parent and/or affiliated or related company under the common ownership and control of a corporate entity;)
2.11.2. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons; for purposes of this section, "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, (except that the gross dollar amount shall not exceed five percent of the total prescription drug sales revenue of either the transferor or transferee pharmacy during any consecutive twelve month period);
2.11.3. The distribution of drug samples by manufacturers' representatives or distributors' representatives;
2.11.4. The sale, purchase, or trade of blood and blood components intended for transfusion;
2.11.5. The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription;
2.11.6. The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of such organization; 2.11.7.. The sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug by a charitable organization described in Section 501(c)(3) of the United States Internal Revenue Code of 1954 to a nonprofit affiliate of the organization to the extent otherwise permitted by law;
2.11.8. The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities that are under common control; for purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, voting rights, by contract, or otherwise;
2.11.9. Drug returns, when conducted by a hospital, health care entity, or charitable institution in accordance with § 203.23 of Title 21 of the Code of Federal Regulations (2020); or
2.11.10. The sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use (except that the gross dollar amount shall not exceed five percent of the total prescription drug sales revenue of either the transferor or transferee pharmacy during any consecutive twelve month period).
2.12. “Wholesale drug distributor” means any person or entity engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers; repackers; own-label distributors; private-label distributors; reverse distributors, jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; prescription drug repackagers; physicians, dentists, veterinarians, birth control and other clinics, individuals, hospitals, nursing homes and/or their providers, health maintenance organizations and other health care providers, and retail and hospital pharmacies that conduct wholesale distributions. A wholesale drug distributor shall not include any for hire carrier or person or entity hired solely to transport prescription drugs.
W. Va. Code R. § 15-5-3 Wholesale Drug Distributor and Third-Party Logistics Provider Licensing and Manufacturer Permit Requirements
3.1. Every wholesale distributor, wherever located, who engages in the wholesale distribution of drugs into, out of, or within the state must be licensed by the West Virginia Board of Pharmacy (hereinafter, the “Board”) in accordance with the laws and regulations of this state before engaging in the wholesale distribution of prescription drugs. Every wholesale distributor, wherever located, who engages in the wholesale distribution of drugs into, out of, or within the state shall report discipline from any jurisdiction within thirty days of the entry of the final order. 3.2 . Any person operating as a manufacturer of prescription drugs must obtain a manufacturing permit issued by the Board in accordance with the laws and regulations of this state before engaging in manufacturing of prescription drugs in this state. 3.3 Notwithstanding any other provision to the contrary, each entity that meets the definition of a third-party logistics provider shall obtain a license as a third-party logistics provider and is not required to obtain a license as a wholesale distributor if the entity never assumes an ownership interest in the product it handles.
W. Va. Code R. § 15-5-4 Minimum Required Information For Wholesale Drug Distributor or Third-Party Logistics Provider Licensure, and Manufacturer Permit; Applications and Renewals
4.1. A wholesale drug distributor or third-party logistics provider, and a manufacturer, including prescription drug manufacturers and outsourcing facilities, as part of the initial licensing procedure and as part of any renewal of license, shall provide on the application form as required by the Board:
4.1.1. The name, full business address, and telephone number of the licensee;
4.1.2. All trade or business names used by the licensee;
4.1.3. Addresses, telephone numbers, and the names of contact persons for the facility used by the licensee for the storage, handling, and distribution of prescription drugs;
4.1.4. The type of ownership or operation (i.e. partnership, corporation, or sole proprietorship) and
4.1.5. The name of the owner and/or operator of the licensee, including:
4.1.5.a. If a person, the name of the person;
4.1.5.b. If a partnership, the name of each partner, and the name of the partnership;
4.1.5.c. If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation, and the name of the parent company, if any;
4.1.5.d. If a sole proprietorship, the full name of the sole proprietor and the name of the business entity.
4.2. Where operations are conducted at more than one location by a single wholesale drug distributor, third-party logistics provider, or manufacturer, each location shall be licensed or permitted by the Board. However, the Board may provide for a single license or permit for a business entity operating more than one facility within this state, or for a parent entity with divisions, subsidiaries, and/or affiliate companies within this state when operations are conducted at more than one location and there exists joint ownership and control among all entities.
4.3. A wholesale drug distributor, third-party logistics provider, or manufacturer shall submit changes in any of the information required by this section to the Board within thirty days after the change.
4.4. Applicants for an original wholesale drug distributor license or third-party logistics provider license shall pay an application fee of Seven Hundred Fifty Dollars which shall be submitted along with a satisfactory application for licensure. Each applicant for a wholesale drug distributor or third-party logistics provider license located in this state where prescription drugs will be handled, stored, or kept must complete an inspection satisfactory to the Board. Each applicant for a wholesale drug distributor or third-party logistics provider license located outside of this state must be properly licensed as such in that state or United States territory, of, if no such licensure is granted by that state or territory, then with the Federal Food and Drug Administration, and must supply proof of that authorization along with its application.
4.5. Applicants for an original manufacturer permit shall pay an application fee of Five Hundred Dollars which shall be submitted along with a satisfactory application for a permit. Each applicant for a manufacturer permit must be authorized to operate as a manufacturer with the Federal Food and Drug Administration, and must supply proof of that authorization along with its application. The manufacturer must supply proof of satisfactory inspection by the FDA within the previous 5-year period, or pay an additional fee of Four Hundred Dollars for inspection by the Board.
4.6. A wholesale drug distributor and third-party logistics provider license shall expire on June 30, of each calendar year. Applications for renewal of wholesale drug distributor and third-party logistics provider licenses shall be provided to each licensee at least thirty days before the first day of July of each calendar year by the Board. The notification may be sent electronically to an e-mail or be mailed to the last known address of the licensee. The fee for renewal is Seven Hundred Fifty Dollars.
4.6.1. If a completed application for renewal is not received in the Board office on or before June 30 of the year in which it expires, the license is expired. Renewal applications received after June 30 shall require the payment of a late fee in the amount of One Hundred Fifty Dollars in addition to the application fee of Seven Hundred Dollars, for a total amount of Nine Hundred Dollars. 4.6.2.If a completed application for renewal is not received in the Board office before the first day of August each year, then, in order to renew, the licensee shall pay a reinstatement fee of two hundred fifty dollars, and pay the required renewal fee of Seven Hundred Fifty Dollars, for a total amount of One Thousand Dollars.
4.7. A manufacturer permit shall expire on June 30, of each calendar year. An application for renewal of a manufacturer permit shall be provided to each licensee at least thirty days before the first day of July of each calendar year by the Board. The notification may be sent electronically to an e-mail or be mailed to the last known address of the licensee. The fee for the annual renewal is Five Hundred Dollars.
4.7.1. If a completed application for renewal is not received in the Board office on or before June 30 of the year in which it expires, the permit shall expire. Renewal applications received after June 30 shall require the payment of a late fee in the amount of One Hundred Fifty Dollars in addition to the application fee of Five Hundred Dollars, for a total amount of Six Hundred Fifty Dollars.
4.7.2. If an application for renewal is not received in the Board office before the first day of August each year, then, in order to, the manufacturer must supply proof of inspection by the FDA within the previous 5-year period, and the permittee shall pay a reinstatement fee of Two Hundred Fifty dollars, in addition to the application fee of Five Hundred Dollars, for a total amount of Seven Hundred Fifty Dollars.
4.8. Licenses and permits issued under this section are not transferable, and become immediately expire upon change of ownership.
W. Va. Code R. § 15-5-5 Minimum Qualifications
5.1. The Board shall consider, at a minimum the following factors in reviewing the qualifications of persons who engage in wholesale distribution of prescription drugs, act as a third-party logistics provider, or manufacturer prescription drugs within or into the state:
5.1.1. Any convictions of the applicant under any Federal, State, or local laws relating to drug samples, drug manufacturing, wholesale or retail drug distribution, or distribution of controlled substances;
5.1.2. Any felony convictions of the applicant under Federal, State, or local laws;
5.1.3. The applicant's past experience in the manufacture or distribution of prescription drugs, including controlled substances;
5.1.4. The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution or acting as a third-party logistics provider;
5.1.5. Suspension or revocation by Federal, State, or local government of any license, permit, or other authorization currently or previously held by the applicant for the manufacture or distribution of, or acting as a third-party logistics provider related to, any drugs, including controlled substances;
5.1.6. Compliance with licensing requirements under previously granted licenses, if any;
5.1.7. Compliance with requirements to maintain and/or make available to the Board or to Federal, State, or local law enforcement officials those records required under this section;
5.18. An outsourcing facility must complete an initial inspection satisfactory to the board; and
5.1.9. Any other factors or qualifications the Board considers relevant to and consistent with the public health and safety.
5.2. The Board may deny a license to any applicant if it determines that the granting of a license would not be in the public interest. The Board shall base public interest considerations upon factors and qualifications that are directly related to the protection of the public health and safety.
W. Va. Code R. § 15-5-6 Personnel
6.1. As a condition for receiving and retaining a wholesale drug distributor or third-party logistics provider license or manufacturer permit, the licensee or permittee shall require each person employed in any prescription drug wholesale distribution activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such manner as to provide assurance that the drug product quality, safety and security will at all times be maintained as required by law.
W. Va. Code R. § 15-5-7 Violations and Penalties
7.1. The Board may reprimand, suspend, restrict, or revoke any licenses or permits granted under this series upon conviction of violations of Federal, State, or local drug laws or regulations. Before any license or permit may be reprimanded, suspended, restricted, or revoked, a licensee or permittee under this series shall have a right to prior notice and a hearing pursuant to Chapter 29A-1-1 et seq., Administrative Procedures Act of the Code of West Virginia.
7.2. The Board may reprimand, suspend, restrict, or revoke any license or permit granted under this section for violations of these regulations.
7.3. In any case where the Board finds that any licensee or permittee under this section shall be disciplined as set forth above, the Board may also levy an administrative penalty not to exceed one thousand dollars per day per violation, and may assess administrative costs against the licensee.
W. Va. Code R. § 15-5-8 Minimum Requirements for Wholesale Drug Distributors for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Records
The following constitutes the minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records by wholesale drug distributors and their officers, agents, representatives, and employees.
8.1. Facilities. All facilities at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:
8.1.1. Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
8.1.2. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
8.1.3. Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;
8.1.4. Be maintained in a clean and orderly condition; and
8.1.5. Be free from infestation by insects, rodents, birds, or vermin of any kind.
8.2. Security.
8.2.1. All facilities used for wholesale drug distribution shall be secure from unauthorized entry.
8.2.1.a. Access from outside the premises shall be kept to a minimum and be well controlled.
8.2.1.b. The outside perimeter of the premises shall be well-lighted.
8.2.1.c. Entry into areas where prescription drugs are held shall be limited to authorized personnel.
8.2.2. All facilities shall be equipped with an alarm system to detect entry after hours.
8.2.3. All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.
8.3. Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF).
8.3.1. If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.
8.3.2. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.
8.3.3. The recordkeeping requirements in 8.6 of this section shall be followed for all stored drugs.
8.4. Examination of materials.
8.4.1. Upon receipt, each outside shipping container shall be visually examined for identity and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.
8.4.2. Each outgoing shipment shall be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have been damaged in storage or held under improper conditions.
8.4.3. The recordkeeping requirements in 8.6 of this section shall be followed for all incoming and outgoing prescription drugs.
8.5. Returned, damaged, and outdated prescription drugs.
8.5.1. Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier.
8.5.2. Any prescription drugs whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.
8.5.3. If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, then the drug shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.
8.5.4. The recordkeeping requirements in 8.6 of this section shall be followed for all outdate, damaged, deteriorated, misbranded, or adulterated prescription drugs.
8.6. Recordkeeping.
8.6.1. Wholesale drug distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include the following information:
8.6.1.a. The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;
8.6.1.b. The identity and quantity of the drugs received and distributed or disposed of; and
8.6.1.c. The dates of receipt and distribution or other disposition of the drugs.
8.6.2. Inventories and records shall be made available for inspection and photocopying by authorized Federal, State, or local law enforcement agency officials for a period of two years following disposition of the drugs.
8.6.3. Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by an authorized official of a Federal, State, or local law enforcement agency.
8.7. Written policies and procedures. Wholesale drug distributors shall establish, maintain, and adhere to written policies and procedures, which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors shall include in their written policies and procedures the following:
8.7.1. A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate.
8.7.2. A procedure to be followed for handling recalls and withdrawals of prescription drugs. The procedure shall be adequate to deal with recalls and withdrawals due to:
8.7.2.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;
8.7.2.b. Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or
8.7.2.c. Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.
8.7.3. A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects the security or operation of any facility in the event of a strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.
8.7.4. A procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two years after disposition of the outdated drugs.
8.8. Responsible persons. Wholesale drug distributors shall establish and maintain a list of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications and provide the board with such list upon licensure and renewal.
8.9. Compliance with Federal, State, and local law. Wholesale drug distributors shall operate in compliance with applicable Federal, State, and local laws and regulations.
8.9.1. Wholesale drug distributors shall permit the Board's authorized personnel and authorized Federal, State, and local law enforcement officials, to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law. Such officials shall show appropriate identification prior to being permitted access to the wholesale drug distributors' premises and delivery vehicles.
8.9.2. Wholesale drug distributors that deal in controlled substances shall register with the Board and with the Drug Enforcement Administration (DEA), and shall comply with all applicable state, local, and DEA regulations.
8.10. Salvaging and reprocessing. Wholesale drug distributors are subject to the provisions of any applicable Federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including 21 CFR, 207, 210, and 211 (2020).
W. Va. Code R. § 15-5-9 Minimum Requirements for Third-Party Logistics Providers and Manufacturers for the Storage and Handling of Prescription Drugs and for the Establishment and Maintenance of Prescription Drug Records
9.1. Third-party logistics providers and manufacturers shall meet the minimum requirements for the storage and handling of prescription drugs, and for the establishment and maintenance of prescription drug distribution records as required by the Federal Food and Drug Administration.
W. Va. Code R. § 15-5-10 The West Virginia Board of Pharmacy inspection powers and access to licensee and permittee records
10.1. A person authorized by the board may inspect during normal business hours any premises being used by a wholesale drug distributor, third-party logistics provider, or manufacturer in this state in the course of its business.
10.2. Licensees and permittees under this series may keep records regarding purchase and sales transactions at a central location apart from the principal office of the licensee or permittee or the location at which the drugs were manufactured, housed, or stored by the licensee or permittee, and from which they were shipped: Provided, That such records shall be made available for inspection within two working days after a request to inspect by the board is made. Such records may be kept in any form permissible under federal law applicable to prescription drugs record keeping.
Series 06 Mail-Order and Non-Resident Pharmacies
W. Va. Code R. § 15-6-1 General
1.1. Scope. -- To establish rules for mail-order pharmacies and non-resident pharmacies.
1.2. Authority. -- W. Va. Code §30-5-7.
1.3. Filing Date. – May 4, 2026.
1.4. Effective Date. – July 1, 2026.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-6-2 Definitions
2.1. “Mail-order pharmacy” means a pharmacy, regardless of its location, which dispenses greater than 25 percent prescription drugs via the mail or other delivery services.
2.2. “Non-resident pharmacy” means a pharmacy outside of this state that dispenses drugs into this state and provides pharmacist care to residents of this state.
2.3. “Pharmacy” means a place within this state where drugs are dispensed and pharmacist care is provided and a place outside of this state where drugs are dispensed and pharmacist care is provided to residents of this state.
2.4. “Prescription or prescription drug order” means a lawful order from a practitioner for a drug or device for a specific patient, including orders derived from collaborative pharmacy practice, where a valid patient-practitioner relationship exists, that is communicated to a pharmacist in a pharmacy.
W. Va. Code R. § 15-6-3 Registrations for Mail-Order Pharmacies
3.1. A mail-order pharmacy shall apply for a registration for authorization to dispense prescription drugs or medicines in West Virginia. A non-resident pharmacy shall be registered in this state in the same manner as a mail-order pharmacy pursuant to this Series by issuance of a mail order registration.
3.2. A mail-order pharmacy or non-resident pharmacy shall submit the application for the registration to the West Virginia Board of Pharmacy. The application shall contain the following information:
3.2.1. The owner of the mail-order pharmacy or non-resident pharmacy, whether an individual, a partnership, or a corporation.
3.2.2. The names and titles of all individual owners, partners or corporate officers.
3.2.3. The pharmacy manager.
3.2.4. The pharmacist-in-charge.
3.2.5. The complete address, telephone number and fax number of the mail-order pharmacy or non-resident pharmacy.
3.2.6. The most current valid inspection report from the home state.
3.3. The mail-order pharmacy or non-resident pharmacy shall obtain separate registrations if it operates more than one pharmacy.
3.4. The mail-order pharmacy or non-resident pharmacy shall maintain a permit, registration, or license as required by the state where located.
3.5. The pharmacist-in-charge shall certify that the mail-order pharmacy or non-resident pharmacy is in compliance with the standards of care relative to the dispensing of prescription drug orders as required by the state where located.
3.6. The pharmacist in charge shall submit the names of all pharmacists employed at the mail-order pharmacy or non-resident pharmacy.
W. Va. Code R. § 15-6-4 Prescription record and reporting
The mail-order pharmacy or non-resident pharmacy shall maintain prescription records which are available for review if required by the Board. The mail order pharmacy shall comply with the reporting requirements of the West Virginia Controlled Substances Monitoring Program as set forth in West Virginia Code § 60A-9-1 and the rules enacted in support thereof.
W. Va. Code R. § 15-6-5 Counseling
Mail-order pharmacies or non-resident pharmacies shall have a toll-free accessible telephone for consumers to obtain counseling with a licensed pharmacist during regular working hours and the telephone number shall be prominently identified on the prescription container or on the prescription container label.
W. Va. Code R. § 15-6-6 Doing Business in West Virginia
Mail-order pharmacies or non-resident pharmacies soliciting, receiving, and dispensing and delivering orders comprising prescription drugs and scheduled controlled drug substances as defined 21 U.S.C. § 301 et seq., and 21 C.F.R. § 1.1 et seq. and delivered to ultimate consumers in West Virginia constitutes doing business in West Virginia.
W. Va. Code R. § 15-6-7 Resident Agent
Mail-order pharmacies or non-resident pharmacies doing business in West Virginia by dispensing and delivering prescription orders to West Virginia consumers shall designate a resident agent for purposes of service of process and notice.
W. Va. Code R. § 15-6-8 Pharmacist-In-Charge Licensure requirement
The pharmacist in charge or at least one designated pharmacist of the out-of-state mail order pharmacy or non-resident pharmacy shall be licensed to practice pharmacist care in West Virginia and act as the PIC of the registration, and any other pharmacist providing pharmacist care from the out-of-state mail order pharmacy or non-resident pharmacy shall be licensed in the state where the pharmacy is located.
Series 07 Board of Pharmacy Rules for Registration of Pharmacy Technicians
W. Va. Code R. § 15-7-1 General
1.1. Scope. -- To establish standards for the training and regulation of pharmacy technicians and pharmacy technician trainees.
1.2. Authority. -- W. Va. Code §30-5-7.
1.3. Filing Date. – May 4, 2026.
1.4. Effective Date. – July 1, 2026.
1.5. Sunset Provision -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-7-2 Definitions
2.1. “Accreditation Council for Pharmacy Education” (“ACPE”) means the national accreditation organization for continuing pharmacy education.
2.2. “Cashier” means a pharmacy employee who only handles a prescription drug at the point of sale to provide the prescription drug to a patient and handles the financial transactions of the pharmacy.
2.3. “Certified Pharmacy Technician” or “CPhT” means a person who holds a current certification as a nationally certified pharmacy technician granted by NHA or PTCB.
2.4. “Continuing Pharmacy Education” (“CPE”) means planned and accredited learning experiences beyond a formal degree program designed to promote the continual development of knowledge, skills, and attitudes on the part of the pharmacist or pharmacy technician which promotes problem-solving and critical thinking and is applicable to the practice of pharmacy.
2.5. “Continuing Pharmacy Education Hour” (“CPE Hour”) means one hour of participation in a board accredited continuing pharmacy education activity under responsible providership, capable direction and qualified instruction. For the purposes of this definition, an hour equals 60 minutes of participation and represents 1.0 continuing pharmacy education contact hour, but Continuing Pharmacy Education activities of less than one hour may be approved as Continuing Pharmacy Education activities in 15-minute increments worth one quarter contact hour per 15-minute period.
2.6. “Medication Reconciliation” means the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage, frequency, and route, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider.
2.7. “National Healthcare Association” or “NHA” means the association which includes the ExCPT Certification Board, which develops, maintains, promotes, and administers a nationally accredited certification and recertification program for pharmacy technicians to become a CPhT, including its ExCPT Pharmacy Exam (ExCPT), which was originally established by the Institute for the Certification of Pharmacy Technicians.
2.8. "Pharmacy Technician" means a person registered with the board to practice certain tasks related to the practice of pharmacist care in this State within the scope of practice permitted by W. Va. Code §30-5-12, as provided, permitted, and limited by the laws and rules governing the practice of pharmacist care.
2.9. “Pharmacy Technician Certification Board” or “PTCB” means the entity established by its five governing organizations, the American Pharmacists Association, American Society of Health-System Pharmacists, Illinois Council of Health-System Pharmacists, Michigan Pharmacists Association, and National Association of Boards of Pharmacy, which develops, maintains, promotes, and administers a nationally accredited certification and recertification program for pharmacy technicians to become a CPhT, including its Pharmacy Technician Certification Exam (PTCE).
2.10. "Pharmacy Technician Trainee" means an individual currently engaged in a competency-based pharmacy technician education and training program which has been approved by the Board and who is performing the duties of a pharmacy technician under the direct supervision of a pharmacist.
2.11. “Reporting Period” means the two-year licensure period beginning on July 1 of a given year through June 30 two years later which coincides with the licensee’s renewal period.
W. Va. Code R. § 15-7-3 Qualifications For Registration as a Pharmacy Technician
3.1. To be eligible for registration as a pharmacy technician, an individual shall comply with W. Va. Code §30-5-11, and shall submit an application on the forms provided by the board, together with the application fee of $25 unless the individual qualifies for a fee waiver, evidencing that the individual:
3.1.1. Was registered as a pharmacy technician in the State of West Virginia prior to July 1, 2014, the registration was still active and in good standing through June 30, 2014, and he or she is otherwise eligible to renew his or her registration; or
3.1.2. Or those obtaining registration beginning July 1, 2014, and forward:
3.1.2.a. Has either:
3.1.2.a.1. Graduated from a competency-based pharmacy technician education and training program of a learning institution or training center approved by the Board;
3.1.2.a.2. Completed a pharmacy-provided, on-the-job, competency-based education and training program approved by the Board; or
3.1.2.a.3. Obtained a national certification as a pharmacy technician and have practiced in another jurisdiction for at least one year; and
3.1.2.b. Successfully passed the ExCPT national examination administered by NHA or the PTCE national examination administered by PTCB, and holds a current certification from NHA or PTCB, respectively, as a CPhT; and
3.1.2.c. Completed a criminal history records check as prescribed in 15 C.S.R. 01.
3.1.2.c.1. The criminal history records must have been requested within the 12 months immediately before the application is filed with the board.
3.1.2.c.2. To be qualified for registration, the results of the criminal history records check must be unremarkable and verified by a source acceptable to the board other than the applicant.
3.1.2.c.3. The board may deny registration to any applicant who fails or refuses to submit the criminal history records checks required by this subsection.
3.1.3. If the individual is seeking registration pursuant to 3.1.2.a.3., then the individual must provide satisfactory proof to the Board of his or her licensure status with the board of pharmacy in the state in which the individual is licensed. In states where there is no Board oversight, then a notarized document of proof of satisfactory employment by the previous pharmacist-in-charge will suffice.
3.2. An applicant may apply for registration as a pharmacy technician under W. Va. Code §30-1-27, the Universal Professional and Occupational Licensing Act of 2025, provided he or she has been a registered pharmacy technician in another state and has:
3.2.1. Established residence in this state; or
3.2.2. Is married to an active-duty member of the armed forces of the United States and has accompanied the member to an official permanent change of station to a military installation located in the state.
W. Va. Code R. § 15-7-4 Learning Institution or Training Center Provided and On-the-Job Pharmacy-Provided Competency-Based Training Program
4.1. A pharmacy may employ an individual as a pharmacy technician trainee and provide on-the-job, competency-based pharmacy technician training for the individual to become qualified for registration as a pharmacy technician. A pharmacy shall submit its pharmacy technician training program to the Board for approval prior to its use. The training program shall be outlined in a training manual which shall be used throughout the program. A competency-based pharmacy technician education and training program shall, at a minimum contain the following:
4.1.1. Written procedures and guidelines for the use and supervision of pharmacy technicians and pharmacy technician trainees. The procedures and guidelines shall:
4.1.1.a. Specify the manner in which the pharmacist-in-charge responsible for the supervision of pharmacy technicians and pharmacy technician trainees, shall supervise the pharmacy technicians and pharmacy technician trainees, and verify the accuracy and completeness of all acts and functions performed by them; and
4.1.1.b. Specify duties which may and may not be performed by pharmacy technicians and pharmacy technician trainees; and
4.1.2. Instruction in the following areas and any additional areas appropriate to the duties of pharmacy technicians and pharmacy technician trainees in the pharmacy:
4.1.2.a. Orientation;
4.1.2.b. Job descriptions;
4.1.2.c. Communication techniques;
4.1.2.d. Legislative rules of the West Virginia Board of Pharmacy;
4.1.2.e. Security and safety;
4.1.2.f. Prescription drugs, including:
4.1.2.f.1. Basic pharmaceutical nomenclature; and
4.1.2.f.2. Dosage forms;
4.1.2.g. Prescription drug orders, including:
4.1.2.g.1. Prescribers;
4.1.2.g.2. Directions for use;
4.1.2.g.3. Commonly used abbreviations and symbols;
4.1.2.g.4. Number of dosage units;
4.1.2.g.5. Strengths and systems of measurement;
4.1.2.g.6. Routes of administration;
4.1.2.g.7. Frequency of administration;
4.1.2.g.8. Interpreting directions for use; and
4.1.2.h. Prescription drug order preparation, including:
4.1.2.h.1. The creation or updating of patient medication records;
4.1.2.h.2. The entering of prescription drug order information into the computer or typing the label in a manual system;
4.1.2.h.3. The selection of the correct stock bottle and the accurate counting of or pouring of the appropriate quantity of drug product;
4.1.2.h.4. The selection of the proper container; and
4.1.2.h.5. The preparation of the finished drug product for inspection, labelling, and final check by pharmacists;
4.1.2.i. Drug product repackaging;
4.1.2.j. The compounding of non-sterile pharmaceuticals; and
4.1.2.k. Written policy and guidelines for the use of and supervision of pharmacy technicians.
4.2. A pharmacy technician trainee shall complete initial training at a pharmacy as outlined by the pharmacist-in-charge in the training manual, prior to the regular performance of his or her duties. The on-the-job, competency-based pharmacy technician training program shall consist of a minimum of 500 hours of employment within an 18-month period under the direct supervision of a pharmacist.
4.3. An individual may work as a pharmacy technician trainee only as a student enrolled in a competency-based pharmacy technician education and training program of a learning institution or training center approved by the Board as part of an experiential education component, or as an employee of a pharmacy in a 500-hour on-the-job, competency-based pharmacy technician training program. Prior to starting work in a pharmacy as a pharmacy technician trainee, the applicant shall submit an application on the forms provided by the board evidencing that he or she:
4.3.1. Has graduated from a high school or obtained a Certificate of General Educational Development (GED) or its equivalent, or is currently enrolled in a high school competency-based pharmacy technician education and training program;
4.3.2. Is not an alcohol or drug abuser;
4.3.3. Has not been convicted of a crime bearing a rational nexus to the practice duties of a pharmacy technician. For other convictions not bearing a rational nexus to the practice of pharmacy, the Board shall permit the applicant to apply for initial licensure if:
4.3.3.a. A period of five years has elapsed from the date of conviction or the date of release from incarceration, whichever is later;
4.3.3.b. The individual has not been convicted of any other crime during the period of time following the disqualifying offense; and
4.3.3.c. The conviction was not for an offense of a violent or sexual nature: Provided, that a conviction for an offense of a violent or sexual nature may subject an individual to a longer period of disqualification from licensure, to be determined by the individual board.
4.3.4. Has completed a criminal history records check as prescribed in 15 C.S.R. 01.
4.4. If the pharmacy technician trainee leaves the competency-based pharmacy technician education and training program of a learning institution or training center identified in his or her application, the learning institution or training center shall notify the Board in writing within 30 days that the trainee is no longer enrolled in the program. Upon leaving, the trainee may not continue to work as a trainee.
4.4.1. If the pharmacy technician trainee is transferring from the original pharmacy identified in his or her application as the pharmacy providing an on-the-job, competency-based pharmacy technician training program, the pharmacist-in-charge of that pharmacy shall notify the Board, in writing, within 30 days that the pharmacy technician trainee is no longer working there. The pharmacist-in-charge of the new pharmacy must notify the Board in writing within 30 days of the pharmacy technician trainee starting to work in the new pharmacy, which is providing the on-the-job, competency-based pharmacy technician training program.
4.4.2. Within 18 months of approval of his or her application to begin working as a pharmacy technician trainee in a training program, the pharmacist-in-charge must submit to the Board a certification in the form of an affidavit from the pharmacist-in-charge that the pharmacy technician trainee has adequately completed the training program, or that he or she has failed to complete the training program, whichever is applicable.
4.4.3. A pharmacy technician trainee shall successfully pass the ExCPT or PTCE national certification examination, obtain certification as a CPhT, and submit this information along with his or her application for registration in this State as a pharmacy technician prior to the expiration date of the pharmacy technician trainee permit.
4.4.4. If the pharmacy technician trainee fails to successfully pass the ExCPT or PTCE national certification examination and obtain certification as a CPhT prior to the expiration date of the pharmacy technician trainee permit, the pharmacy technician trainee shall cease working in the pharmacy immediately until he or she satisfies this requirement. Provided that, the Board may, upon approval of a petition to the Board by a pharmacy technician trainee, provide an extension of time for completion of a personal remediation or re-training program which is presented to the Board with the petition.
4.5. The pharmacist-in-charge of the pharmacy providing on-the-job, competency-based pharmacy technician training program shall document whether or not the pharmacy technician trainee has completed the training program and certify the competency of each technician completing the training. The pharmacist-in-charge shall maintain a written record of the initial training of each pharmacy technician. The written record shall contain the following information:
4.5.1. The name of the person receiving the training;
4.5.2. The date of the training;
4.5.3. A general description of the topics covered;
4.5.4. A statement or statements that certify that the pharmacy technician is competent to perform the duties assigned;
4.5.5. The name of the person supervising the training; and
4.5.6. The signature of the pharmacy technician trainee and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for the training of pharmacy technicians.
W. Va. Code R. § 15-7-5 Duties and Restrictions of a Pharmacy Technician and Pharmacy Technician Trainee
5.1. A pharmacy technician or pharmacy technician trainee may not:
5.1.1. Receive verbal prescription drug orders and reduce these orders to writing either manually or electronically;
5.1.2. Interpret and evaluate prescription drug orders;
5.1.3. Select drug products;
5.1.4. Interpret patient medication records and perform drug regimen reviews;
5.1.5. Deliver the prescription to the patient before a pharmacist performs the final check of the dispensed prescription to ensure that the prescription has been dispensed accurately as prescribed;
5.1.6. Communicate to the patient or the patient's agent, information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist considers significant;
5.1.7. Communicate to the patient or the patient's agent, information concerning any prescription drugs dispensed to the patient by the pharmacy;
5.1.8. Receive or place a call for a transferred prescription;
5.1.9. Perform any act within the practice of pharmacist care that involves discretion or independent professional judgment; or
5.1.10. Perform all pharmacy related functions which the registrant has not been trained and the function has not been specified in a written protocol with competency established.
5.2. The duties of a registered pharmacy technician or pharmacy technician trainee may include, but are not limited, to the following:
5.2.1. The placement, receipt, unpacking and storage of drug orders;
5.2.2. Maintenance of the work area and equipment in a clean and orderly condition;
5.2.3. The ordering and stocking of all pharmacy supplies;
5.2.4. The checking of all prescription and non‑prescription stock for outdates and the processing of outdated returns;
5.2.5. The operation of the cash register. However, the pharmacy technician shall
5.2.5.a. Only handle the complete transaction on refill prescriptions when specifically requested to do so by the pharmacist and when the patient has no questions for the pharmacist;
5.2.5.b. Only handle the transactions on new prescriptions after counseling by the pharmacist has been offered; and
5.2.5.c. Refer all questions regarding over the counter and prescription drug product selection or advice to the pharmacist;
5.2.6. The filing of completed hard‑copies of new prescriptions, in numerical order;
5.2.7. The placement of completed prescription orders on the will‑call shelf;
5.2.8. The wrapping of completed orders for mailing and the logging of mailed and delivered orders into a record;
5.2.9. The printing of third‑party billings, the processing of the billings for mailing and the transmission of electronically handled third‑party billings;
5.2.10. The reconciliation of third‑party payments;
5.2.11. The contacting of third‑party billers and payers if problems arise while handling a patient’s insurance transmissions;
5.2.12. The posting of patient purchases to private charge accounts and assisting with the printing and distribution of the monthly statements;
5.2.13. The handling of non‑professional phone calls to or from:
5.2.13.a. Patients requesting refills of prescriptions by number and patient name;
5.2.13.b. Physicians' offices authorizing refills, if no changes in the prescription are involved, and where the patient's name, medication and strength, number of doses, and date of prior fill is stated. The pharmacy technician shall refer any other inquiries by the prescribing physician's office to the pharmacist;
5.2.13.c. Patients concerning price information that has been calculated by computer;
5.2.13.d. Patients concerning business hours, mailing and delivery services, and the availability of goods and services;
5.2.13.e. Patients asking if their prescriptions are refillable and the number of refills remaining. Any interpretation of the proper length of time between refills must be handled by the pharmacist;
5.2.13.f. Wholesalers and distributors dealing with the ordering of goods and supplies; and
5.2.13.g. Physicians' offices regarding patient profile information, where no interpretation or judgment is necessary and only after the pharmacy technician verifies to whom the information is being given.
5.2.14. The acceptance of refill requests and the acceptance of new written prescriptions from patients or their agents after determining the following: the patient's correct name, address, phone number, birth date, drug allergies, disease state(s), and the method of payment; .5.2.15. The entering of prescription data and patient profile data into the computer. The pharmacy technician shall refer any information needing clarification or interpretation to the pharmacist. The pharmacy technician or pharmacy technician trainee shall:
5.2.15.a. Monitor the label printing; and
5.2.15.b. Alert the pharmacist to any duplication of medication, drug therapy overlap, drug interactions, drug‑disease state interactions, and any questions that arise from entering the information.
5.2.16. The performance of tasks under the pharmacist's supervision, such as obtaining stock bottles for prescription filling;
5.2.17. The counting and pouring from stock bottles for individual prescriptions only under the direct supervision of a pharmacist. The pharmacist shall initial the hard copy of the prescription and the label to account for the accuracy of the prescription contents and the accuracy of the labeling;
5.2.18. The reconstitution and restoration of the original form of medication previously altered for preservation and storage by the addition of a specific quantity of an appropriate diluent requiring no calculations. The pharmacy technician or pharmacy technician trainee may assist in the preparation of compounded sterile and non-sterile preparations under the direct supervision of a pharmacist. In all cases, the pharmacist shall check and verify the accuracy of the pharmacy technician or pharmacy technician trainee;
5.2.19. The weighing or measuring of specific ingredients for the pharmacist to use in extemporaneous compounding. In all cases the accuracy of the weighing and measuring must be verified by the pharmacist;
5.2.20. Under the direct supervision of a licensed pharmacist, a pharmacy technician may perform the following:
5.2.20.a. Perform pharmacy technician product verification where no clinical judgment is necessary and the pharmacist provides the final verification;
5.2.20.b. Complete a list of a patient’s current prescription and nonprescription medications to provide for medication reconciliation;
5.2.20.c. Supervise registered pharmacy technicians and pharmacy technician trainees;
5.2.20.d. Medical records screening;
5.2.20.e. Administer immunizations per 15 C.S.R. 12.
5.3. The pharmacist-in-charge shall not allow anyone within the pharmacy area to perform pharmaceutical care other than, pharmacists, registered pharmacy technicians, pharmacy technician trainees and pharmacy interns. A ratio of no more than six pharmacy technicians and/or pharmacy technician trainees per on-duty pharmacist operating in any pharmacy shall be maintained, to be determined by the discretion of the pharmacist-in-charge (PIC). This ratio shall not include pharmacy interns. The PIC shall have final approval of the ratio of pharmacy technicians operating in the pharmacy. Any decisions overriding such control of the PIC may be grounds for disciplinary action against the pharmacy permit.
5.4. A registered pharmacy technician or pharmacy technician trainee shall not handle any telephone calls for new prescriptions from a physician's office and shall immediately transfer the calls to a pharmacist, except in the case of refill requests as set forth in subsection 5.2.m.
5.5. A person who handles a prescription drug only during the point of sale to provide the prescription drug to a patient and accept payment is not subject to the licensure requirements of 15 C.S.R. 07. This handling process includes the cashier having access to the pharmacy’s operating system to verify unique information for each patient. A pharmacy may require an individual to complete a criminal background check before he or she is hired.
W. Va. Code R. § 15-7-6 Nuclear Pharmacy Technician Endorsement Requirements
6.1. Submit a written application to the board;
6.2. Pay the applicable fees;
6.3. Have graduated from high school or obtained a Certificate of General Educational Development (GED) or equivalent;
6.4. Have successfully completed a pharmacy provided, competency-based nuclear pharmacy technician education and training program approved by the board;
6.5. Have all applicable national certifications and comply with all federal rules and regulations;
6.6. Not be an alcohol or drug abuser, as these terms are defined in W. Va. Code §27-1A-11: Provided, That an applicant in an active recovery process, which may, in the discretion of the board, be evidenced by participation in a 12-step program or other similar group or process, may be considered;
6.7. Not have been convicted of a felony in any jurisdiction within 10 years preceding the date of application for license, which conviction remains unreversed;
6.8. Not have been convicted of a misdemeanor or felony in any jurisdiction if the offense for which he or she was convicted bearing a rational nexus to the practice of pharmacist care, which conviction remains unreversed; and
6.9. Have fulfilled any other requirement specified by the board in any rule.
6.10. A person whose license to practice pharmacist care has been denied, revoked, suspended, or restricted for disciplinary purposes in any jurisdiction is not eligible to be registered as a nuclear pharmacy technician.
W. Va. Code R. § 15-7-7 Nuclear Pharmacy Technician Endorsement Scope of Practice
7.1. A registered pharmacy technician who has obtained a nuclear pharmacy technician endorsement, may under the direct supervision of the licensed nuclear pharmacist, perform the following:
7.1.1. Assist in the dispensing process;
7.1.2. Receive new written or electronic prescription drug orders;
7.1.3. Mix compound ingredients for liquid products, suspensions, ointments, mixes, or blend for tablet granulations and capsule powders;
7.1.4. Prepare radiopharmaceuticals;
7.1.5. Record keeping;
7.1.6. File and organize prescriptions;
7.1.7. Create reports;
7.1.8. Inventory tasks;
7.1.9. Handle raw materials and intermediate or finished products;
7.1.10. Perform general maintenance as required on pumps, homogenizers, filter presses, tablet compression machines, and other like machines;
7.1.11. Perform standard operating procedures to meet current good manufacturing practices (GMP);
7.1.12. Maintain records;
7.1.13. Monitor and verify quality in accordance with statistical process or other control procedures; and
7.1.14. Stock medications.
7.2. A registered pharmacy technician who has obtained a nuclear pharmacy technician endorsement may not perform the following:
7.2.1. Drug regimen review;
7.2.2. Clinical conflict resolution;
7.2.3. Contact a prescriber concerning prescription drug order clarification or therapy modification;
7.2.4. Receive new oral prescription drug orders.
W. Va. Code R. § 15-7-8 Identification of Technicians and Technician Trainees
8.1. Pharmacy technicians shall wear a name tag which contains the designation "Pharmacy Technician" while working in a pharmacy within this State. The name tags shall contain lettering of a legible size. Pharmacy technicians and pharmacy technician trainees shall wear appropriate sanitary attire, other than a white coat.
8.2. During the period of training, a pharmacy technician trainee shall wear a name tag which contains the designation "Pharmacy Technician Trainee.”
W. Va. Code R. § 15-7-9 Certificate of Registration; Transfer of Registration
9.1. The Board will provide a certificate of registration to applicants meeting the requirements for registration as a pharmacy technician or pharmacy technician trainee.
9.2. The registration of the pharmacy technician trainee may not be transferred to another pharmacy unless:
9.2.1. The pharmacies are under common ownership and control and have a common training program; or
9.2.2. The pharmacist-in-charge of the pharmacy at which the pharmacy technician trainee intends to work certifies that the pharmacy technician trainee is competent to perform the duties assigned in that pharmacy and submits to the Board certification in the form of an affidavit that the pharmacy technician trainee intends to complete the board-approved on-the-job, pharmacy-provided competency-based training program at that pharmacy as outlined in subsection 4.1. .
W. Va. Code R. § 15-7-10 Renewal of Registration
10.1. A registered pharmacy technician obtaining registration beginning July 1, 2014, and forward after having successfully passed the ExCPT national examination administered by NHA or the PTCE national examination administered by PTCB, and who holds a current certification from NHA or PTCB, respectively, as a CPhT, shall submit a valid, current copy of the national pharmacy certification in order to renew the registration.
10.2. A pharmacy technician who obtained registration prior to July 1, 2014, or as defined in W. Va. Code §30-1-27 shall complete a minimum of 20 CPE hours every two years in order to renew the registration.
10.2.1. The hours earned may only be used to meet the requirements for one reporting period. Hours in excess of the number required at the end of each reporting period shall not be transferred or applied to future reporting periods to satisfy future CPE requirements. Hours earned in a new reporting period but used to meet the requirements of a prior reporting period may only be used for the prior reporting period.
10.2.2. Of the required 20 CPE hours, one hour must be in the subject of pharmacy law and one hour must be in the subject of patient safety.
Series 08 Controlled Substances Monitoring Program
W. Va. Code R. § 15-8-1 General
1.1. Scope. -- This rule establishes requirements for the recordation and retention in a single repository of information regarding the prescribing, dispensing and consumption of certain controlled substances, drugs of concern, and opioid antagonists.
1.2. Authority. -- W. Va. Code §§ 30-5-7, 60A-9-6, and 60A-9-9.
1.3. Filing Date. -- April 14, 2022
1.4. Effective Date. -- April 14, 2022
1.5. Sunset Date. -- This rule shall terminate and have no further force or effect upon August 1, 2027.
W. Va. Code R. § 15-8-2 Definitions
2.1. The definitions applicable to the Uniform Controlled Substances Act set forth in West Virginia Code § 60A-1-101 apply to this Series.
2.2. The following words and phrases have the following meanings:
2.2.a. "Central repository" means the repository designated by the board for the collection of the transmitted information, which may be a vendor designated by the board and under contract with the board to act as the central repository.
2.2.b. “Controlled Substances Monitoring Program” or “CSMP” means the database maintained through the central repository for the information required to be transmitted by this rule.
2.2.c. “Date sold” means, for purposes of American Society for Automation in Pharmacy (ASAP) standard prescription drug monitoring program reporting formats, the date a prescription is delivered to the patient or the patient’s caregiver or agent on behalf of the patient For prescriptions delivered by mail or other common carrier, it is the date placed in the mail or for delivery.
2.2.d. "Deliver" or "delivery" means the actual, constructive or attempted transfer from one person to another of: (1) A controlled substance, whether or not there is an agency relationship; (2) a counterfeit substance; or (3) an imitation controlled substance.
2.2.e. "Dispense" means to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, administering, packaging, labeling or compounding necessary to prepare the substance for that delivery. Dispensing has not occurred for purposes of this definition until the controlled substance is actually delivered to the recipient or recipient representative.
2.2.f. “Drugs of concern” means prescription drugs which are not controlled substances but which have a high potential for abuse.
2.2.g. “Authorized agent” means an individual, who is an employee of any of the covered persons or entities permitted to have access to the central repository pursuant to Rule 15-8-7.3 of this rule, who is specifically designated by the covered person or authorized representative of the covered entity to access the central repository on behalf of the covered person or entity.
2.2.h. “Electronic access” means the ability to connect with and view the information in the central repository maintained by the board using electronic means permits real-time connectivity to the central repository.
2.2.i. “Government-issued photo identification card” means an identification card of an individual that provides a photograph of him or her and is issued by a State or the Federal Government of the Unitesd States of America, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations (2020).
2.2.j. “Internet” means an interconnected system of networks that connects computers around the world via the Transmission Control Protocol (TCP) and the Internet Protocol (IP) established by the Internet Society (ISOC).
2.2.k. “Intranet” means a privately maintained computer network that can be accessed only by authorized persons, especially members or employees of the organization that owns it.
2.2.l. "Medical Services Provider" means a licensed practitioner with the legal authority to dispense controlled substances. 2.2.m.“Opioid antagonist or opiate antagonist” means drugs approved by the federal Food and Drug Administration for treatment of drug overdose which have a high affinity for opiate receptors but do not activate these receptors, and which block the effects of exogenously administered opioids such as morphine, heroin, meperidine, and methadone, or of endogenously released endorphins and enkephalins.
2.2.n. “Patient” means an individual who:
2.2.n.1. has a valid ongoing practitioner-patient relationship; or
2.2.n.2. has not yet established an ongoing practitioner-patient relationship, but:
2.2.n.2.A. has requested to establish such a relationship with the practitioner; or
2.2.n.2.B. has been referred to that practitioner for evaluation or care by another practitioner.
2.2.o. "Recipient" means the patient, ultimate user or research subject for whom a controlled substance is dispensed or filled.
2.2.p. "Recipient representative" means an individual to whom a controlled substance is dispensed or filled if the recipient is either less than 18 years of age or unavailable to receive the controlled substance.
2.2.q. "Reporter" means a medical services provider, health care facility, pharmacist, or pharmacy that is required to submit the information outlined in section 4 of this rule.
2.2.r. "Schedule II, III, IV, or V Controlled Substance" means a controlled substance classified in those categories under W. Va. Code §§60A-2-206, 208, 210, and 212.
2.2.s. "Security prescription blank" means a prescription blank that complies with the requirements of §15-1-273 of the West Virginia Code of State Rules.
2.2.t. "Universal Claim Form" means a nationally recognized standard form developed by the National Council for Prescription Drug Programs used for billing drug claims to insurance plans.
W. Va. Code R. § 15-8-3 Prescription Monitoring Program
3.1. Each time a Schedule II, III, IV, or V Controlled Substance, drug of concern, or opioid antagonist is dispensed for out-patient use, the medical services provider, health care facility, or pharmacy that dispensed the controlled substance, drug of concern, or opioid antagonist shall transmit to the central repository the information required by West Virginia Code § 60A-9-4 in the appropriate American Society for Automation in Pharmacy format used by the central repository for reporting to it. This includes the following:
3.1.a. The name, address, pharmacy prescription number and Drug Enforcement Administration controlled substance registration number of the dispensing pharmacy or the dispensing medical services provider;
3.1.b. The full legal name, address and birth date of the recipient. When reporting the full legal name, address, and date of birth of the recipient, the reporter shall include any middle name or initial and any suffix (e.g., Jr., II, III) as listed on the patient’s government-issued photo identification card If the patient does not have such an identification card, such as a minor, then the reporter shall obtain and input the information to the best of his or her knowledge and ability based upon the information available to it from the prescription, the patient profile or record, and any other information known to the reporter. Examples of acceptable forms of ID include, but are not limited to: driver’s licenses, non-driver identification cards, passports, and military IDs;
3.1.c. The Drug Enforcement Administration controlled substances registration number of the practitioner writing the prescription. By providing this registration number, the Controlled Substances Monitoring Program database will extract the prescriber’s name and address required by statute; therefore, the reporters do not need to additionally supply the prescriber’s name and address in addition to the prescriber’s DEA number;
3.1.d. The national drug code number of the Schedule II, III, IV, or V controlled substance, drug of concern, or opioid antagonist dispensed. By providing this NDC number, the Controlled Substances Monitoring Program database will extract the name and dosage or strength of the controlled substance required by the statute such that the reporters do not need to additionally supply the name and dosage;
3.1.e. The quantity of the Schedule II, III, IV, or V controlled substance, drug of concern, or opioid antagonist dispensed;
3.1.f. The date the prescription was written and the date filled;
3.1.g. The number of refills, if any, authorized by the prescription;
3.1.h. If the prescription being dispensed is being picked up by a recipient representative on behalf of the recipient, the first and last name of the recipient representative as set forth on the person’s government-issued photo identification card, the appropriate code for the type of ID, the ID number, the appropriate code indicating the relationship of the recipient representative to the patient, and the appropriate code for the issuing jurisdiction of the ID; and
3.1.i. The source of payment for the controlled substance, drug of concern, or opioid antagonist dispensed. 3.2 The board and the central repository shall provide for the electronic transmission of the information required to be provided by and through the use of a toll-free telephone line or other Internet connection.
W. Va. Code R. § 15-8-4 Information To Be Transmitted Within 24 Hours
4.1. The information may be transmitted at any time, but shall be transmitted at least within twenty-four hours of the dispensing. If the dispensing is done by mail or other postal, courier, or logistics services such as United Parcel Service or Federal Express, then the information shall be submitted at least within forty-eight hours of the time the dispensing is placed in the mail for delivery. If a reporter is closed for a holiday, or week-end day, the reporter shall make the required report as soon as is practicable upon reopening, or within forty-eight hours, whichever occurs first. If there are no dispensings of any Schedule II, III, IV, or V controlled substances, drug of concern, or opioid antagonists, then the reporter shall submit a daily “zero” report If there are no such dispensings within up to seven days of the last report, the reporter may submit a weekly “zero” report no later than seven days after the last date and time reported on the previous report. If a reporter is unable to make the required reporting in a timely manner due to an emergency, the reporter shall inform the board of the emergency and provide the board with information on when the reporter believes it will return to full compliance. Such notification may be taken into consideration by any agency, licensing board, or court, when determining if the reporter is in compliance with reporting requirements of West Virginia Code §60A-9-3 and section three of this rule, and any penalties that may attach for any violation thereof.
4.2. If a reporter does not possess for the purpose of dispensing any Schedule II, III, IV, or V controlled substances, drug of concern, or opioid antagonists, the dispenser may notify the board in writing by requesting a waiver from reporting on a form supplied by the board. If the waiver is granted by the board, the reporter is not required to submit a zero report unless and until the reporter possesses a Schedule II, III, IV, or V controlled substance or opioid antagonist for the purpose of dispensing.
W. Va. Code R. § 15-8-5 Accuracy of Information Transmitted
5.1. Information shall be reported accurately. If the reporting individual or entity discovers that information contained in the central repository is not accurate, he or she shall make the necessary corrections and resubmit the correct information as soon as possible, but in no event longer than 7 days after the discovery of the inaccurate reporting.
W. Va. Code R. § 15-8-6 Central Repository; Designation; Powers and Duties
6.1. The central repository shall maintain a database for the information required to be transmitted by this rule. This database shall be referred to as the “Controlled Substances Monitoring Program”, or the “CSMP”.
6.2. The central repository shall provide the board with continuous 24-hour a day, on-line access.
6.3. The central repository shall secure the information collected and the database maintained against access by unauthorized persons.
6.4. If the relationship between the board and the central repository is terminated by statute, the central repository shall provide to the board within a reasonable time, all collected information and the database maintained.
6.5. The board may accept a designated grant, public and private financial assistance, and licensure fees to provide funding for the central repository.
W. Va. Code R. § 15-8-7 Confidentiality
7.1. The board shall carry out a program to protect the confidentiality of the information received by the central repository.
7.2. The board may disclose confidential information received by the central repository to a person who is engaged in receiving, processing, or storing the information.
7.3. The board may release confidential information received by the central repository to the following persons:
7.3.a. An authorized agent of a board in this state or another state that licenses practitioners authorized to prescribe Schedule II, III, IV, or V controlled substances who is engaged in an investigation, an adjudication, or a prosecution of a violation under any state or federal law that involves a controlled substance;
7.3.b. Members of the West Virginia State Police expressly authorized by the superintendent of the West Virginia State Police to have access to the information;
7.3.c. An authorized agent of a local law-enforcement agency who is acting as a member of a Federally affiliated drug task force engaged in an investigation, an adjudication, or a prosecution of a violation under any state or federal law that involves a controlled substance;
7.3.d. Authorized agents of the Drug Enforcement Administration who is engaged in an investigation, an adjudication, or a prosecution of a violation under any state or federal law that involves a controlled substance;
7.3.e. Authorized agents of the West Virginia Bureau for Medical Services;
7.3.f. The Chief Medical Examiner for the State of West Virginia or his or her authorized agent for use in post-mortem examinations;
7.3.g. Authorized agents of the West Virginia Office of Health Facility Licensure and Certification for use in certification, licensure and regulation of health facilities;
7.3.h. A dean of a medical school located in this State or his or her designee to access prescriber level data to monitor prescribing practices of faculty members, prescribers and residents enrolled in a degree program at the school where he or she serves as dean;
7.3.i. A physician reviewer designated by an employer of medical providers to monitor prescriber level information of prescribing practices of physicians, advance practice registered nurses, or physician assistants in their employ;
7.3.j. A chief medical officer of a hospital, or a physician designated by the chief executive officer of a hospital which does not have a chief medical officer, to monitor prescriber level information of prescribing practices of prescribers who have admitting privileges to the hospital;
7.3.k. A person with an enforceable court order or regulatory agency administrative subpoena;
7.3.l. Inspectors and agents of the board to carry out the lawful purposes of the CSMP program, for purposes of a pharmacy inspection or drug inventory, or who are engaged in an investigation, an adjudication, or a prosecution of a violation under any state or federal law that involves a controlled substance;
7.3.m. Prescribing practitioners or their authorized agents for purposes of treating a patient;
7.3.n. Pharmacists or a registered pharmacy technician as the agent of the pharmacist for purposes of treating a patient; and
7.3.o. A person using the data for compilation of educational, scholarly, or statistical purposes so long as the individually identifiable data of the persons or entities stored in the central repository remains confidential.
7.4. All information released by the board shall be related to a specific patient or a specific individual or entity under investigation by any of the persons set forth in subsection 7.3 (a) through (n) of this section except that practitioners who prescribe or dispense controlled substances may also request specific data related to all dispensings reported to the database as prescribed and/or dispensed under their drug enforcement administration controlled substance registration number or for the purpose of providing treatment to a patient.
7.4.a. A practitioner or practitioner’s delegate may, prior to affirmatively accepting a patient into the practitioner’s practice, obtain confidential information from the CSMP related to that patient for the purpose of determining whether or not to accept the patient and provide treatment.
7.4.b. If the patient is a newborn child or child being fed human breast milk, a practitioner or practitioner’s delegate may obtain confidential information from the CSMP related to the child’s mother, wet nurse, or other direct source of human breast milk, as the practitioner believes may be relevant for the purpose of providing treatment to that child-patient.
7.5. Access to the data collected by the central repository shall be limited to regular business hours of the board’s office unless an individual authorized to receive the information proves that an immediate danger to the public exists and immediate access is necessary to prevent further harm The board may permit access at any time to authorized users through the use of a secure connection and through the use of proper security features designed to protect the integrity and confidentiality of the information from unauthorized access or disclosure.
7.6. A person or entity having access to the central repository and who is permitted to designate an authorized agent to have access to the central repository pursuant to this rule shall make the designation on a form to be supplied by the board. It is the responsibility of the designating individual to ensure that the designated agent maintains the confidentiality of the information in the central repository as required. If the designating individual remove the authority of the designated agent to act as the authorized agent, or should the designated agent leave the employment of the designating individual or entity then the designating individual shall immediately notify the board, at which time the designee’s access to the central repository shall be removed.
7.7. A practitioner may file or store copies of a patient-specific report obtained from the CSMP in the patient’s confidential medical file or chart maintained by the practitioner. The practitioner may share the information contained in the report with other practitioners providing treatment to the patient, the patient, or the patient’s authorized guardian or representative for the purpose of providing treatment. If the information held in the patient file or chart is not subject to discovery in a civil or criminal matter absent a court order. The information is obtainable from the practitioner in a proper regulatory agency administrative matter through a regulatory agency administrative subpoena.
7.8. The board shall review records in the CSMP in accordance with parameters set by the Advisory Committee to identify abnormal or unusual practices of patients who exceed those parameters and are therefore outliers in the CSMP data. The board shall issue reports of the results of these searches to the Review Committee for its regular review and action. The board shall communicate with prescribers and dispensers of the patients who exceed the parameters to inform them of each practitioner’s patient’s activities as demonstrated in the CSMP reports. Reports and communications produced by the board shall be kept confidential by the board and the Review Committee.
7.9. The Review Committee may query the CSMP based on parameters established by the advisory committee to identify abnormal or unusual practices of patients who are outliers in the data according to their controlled substance prescribing, dispensing, or usage patterns or other indicators available in the system. The Review Committee may also query the CSMP based on parameters established by the advisory committee to identify abnormal prescribing and/or dispensing patterns of practitioners indicated by outliers in the system. The Review Committee may also query the CSMP for any relevant prescribing or dispensing records of involved patients or practitioners as it carries out its duty to review notices provided by the chief medical examiner pursuant to West Virginia Code § 61-12-10(h) and determine on a case-by-case basis whether a practitioner who prescribed or dispensed a controlled substance may have resulted in or contributed to the drug overdose, and, if so, if the practitioner may have breached professional or occupational standards or committed a criminal act when prescribing the controlled substance at issue to the decedent. The Review Committee, in accordance with parameters established by the Advisory Committee, may provide any pertinent information in its discretion from the CSMP to the relevant practitioner, the practitioner’s licensing board, or law enforcement as permitted by West Virginia Code § 60A-9-5(b). The Review Committee, in accordance with parameters established by the Advisory Committee, may also communicate with pertinent practitioners or patients to make them aware of the practitioner’s own prescribing or dispensing patterns or history, or the patient’s own usage patterns or history as reflected in the CSMP in an effort to reduce inappropriate use of prescription drugs in accordance with West Virginia Code § 60A-9-5(a)(3)(C). The information obtained and developed by or on behalf of the Review Committee may not be shared except as provided in West Virginia Code § 60A-9-5(b) and as provided specifically in subsection 7.8 and this subsection of this section.
W. Va. Code R. § 15-8-8 Pharmacist Requirement to Check the Controlled Substances Monitoring Program Database
8.1. A pharmacist shall access the West Virginia Controlled Substances Monitoring Program Database for information regarding specific patients in the following scenarios:
8.1.a. upon initially dispensing any Schedule II controlled substance, any opioid, or any benzodiazepine to a patient who is not suffering from a terminal illness; and
8.1.b. at least annually thereafter should the pharmacist continue to dispense the patient with a controlled substance.
Series 09 Disciplinary Procedures
W. Va. Code R. § 15-9-1 General
1.1. Scope. -- This rule relates to the complaint and hearing procedures for all licensees and registrants.
1.2. Authority. -- W. Va. Code 30-5-1 et. seq. and 30-1-8(h).
1.3. Filing Date. – August 26, 2020
1.4. Effective Date. -- September 27, 2020
W. Va. Code R. § 15-9-2 Complaint Procedures
2.1. Any individual may make a complaint to the board concerning a licensee or registrant. The Board may also file a complaint against a licensee or registrant.
2.2. The board may accept an anonymous complaint if the information provided is adequate to begin an investigation.
2.3. The board may accept a complaint in writing, online via the Board’s website, or in person. The board may provide a form for the purpose of submitting a written complaint or online complaint.
2.4. All complaints shall be referred to the Executive Director, Investigator, inspector, or counsel for the Board, who shall act as a representative for the board. A complaint committee shall be established to review such matters. This committee shall consist of two (2) board members, including at least one pharmacist.
2.5. The board shall maintain a complaint log which records the receipt of each complaint, and the nature and the disposition of the complaint. The board shall also maintain a separate file on each complaint received, and each file shall have a number assigned to it.
2.6. Upon receipt of a complaint or on its own initiative, the representative for the board shall initiate an investigation into the conduct which is occurring or has occurred which violates W. Va. Code § 30-5-1 et seq. or rules governing the practice of pharmacy. The complaint committee may employ the services of consultants or other employees necessary to assist the representative for the board in an investigation and prosecution of a case.
2.6.1. The representative for the board shall may issue subpoenas to gather necessary facts and evidence to determine validity of the allegations contained in the complaint. The representative shall have the authority to institute proceedings in the courts of this state to enforce its subpoenas for the production of documents and witnesses and its orders and to restrain and enjoin violations of W. Va. Code § 30-5-1 et seq., or rules governing the practice of pharmacy.
2.6.2. The representative for the board may depose witnesses, take sworn statements, and collect other evidence.
2.6.3. The representative for the board may require a criminal history records check. The licensee or registrant under investigation shall furnish to the board a full set of fingerprints for purposes of conducting a criminal history check. Records will be checked through the criminal identification bureau of the West Virginia State Police, a similar agency within the licensee’s or registrant’s state of residence, and the United States Federal Bureau of Investigation. 2.6 4. The representative for the board shall evaluate the complaint, any licensee response and other investigative information to determine if a violation of law has occurred and to determine the need for additional investigation. The representative shall have the authority to enter any pharmacy to review documents related to the complaint and to interview any individual during the course of an investigation. Subpoenas duces tecum to compel the production of documents may be issued by the representative for the board. The subpoenas shall be issued pursuant to W. Va. Code § 29A-5-1(b).
2.7. Upon completion of the investigation, the representative for the board shall present investigative information in a report to the complaint committee. The report shall contain a statement of allegations, a statement of facts, and an analysis of the complaint. The analysis shall consist of a description of the conduct of the licensee or registrant, the records reviewed, and a statement of findings and recommendations. If probable cause for further action is not identified, the representative may make a recommendation that a complaint be dismissed. All investigative information shall be provided to the committee for review. The committee may approve dismissal of the case or direct the representative for the board to proceed with further investigation if the committee believes further investigation is necessary.
2.8. Upon completion of the investigation and after the investigative information has been reviewed by the complaint committee and probable cause is established, the committee shall make a formal recommendation of discipline to the full Board for its consideration.
2.9. The full Board shall vote on the Complaint Committee’s recommendation. The Board may accept the recommendations or amend the recommendations. The Board representative may draft a consent agreement reflecting the discipline voted upon by the full Board. The Board may vote to give the Board representative discretion in settling the case within certain discipline parameters voted upon by the Board.
2.10. If the licensee or registrant contests the allegations and refuses to enter into a consent agreement,. the Board representative may present the Board with an amended discipline charge or recommend that the case be set for hearing. All hearings shall be in accordance with W. Va. Code § 29A-1-1 et seq. and the board’s legislative rules. All complaint committee recommendations shall be presented to the board in an anonymous fashion so as not to identify the specific individual(s) or location(s) involved. The board members that are not on the complaint committee shall vote upon the recommendations.
2.11. Members of the complaint committee shall be disqualified from the formal hearing process if the case has been presented to the committee prior to the formal hearing and the Board is set to hear the case.
2.12. All powers of the board, the complaint committee, and its representatives may be exercised to investigate a matter, even if a hearing or disciplinary action does not result from the investigative findings.
W. Va. Code R. § 15-9-3 Proceedings for Disciplinary Action
3.1. Contested case hearings shall be held as provided in W. Va. Code §§29A-5-1. et. seq., and 30-1-1. et. seq.
3.2. The board may amend the charges set forth in a statement of charges as it considers proper.
3.3. Motions for a continuance of a hearing may be granted upon a showing of good cause. Motions for continuance shall be in writing and received in the office of the board or with the delegated hearing examiner no later than seven (7) days prior to the hearing date. In determining whether good cause exists, the board or delegated hearing examiner shall give consideration to the ability of the party requesting the continuance to proceed effectively without a continuance. The board or designated hearing examiner shall deny a motion for continuance filed less than seven (7) days from the date of the hearing unless the reason for the motion could not have been ascertained earlier. Motions for continuance filed prior to the date of the hearing may be ruled on by the officer of the board to preside or the designated hearing examiner. The board member or the hearing examiner presiding over the hearing shall rule on all other motions for continuance.
3.4. All motions related to a case set for hearing before the board, except motions for continuance shall be received in the office of the board or with the designated hearing examiner at least ten (10) days before the hearing. Prehearing motions shall be heard at the prehearing conference or at the hearing prior to the commencement of testimony. The board member or the hearing examiner presiding at the hearing shall hear the motions and the response from the non-moving party and shall rule on the motions accordingly.
3.5. Any party may submit proposed findings of fact and conclusions of law at the time and manner designated by the board or its duly appointed hearing examiner.
W. Va. Code R. § 15-9-4 Conferences; Informal Disposition of Cases
4.1. At any time prior to the hearing or thereafter, the board, its designee or its duly appointed hearing examiner may hold conferences for the following purposes:
To dispose of procedural requests, prehearing motions or similar matters;
To simplify or settle issues by consent of the parties; or To provide for informal disposition of cases by stipulation or agreement.
4.2. The board or its duly appointed hearing examiner may cause the conferences to be held on the board’s or the hearing examiner’s own motion or by the request of a party.
4.3. The board may also initiate or consider stipulation or agreement proposals with regard to the informal disposition of cases and may enter into the stipulations or agreements without conference.
4.4. Subpoenas to compel the attendance of witnesses and subpoenas duces tecum to compel the production of documents in connection with a hearing may be issued by any member of the board or the board’s executive director.
15CSR9
Series 10 Board of Pharmacy Rules for Pharmacist Recovery Networks
W. Va. Code R. § 15-10-1 General
1.1. Scope -- This rule provides for the operation of Pharmacist Recovery Networks.
1.2. Authority -- W. Va. Code §30-5-7.
1.3. Filing date -- May 4, 2026.
1.4. Effective date -- July 1, 2026.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-10-2 Definitions
2.1. “Applicant” means a person applying to the Board for licensure as a pharmacist, licensed intern, or registered pharmacy technician.
2.2. “Board” means the West Virginia Board of Pharmacy.
2.3. “Committee” means the Board of Directors established to function as a supervisory and advisory body to the WVPRN, made up of professional peers actively licensed or registered to practice pharmacist care in West Virginia.
2.4. “Executive Director” means a person selected by the committee to administer the WVPRN.
2.5. “Facility” means a residential or in-patient treatment hospital or institution, a partial hospital programming hospital or institution with a housing component, or an intensive outpatient programming hospital or institution, all of which have a specific program with expertise in treating healthcare professionals.
2.6. “Impairment” means mental illness, chemical dependency, physical illness, or any abnormal physical or mental condition of a pharmacist, intern or technician which threatens a licensee or the safety of persons to whom that licensee might sell or dispense prescription drugs or devices.
2.7. “Licensee” means a licensed pharmacist, licensed intern, or registered pharmacy technician or registered pharmacy technician trainee.
2.8. “West Virginia Pharmacist Recovery Network (WVPRN)” means the program established by agreement between the special impaired pharmacist peer review organization and the Board.
W. Va. Code R. § 15-10-3 Board of Directors
3.1. The Board of Directors shall consist, at a minimum, of the following:
3.1.1. Six licensed pharmacists representing various practice settings and state regions, a minimum of two shall be past clients of the WVPRN in recovery, or if not past clients of the WVPRN, otherwise be in recovery from alcohol or drug dependency or other mental impairment;
3.1.2. One pharmacy technician actively registered with the Board; and
3.1.3. One actively licensed intern from each ACPE accredited school of pharmacy located in the state.
W. Va. Code R. § 15-10-4 Pharmacist Recovery Network Agreements
4.1. Pharmacist Recovery Network Agreements with the board require the following:
4.1.1. Upon receiving information about possible impairment of a licensee or applicant from a person the Executive Director shall contact the licensee or applicant to verify the information.
4.1.2. If it is determined there is sufficient reason for action, such as behavioral signs, documented evidence of impairment, and/or drug diversion, the Executive Director shall encourage the licensee or applicant to present himself or herself to a WVPRN-approved evaluator’s office within seven days of initial contact for a complete substance abuse and mental health assessment.
4.1.2.a. If the licensee or applicant resists coming in for an assessment, the Executive Director shall pursue one repeat contact.
4.1.2.b. After two unsuccessful interventions within a period not to exceed 14 days, the Executive Director shall inform the licensee or applicant of the WVPRN’s intent to close the file and disclose all evidence of impairment allowed by law to the board. If the licensee or applicant still refuses to cooperate, then the WVPRN shall inform the board of any and all findings of the WVPRN developed during the course of its investigation.
4.1.3. The evaluator shall conduct an in-person substance abuse evaluation to include among other things, a psychoactive substance use history, administration of a Substance Abuse Subtle Screening Inventory (SASSI) or other diagnostic tool the evaluator deems necessary, and urinalysis utilizing a minimum of a 14-panel screen and Ethyl Glucuronide Test (ETG);
4.1.4. If a diagnosis of substance abuse or dependence or an impairing mental disorder as per the current edition of the Diagnostic and Statistical Manual of Mental Disorders published by the American Psychiatric Association is made, the Executive Director shall arrange for further evaluation and treatment of the licensee to be conducted at a facility or by an individual approved by the WVPRN. If there is insufficient evidence to warrant a diagnosis of substance abuse or dependence, or an impairing mental disorder, the Executive Director shall place the file in an inactive status and destroy the file after five years.
4.1.5. The Executive Director shall draw up a final agreement or “contract” between the licensee and the WVPRN for the licensee to enter into a treatment or other appropriate program. The Executive Director shall work with the treatment provider to determine the guidelines of treatment and aftercare, and shall consult with the primary care giver on a regular basis;
4.1.6. The Executive Director shall collect appropriate paperwork, as specified in the contract, regarding treatment progress, group therapy participation, urine and blood analysis, discharge summaries, or any other treatment documentation, including recommendations to return to practice, if applicable;
4.1.7. The Executive Director shall assist the licensee in transition into the workplace by providing information if requested to the supervisors and co-workers regarding chemical dependency, relapse, and diversion; and
4.1.8. Upon the completion of treatment and rehabilitation, and the expiration of the recovery contract, the network shall conclude involvement with the licensee.
W. Va. Code R. § 15-10-5 Due Process
5.1. Any action taken pursuant to the WVPRN shall afford the licensee all due process rights enumerated in W. Va. Code §29A-1-1 et seq.
W. Va. Code R. § 15-10-6 Receipt and Use of Information of Suspected Impairment
6.1. Licensees, family members, and other persons may submit reports containing information concerning suspected impairment of a licensee to the WVPRN.
6.2. Upon receipt of information of a suspected impairment, the WVPRN shall initiate an investigation.
6.3. The WVPRN may conduct routine inquiries regarding suspected impairments.
6.4. The WVPRN may require a licensee suspected of impairment to submit to personal interviews before any person authorized by the WVPRN, including but not limited to evaluators or treatment centers.
W. Va. Code R. § 15-10-7 Intervention and Referral
7.1. When, following an investigation, the impairment of a licensee is confirmed, the Executive Director shall cause an intervention to be conducted using specialized techniques designed to assist the licensee in acknowledging responsibility for dealing with the impairment. The Executive Director shall request the licensee to surrender their license to the WVPRN to be put into inactive status at the Board and then refer the licensee to an appropriate treatment source acceptable to the WVPRN.
7.2. The WVPRN shall decide the methods and objectives of interventions on a case-by-case basis.
7.3. The WVPRN shall arrange and conduct interventions as soon as possible.
7.4. The WVPRN shall evaluate treatment sources before making case referrals for treatment.
7.5. The WVPRN shall record intervention outcomes including treatment contracts that result from the administration of the case.
W. Va. Code R. § 15-10-8 Monitoring Treatment
8.1. The WVPRN shall monitor a treatment source by receiving updates from it as to the treatment source’s ability to provide:
8.1.1. Adequate medical and non-medical staffing, facilities, and experience with health professional clients;
8.1.2. Appropriate treatment;
8.1.3. Affordable treatment; and
8.1.4. Appropriate post-treatment support.
W. Va. Code R. § 15-10-9 Monitoring Rehabilitation and Performance
9.1. The WVPRN shall designate monitoring requirements for each licensee participating in the WVPRN. Licensees may be required to be tested regularly or randomly on demand of the WVPRN.
9.2. The WVPRN may require treatment sources to submit reports regarding a licensee’s rehabilitation and performance to the WVPRN.
9.3. The WVPRN may require impaired licensees to submit to periodic personal interviews before any person authorized by the WVPRN.
9.4. The WVPRN shall maintain appropriate case records in a HIPPA encrypted data file regarding each licensee that is a participant.
W. Va. Code R. § 15-10-10 Monitoring Post-Treatment Support
10.1. Post-treatment support may include family counseling, advocacy and other services and programs considered appropriate to the licensee’s recovery.
10.2. The WVPRN shall monitor the post-treatment support of treatment sources on an ongoing basis.
10.3. The WVPRN’s own post-treatment support shall be monitored by the WVPRN on an ongoing basis utilizing recognized performance measures.
W. Va. Code R. § 15-10-11 Reports of Cases of Impairment to the Board
11.1. A voluntary agreement entered into between the WVPRN and a licensee is not considered a disciplinary action or order by the Board, shall not be disclosed to the Board, and shall not be public information if:
11.1.1. The voluntary agreement is the result of the licensee or applicant self-enrolling or voluntarily participating in the WVPRN;
11.1.2. The Board has not received nor filed any written complaints regarding the licensee or applicant relating to an alcohol, chemical dependency or major mental illness affecting the care and treatment of patients; and
11.1.3. The licensee or applicant is in compliance with the voluntary treatment program and the conditions and procedures to monitor compliance.
11.2. If a licensee or applicant enters into a voluntary agreement with the WVPRN, and then fails to comply with or fulfill the terms of said agreement, the Executive Director shall report the noncompliance to the Board within 24 hours, so the Board may determine whether to initiate disciplinary proceedings.
11.3. If the board has not instituted a disciplinary proceeding, any information received, maintained or developed by the WVPRN relating to the alcohol or chemical dependency impairment or mental impairment of a licensee or applicant and the voluntary agreement shall be confidential and not available for public information, discovery or court subpoena, nor for introduction into evidence in any medical professional liability action or other action for damages arising out of the provision of or failure to provide health care services.
11.4. If WVPRN becomes aware that the licensee or applicant has diverted controlled substances to a person other than himself or herself, or the individual constitutes an immediate danger to the public or himself or herself, the WVPRN shall report this infraction to the board. In this case, the licensee is not protected by the program’s confidentiality provisions or from disciplinary action by the Board.
W. Va. Code R. § 15-10-12 Periodic Reporting of Statistical Information
12.1. The WVPRN shall annually report to the board comprehensive statistical reports concerning suspected impairments, impairments, self-referrals, post-treatment support and other significant demographic and substantive information collected through program operations. The WVPRN may not disclose any personally identifiable information relating to any pharmacist, intern, pharmacy technician, or pharmacy technician trainee participating in a voluntary agreement as provided herein.
12.2. The WVPRN shall, on a quarterly basis, report on the status of licensees subject to monitoring by the WVPRN by Order of the Board.
W. Va. Code R. § 15-10-13 Confidentiality
13.1. All information, interviews, reports, statements, memoranda, or other documents furnished to or produced by the WVPRN, all communications to or from the WVPRN, and all proceedings, findings, and conclusions of the WVPRN, including those relating to intervention, treatment, or rehabilitation, that in any way pertain to or refer to a person participating in a pharmacist recovery network are privileged and confidential.
13.2. All records and proceedings of the WVPRN that pertain or refer to a person participating in a pharmacist recovery network shall be privileged and confidential, used by the WVPRN and its members only in the exercise of the proper function of the program, not be considered public records, and not be subject to court subpoena, discovery, or introduction as evidence in any civil, criminal, or administrative proceedings, except as provided in subsections 4.1.2.b. and 11.4. of this rule.
13.3. The WVPRN may only disclose the information relative to an impaired licensee if:
13.3.1. It is essential to disclose the information to a person or an organization needing the information in order to address the intervention, treatment, or rehabilitation needs of the impaired licensee and a release by the licensee has been executed;
13.3.2. The release is authorized in writing by the impaired licensee; or
13.3.3. The WVPRN is required to make a report to the board pursuant to subsections 4.1.2.b. or 11.4. of this rule.
W. Va. Code R. § 15-10-14 Discretionary Authority of the Board to Designate Program
14.1. The board has the sole discretion to designate pharmacy recovery programs for licensees of the board and no provision of this rule may be construed to entitle any pharmacist, pharmacy intern, pharmacy technician, or pharmacy technician trainee to the creation or designation of a pharmacy recovery program for any individual qualifying illness or group of qualifying illnesses.
W. Va. Code R. § 15-10-15 Fees
15.1. The board shall assess the following fees to be added to each application fee for initial licensure and license renewal payable to the board with any revenue generated by the assessment dedicated to the operation of the pharmacist recovery network:
15.1.1. Pharmacist - $20 with the initial application and each biennial renewal;
15.1.2. Intern - $25 for the six-year license. For any renewal intern applicant under a previous version of this rule the fee shall be $25 minus the amount of any fees previously paid to the board for the assessment dedicated to the operation of the pharmacist recovery network. An intern applicant only requesting a one-year license may apply for a one-year license and the assessment dedicated to the operation of the pharmacist recovery network shall be $5; and
15.1.3. Pharmacy Technician - $10 with the initial application and each biennial renewal.
Series 11 Ephedrine and Pseudoephedrine Control
W. Va. Code R. § 15-11-1 General
1.1. Scope. -- To establish rules for ephedrine and pseudoephedrine control in West Virginia including pharmacy reporting requirements; notification processes; and special registration for distributors.
1.2. Authority. -- W. Va. Code §60A-10-1 et.seq .
1.3. Filing Date. -- June 10, 2013.
1.4. Effective Date. -- June 10, 2013.
W. Va. Code R. § 15-11-2 Definitions
2.1. "Central repository" refers to the central repository designated by the board for the collection of controlled substance information. It may be a vendor designated by the board and under contract with the board to act as the central repository.
2.2. “Government-issued photo identification card” means an identification card of an individual that provides a photograph of him or her and is issued by a State or the Federal Government of the Unites States of America, or a document that, with respect to identification, is considered acceptable for purposes of sections 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B) of title 8, Code of Federal Regulations.
2.3. “Schedule V pseudoephedrine products” means any compound, mixture or preparation containing ephedrine, pseudoephedrine or phenylpropanolamine, their salts or optical isomers, or salts of optical isomers, including any drug products added to the supplemental list pursuant to W. Va. Code §60A-10-7, except products which are for pediatric use primarily intended for administration to children under the age of twelve.
W. Va. Code R. § 15-11-3 Pharmacy Requirements
3.1. Schedule V pseudoephedrine products may be sold, delivered, or provided only in licensed pharmacies, behind the pharmacy counter, by a pharmacist, registered pharmacy intern, or registered pharmacy technician. This limitation applies to consumer transactions or dispensings, and does not apply to wholesale or distribution transactions between licensed manufactures, wholesale drug distributors, pharmacies or other healthcare practitioners holding the products as stock. Schedule V pseudoephedrine products may not be sold, delivered, or provided to any person who is under the age of eighteen.
3.2. The pharmacy, pharmacist, registered pharmacy intern, and registered pharmacy technician with access to the Schedule V pseudoephedrine products have an affirmative duty to guard against the theft and diversion of the products.
3.3. A pharmacy that sells Schedule V pseudoephedrine products shall offer patient counseling for each transaction, and require the person purchasing, receiving or otherwise acquiring the drug product to:
3.3.a. Produce a valid government-issued photo identification showing his or her date of birth. Examples of acceptable forms of ID include, but are not limited to: driver’s licenses, non-driver identification cards, passports, and military IDs; and
3.3.b. Sign a logbook containing the information required by subsection 4.1 of this rule and attesting to the validity of the information. The signature may be captured electronically and the information maintained as an electronic record as long as a hard copy may be produced upon request.
3.4. The pharmacy, pharmacist, registered pharmacy intern, and/or registered pharmacy technician involved in the sale of the product have the responsibility to ensure that the information required in this rule provided by the customer is recorded accurately as indicated on the required government-issued photo identification.
3.5. The bound record book kept for distribution of Schedule V exempt narcotics pursuant to West Virginia Board of Pharmacy Rule, Rules of the Board of Pharmacy for the Uniform Controlled Substances Act, 15 CSR 2.7.19.1(e), may be used for recording the information required by this rule.
W. Va. Code R. § 15-11-4 Pseudoephedrine Monitoring Program
4.1. After January 1, 2006, and continuing thereafter until January 1, 2013, each time any Schedule V pseudoephedrine product is transferred, sold, or delivered, the pharmacy shall electronically transmit not less than monthly to the central repository the information required by West Virginia Code § 60A-10-8.
4.2. The information may be transmitted at any time during the month as a batch transmission and may be sent with the Schedule II, III, and IV information.
4.3. Until January 1, 2013, the board and the central repository shall receive the electronic transmission of the information required to be provided by and through the use of a secure upload from the pharmacy via the internet or other means approved by the board. Beginning on January 1, 2013, the information shall be transmitted to the Multi-State Real-Time Tracking System as required by West Virginia Code § 60A-10-8. The pharmacy shall retain the information until transmission to the central repository has been confirmed.
W. Va. Code R. § 15-11-5 Lawful Possession of Schedule V Pseudoephedrine Products
5.1. The following persons are allowed to lawfully possess Schedule V pseudoephedrine products while in the course of legitimate business:
5.1.a. Any Schedule V pseudoephedrine-only limited pharmaceutical distributor, or it agents, licensed by the board;
5.1.b. Any wholesale distributor, or its agents, licensed by the board;
5.1.c. Any manufacturer of controlled substances, or its agents, licensed by the board;
5.1.d. A pharmacy, pharmacist, registered pharmacy intern, registered pharmacy technician, or other pharmacy employee under the direct supervision of a pharmacist;
5.1.e. Health care professionals appropriately licensed and engaged in legitimate patient care: and
5.1.f. Persons possessing the products pursuant to a valid prescription.
W. Va. Code R. § 15-11-6 Prescriptions for Schedule V Pseudoephedrine Products
6.1. Schedule V pseudoephedrine products that are dispensed pursuant to a valid prescription are exempt from the reporting required by this Rule, and by West Virginia Code Chapter 60A, Article 10, and are subject to the requirements of non-scheduled prescription drugs. Any product that is dispensed by prescription shall be provided in a container that is supplied by the pharmacy and shall be labeled with the information required on a prescription label.
W. Va. Code R. § 15-11-7 Records and Invoices
7.1. Any pharmacy, wholesaler, manufacturer, or distributor of Schedule V pseudoephedrine products shall keep readily retrievable records and invoices documenting the sale and distribution of these products. All pharmacy log records of sales of Schedule V pseudoephedrine products shall be kept for a minimum of 5 years from the date of sale or distribution.
W. Va. Code R. § 15-11-8 Registration to Sell, Distribute, or Transfer Schedule V Pseudoephedrine Products
8.1. Every wholesaler, manufacturer, or distributor of Schedule V pseudoephedrine products shall obtain a registration annually from the board.
8.2. A facility that holds a license as a pharmacy, manufacturer, or wholesaler from the board does not need to obtain an additional permit to sell, distribute, or transfer Schedule V pseudoephedrine products or be required to meet any additional storage or security requirements.
8.3. A facility that does not hold a license as a pharmacy, manufacturer, or wholesaler from the board may apply for and be granted a limited Schedule V pseudoephedrine distributor license. An applicant for this registration shall meet the following conditions:
8.3.a. The applicant is actively engaged in the interstate sale of grocery or pharmaceutical items;
8.3.b. The applicant’s sales are not limited to pseudoephedrine items alone, or to pseudoephedrine items in conjunction with other items associated with the illegal manufacture of methamphetamine or other controlled drugs;
8.3.c. The applicant does not have a history of diversion of pseudoephedrine; or of having failed to guard against the diversion of pseudoephedrine or other products used in manufacturing illegal drugs
8.3.d. The applicant verifies that Schedule V pseudoephedrine products shall be stored in a locked area that is monitored and the applicant has established security measures to guard against diversion; and
8.3.e. The applicant submits a fully completed application to the board with a fee of $200 for annual registration.
8.4. Licenses allowing the sale, distribution, or transfer of Schedule V pseudoephedrine products expire on June 30th of each year, and shall be renewed on an annual basis.
W. Va. Code R. § 15-11-9 Supplemental List
9.1. The Superintendent of the State Police and the Executive Director of the board shall meet at least quarterly to identify drug products which are a designated precursor, in addition to those that contain ephedrine, pseudoephedrine, or phenylpropanolamine, that are commonly being used in the production and distribution of methamphetamine.
9.2. The Superintendent of the State Police shall demonstrate by empirical evidence those drug products being used in the manufacture of methamphetamine and recommend the addition of these products to the list of Schedule V pseudoephedrine products.
9.3. The board, upon receiving a recommendation from the Superintendent of the State Police, shall promulgate emergency and legislative rules to implement an updated supplemental list of Schedule V pseudoephedrine products.
9.4. The board shall provide written notification to the pharmacist-in-charge of each pharmacy physically located in West Virginia and to the West Virginia Community Pharmacy Council that Schedule V pseudoephedrine products shall be sold, transferred or dispensed only from behind a pharmacy counter and a list of brand name Schedule V pseudoephedrine products that are subject to this rule.
9.5. The board shall provide written notification to the pharmacist-in-charge of each pharmacy physically located in West Virginia and to the West Virginia Retailers Association Community Pharmacy Council, West Virginia Oil Marketers and Grocers Association, and West Virginia Wholesalers Association of each drug product added to the list of Schedule V pseudoephedrine products pursuant to the legislative rule referred to in subsection 9.3 of this rule. Any changes in pseudoephedrine products subject to this rule shall become effective 30 days after notice is provided pursuant to this section.
Series 12 Board of Pharmacy Rules for Immunizations Administered by Pharmacists, Pharmacy Interns, and Pharmacy Technicians
W. Va. Code R. § 15-12-1 General
1.1. Scope. -- To provide the rules for pharmacists, pharmacy interns, and pharmacy technicians to administer immunizations to patients in this State through joint rulemaking by the West Virginia Board of Pharmacy, Board of Medicine, and Board of Osteopathic Medicine.
1.2. Authority. -- W. Va. Code §30-5-7.
1.3. Filing Date. – May 4, 2026.
1.4. Effective Date. – July 1, 2026.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-12-2 Definitions. 2.1 “ACPE” means American Council for Pharmacy Education
2.2. “Board” means the West Virginia Board of Pharmacy.
2.3. “CDC” means the United States Centers for Disease Control and Prevention.
2.4. “CPR” means cardiopulmonary resuscitation.
2.5. “Direct supervision” means the supervising immunizing pharmacist is physically present and readily and immediately available during the administration of an immunization.
2.6. "Immunizations" means the action of making a person immune to infection, typically by inoculation.
2.7. “VAERS” means vaccine adverse event reporting system which is the national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) and is available at http://vaers.hhs.gov/index.
W. Va. Code R. § 15-12-3 Qualifications
3.1. A licensed pharmacist may order and administer immunizations as permitted by this rule provided that the pharmacist:
3.1.1. Is registered with the board to administer immunizations;
3.1.2. Has successfully complete the American Pharmacists Association's (APhA) immunization training program or Board-approved training program, as provided in section 8, which courses shall be based on the standards established for immunization training by the Centers for Disease Control and Prevention (CDC) in the public health service of the United States Department of Health and Human Services;
3.1.3. Maintains current certification in basic life-support training, including basic cardiopulmonary resuscitation (CPR), from the American Heart Association, or the American Red Cross or other Board-approved course; and
3.1.4. Completed a minimum of four hours of continuing pharmacy education related to immunizations each renewal period. The continuing education shall be by a provider approved by the Accreditation Council for Pharmacy Education (ACPE).
3.2. A pharmacy intern licensed by the Board may administer immunizations as permitted by this rule provided that the pharmacy intern:
3.2.1. Is under the direct supervision of a pharmacist who is registered with the board to administer immunizations; and
3.2.2. Has completed all of the training and current certification required by subsections 3.1.2. and 3.1.3. of this section.
3.3. A pharmacy technician licensed by the Board may administer immunizations as permitted by this rule provided that the pharmacy technician:
3.3.1. Is registered with the Board to administer immunizations;
3.3.2. Is under the direct supervision of a pharmacist who is registered with the Board to administer immunizations; and
3.3.3. Has successfully completed a practical training program approved by the ACPE and the Board. This training must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines; and
3.3.4. Maintain current certification in basic life-support training, including basic CPR, from the American Heart Association, or the American Red Cross or other Board-approved course; and
3.3.5. Complete a minimum of two hours of continuing pharmacy education related to immunizations each licensing renewal period. The continuing education shall be by a provider approved by the ACPE.
3.4. It is unprofessional conduct for a pharmacist, pharmacy intern, or pharmacy technician to administer an immunization in violation of this rule.
W. Va. Code R. § 15-12-4 Registration
4.1. Prior to administering immunizations, a pharmacist shall submit an application supplied by the Board for review and approval of the Board, providing that all of the requirements of section 3.1. have been met. The application shall be submitted along with a required fee of $10. Provided all requirements of section 3.1. have been met and the required fee is received, the Board shall issue the pharmacist a registration to administer immunizations. Registrations shall expire biennially on June 30 of the year in which the pharmacist’s license to practice pharmacy expires.
4.2. The registration shall be posted conspicuously at all locations at which the pharmacist administers an immunization.
4.3. Prior to administering immunizations, a pharmacy intern shall provide to his or her supervising pharmacist documentation that the pharmacy intern has completed all of the training and current certification required by subsections 3.1.2. and 3.1.3 of this rule. The supervising pharmacist shall maintain this documentation in the pharmacy where the pharmacist and pharmacy intern who administers an immunization is employed or otherwise practicing at the time any immunization is administered by a pharmacy intern. 4.4 Prior to administering immunizations, a pharmacy technician shall submit an application supplied by the Board providing that all of the requirements of Section 3.3 have been met. Providing all requirements of Section 3.3 have been met, the Board shall issue a registration to administer immunizations. Registrations shall expire biennially on June 30 of the year in which the pharmacy technician’s license expires.
W. Va. Code R. § 15-12-5 Immunizations
5.1. A licensed pharmacist may order and a licensed pharmacist, pharmacy intern or pharmacy technician may administer immunizations in accordance with this rule.
5.2. Immunizations authorized by this rule shall be administered:
5.2.1. In accordance with a prescription order from a healthcare provider for a person age 3 years and up; or
5.2.2. In accordance with definitive treatment guidelines for immunizations promulgated by the latest notice from the U.S. Department of Health and Human Services, CDC, including, but not limited to, CDC's recommended immunization schedule for adults and children and adolescents, including the footnotes provided for each schedule, available at https://www.cdc.gov/vaccines/ or a successor webpage created for the same purpose. Such immunizations administered to a person age 3 to 17 years shall be given only:
5.2.2.a. With parental written, informed consent;
5.2.2.b. Provided there are no contraindications to that person receiving that vaccine; and
5.2.2.c. After informing the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and referral for patients as appropriate.
5.3. Administration shall be done in accordance with the training required by section 3. including, but not limited to indications, contraindications, route of administration, sanitary environment for administration, specifics regarding administration, and storage requirements for each specific immunization authorized by this rule, and, when done pursuant to a prescription, in accordance therewith;
5.4. Administration shall include implementation of the CDC’s recommended appropriate observation for an adverse reaction of an individual following an immunization.
5.5. A pharmacist may not delegate the authority to administer immunizations to any other person, unless administered by a licensed pharmacy intern or registered pharmacy technician under the direct supervision of a pharmacist of whom the pharmacist, the pharmacist technician and intern have successfully completed all required training.
5.6. A current Vaccine Information Statement, as provided by CDC, shall be provided to each person receiving an immunization for each immunization administered.
W. Va. Code R. § 15-12-6 Record-keeping and reporting
6.1. An immunization questionnaire and consent form shall be completed for each person receiving an immunization. When the immunization is for a minor age 3 through 17 years of age, the questionnaire and consent form shall include written informed parental consent for the minor.
6.2. A record of the immunization administration shall be forwarded to the primary care physician or other licensed health care provider as identified by the person receiving the immunization, within 30 days of the date of the administration. In the event that the patient affirmatively indicates in writing that he or she does not have a primary care physician or other health care provider to whom to forward the report, the pharmacist, pharmacy intern, or pharmacy technician shall document such in the immunization record and provide a record of the immunization administration to the patient. The record shall contain the name of the pharmacist, and, where applicable, the name of the pharmacy intern or pharmacy technician administering the immunization.
6.3. The pharmacist shall report the administration of the patient immunization to the West Virginia Statewide Immunization Information (WVSII) database in the format and containing such information as may be required by the WVSII within 30 days of the date of the administration.
6.4. The immunization questionnaire, consent form and record of the immunization administration shall be filed in the pharmacy in a manner that will allow timely retrieval and shall be kept on file for a time period not less than five years from the date of the immunization. All such records shall be maintained in the pharmacy where the immunization is administered. In the event it is administered off-site, then the records shall be maintained in the pharmacy where the pharmacist, pharmacy intern, or pharmacy technician who administered the immunization is employed or otherwise practicing at the time the immunization is given.
6.5. A pharmacist shall report all adverse events to the Vaccine Adverse Events Reporting System (VAERS), and promptly provide a copy of all reports to the Board; the West Virginia Department of Health Bureau for Public Health, Office of Epidemiology and Prevention Services, Division of Immunization Services; and the patient’s primary care physician or other licensed health care provider as identified by the person receiving the immunization in accordance with subsection 6.2.
W. Va. Code R. § 15-12-7 Emergencies
7.1. A pharmacist, pharmacy intern, or pharmacy technician authorized to administer immunizations under this rule may administer epinephrine and diphenhydramine in the management of an acute allergic reaction to an immunization following guidelines issued by CDC.
7.2. A pharmacist, pharmacy intern, or pharmacy technician shall have a readily retrievable emergency response plan as outlined by the CDC and maintain a readily retrievable emergency kit to manage an acute allergic reaction to an immunization administered.
W. Va. Code R. § 15-12-8 Immunization Training Programs
8.1. The Board shall approve a course or program in immunization administration for pharmacists and pharmacy interns to be used to meet the qualification requirement of section 3.1.2. In order to be approved by the Board, the course or program, at a minimum, shall include practical training and instruction on the following:
8.1.1. Basic immunology, including the human immune response;
8.1.2. Adverse reactions, contraindications, warnings and precautions;
8.1.3. Response to emergency situations, including administration of epinephrine and diphenhydramine;
8.1.4. Storage and handling requirements;
8.1.5. Recordkeeping and reporting requirements, including screening and informed consent documentation;
8.1.6. Proper environment for administration and observation;
8.1.7. Legal and regulatory issues, including, but not limited to, state law and regulations, OSHA compliance, biohazard control, and such other relevant and applicable standards; and
8.1.8. Policies and procedures for establishing and implementing appropriate immunization treatment guidelines.
8.2. A course approved by the Board for pharmacists and pharmacy interns shall include a minimum of 15 hours of didactic and practical based components of instruction and training, including self-study and live instruction. The live instruction shall be a minimum of six hours and shall include documented and supervised instruction on physical administration of vaccinations. 8.3 The Board shall approve a course or program in immunization administration for pharmacy technicians to be used to meet the qualification requirement of section 3.3.3. In order to be approved by the Board, the course or program, at a minimum shall include practical training and instruction on the following:
8.3.1. Proper technique of drawing up and administering immunizations;
8.3.2. Commonly used vaccines and their corresponding routes of administration;
8.3.3. Proper needle length selection based on vaccine, patient age, and patient size;
8.3.4. Proper vaccine storage requirements;
8.3.5. Safety measures to avoid accidental needle stick injuries; and
8.3.6. Appropriate actions to take in emergency situations. 8.4 A course approved by the Board shall include a self-study component combined with a practical component that teaches hands-on immunization techniques.
Series 13 Regulation Of Charitable Clinic Pharmacies
W. Va. Code R. § 15-13-1 General
1.1. Scope. -- This rule establishes the requirements for charitable clinic pharmacies to operate in West Virginia to prepare and dispense prescriptions to patients of the clinics in this State.
1.2. Authority. -- W. Va. Code §§ 30-5-14 and 30-5-19.
1.3. Filing Date. -- June 9, 2009.
1.4. Effective Date. -- July 1, 2009.
W. Va. Code R. § 15-13-2 Definitions
2.1. The following terms and phrases as used in this Rule shall have the following meanings:
2.1.1. "Charitable clinic pharmacy" means a clinic or facility organized as a not-for-profit corporation that offers pharmaceutical care and dispenses prescriptions free of charge to appropriately screened and qualified patients. A charitable clinic pharmacy shall meet the minimum standards for a pharmacy as set forth in W. Va. Code §30-5-1, et seq., and by this rule, but may not be charged any applicable licensing fees. A charitable clinic pharmacy may have pharmacists-in-charge, as that term is defined in this section, who volunteers his or her services. A charitable clinic may also receive donated drugs. It is not the intent of this rule to affect any organizations which are merely operating a prescribing practitioner’s or clinic’s free sample drug room.
2.1.2. "Charitable organization" means an organization which operates a clinic or facility organized as a not-for-profit corporation which is qualified as a charitable organization pursuant to Section 501(c)(3) of the Internal Revenue Code, or its successor.
2.1.3. "Legend drug sample" for purposes of this Series means an unopened package of a manufacturers legend drug product that has been distributed to either a practitioner or the charitable clinic pharmacy in accordance with the provisions of the Prescription Drug Marketing Act of 1987, 21 U.S.C. §301 et seq, or its successor.
2.1.4. "Qualified patient" means a patient of the charitable clinic pharmacy that has been screened and approved by the charitable organization as meeting the organization’s mission of providing pharmaceutical care to those who are without sufficient funds to obtain needed legend drugs. The requirements and screening process employed by the charitable organization must be in accordance with the “Guidelines” and other program requirements developed by the West Virginia Department of Health and Human Resources, Office of Community Health Systems, Division of Primary Care, for eligibility to receive funding as a “Free Clinic” for “Uncompensated Care and Equipment and Capital Costs Funding”.
W. Va. Code R. § 15-13-3 Charitable Clinic Pharmacy Permit Required
3.1. A charitable clinic pharmacy is considered to be a pharmacy and must follow all federal and state laws, rules, and regulations that pertain to pharmacies and the practice of pharmacy, except as otherwise provided specifically herein. A charitable clinic pharmacy permit is required for a charitable organization to operate a pharmacy in this State to dispense prescription drugs to qualified patients. No fee is required to apply for or obtain the permit.
3.2. Permits obtained pursuant to this section expire on June 30 of each calendar year. Renewal will be conducted in accordance with the laws and rules for renewing pharmacy permits as outlined in this rule.
3.3. Charitable Clinic Pharmacies may petition the Board for exemptions from portions of the requirements set forth in this rule which are not addressed here on a case by case basis, including, but not limited to, such things as the requirement for weights and measures if no compounding is to be done, the requirement for separate security features and alarms if they are available on the clinic building as a whole, and other such requirements.
W. Va. Code R. § 15-13-4 Controlled Substances Restricted; Prescriptions to qualified patients
4.1. A charitable clinic pharmacy shall not purchase, possess, trade, distribute, or dispense controlled substances.
4.2. Patient Dispensing. Prescriptions filled in a charitable clinic pharmacy may only be dispensed to qualified patients of that pharmacy on lawful orders or prescriptions of practitioners authorized by law to prescribe or administer said drugs.
4.2.1. All prescriptions filled by the charitable clinic pharmacy must be checked by a pharmacist or a prescribing practitioner licensed as such in the State of West Virginia prior to being dispensed; Provided That any prescribing practitioner licensed in this State may access the charitable clinic pharmacy to fill, check, or dispense prescriptions when no pharmacist is present, provided that he or she insures proper labeling and documentation of the dispensing.
4.2.2. Any other rule notwithstanding, in the absence of a pharmacist, a prescribing practitioner who is licensed in the State of West Virginia may also supervise the work of pharmacy technicians within the pharmacy, so that they may continue to work during that period of time.
4.2.3. Any other rule notwithstanding, if there is no pharmacist or prescribing practitioner who is licensed in the State of West Virginia present to supervise the pharmacy technicians, the pharmacy technicians may continue to process and fill prescriptions, and perform all other duties which may be performed by a pharmacy technician, for up to two hours during the charitable clinic pharmacy’s regular hours of operation provided that no actual dispensing may occur until the prescriptions filled are checked in accordance with subsection 4.2.1 above.
4.3. The charitable clinic pharmacy may not charge any fee for dispensing prescription drug samples or prescription legend drugs to qualified patients of the charitable clinic pharmacy. However, this rule does not prevent a charitable clinic or charitable clinic pharmacy from requesting voluntary donations from its patients who receive prescriptions, provided that a sign is posted in a conspicuous location where it can be seen by all patients stating that a donation is not required to receive prescription drugs.
4.4. Any other rule notwithstanding, a charitable clinic pharmacy may allow completed prescription orders to be dispensed to its patients by permitting a pharmacy technician or other licensed health care provider working on behalf of the charitable clinic to transport the completed prescription to another remote clinic operated by the charitable clinic, Provided That:
4.4.1. the completed prescriptions are kept in a locked tote or other such storage container and remain in the possession of the licensed health care provider until such time as they are actually dispensed directly to the patient or someone picking up on behalf of the patient;
4.4.2. the completed prescriptions are accompanied by a manifest indicating the contents of the tote at the time they leave the pharmacy;
4.4.3. the patient or person picking up the prescription on behalf of the patient signs for receipt of the prescription; and
4.4.4. any prescriptions which are not dispensed at the remote clinic site are returned in the locked tote to the charitable clinic pharmacy, along with the manifest, by a licensed health care provider working on behalf of the charitable clinic, and are reconciled by the pharmacy.
4.5. Charitable clinic pharmacies are exempt from the restrictions in Section 15-1.19.10 insofar as the charitable clinic pharmacy may provide prescription blanks imprinted with its name for prescribers working in the clinic to write prescriptions to be filled at the charitable clinic pharmacy.
W. Va. Code R. § 15-13-5 Prescription Drug Samples
5.1. Except insofar as it may conflict with federal law, charitable clinic pharmacies are exempt from any State law or rule which restricts who may receive sample drugs from a manufacturer. Specifically, unless it conflicts with federal law, a charitable clinic pharmacy may accept donated prescription drugs in their unbroken original packaging from pharmacies, licensed prescribers, wholesalers, or manufacturers provided appropriate records of transfer, donation, and receipt are maintained: Provided That the samples have been stored under the proper conditions required by the manufacturer and applicable law to prevent deterioration or contamination. However, a charitable clinic pharmacy may only receive, possess, and dispense prescription drug samples if the following conditions are satisfied:
5.1.1. The samples are dispensed at no charge to qualified patients of that charitable clinic pharmacy;
5.1.2. The samples are possessed in compliance with the Federal Prescription Drug Marketing Act of 1987, 21 U.S.C. §301 et seq, or its successor;
5.1.3. The samples are in the original container in which they were placed by the manufacturer and the container is clearly marked sample;
5.1.4. Prior to being furnished or dispensed, the samples have been stored under the proper conditions to prevent deterioration or contamination;
5.1.5. The samples are clearly marked with an expiration date and lot number;
5.1.6. The samples are not expired; and
5.1.7. The samples are not a controlled substance.
5.2. If donated samples are received which do not comply with Section 15-13-5.1, then they must be refused, returned, or properly disposed of by the charitable clinic pharmacy.
5.3. A charitable clinic pharmacy may not sell, purchase, or trade prescription drug samples.
5.4. A Charitable Clinic Pharmacy dispensing a sample drug shall comply with the following:
5.4.1. A pharmacist in a charitable clinic pharmacy must have a valid prescription prior to dispensing a sample drug to a patient.
5.4.2. The charitable clinic pharmacy must determine the eligibility requirements for a patient to receive a sample drug.
5.4.3. The sample drug is dispensed:
5.4.3.a. In the original container in which it was placed by its manufacturer where the container is clearly marked as sample; or
5.4.3.b. By removing the sample drug from the original container only if the prescription label on the appropriate container clearly states that the drug dispensed is a sample drug.
5.4.4. Nothing is this rule shall restrict a prescribing practitioner from providing samples in their original container from being given to the practitioner’s patients in accordance with federal law.
W. Va. Code R. § 15-13-6 Pharmacist-In-Charge Responsibilities
6.1. The pharmacist-in-charge at the charitable clinic pharmacy is responsible for implementing policies and procedures and a quality assurance program for operation of the charitable clinic pharmacy.
6.2. The pharmacist-in-charge at the charitable clinic pharmacy shall ensure through implementation of policies and procedures that the following occurs at the charitable clinic pharmacy:
6.2.1. donated drugs dispensed from pharmacy are properly labeled;
6.2.2. donated drugs that are expired, adulterated, misbranded, recalled, deteriorated, not kept under proper conditions, or did not have the identifying drug information on them as required are not dispensed to patients;
6.2.3. donated drugs are inspected prior to dispensing to determine that the donated drugs meet all federal and state requirements for product integrity;
6.2.4. donated drugs that are expired, adulterated, misbranded, recalled, deteriorated, not kept under proper conditions, or did not have the identifying drug information on them as required are destroyed; and
6.2.5. manifests for donated drugs that are dispensed pursuant to prescriptions from the charitable clinic pharmacy are created and maintained at the charitable clinic pharmacy as required for all prescription records.
W. Va. Code R. § 15-13-7 Limitations of Charitable Clinic Pharmacies
Charitable Clinic Pharmacies shall comply with the following:
7.1. All drug therapies and prescriptions shall be prescribed on an individual basis.
7.2. A Charitable Clinic Pharmacy may not accept lost identity or unknown drugs.
7.3. Misbranded drugs may not be accepted by the Charitable Clinic Pharmacy.
7.4. A Charitable Pharmacy may accept donated and unadulterated prescription drugs in their unbroken original manufacturer packaging from pharmacies, licensed prescribers, wholesalers or manufacturers, the State of West Virginia, the Board of Pharmacy or by other means, provided appropriate records of receipt are maintained.
W. Va. Code R. § 15-13-8 Continuing Education Credits for Volunteering in Charitable Clinic Pharmacy
A pharmacists who volunteers as a pharmacist-in-charge or a staff pharmacist in a charitable clinic pharmacy may earn up to a maximum of six live continuing education credits for such activities. For every eight hours worked in a charitable clinic pharmacy as the PIC, the PIC may earn one hour of live continuing education credit. For every ten hours worked in a charitable clinic pharmacy as a staff pharmacist, the pharmacist may earn one hour of live continuing education credit.
W. Va. Code R. § 15-13-9 Inspection and Investigation of Charitable Clinic Pharmacies
9.1. The Board of Pharmacy will use an Inspection Form which is consistent with the requirements under which a Charitable Clinic Pharmacy shall operate as contemplated by W. Va. Code §30-5-1b.
9.2. Upon receipt of the completed inspection form, the Board of Pharmacy and any appointed Quality Control Committee or other such body of the Charitable Clinic Pharmacy may meet and confer to address and resolve issues which may impact the health and safety of the pharmacy’s patients. To the extent necessary, corrective plans may result from such meeting(s) with timeframes established by the Board of Pharmacy for the resolution of Quality control issues.
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Series 14 Centralized Prescription Processing
W. Va. Code R. § 15-14-1 General
1.1. Scope -- To establish standards for central prescription processing.
1.2. Authority -- W. Va. Code §30-5-7.
1.3. Filing date -- May 3, 2024.
1.4. Effective date -- May 3, 2024.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect on August 1, 2034.
W. Va. Code R. § 15-14-2 Definitions
2.1. The following words and phrases have the following meanings:
2.1.a. “Central fill pharmacy” means a pharmacy or central filling operation registered as a pharmacy by the Board acting as an agent of or under contract with the originating or delivering pharmacy to fill or refill a prescription.
2.1.b. “Central prescription filling” means filling of a new or refilling of a prescription drug order by a central fill pharmacy at the request of an originating or delivering pharmacy for delivery to the patient or patient’s agent pursuant to the lawful order of a practitioner.
2.1.c. “Originating pharmacy” means a pharmacy registered with the Board that uses a central fill pharmacy to fill or refill a prescription order received by or transferred to that pharmacy by the patient, the patient’s agent, or the patient’s prescriber.
W. Va. Code R. § 15-14-3 General Requirements
3.1. Any other rule notwithstanding, a pharmacy may outsource a prescription drug order filling, excluding prescription drug orders for Schedule II controlled substances listed in West Virginia Code § 60A-2-206, to another pharmacy via central prescription filling provided the pharmacies:
3.1.a. Have the same owner; or
3.1.b. Have entered into a written contract or agreement which outlines the services to be provided and responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations, and include confidentiality of patient information; and
3.1.c. Share a common electronic file or have appropriate technology or interface to allow secure access to sufficient information necessary or required to fill or process a prescription drug order.
3.2. The pharmacist in charge of the central fill pharmacy shall assure that:
3.2.a. The pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication through the delivery process; and
3.2.b. The filled prescriptions are shipped in containers which are sealed in a manner as to show evidence of opening or tampering.
3.3. The filling, processing, and delivering of a drug order by a central fill pharmacy for an originating or delivering pharmacy pursuant to this series is not to be considered a drug order transfer or a wholesale distribution.
3.4. Any filled prescription which was not picked up by or actually delivered to the patient must be put into the originating or delivering pharmacy’s inventory.
3.5. Prior to outsourcing the filling of a prescription to a central fill pharmacy, the originating or delivering pharmacy must notify patients that their prescription may be outsourced to a central fill pharmacy and provide the name and address of the central fill pharmacy. Such notice may be provided through a one-time written notice to the patient or through the use of a sign in the pharmacy.
3.6. The originating or delivering pharmacy is responsible for making the offer to counsel to the patient or patient’s agent picking up the prescription on behalf of the patient.
3.7. Pharmacies that perform central prescription filling shall create operating policies and procedures. The policies and procedures must include:
3.7.a. an audit trail that records and documents the central prescription filling process and the individuals accountable at each step in the process for complying with Federal and State laws and regulations including recordkeeping; and
3.7.b. provisions for dispensing prescription drug orders when the filled order is not received from the central fill pharmacy, or the patient or patient’s representative comes into the originating or delivering pharmacy before the order is received from the central fill pharmacy. The standard of care must not be altered by the pharmacies’ central fill program. Ultimately the patient’s therapy cannot be unreasonably delayed.
3.8. The prescription label of a centrally filled prescription shall display the name and address of the originating or delivering pharmacy and may include the name of the central fill pharmacy, as well as all other information required by Rule § 15-1-22.
3.9. Each pharmacy engaging in central prescription filling shall be jointly responsible for:
3.9.a. Maintaining manual or electronic records that identify, individually for each drug order processed, the name, initials, or other unique identifier of each pharmacist, intern or pharmacy technician who took part in the central prescription filling functions performed at that pharmacy;
3.9.b. Maintaining manual or electronic records that identify, individually for each drug order filled or dispensed, the name, initials, or other unique identifier of each pharmacist, pharmacy intern, pharmacy technician, and pharmacy technician trainee who took part in the filling and dispensing functions performed at that pharmacy;
3.9.c. Maintaining a mechanism for tracking the drug order during each step of the processing and filling procedures performed at the pharmacy. The central fill pharmacy must keep a record of the date the filled prescription was delivered to the originating or delivering pharmacy and the method of delivery (i.e., private, common or contract carrier). The originating or delivering pharmacy must keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (i.e. private, common or contract carrier) and the name of the originating or delivering pharmacy employee accepting delivery;
3.9.d. Providing for adequate security to protect the confidentiality and integrity of patient information; and
3.9.e. Providing for inspection of any required record or information within 72 hours of any request by the Board or its designee.
W. Va. Code R. § 15-14-4 Remote Order Entry and Remote Order Review
4.1. Remote-order-entry or remote-order-review of prescription orders for prescriptions received at a pharmacy registered by this state is permitted to be performed by another pharmacy registered by the state, Provided that:
4.1.a. for purposes of data entry, the data entry must be performed by a licensed pharmacist, licensed pharmacy intern, or registered pharmacy technician or pharmacy technician trainee who is located at the other pharmacy registered by the state which shares a common automated data processing system, and such system creates an audit trail of which pharmacist, pharmacy intern, or pharmacy technician or pharmacy technician trainee entered the data; and
4.1.b. for purpose of drug regimen review, the review must be performed by a licensed pharmacist who is located at the other pharmacy registered by the state which shares a common automated data processing system, and such system creates an audit trail of which pharmacist provided the drug regimen review.
4.1.c. Nothing in this Section shall prohibit an individual licensed pharmacist licensed in the state, who is an employee of or under contract with a licensed pharmacy, or a licensed pharmacy technician or pharmacy intern, working under the supervision of the pharmacist, from accessing that pharmacy’s electronic database from inside or outside the pharmacy and performing the prescription drug order processing functions permitted by the W.Va. Code 30-5.1 et seq., if the following conditions are met:
4.1.c.1. The pharmacy establishes controls to protect the confidentiality and integrity of Protected Health Information; and
4.1.c.2. No part of the database is duplicated, downloaded, or removed from the pharmacy’s electronic database; and
4.1.c.3. The pharmacy’s electronic database shall only be accessed outside of the pharmacy via a virtual private network (VPN).
Series 15 Rules Governing Pharmacy Permits
W. Va. Code R. § 15-15-1 General
1.1. Scope. -- Licensure and regulations governing pharmacy permits.
1.2. Authority -- W. Va. Code §30-5-7.
1.3. Filing date -- May 4, 2026.
1.4. Effective date -- July 1, 2026.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-15-2 Definitions
2.1. “Board” means the West Virginia Board of Pharmacy.
2.2. “Common carrier” means any person who undertakes, whether directly or by any other arrangement, to transport property including prescription drugs for compensation.
2.3. “Direct-to-patient system” or “DTP system” means any delivery system through which a pharmacy dispenses drugs, devices, or medical equipment to a patient through any means other than:
2.3.1. In-person dispensing to a patient by pharmacy personnel inside a pharmacy, or
2.3.2. In-person dispensing by delivery to a patient’s residence or to a health care provider treating that patient, or 2.3.3 Shipping through common carrier to a patient or to a health care provider treating that patient.
2.3.4. Except as provided in this rule or in the exceptions in subdivisions 1-3 of this definition, no person holding any license or permit from the Board shall participate in any arrangement whereby prescriptions may be left at, picked up from, accepted by, or delivered to any other place. The only DTP system allowed are “lockers.”
2.4. “Home pharmacy” means the pharmacy responsible for dispensing drugs, devices or medical equipment through a DTP system.
2.5. “Locker” means a secure container in which pharmacy personnel place labeled patient-specific drugs, devices, or medical equipment to be picked up by the patient.
2.6. “Pharmacist” means an individual currently licensed by this state to engage in the practice of pharmacist care.
2.7. “Pharmacist Care” means the provision by a pharmacist of patient care activities, with or without the dispensing of drugs or devices, intended to achieve outcomes related to the cure or prevention of a disease, elimination, or reduction of a patient’s symptoms, or arresting or slowing of a disease process and as provided for in W. Va. Code §30-5-10.
2.8. "Pharmacist-in-charge" means a pharmacist currently licensed in this state who:
2.8.1. Accepts responsibility for the operation of a pharmacy in conformance with all state and federal laws and rules pertinent to the practice of pharmacist care and the distribution of drugs;
2.8.2. Has the responsibility for the practice of pharmacist care, as defined in this rule, at the pharmacy for which he or she is pharmacist-in-charge. The pharmacy permit holder has responsibility for all other functions, administrative and operational, of the pharmacy. The pharmacist-in-charge may advise the pharmacy permit holder in writing of administrative and operational matters. The pharmacist-in-charge is not legally responsible if the permit holder does not follow the written advice; and
2.8.3. Work requirements as required in W.Va. 15 C.S.R . 01..
W. Va. Code R. § 15-15-3 Registration
3.1. A pharmacy shall obtain a registration from the Board and comply fully with W. Va. Code §30-5-22 before it may lawfully conduct a pharmacy.
3.2. A pharmacy shall obtain a registration biennially. Not more than one registration may be issued in any one name in more than one location. Every registered pharmacy shall be under the direct charge of a pharmacist, designated the Pharmacist-in-charge, and shall operate in compliance with the state and federal laws and rules and regulations.
3.2.1. The application for a new registration shall be completed on a form prescribed and furnished by the Board.
3.2.2. Each pharmacy shall make a separate application and a separate registration shall be issued for each pharmacy.
3.2.3. A pharmacy shall have applicable current references readily available according to practice setting as required by this rule.
3.2.4. An initial application for a pharmacy registration shall be accompanied by a fee of $150.
3.2.5. A pharmacy compounding compounded sterile preparations shall also apply for a compounding permit as required by this rule.
W. Va. Code R. § 15-15-4 Issuance of Permit
4.1. The Board shall issue a registration to conduct a pharmacy to the applicant after a satisfactory inspection of the facility.
4.2. The registration is not transferrable. It is issued on the joint application of the owner and the pharmacist-in-charge, on the sworn statement that it will be conducted in accordance with the provisions of the federal and state laws, rules and regulations.
4.3. A registration shall be posted in a visibly conspicuous place.
W. Va. Code R. § 15-15-5 Renewal of registration
5.1. The biennial renewal of a registration takes place on the first day of July of every other year. The fee for the biennial renewal is $150. Registrations expire on the thirtieth day of June of every other calendar year. Renewal applications shall be completed and submitted to the Board office by the fifteenth day of June to allow time for processing. Pharmacies shall have a grace period for renewal until July 31 of the year in which the permit expires; however, renewal applications received in the Board office after June 30 of the year in which the registration expires shall require the payment of a late fee in the amount of $150 in addition to the application fee of $150, for a total amount of $300.
5.2. If a pharmacy does not make application for renewal by the first day of August biennially, to renew an expired registration the Board shall re-inspect the pharmacy and the permittee shall pay the required renewal fee and late fee totaling $300 for the registration, and $300 for the re-inspection, for a total amount of $600.
W. Va. Code R. § 15-15-6 Surrender of registration
6.1. When a pharmacist-in-charge changes at a pharmacy, both the pharmacist-in-charge and pharmacy permit holder must notify the Board in writing within 14 days. The original permit should be copied and the change in pharmacist-in-charge written on the original and copy of the permit. The copy of the modified permit shall be posted in the pharmacy. The original modified permit should be surrendered to the Board along with a $10.00 fee for the new registration reflecting the new pharmacist-in-charge. Upon receipt of the notification, the Board shall provide for the new registration to the pharmacy. An Interim pharmacist-in-charge may be designated for a period not to exceed 60 days. If an interim pharmacist-in-charge is designated who is not the permanent pharmacist-in-charge, the fee shall not be charged, and a new permit shall not be issued until a permanent pharmacist-in-charge is designated.
6.2. A pharmacy that moves to a new address or a different location within the current building shall apply for a new registration and submit the appropriate fees. The Board shall inspect the facility before a new registration may be issued.
6.3. When a pharmacy changes ownership the registration expires, and a new registration shall be obtained from the Board.
W. Va. Code R. § 15-15-7 Security
7.1. A board approved operating plan shall be implemented if a pharmacy is to be operated for a period less than regular business hours of the entire store or institution.
7.2. A device for the detection of breaking and/or entering shall be installed in each prescription department in each pharmacy. The installation and the device shall be based on accepted burglar alarm industry standards, and are subject to the following conditions:
7.2.1. The device shall be maintained in functioning order and shall have an auxiliary source of power;
7.2.2. Deactivation of the alarm system for the prescription department shall be restricted to the pharmacists working at the pharmacy, and the system shall be activated whenever a pharmacist is not on duty. The pharmacy registration holder may deactivate the system for security or surveillance purposes as long as the reason for the deactivation, the person deactivating the system, and time and date of deactivation are documented and readily retrievable to the Board; and
7.2.3. This subsection does not apply to pharmacies which are open and staffed by pharmacists 24 hours a day;
7.3. The door keys and alarm activation and de-activation codes to the prescription areas are subject to the following:
7.3.1. Only licensed pharmacists may possess any keys to the prescription area;
7.3.2. During times that an institutional pharmacy may be unattended by a pharmacist, arrangements shall be made in advance by the pharmacist-in-charge for provision of drugs to the medical staff and other authorized personnel and shall ensure that:
7.3.2.a. Drugs are properly labeled;
7.3.2.b. Only prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements;
7.3.2.c. Whenever access to the cabinet occurs, written practitioner’s orders and proof-of-use are provided;
7.3.2.d. All drugs in the cabinet are inventoried no less than once per week;
7.3.2.e. A complete audit of all activity concerning the cabinet is conducted no less than once per month; and
7.3.2.f. Written policies and procedures are established to implement the patient care provisions of this subdivision.
7.3.3. Whenever any drug is not available from floor supplies or night cabinets, and the drug is required to immediately treat a life-threatening situation of a patient, the drug may be obtained from the pharmacy by a supervisory nurse in accordance with the requirements of this subdivision. The pharmacist-in-charge shall, in conjunction with the appropriate committee of the institution, designate in writing one supervisory nurse in any given eight-hour shift who is responsible for obtaining drugs from the pharmacy during any emergency situation. Removal of any drug from the pharmacy by an authorized nurse shall be recorded on a suitable form showing the patient’s name, and location within the institution, the name of the drug, its strength and amount, and date and time, and the signature of the nurse. The form shall be left with the container from which the drug was removed, and the supervisory nurse shall contact the pharmacist “on call”;
7.4. In the absence of a pharmacist, a sign with a minimum of four-inch letters shall be prominently displayed stating: “Pharmacy Closed. No Pharmacist On Duty”, and the pharmacist shall secure the pharmacy by implementing any barriers and security devices prior to leaving the pharmacy;
7.5. Except as provided in 15 C.S.R. 14, for central prescription filling, and this rule for direct-to-patient delivery systems, completed prescription orders shall be bagged and kept in the pharmacy and cannot be removed from the pharmacy unless the pharmacist is present and the removal is for the immediate delivery to the patient, the patient’s authorized designee picking up the prescription for the patient, or person delivering the prescription to the patient at his or her residence or other place designated by the patient or the patient’s authorized designee. If the patient or the patient’s designee is unknown to the pharmacist, then his or her identity shall be established by photo identification card;
7.6. Dispensing does not occur until the drug is actually picked up by or delivered to the patient or patient’s representative. Completed prescriptions must be picked up at or delivered from the same pharmacy at which they were prepared, except that this subsection does not apply to a mail order pharmacy licensed by the Board, a central fill pharmacy licensed by the Board, direct-to-patient delivery systems operated in accordance with this rule, or to transfers of prescription drugs by a retail pharmacy to alleviate a temporary shortage; and
7.7. Emergency facilities to provide pharmaceutical services during emergency conditions or natural disasters may be approved by the Board for a period not to exceed 180 days.
W. Va. Code R. § 15-15-8 Professional Work Environment
8.1. A pharmacist, pharmacy intern, and pharmacy technician who works eight continuous hours or longer per day shall take, at a minimum, one 30-minute uninterrupted meal break during that work period. If such a pharmacist, pharmacy intern, or pharmacy technician is required to work 12 continuous hours per 24 hours, at a minimum, the individual qualifies for an additional 20-minute break. A pharmacist, pharmacy intern, or pharmacy technician, who is entitled to take such breaks shall not be required to work more than five continuous hours, excluding a 20-minute break, before being given the opportunity to take a 30-minute uninterrupted meal break.
8.2. A pharmacy shall not require a pharmacist, pharmacy intern, or pharmacy technician to work longer than 12 continuous hours per 24-hour period, inclusive of the required breaks under subsection 8.1.
8.3. A pharmacy shall keep and maintain a complete and accurate record showing its pharmacists' daily break periods. This record may be a pharmacist attestation of compliance with required breaks under subsection 8.1.
8.4. In the case of an emergency, as deemed by the professional judgement of the pharmacist, a pharmacist, pharmacy intern, or pharmacy technician may work longer than 12 continuous hours, work without taking meal breaks, or have a break interrupted in order to minimize immediate health risks for patients. The pharmacist must document and date the amount of time worked beyond the 12-hour limit or breaks missed along with the reason and make it available to the Board.
8.5. The pharmacist-in-charge or designee shall determine the work schedule for pharmacy technicians based upon prior dispensing records. The pharmacist shall ensure adequate staffing levels based on prior dispensing records and patient care tasks. The pharmacist-in-charge shall have final approval of the work schedule. Any decision overriding such control of the PIC may be grounds for disciplinary action against the pharmacy permit.
8.6. The pharmacist on duty or the pharmacy registrant shall notify the pharmacist-in-charge via telephone, e-mail, or text message whenever a prescription error, loss of drugs, or a violation of any statute or rule occurs and the pharmacist-in-charge is not present.
8.7. A pharmacy shall not use advertisements or make solicitations that may jeopardize the health, safety, or welfare of patients, including, but not limited to, the use of advertisements or solicitations that:
8.7.1. Are false, fraudulent, deceptive, or misleading;
8.7.2. Include any claim regarding a professional service or product or the cost or price thereof that cannot be substantiated by the licensee.
8.8. A pharmacy shall not require a pharmacist to participate in the use or distribution of advertisements.
8.9. A pharmacy shall provide a working environment for all pharmacy personnel that protects the health, safety, and welfare of a patient, which includes, but is not limited to:
8.9.1. Employing sufficient personnel to prevent fatigue, distraction or other conditions that interfere with a pharmacist’s ability to practice with competency and safety or creates an environment that jeopardizes patient care as determined by the pharmacist-in-charge or pharmacists based on prior dispensing records and current patient care responsibilities;
8.9.2. Providing appropriate opportunities for uninterrupted rest periods and meal breaks;
8.9.3. Providing adequate time for a pharmacist to complete professional duties and responsibilities, including but not limited to:
8.9.3.a. Drug utilization review;
8.9.3.b. Immunization;
8.9.3.c. Counseling;
8.9.3.d. Verification of the accuracy of a prescription;
8.9.3.e. All other duties and responsibilities of a pharmacist as listed in the rules of the Board.
W. Va. Code R. § 15-15-9 Notification
9.1. The violation of any of these rules shall be considered cause for disciplinary action.
9.2. An employer who employs a licensed pharmacist shall notify the Board within 14 days, in writing, of any discharge or termination of the licensed pharmacist or change of the status of the pharmacist-in-charge.
9.3. A person who employs a licensed pharmacist shall, within three business days from the time of discovery, notify the Board, in writing, of any violations of board rules or laws by the licensed pharmacist.
W. Va. Code R. § 15-15-10 Whistleblower protection
10.1. A permit or license holder of the Board who is found to be in violation of 29 C.F.R. §1977.3 or W. Va. Code §6C-1-1 et seq., known as the “Whistle-blower law” may be subject to disciplinary action by the Board.
10.2. Nothing in this Section shall be deemed to diminish the rights, privileges, or remedies of an employee of a pharmacy under any other federal or State law, rule, or regulation or under any employment contract.
W. Va. Code R. § 15-15-11 Temporary, Permanent, or Emergency Closure of a Pharmacy
11.1. For a temporary closure of a pharmacy, the pharmacy shall:
11.1.1. 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 two hours after the temporary closure begins. The posting must include:
11.1.1.a. Estimated period of time the pharmacy will be closed; and
11.1.1.b. Options for prescription pick-up (e.g., another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).
11.1.2. 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:
11.1.2.a. Estimated period of time the pharmacy will be closed; and
11.1.2.b. Options for prescription pick-up (e.g., another local pharmacy, contact prescriber for new prescription, reverse processed prescriptions).
11.1.3. If the pharmacy is temporarily closed greater than two consecutive business days or has planned closures greater than two days in a seven day period deviating from the regular business hours, 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.
11.2. For a permanent closure of a pharmacy, the pharmacy shall:
11.2.1. Prior to closing, the pharmacy must comply with the following:
11.2.1.a. Provide notification of the closing to each patient who has filled a prescription at that pharmacy within the previous 12 months. This notification must be made a minimum of 14 calendar days prior to closing and must include:
11.2.1.a.1. The last day the pharmacy will be open;
11.2.1.a.2. 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;
11.2.1.a.3. Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and
11.2.1.a.4. The last day a transfer may be initiated.
11.2.1.b. The notification must be made via:
11.2.1.b.1. Distribution by direct mail, electronic mail, phone, text, or written notice with each prescription dispensed; and
11.2.1.b.2. Public notice in a newspaper, online, or print, of general circulation, if available, in the area served by the pharmacy; and
11.2.1.b.3. Posting a closing notice on each pharmacy entrance, on each telephone greeting, and pharmacy-operated internet (e.g., website, social media, mobile applications).
11.2.1.c. Provide any new patients filling prescriptions during the 14-calendar day period prior to the pharmacy closing with written notification that includes:
11.2.1.c.1. The last day the pharmacy will be open;
11.2.1.c.2. 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;
11.2.1.c.3. Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and
11.2.1.c.4. The last day a transfer may be initiated.
11.2.1.d. Notify DEA of any controlled substances, as defined by W. Va. Code 60A-2-201 et seq., being transferred to another registrant as specified in 21 C.F.R. 1301.52.
11.2.2. On the date of closing or up to 24 hours after the permanent closure begins, the pharmacist-in-charge must comply with the following:
11.2.2.a. Complete and document an inventory of all controlled substances.
11.2.2.b. If the pharmacy dispenses prescriptions:
11.2.2.b.1. Transfer the prescription drug order files, including refill information, and patient medication records to a licensed pharmacy pursuant to 15 C.S.R. 15 who will serve as the custodian of records;
11.2.2.b.2. Update the pharmacy operating status with each electronic prescribing vendor; and
11.2.2.b.3. Remove all signs and symbols indicating the presence of the pharmacy including pharmacy-operated internet (e.g., website, social media, mobile applications).
11.2.2.c. Notify the Board of the closing of the pharmacy.
11.2.3. After closing. Within 30 calendar days after the closing of the pharmacy, the pharmacist-in-charge must:
11.2.3.a. Complete and document an inventory of all non-controlled drugs and devices.
11.2.3.b. Remove all prescription and non-prescription drugs, devices, and related supplies from the pharmacy by one or a combination of the following methods:
11.2.3.b.1. Return to manufacturer or supplier (credit or disposal);
11.2.3.b.2. Transfer to a licensed healthcare professional or outlet who is legally authorized to possess drugs; or
11.2.3.b.3. Destroy and document the destruction by two Board licensees. For controlled substances, the registrant must comply with 21 C.F.R. § 1304.21, 21 C.F.R. § 1304.22, 21 C.F.R. § 1317.05, 21 C.F.R. § 1317.90 and 21 C.F.R. § 1317.95.
11.2.3.c. Provide the board a written notice of the closing on a Board prescribed form available at www.wvbop.com which includes the following information:
11.2.3.c.1. Date of closing to the public and discontinuance of the business;
11.2.3.c.2. Date and time the inventory of all prescription drugs and devices was conducted;
11.2.3.c.3. Name, address, phone number, and applicable registration number where all legend and controlled substances possessed by the pharmacy were transferred or disposed;
11.2.3.c.4. If drugs were destroyed, the names and license numbers of individuals who witnessed the destruction;
11.2.3.c.5. If the pharmacy is registered to possess controlled substances, confirmation that the pharmacy complied with all applicable federal requirements in 21 C.F.R. § 1301.52 for discontinuing operation as a pharmacy that dispenses controlled substances.
11.2.3.c.6. The name, address, and phone number of the pharmacy that took possession of the pharmacy records or the licensed pharmacist who serves as the custodian of pharmacy records which must be maintained according to 15 C.S.R. 04;
11.2.3.c.7. Confirmation all pharmacy labels and blank prescriptions were destroyed;
11.2.3.c.8. 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
11.2.3.c.9. Confirmation that each registration certificate issued to the pharmacy by the Board has been mailed to the board office.
11.2.3.d. Once the pharmacy has notified the Board that the pharmacy is permanently closed, the license may not be renewed.
11.2.3.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.
11.2.3.f. The pharmacist-in-charge may be permitted, by written permission from the Board, an extension for compliance with Section 11.2.3 if the requestor shows good cause for the extension.
11.3. Emergency closing. If a pharmacy is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, insolvency, inclement weather, or other emergency circumstances and the pharmacist-in-charge cannot provide notification as required in subsection 11.1, the pharmacist-in-charge must comply with the provisions of subsection 11.1 as far in advance or as soon after the closing as allowed by the circumstances.
11.4. Non-resident pharmacies, as defined by 15 C.S.R. 06, are exempt from subsections 11.1, 11.2, and 11.3 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 available at www.wvbop.com which includes the following information:
11.4.1. Date of closing to the public and discontinuance of the business;
11.4.2. If the pharmacy dispenses prescriptions, the name, address and phone number of the pharmacy or licensed pharmacist who will serve as the custodian of records for West Virginia patients to which the prescriptions, including refill information, and patient medication records were transferred; and
11.4.3. Confirmation that each registration certificate issued to the pharmacy by the Board has been mailed to the board office.
11.5. The Board may conduct an inspection of the pharmacy and records to verify all requirements in this subsection.
W. Va. Code R. § 15-15-12 Direct-to Patient Delivery Systems
12.1. Any DTP system located within West Virginia (lockers) shall meet the following requirements:
12.1.1. Before any drugs, devices, or medical equipment may be picked up from a DTP system, the home pharmacy shall have been issued a pharmacy permit by the Board.
12.1.2. The home pharmacy shall notify the Board via the form on the website at www.wvbop.com prior to beginning to use any DTP system. The home pharmacy shall notify the Board within 10 days after discontinuing patient use of any DTP system.
12.1.3. Any DTP system shall be located at the physical address of the permitted home pharmacy.
12.1.4. The home pharmacy shall prohibit access to the DTP system and its contents by unauthorized personnel and maintain confidentiality of patient information. The DTP system shall be under the continuous supervision of a pharmacist employed by the home pharmacy or under contract with a licensed pharmacy, which may be satisfied by real-time remote supervision of the pharmacy through video and audio connections.
12.1.5. The home pharmacy shall ensure that there is continuous, recorded video surveillance of the DTP system and any persons using or accessing the DTP system. It shall maintain any recordings for a minimum of 90 days.
12.1.6. The home pharmacy shall develop, maintain, and follow a manual of policies and procedures that includes policies and procedures for:
12.1.6.a. Maintaining the security of the DTP system and the drugs, devices, and medical equipment within the DTP system.
12.1.6.b. Determining and applying criteria regarding which drugs, devices, and medical equipment are appropriate for placement in the DTP system and which patients are eligible to use the DTP system.
12.1.6.c. Maintaining any drugs, devices, and medical equipment at temperatures, humidities and other environmental conditions to ensure that they do not become adulterated and to ensure that they are transported and stored in accordance with manufacturer's specifications, if any, for those items.
12.1.6.d. Removing outdated drugs, devices, and medical equipment from the DTP on a regular basis so that patients do not receive drugs, devices, and medical equipment with a beyond use date during the period when the patient is to use the item.
12.1.6.e. Describing the assignment of responsibilities to, and training of, pharmacy personnel regarding the maintenance and filling procedures for the DTP system.
12.1.6.f. Orienting participating patients on use of the DTP system; notifying patients when expected drugs, devices, or medical equipment are not available in the DTP system or when the DTP system is not functioning and notifying them of alternate methods for having those prescriptions filled; and ensuring that patient use of the DTP system does not interfere with the delivery of drugs, devices, and medical equipment to patients.
12.1.6.g. Self-inspection of the DTP system for required compliance with West Virginia Code and the Rules of this Board and all Federal laws and regulations.
12.1.7. The written manual of policies and procedures shall be reviewed and updated annually by the pharmacist-in-charge of the home pharmacy.
12.1.8. The home pharmacy shall comply with any federal and state controlled substance laws and rules before any controlled substances are picked up from any DTP systems. The home pharmacy shall comply with W. Va. Code §60A-3-308 in delivering any drugs covered by that statute from a DTP system and shall visually confirm that the person seeking the dispensation is the same as the person on the government issued photo identification.
12.1.9. Only pharmacy personnel who are licensed with this Board as pharmacists or registered with this Board as pharmacy technicians, pharmacy technician trainee, or pharmacy interns may stock prepared drugs, devices, and medical equipment in, or remove drugs, devices, and medical equipment from the inventory of a DTP system. The home pharmacy shall maintain records of any access to the DTP system by pharmacy personnel stocking or otherwise accessing the DTP system.
12.1.10. Before a home pharmacy allows pick up of drugs, devices and medical equipment to a patient through a DTP system, the home pharmacy shall secure the written consent of the patient to use the DTP system.
12.1.11. The dispensing pharmacist on any drugs, devices, or medical equipment picked up from a DTP system in West Virginia shall be licensed with this Board.
12.1.12. The counseling pharmacist on any drugs, devices, or medical equipment picked up from a DTP system in West Virginia shall be licensed with this Board or be employed at a non-resident pharmacy licensed with this Board.
12.1.13. Before a prescription is picked up from the DTP system, the dispensing pharmacist shall verify each prescription and shall conduct a drug utilization review and otherwise assure that the drug, device, or medical equipment may safely be picked up by the patient.
12.1.14. The labels of any drugs, devices, and medical equipment picked up from a DTP system shall be labeled for the individual patient and contain all information required by law.
12.1.15. The home pharmacy shall create and maintain records for any drugs, devices, and medical equipment picked up from a DTP system in compliance with State and federal law.
12.1.16. The DTP system shall have a means to identify each patient (or that patient's authorized agent) and release only that patient's prescription drugs, devices, or medical equipment to the patient (or the patient's authorized agent).
12.1.17. The DTP system shall convey the home pharmacy's offer to counsel a patient as required by 15 C.S.R. 01 and shall provide the ability for the patient to have an immediate real-time consultation with a pharmacist licensed by this Board and employed by the home pharmacy who has access to all of the home pharmacy's information related to the patient. The communication link shall protect the confidentiality of the patient's information. The home pharmacy shall check the communication link at least daily and the DTP system shall be closed if the link malfunctions or if a licensed pharmacist is not available for counseling, unless a licensed pharmacist is physically present at the DTP system. A pharmacist who is responsible for counseling may not provide that service for more than three sites simultaneously. If the dispensing pharmacist has determined that the patient should receive counseling before the prescription is dispensed, the DTP system shall provide the ability for the pharmacist to force counseling before the DTP system allows pick up of the drug, device, or medical equipment.
12.1.18. The home pharmacy shall record and review any incident involving a complaint, delivery error, or omission regarding a DTP as part of the home pharmacy's quality assurance program.
12.1.19. Drugs, devices, or medical equipment that are not picked up by a patient may be returned to stock under the same conditions as if the item had been maintained in the pharmacy, as long as the requirements of this Rule for operating the DTP system have been followed.
12.2. This Rule does not alter the method by which patients or providers shall transmit prescriptions to the home pharmacy. Prescriptions may not be collected by the home pharmacy through the DTP system.
Series 16 Rules Governing Pharmacists
W. Va. Code R. § 15-16-1 General
1.1. Scope. -- Licensure and practice of pharmacist care.
1.2. Authority -- W. Va. Code §30-5-7.
1.3. Filing date -- April 23, 2026.
1.4. Effective date -- April 23, 2026.
1.5. Sunset Date -- This rule shall terminate and have no further force or effect upon August 1, 2031.
W. Va. Code R. § 15-16-2 Examination for Licensure and Registration and Biennial Renewal Requirements
2.1. Application – An applicant for examination to become a licensed pharmacist shall apply in writing to the Board at least 15 days before the date of examination is to be conducted and shall transmit with the application the prescribed fee of $125. The application shall be made on a form provided by the Board.
2.2. The requirements for application as a pharmacist are as follows:
2.2.1. An applicant shall be 18 years of age or older, proof of which shall be shown by birth certificate or other acceptable document.
2.2.2. An applicant shall present to the Board satisfactory evidence that he or she has not been convicted of a crime that bears a rational nexus to the practice of pharmacy. For other convictions not bearing a rational nexus to the practice of pharmacy, the Board shall permit the applicant to apply for initial licensure if;
2.2.2.a. A period of five years has elapsed from the date of conviction or the date of release from incarceration, whichever is later;
2.2.2.b. The individual has not been convicted of any other crime during the period of time following the disqualifying offense; and
2.2.2.c. The conviction was not for an offense of a violent or sexual nature: Provided, that a conviction for an offense of a violent or sexual nature may subject an individual to a longer period of disqualification from licensure, to be determined by the individual board.
2.2.3. An applicant shall present to the Board satisfactory evidence that he or she is a graduate of an approved school of pharmacy or has met the requirements for educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee Certification through the program administered by the National Association of Boards of Pharmacy (NABP).
2.2.4. An applicant shall have acquired 1500 hours of internship under the supervision of a licensed pharmacist.
2.2.5. An applicant shall complete a criminal history records check as prescribed in 15 C.S.R. 01.
W. Va. Code R. § 15-16-3 Examinations
3.1. State and national examinations required for licensure are administered on behalf of the Board by NABP.
3.2. Examinations for the North American Pharmacist Licensure Examination (NAPLEX), a jurisprudence exam approved by the Board, and as part of the Foreign Pharmacy Graduate Examination Committee Certification shall be done in accordance with the processes and procedures required by NABP.
3.3. An applicant for licensure as a pharmacist shall pass the NAPLEX and a jurisprudence exam approved by the Board, administered by NABP.
3.4. An applicant failing to achieve the required grades may repeat the failed examination or examinations one time without re-applying to the board within six months of the date of the original application, but one re-examination exhausts the applicant’s privilege to sit for the examinations under the current application.
3.5. An applicant failing to achieve the required grade on each examination a second time may apply for licensure a second time and again have two chances to pass the examinations.
3.6. An applicant failing to achieve the required grade on each examination a third time must petition the board before making reapplication a third or any subsequent time. At this time the board may require the applicant to complete a remediation evaluation and/or program before the applicant may reapply for licensure and sit for the examinations.
W. Va. Code R. § 15-16-4 Certificate of Licensure
4.1. An applicant for licensure who has successfully passed all the required examinations may receive a letter signed by the Secretary prior to preparation of a permanent certificate, or a permanent certificate, evidencing that he or she is a licensed pharmacist. The permanent certificate of licensure shall bear a serial number, the full name of the applicant, the date of its issuance, the seal of the Board, and shall be signed by at least four members of the Board and attested by the President and Secretary. For any duplicate of this certificate the Board shall charge $25. A certificate is not assignable.
W. Va. Code R. § 15-16-5 License and registration renewal
5.1. The board shall charge and collect the following fees:
5.1.1. Biennial renewal of license of pharmacist: $100, provided that if the applicant is 65 years of age or older at the time of renewal then the fee shall be $50;
5.1.2. License of pharmacy intern: $30 valid for the six-year duration of the license. For any renewal intern applicant under a previous version of this rule the fee shall be $30 minus the amount of any fees previously paid to the Board for the intern license. An intern applicant only requesting a one-year license may apply for a one-year license and the license fee shall be $5; and
5.1.3. Registration of a consultant pharmacist: $20 for each application; and
5.1.4. Registration of a pharmacy technician: $25 for the original registration; $20 for each biennial renewal
5.2. All licenses of pharmacists and registrations of pharmacy technicians expire on the thirtieth day of June. One half of all licenses for pharmacists and registrations for pharmacy technicians shall be renewed in even years and one half in odd years. Every licensed pharmacist or pharmacy technician who desires to renew his or her license or registration shall apply to the state board of pharmacy for renewal of his or her license or registration and shall transmit with his or her application the fee prescribed. The renewal application shall be available on the Board’s website, www.wvbop.com or a subsequent website, at least 30 days prior to June 30th or notification sent to renewal applicants with instructions for how to renew. It is the responsibility of the applicant to make timely application for renewal Applications for renewal received in the office after June 30 of the year in which his or her authorization expires will require the payment of a late fee equal to the amount of the renewal application fee, as well as the regular renewal fee. If the applicant submits a renewal application by June 30 and has not received his or her license or registration by July 31, the applicant should contact the Board.
5.3. If any pharmacist, pharmacy intern, or pharmacy technician whose license or registration has expired fails to apply to the board for a renewal of his or her license or registration by August 31 of the year in which his or her authorization expires, the Board shall remove his or her name from the register of pharmacists, pharmacy interns, and pharmacy technicians.
5.4. In order for any pharmacist, pharmacy intern, or pharmacy technician whose name has been removed from the register of the board to again become licensed or registered, the pharmacist, pharmacy intern or pharmacy technician shall petition the board, or an authorized committee of the board, for reinstatement, in writing, to show cause for permitting the license or registration to lapse. If his or her license or registration has been expired for one year or less (i.e., the petition for reinstatement is received on or before June 30 of the year after his or her authorization expired), and if the board finds the person otherwise eligible and qualified to practice, the Board shall reinstate that person upon payment of reinstatement fee of $250. for a pharmacist plus the renewal fee of $100., or upon payment of a reinstatement fee of $50 for a pharmacy technician plus the renewal fee of $20. If the pharmacist license or pharmacy technician registration has been expired for more than one year (i.e., the petition is received after June 30 of the year after his or her authorization expired), the board finds the person has submitted to the board satisfactory reasons for allowing the license or registration to lapse, and satisfies the board as to his or her qualifications to practice the profession by successfully passing the examinations administered or otherwise required by the board for reinstatement, the Board shall reinstate that person upon payment of reinstatement fee of $250 for a pharmacist plus the renewal fee of $100, or upon payment of a reinstatement fee of $50 for a pharmacy technician plus the renewal fee of $20. If a pharmacy intern’s license has been expired for more than a year, he or she must make new application as an intern and pay the required application fee for an initial pharmacy intern license.
W. Va. Code R. § 15-16-6 Reciprocity; Licensure of Pharmacists from Other States or Countries
6.1. The Board may license and admit to practice pharmacists in this state that have been legally licensed or registered as pharmacists in other states or countries if:
6.1.1. The applicant is at least 18 years of age;
6.1.2. The applicant is in good standing in the state or country from which he is seeking to transfer his or her licensure or registration;
6.1.3. The applicant is in fact competent and physically and mentally qualified to function as a pharmacist;
6.1.4. The applicant is not addicted to alcohol or a controlled substance;
6.1.5. The applicant has not been convicted or had his or her license in any other state or country suspended or revoked for violation of pharmacy, liquor, controlled substance, or food and drug laws.
6.1.6. The applicant originally passed a written examination in subjects determined by the Board as being reasonable; and
6.1.7. The applicant passes a jurisprudence exam approved by the Board.
6.1.8. The applicant must complete a criminal history records check as prescribed in 15 C.S.R. 01.
6.2. An applicant may serve all or part of his or her internship in another state and up to one-third (1/3) of his or her internship in another country. In order to receive credit for that service an affidavit shall be signed by the supervising pharmacist and attested by the secretary of the board of pharmacy of the state or country where the internship was served.
6.3. Applicants for licensure by reciprocity shall not work as pharmacists until they receive a certificate of licensure from the board.
6.4. A foreign pharmacy graduate whose undergraduate pharmacy degree was conferred by a school of pharmacy outside of the United States, and its territories, may establish educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee Certificate (FPGEC) from the National Association of Boards of Pharmacy (NABP). An applicant for licensure who receives FPGEC certification meets the educational requirement for licensure and may sit for the NAPLEX and a jurisprudence exam approved by the Board provided he or she has completed 1500 hours of internship, of which 500 hours may have been earned in a foreign country, as certified on a letter of credit or certification from the Board of Pharmacy or other regulatory body of the foreign state, province, or country responsible for regulation of the practice of pharmacy in the foreign location, and must complete a criminal history records check as prescribed in 15 C.S.R. 01.
6.5. An applicant may apply for licensure as a pharmacist under W. Va. Code §30-1-27, the Universal Professional and Occupational Licensing Act of 2025, provided he or she has been a licensed pharmacist in another state and has:
6.5.1. Established residence in this state; or
6.5.2. Is married to an active-duty member if the armed forces of the United States and has accompanied the member to an official permanent change of station to a military installation located in the state.
6.6. Licensure as a pharmacist under subsection 6.5. shall require a passing score on the jurisprudence exam approved by the Board.
W. Va. Code R. § 15-16-7 Application
7.1. The applicant shall complete the application forms available from the National Association of Boards of Pharmacy and submit it to that organization. The applicant shall also complete the applications forms available on the Board of Pharmacy website at www.wvbop.com and submit a fee of $250.
7.2. The application shall include the following provided by the applicant:
7.2.1. A certified copy of proof of experience, or the original pharmacist preceptor’s affidavit proving experience, that was filed by the applicant when he or she took the examination in the state or country in which he or she is licensed or registered;
7.2.2. A recent head shot photograph with a statement signed by the applicant that it is a photograph of the applicant and has been made within the previous 12 months; and
7.2.3. A signed waiver from the applicant allowing the Board to obtain a certified criminal records check on the applicant.
7.3. Appearance before the Board – Applicants for licensure by reciprocity may be required to appear before the Board or its designated agent at the time specified, for checking of credentials, an interview and examination as necessary 99to determine the fitness of the applicant to practice in West Virginia. The Board may revoke any applicant who misrepresents himself or herself to the Board.
Series 17 Substitution of Biological Pharmaceuticals
W. Va. Code R. § 15-17-1 General
1.1. Scope. -- To establish standards for the substitution of biological pharmaceuticals.
1.2. Authority. -- W. Va. Code§§ 30-5-7 and 30-5-12c.
1.3. Filing Date. -- April 25, 2024
1.4. Effective Date. -- April 25, 2024
1.5. Sunset Date -- This rule shall terminate and have no further force or effect upon August 1, 2034.
W. Va. Code R. § 15-17-2 Definitions
2.1. “Biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative or arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.
2.2. “Biosimilar” means a biological product that has been licensed as a biosimilar pursuant to 42 U.S.C. § 262(k), reflecting that it is highly similar to the specific reference biological product notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the reference biological product in terms of safety, purity, and potency of the product.
2.3. “Brand name” means the proprietary or trade name selected by the manufacturer and placed upon a drug or drug product, its container, label, or wrapping at the time of packaging.
2.4. “Interchangeable biological product” means a biological product that the federal Food and Drug Administration has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C § 262(k)(4) or determined is therapeutically equivalent as set forth in the latest edition of or supplement of the federal Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations.
2.5. “Original prescription” means either the original written prescription drug order, or the original verbal or electronic prescription drug orders reduced to writing either manually or electronically by the pharmacist.
2.6. “Proper name” means the nonproprietary name of a biological product.
2.7. “Reference biological product” means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which a biological product is evaluated in an application submitted to the U.S. Food and Drug Administration for licensure of biological products as biosimilar or interchangeable pursuant to 42 U.S.C. § 262(k).
2.8. “Substitute” means to dispense without the prescriber's express authorization an interchangeable biological product in the place of the drug ordered or prescribed.
2.9. “Therapeutically equivalent” means pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.
W. Va. Code R. § 15-17-3 Substitution Requirements
3.1. A pharmacist may dispense an interchangeable biological product if:
3.1.1. The interchangeable biological product costs the patient less than or the same amount as the prescribed drug product;
3.1.2. The patient does not refuse the substitution; and
3.1.3. The practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subsection (c) of this section.
3.2. Dispensing directive.
3.2.1. General requirements. The following is applicable to the dispensing directive outlined in this subsection.
3.2.1.a. When a prescription is issued for a brand name product that has no interchangeable biological equivalent, the pharmacist must dispense the brand name product. If an interchangeable biological product becomes available, a pharmacist may substitute the interchangeable biological product unless the practitioner has specified on the initial prescription that the brand name product is medically necessary.
3.2.1.b. If the practitioner has prohibited substitution through a dispensing directive in compliance with this subsection, a pharmacist shall not substitute an interchangeable biological product unless the pharmacist obtains verbal or written authorization from the practitioner, notes such authorization on the original prescription drug order, and notifies the patient. 3.2.2 Written prescriptions. 3.2.2.a A practitioner may prohibit the substitution of an interchangeable biological product for a brand name drug product by writing across the face of the written prescription, in the practitioner’s own handwriting, the phrase “brand necessary” or “brand medically necessary.”
3.2.2.b. The dispensing directive shall comply with federal and state law, including rules, with regard to formatting and security requirements
3.2.2.c. The dispensing directive specified in this section may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.
3.2.2.d. A practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this section. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate “substitution instructions” are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.
3.2.3. Verbal prescription.
3.2.3.a. If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner’s agent shall prohibit substitution by specifying “brand necessary” or “brand medically necessary.” The pharmacist shall note any substitution instructions by the practitioner or practitioner’s agent, on the file copy of the prescription drug order.
3.2.3.b. If the practitioner’s or practitioner’s agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug or interchangeable biological product.
3.2.4. Electronic prescription drug orders.
3.2.4.a. To prohibit substitution, the practitioner or practitioner’s agent shall clearly indicate substitution instructions in the electronic prescription drug order.
3.2.4.b. If the practitioner or practitioner’s agent does not indicate or does not clearly indicate in the electronic prescription drug order that the brand is necessary, the pharmacist may substitute an interchangeable biological product.
3.2.5. Refills. All refills shall follow the original substitution instructions unless otherwise indicated by the practitioner or practitioner’s agent.
W. Va. Code R. § 15-17-4 Patient Notification
4.1. Substitution notification. Before delivery of a prescription for an interchangeable biological product, a pharmacist must personally, or through his or her agent or employee inform the patient or the patient’s agent that a less expensive interchangeable biological product is available for the brand prescribed; and ask the patient or the patient’s agent to choose between the interchangeable biological product and the brand prescribed.
4.2. Exceptions. A pharmacy is not required to comply with the provisions of subsection 4.1. of this section:
4.2.1. in the case of the refill of a prescription for which the pharmacy previously complied with subsection 4.1. of this section with regard to the same patient or patient’s agent; or
4.2.2. if the patient’s physician or physician’s agent advises the pharmacy that:
4.2.2.a. the physician has informed the patient or the patient’s agent that a less expensive interchangeable biological product is available for the brand prescribed; and
4.2.2.b. the patient or the patient’s agent has chosen either the brand prescribed or the less interchangeable biological product.
4.3. Notification by pharmacies delivering prescriptions by mail.
4.3.1. A pharmacy that supplies a prescription by mail is considered to have complied with the provision of subsection 4.1. of this section if the pharmacy includes on the prescription order form completed by the patient or the patient’s agent language that clearly and conspicuously:
4.3.1.a. states that if a less expensive generically equivalent drug or interchangeable biological product is available for the brand prescribed, the patient or the patient’s agent may choose between the generically equivalent drug or interchangeable biological product and the brand prescribed; and
4.3.1.b. allows the patient or the patient’s agent to indicate the choice of the generically equivalent drug or interchangeable biological product or the brand prescribed.
4.3.2. If the patient or patient’s agent fails to indicate otherwise to a pharmacy on the prescription order form under 4.1.a. of this subsection, the pharmacy may dispense an interchangeable biological product.
W. Va. Code R. § 15-17-5 Communication with prescriber
5.1. Not later than the fifth business day after the date of dispensing a biological product, the dispensing pharmacist or the pharmacist’s designee shall communicate to the prescribing practitioner the specific product provided to the patient, including the name of the product and the manufacturer or national drug code number.
5.2. The communication must be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy benefit management system or a pharmacy record, which may include information submitted for the payment of claims, that a pharmacist reasonably concludes is electronically accessible by the prescribing practitioner. Otherwise, the pharmacist or the pharmacist’s designee shall communicate the biological product dispensed to the prescribing practitioner, using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication is not required if:
5.2.1. there is no interchangeable biological product approved by the United States Food and Drug Administration for the product prescribed; or
5.2.2. a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
W. Va. Code R. § 15-17-6 Records
6.1. When a pharmacist dispenses an interchangeable biological product, the following information shall be noted on the original prescription or in the pharmacy’s data processing system:
6.1.1. any substitution instructions communicated orally to the pharmacist by the practitioner or practitioner’s agent; and
6.1.2. the name and strength of the actual drug product dispensed shall be noted on the original or hard-copy prescription drug order. The name shall be either:
6.1.2.a. the brand name and strength; or
6.1.2.b. the name of the interchangeable biological product, strength, and name of the manufacturer or distributor of such generic drug or interchangeable biological product. (The name of the manufacturer or distributor may be reduced to an abbreviation or initials, provided the abbreviation or initials are sufficient to identify the manufacturer or distributor. For combination drug products having no brand name, the principal active ingredients shall be indicated on the prescription.)
6.2. If a pharmacist refills a prescription drug order with a generically equivalent product or interchangeable biological product from a different manufacturer or distributor than previously dispensed, the pharmacist shall record on the prescription drug order the information required in subsection 6.1 of this section for the product dispensed on the refill.
6.3. If a pharmacy utilized patient medication records for recording prescription information, the information required in subsections 6.1. and 6.2. of this section shall be recorded on the patient medication records.
6.4. The National Drug Code (NDC) of a drug or any other code may be indicated on the prescription drug order at the discretion of the pharmacist, but such code shall not be used in place of subsections 6.1. and 6.2.
W. Va. Code R. § 15-17-7 Dispensing Responsibilities
7.1. The determination of the drug product to be substituted as authorized by West Virginia Code of State Rules §15-17 et seq. is the professional responsibility of the pharmacist, and the pharmacist may not dispense any product that does not meet the requirements of the West Virginia Code of State Rules §15-17 et seq.
7.2. Pharmacists shall use as a basis for the determination of interchangeability as defined in West Virginia Code of State Rules §15-17 et seq., most recent edition or supplement of the United States Food and Drug Administration’s references (e.g. the Purple Book).
7.3. Pharmacists shall use Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication, to determine biosimilarity to or interchangeability with a reference biological product.
Series 18 Application for Waiver of Initial Licensing Fees for Certain Individuals
W. Va. Code R. § 15-18-1 General
1.1. Scope. -- This rule establishes procedures for waiving the initial licensing fee for low-income individuals and military personnel and their spouses.
1.2. Authority. -- W. Va. Code §30-5-7 and §30-1-22.
1.3. Filing Date. – May 30, 2025.
1.4. Effective Date. – July 1, 2025.
1.5. Sunset Provision. -- This rule shall terminate and have no further force or effect on August 1, 2035.
W. Va. Code R. § 15-18-2 Definitions
2.1. “Board” means the West Virginia Board of Pharmacy.
2.3. “Initial license” means an individual applying for a pharmacist intern, pharmacist, pharmacy technician, or pharmacy technician trainee license in West Virginia for the first time; 2.4 "Local labor market" means every county in West Virginia, and any county outside of West Virginia if any portion of that county is within fifty miles of the border of West Virginia, pursuant to W.Va. Code §21-1C-2;
2.5. “Low-income individual” means an individual in the local labor market as defined in §21-1C-2, whose household adjusted gross income is below 130 percent of the federal poverty line. This term also includes any person enrolled in a state or federal public assistance program including, but not limited to, the Temporary Assistance for Needy Families Program, Medicaid, or the Supplemental Nutrition Assistance Program;
2.6. “Military families” means any person who serves as an active member of the armed forces of the United States, the National Guard, or a reserve component as described in 38 U. S. C. §101, honorably discharged veterans of those forces, and their spouses. This term also includes surviving spouses of deceased service members who have not remarried; and
W. Va. Code R. § 15-18-3 Application for Waiver of Initial Licensure Fees
3.1. An applicant seeking a low income or military family waiver of the initial licensing fee shall apply for licensure to the board and provide the required documentation.
3.2. The Board shall provide the application form and instructions on what documentation is necessary to submit with the license application requesting the low income or military family initial licensing fee waiver.
3.3. An applicant shall submit all required documentation to the board and upon the submission of a complete application, the board shall review the application and issue a decision within 30 days of receipt of the completed application.
3.4. The board may issue a license to an applicant who meets the requirements of W. Va. Code
§30-5-1 et seq., the rules promulgated by the board, and the board shall waive the initial licensing fee for an applicant that meets the requirement of “low-income individuals” or “military families” as defined in W.Va. Code §30-1-22.
W. Va. Code R. § 15-18-4 Required Documentation for Waiver of Initial Licensure Fees
4.1. Individuals requesting a waiver of initial licensure fees for low income or military service personnel and their spouses, shall submit with the application for licensure the initial licensure waiver forms provided by the board and the appropriate documentation as specified in this section.
4.2. To establish low income eligibility for the initial licensing fee waiver, an applicant shall submit to the board evidence that the adjusted gross income of the household of the applicant is at or below 130% of the federal poverty level by submitting documentation of eligibility for:
4.2.1. Temporary Assistance for Needy Families Program;
4.2.2. Medicaid;
4.2.3. Supplemental Nutrition Assistance Program; or
4.2.4. A Federal Tax Return.
4.3. To establish military family eligibility for the initial licensing fee waiver, an applicant shall submit to the board proof of qualifying military service and proof of eligibility as a qualifying spouse or widow, as follows:
4.3.1. A service members DD-214 form;
4.3.2. A service members NGB-22 form;
4.3.3. A service members DD-1300 form; or
4.3.4. A copy of their current military orders; and
4.3.5. A copy of the marriage certificate with the qualifying service member and, where applicable, the death certificate of the service member if the widow is applying for the military family waiver.
4.4. Honorably discharged applicants shall submit a completed application, and a DD-214 form or an NGB-22 form showing the applicant has been an honorably discharged from military service.
Series 19 Inspections
W. Va. Code R. § 15-19-1 General
1.1. Scope. -- Inspection process for the West Virginia Board of Pharmacy.
1.2. Authority -- W. Va. Code §30-5-7.
1.3. Filing date -- May 4, 2026.
1.4. Effective date -- July 1, 2026.
1.5. Sunset Provision -- This rule will terminate and have no further force or effect on August 1, 2031.
W. Va. Code R. § 15-19-2 Definitions
2.1. The following words and phrases as used in this Rule mean:
2.1.1. “Board” means the West Virginia Board of Pharmacy.
2.1.2. "Charitable clinic pharmacy" means a clinic or facility organized as a not-for-profit corporation that offers pharmaceutical care and dispenses prescriptions free of charge to appropriately screened and qualified patients. A charitable clinic pharmacy shall meet the minimum standards for a pharmacy as set forth in W. Va. Code §30-5-1 et seq., and by this rule, but may not be charged any applicable licensing fees. A charitable clinic pharmacy may have pharmacists-in-charge, as that term is defined in this section, who volunteers his or her services. A charitable clinic may also receive donated drugs. It is not the intent of this rule to affect any organizations which are merely operating a prescribing practitioner’s or clinic’s free sample drug room.
2.1.3. “Controlled Substance Permit” means the permit required to be obtained by the Board, unless otherwise exempt, for every person who manufactures, distributes, including reverse distributing, or dispenses any controlled substances or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance within this state.
2.1.4. “Inspection” means the process by which the Board verifies certain information of Board licenses.
2.1.5. “Inspector” means a person employed by the Board to perform inspections.
2.1.6. “Institutional pharmacy” means that physical portion of an institutional facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease and which holds a pharmacy license from the Board.
2.1.7. “Manufacturer” means any person who is engaged in manufacturing, preparing, propagating, processing, packaging, repackaging, or labeling of a prescription drug, whether within or outside this state.
2.1.8. “Non-compliance report” means a report created noting a deficiency discovered during an inspection.
2.1.9. “Non-sterile compounding” means the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug or bulk drug substance to create a non-sterile preparation.
2.1.10. "Nuclear pharmacy" means a place where radioactive drugs are prepared and dispensed and which operates under specialized rules.
2.1.11. "Outpatient pharmacy" means any pharmacy, apothecary, or place within this state where drugs are dispensed and sold at retail or displayed for sale at retail and where the practice of pharmacy is conducted and pharmacist care is provided; and any place outside of this state where drugs are dispensed and the practice of pharmacy and pharmacist care is provided to residents of this state.
2.1.12. “Unscheduled inspection” means an unannounced inspection.
2.1.13. “Sterile compounding” means compounding or mixing prescription orders for sterile solutions or suspensions to be administered parenterally, enterally, by irrigation or ophthalmic drops.
2.1.14. “Wholesale drug distributor” or “wholesale distributor” means any person or entity engaged in wholesale distribution of prescription drugs, including, but not limited to, manufacturers, repackers, own-label distributors, jobbers, private-label distributors, brokers, warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses and wholesale drug warehouses, independent wholesale drug traders, prescription drug repackagers, physicians, dentists, veterinarians, birth control and other clinics, individuals, hospitals, nursing homes or their providers, health maintenance organizations and other health care providers, and retail and hospital pharmacies that conduct wholesale distributions, including, but not limited to, any pharmacy distributor as defined in this section. A wholesale drug distributor shall not include any for hire carrier or person or entity hired solely to transport prescription drugs.”
W. Va. Code R. § 15-19-3 Inspector Qualifications
3.1. In order to qualify for the position of inspector, a candidate must be a WV licensed pharmacist and have at least 10 years of pharmacy practice experience.
3.2. Upon being hired, each inspector shall complete a training program in accordance with the Board’s training manual.
W. Va. Code R. § 15-19-4 Regions. 4.1 The Board shall establish regions within the state. Each region shall have approximately the same amount of licensed facilities requiring inspection pursuant to W. Va. Code §30-5-1 et seq
4.2. Each inspector shall be assigned a region.
W. Va. Code R. § 15-19-5 Scheduling of Inspections
5.1. Inspections shall be conducted within 90 days of the regularly scheduled inspection frequency, unless circumstances make compliance with this timeframe unattainable.
5.2. Inspectors shall schedule Inspections by notifying the facility to be inspected at least one week in advance of the inspection.
5.3. Unscheduled inspections shall be conducted by each Inspector on an annual basis for an amount of inspections not to exceed 10% of the facilities within the Inspector’s region.
W. Va. Code R. § 15-19-6 Conducting Inspections
6.1. At a minimum, the methods established by the Board for conducting inspections shall include the following:
6.1.1. Presentation of credentials;
6.1.2. Copies of the inspection forms to be used;
6.1.3. Details on the use of electronic inspection forms;
6.1.4. A listing of documents to be reviewed; and
6.1.5. Listing of staff that may be interviewed.
6.2. Completed hard copy inspections shall be submitted to the Board office within 90 days.
6.3. Completed hard copy inspections shall be recorded in the Board database.
6.4. Inspections completed on the electronic inspection form shall be automatically entered into the Board database.
6.5. Copies of the completed inspection form shall be provided to the facility inspected.
6.6. Non-compliance reports shall be completed and entered into the Board database.
6.7. Completed inspections shall be reviewed by the Chief Compliance Officer within 90 days. This review shall be documented in the Board database.
6.8. Non-compliance reports shall be logged in a manner which allows for the systematic monitoring of a facility’s actions toward correcting areas of significant deficiencies.
6.9. Facilities not meeting the expected corrections within the timeframe established by the inspector may be referred to the Complaint Committee of the Board.
6.10. All records, documents, communications, and images shall be maintained in the Board database for a period of five years.
W. Va. Code R. § 15-19-7 Inspection Forms
7.1. The Board shall create inspection forms for each type of facility inspected. The inspection forms shall contain citations to relevant laws and appropriate Board of Pharmacy Rules.
7.2. The inspection forms used by the Board shall be made available to the public on the Board’s website www.wvbop.com.
W. Va. Code R. § 15-19-8 Inspection Frequency
8.1. The following facility types shall be inspected annually:
8.1.1. Outpatient pharmacies;
8.1.2. Institutional pharmacies;
8.1.3. Charitable clinic pharmacies;
8.1.4. Nuclear pharmacies;
8.1.5. Sterile compounding facilities;
8.1.6. Non-sterile compounding facilities;
8.1.7. Wholesale drug distributors; and
8.1.8. Manufacturers.
8.2. Facilities that only hold a controlled substance permit and no other Board permit or license shall be inspected biennially.
Series 20 Donated Drug Repository Program
W. Va. Code R. § 15-20-1 General Scope. – To establish requirements and process for donated drug repository programs
Authority – W. Va. Code §60B-1-8 Filing Date --- May 2, 2023 Effective Date --- May 2, 2023 Sunset Date – This rule shall terminate and have no further force or effect on August 1, 2028.
W. Va. Code R. § 15-20-2 Definitions
2.1. The following words and phrases as used in this rule mean:
2.1.1. “Board” means the West Virginia Board of Pharmacy.
2.1.2. “Controlled substance” means a drug, substance, or immediate precursor in Schedules I through V of §60A-2-1 et seq. of this code, and Schedules I through V of 21 CFR Part 1308.
2.1.3. “Donor” means any person, including an individual member of the public, or any entity legally authorized to possess drugs with a license or permit in good standing in the state in which it is located, including, but not limited to, a wholesaler or distributor, third party logistic provider, pharmacy, dispenser, clinic, surgical or health center, detention and rehabilitation center, laboratory, medical or pharmacy school, prescriber or other health care professional, or healthcare facility. Donor also means government agencies and entities that are federally authorized to possess drugs including, but not limited to, drug manufacturers, repackagers, relabelers, outsourcing facilities, Veteran Affairs hospitals, and prisons.
2.1.4. “Drugs” means both prescription and nonprescription (“over-the-counter”) drugs.
2.1.5. “Donated drug repository program" means a program authorized to accept prescription and non-prescription drugs donated or given for the purpose of being dispensed or personally furnished to individuals who are residents of this state and meets eligibility standards
2.1.6. “Eligible patient” means an indigent person. However, if the recipient’s supply of donated drugs exceeds the need for donated drugs by indigent patients, then any other person in need of a particular drug can be an eligible patient.
2.1.7. “Eligible recipient” means a pharmacy, wholesaler, reverse distributor, hospital, federally qualified health center, nonprofit clinic, healthcare facility, an entity participating in a drug donation or repository program pursuant to another state’s law, or a private office of a healthcare professional that has been authorized by the West Virginia Board of Pharmacy.
2.1.8. “Healthcare facility” means a facility licensed by the State of West Virginia as a:
Nursing home;
Personal care home;
Assisted living community;
Residential care facility for the elderly;
Hospice;
Hospital;
Home health agency; or (8) A similar entity licensed in the state in which it is located.
2.1.9. “Health care professional” means a person who is licensed by the State of West Virginia to practice as a:
Physician;
Registered nurse or licensed practical nurse;
Physician assistant;
Dentist or dental hygienist;
Optometrist; or (6) Pharmacist.
2.1.10. “Indigent patient” means a patient whose income is at or below the income eligibility requirements of the West Virginia Medicaid program, or who is uninsured, underinsured, or enrolled in a public assistance health benefits program.
2.1.11. “Program” means the donated drug repository program established by rule pursuant to §60B-1-8 of this code.
2.1.12. “Responsible individual” means a person permitted by law to have legal possession of prescription drugs.
2.1.13. “Transaction date” means the date on which ownership of the drugs is transferred between two participants of the program as established by contract or other arrangement. If no such contract or arrangement exists, the transaction date shall be the date the drug was accepted into inventory by the recipient.
W. Va. Code R. § 15-20-3 Waivers
3.1. A donor or eligible recipient may request a waiver from the board with regard to any rule related to this program by demonstrating the waiver is in the interest of public health and safety.
3.2. The donor or eligible recipient seeking the waiver will receive correspondence from the board with the decision.
W. Va. Code R. § 15-20-4 Authorization process for eligible recipients
4.1. To be eligible for participation in the program, a pharmacy, wholesaler, reverse distributor, hospital, federally qualified health center, nonprofit clinic, healthcare facility, an entity participating in a drug donation or repository program pursuant to another state’s law, or private office of a healthcare professional shall be in compliance with all applicable federal and state laws, including laws applicable to the storage and distribution of drugs and all the appropriate licensure standards, and shall hold active, state-issued licenses or registrations in good standing.
4.2. An eligible recipient may establish a donated drug repository program at an authorized address.
4.3. The eligible recipient shall provide written notification to the Board of participation in the program on the form provided on the Board of Pharmacy website at www.wvbop.com.
4.4. Each eligible recipient shall make a separate notification to the board for each drug repository program address.
4.5. Each donated drug repository program must designate a responsible individual.
4.6. Each donated drug repository program notification shall be accompanied by a notification fee of $50 annually.
4.7. The notification shall serve for participation in the program for a period of one year, unless revoked by the Board. The eligible recipient may renew its authority via renotification annually by June 30.
4.8. Withdrawal from participation. A donated drug repository program may withdraw from the Program at any time by providing written notice to the Board on a form provided and available on the Board's website.
4.9. Failure to comply with any provision of §60B-1-1 et seq. or statutes governing prescription drugs may result in revocation of authority to participate in the program. Revocation shall be provided as a written notice including the specific requirements that were violated and corrective actions necessary to reinstate its authority to participate in the program.
W. Va. Code R. § 15-20-5 Eligible Drugs
5.1. Any individual who is 18 years of age or older may donate legally obtained prescription drugs or supplies to a drug repository program if the drugs meet the requirements of this rule, as determined by the pharmacist or responsible healthcare provider of the drug repository program. The 18 year or older parent or guardian of a minor may donate the minor’s legally obtained drugs or supplies if all requirements are met.
5.1.1. The donor shall remove or redact any patient names and prescription numbers on donated drugs or otherwise maintain patient confidentiality by executing a confidentiality agreement with the eligible recipient.
5.2. No drugs that require storage temperatures other than normal room temperature as specified by the manufacturer or United States Pharmacopeia shall be donated or accepted as part of the donated drug repository program due to the increased potential for adulteration. Drugs donated directedly from a drug manufacturer, wholesaler, third party logistics provider, or pharmacy are excluded from this provision and may be donated. 5.3 Controlled substances shall not be donated or accepted. 5.4 Drugs subject to a federal Food and Drug Administration managed risk evaluation and mitigation strategy pursuant to 21 U.S.C. §355-1 if inventory transfer is prohibited may not be donated or accepted. 5.5 Drugs may be dispensed by a donated drug repository program only if all of the following are met: 5.5.1 The drug is in unopened, tamper-evident packaging as defined by the United States Pharmacopeia General Chapter 659, Packaging and Storage Requirements, including but not limited to unopened, unit-dose and multiple dose packaging. A drug in a single-unit dose or blister pack with the outside packaging opened may be dispensed if the single unit-dose packaging is undisturbed and meets the labeling requirements of 15 CSR 1-20.2.1; 5.5.2 The drug has been stored according to manufacturer's or USP storage conditions; 5.5.3 The packaging contains the expiration date; 5.5.4 The drug has an expiration date that is more than six months after the date that the drug was donated. However, a donated prescription drug bearing an expiration date that is six months or less after the date the prescription drug was donated may be accepted and dispensed if the drug is in high demand and can be dispensed for use prior to the drug’s expiration date; 5.5.5 The drug does not have any physical signs of tampering or adulteration, and there is no reason the believe that the drug is adulterated; 5.5.6 The packaging does not have any physical signs of tampering, misbranding, deterioration, compromised integrity, or adulteration; and 5.6 A drop box may not be used to deliver or accept donations.
W. Va. Code R. § 15-20-6 Storage and handling of donated drugs by eligible recipients 6.1 A licensed pharmacist or the responsible healthcare professional for the donated drug repository program shall inspect the donated drugs prior to dispensing to determine, to the extent reasonable possible in their professional judgement, that the drugs are not adulterated or misbranded, are safe and suitable for dispensing. 6.2 The eligible recipient shall store and maintain donated drugs in a secure and temperature-controlled environment that meets the drug manufacturers’ recommendations and United States Pharmacopeia Standards. 6.3 If a recall notification is received, the donated drug repository program shall identify all recalled prescription product in the facility, dispose of all recalled drug as directed in the recall, and document the disposal in the records for the donated drug repository program. If a recalled drug has been dispensed, the donated drug repository program shall immediately notify the recipient of the recalled drug pursuant to established drug recall procedures
W. Va. Code R. § 15-20-7 Eligible Patients 7.1 An individual must meet the following criteria to be eligible to receive medication from a donated drug repository: 7.1.1 Income is at or below the income eligibility requirements of the West Virginia Medicaid Program; 7.1.2 Uninsured; 7.1.3 Underinsured; or 7.1.4 Enrolled in a public assistance health benefits program. 7.2 If a donated drug repository program’s supply of donated drugs exceeds the need for donated drugs by indigent patients, then any other person in need of a particular drug can be an eligible patient
W. Va. Code R. § 15-20-8 Dispensing of donated drugs
8.1. Donated drugs may only be dispensed to eligible patients pursuant to a valid prescription order.
8.2. A donated drug repository program shall dispense donated prescription drugs in compliance with federal and state laws and regulations for dispensing prescription drugs, including but not limited to all requirements relating to packaging, labeling, record keeping, drug utilization review, and patient counseling. The eligible patient will be counseled and sign an acknowledgement that the drug was donated.
8.3. Donated drugs may not be resold and shall be considered nonsalable. However, reimbursement for any handling fee does not constitute reselling. A donated drug repository program may charge the eligible recipient a handling fee not to exceed the reasonable costs of participating in the program including, but not limited to, the current and anticipated costs of educating eligible donors, providing technical support to participating donors, shipping and handling, labor, storage, licensing, utilities, advertising, technology, supplies, and equipment.
8.4. The fees charged, and costs listed in 15 CSR 20-8.3 shall be included in the audit information made available to the Board.
8.5. Nothing in the preceding paragraph limits an eligible recipient from charging fees, including, but not limited to, a usual and customary charge, to donors, eligible recipients, health plans, pharmacy benefit managers, and other entities.
W. Va. Code R. § 15-20-9 Required Records
9.1. Prior to accepting a donation into inventory, a donated drug repository program that dispenses donated drugs or supplies to an eligible patient shall maintain a written or electronic inventory of each donated drug or supply that shall include the following information:
9.1.1. The transaction date;
9.1.2. The name, strength, and quantity of each accepted drug; and
9.1.3. The name, address, and phone number of the eligible donor providing each drug or supply.
9.2. A donated drug repository program shall keep all donated drugs physically or electronically separated from other inventory. Donated inventory may be used to replenish purchased inventory with the same drug name and strength that was previously dispensed or administered to an eligible person. Replenishment shall follow applicable provisions of the federal 340B Drug Pricing Program. Replenishment may not be done using drugs donated by the public.
9.3. In addition to all records required for dispensing a prescription drug or supply under W. Va. Code 30-5 and rules, a donated drug repository program shall note, either on the face of a written prescription or in the electronic record of a prescription, that a donated drug was dispensed to the patient if the site dispenses both donated and non-donated drugs.
9.4. All records must be made available for audit by the Board within five business days.
9.5. All records must be kept for six years.
9.6. Prior to the first donation from a new donor, an eligible recipient shall collect an attestation signed electronically or physically by the person making the donation or that person’s authorized representative, verifying and recording information required by W. Va. Code §60B-1-5(c).
W. Va. Code R. § 15-20-10 Exemption from disciplinary action, civil liability or criminal prosecution
10.1. Unless an action or omission constitutes willful or wanton misconduct, the following persons or entities shall not be subject to criminal or civil prosecution, criminal or civil liability from injury, death, or loss to person or property, or other criminal or civil action, or disciplinary actions by licensing, professional, or regulatory agencies:
10.1.1. A person who donates or gives drugs to an eligible recipient, including a drug wholesaler, drug manufacturer, reverse distributor, pharmacy, third-party logistics provider, government entity, hospital or health care entity;
10.1.2. An eligible recipient;
10.1.3. A healthcare professional who prescribes or dispenses a donated drug;
10.1.4. The Board of Pharmacy;
10.1.5. An intermediary that helps administer the program by facilitating the donation or transfer of drugs to eligible recipients;
10.1.6. A repackager or manufacturer of a donated drug; and
10.1.7. Any employee, volunteer, trainee, or other staff of individuals and entities listed in (1) through (6)
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