K.A.R. Agency 68 | Kan. Admin. Regs. Agency 68 — State Board of Pharmacy

Article 1 Registration and Examination of Pharmacists

Kan. Admin. Regs. § 68-1-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-1-1a Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630 and K.S.A. 2000 Supp. 65-1631; effective, E-76-31, Aug. 11, 1975; effective May 1, 1976; amended May 1, 1978; amended May 1, 1983; amended June 6, 1994; amended March 20, 1995; amended May 31, 2002; revoked Jan. 30, 2026.)

Kan. Admin. Regs. § 68-1-1b Continuing education for pharmacists

(a)(1) "Continuing education" shall mean an organized and systematic education experience beyond basic preparation that is designed to achieve the following:

(A)(i) Increase knowledge, improve skills, or enhance the practice of pharmacy; or

(ii) improve protection of the public health and welfare; and

(B) ensure continued competence.

(2) "ACPE-NABP CPE monitor service" shall mean the electronic tracking service of the accreditation council for pharmacy education and the national association of boards of pharmacy for monitoring continuing education that pharmacists receive from continuing education providers.

(b)(1) Thirty clock-hours of continuing education shall be required for renewal of a pharmacist license during each licensure period. Continuing education clock-hours may be prorated for licensure periods that are less than biennial at a rate of 1.25 clock-hours per month.

(2) Each licensee shall complete a continuing education course consisting of one clock-hour that is provided by the board for renewal of a pharmacist license, which shall be counted toward the 30 clock-hour requirement. This paragraph shall take effect on July 1, 2023.

(c)(1) Each continuing education program shall be approved by the board. Each provider or licensee shall submit the continuing education program to the board at least 10 days in advance for consideration for approval. Each provider shall advertise the continuing education program as having only pending approval until the provider is notified of approval by the board.

(2) Continuing education programs shall not include in-service programs, on-the-job training, orientation for a job, an education program open to the general public, a cardiopulmonary resuscitation (CPR) course, a basic cardiac life support (BCLS) course, emergency or disaster training or direct experience at a healthcare facility under a code blue, testing out of a course, and medical school courses.

(3) Each provider shall furnish a certificate of completion to the licensee for each continuing education program that the licensee has successfully completed. Each certificate shall be in a format approved by the board and shall include the following:

(A) The licensee's name;

(B) the title and date of the approved continuing education program;

(D) the number of continuing education clock-hours approved by the board;

(E) the number of continuing education clock-hours completed by the licensee;

(F) the approved program number issued by the board; and

(G) the provider's dated signature, certifying program completion.

(d) Within 30 days of completion, each licensee shall submit to the board proof of completion of any approved continuing education program not reported to the ACPE-NABP CPE monitor service. No credit shall be given for any certificate of completion received by the board after the June 30 expiration date of each licensure period.

(e) A licensee shall not be allowed to carry forward excess clock-hours earned in one licensure period into the next licensure period.

(f) The required continuing education shall be obtained in the two-year licensure period ending on the June 30 expiration date of each license.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1632; effective, E-76-31, Aug. 11, 1975; effective May 1, 1976; amended May 1, 1978; amended May 1, 1983; amended May 1, 1986; amended May 1, 1987; amended July 1, 1990; amended July 31, 1998; amended Oct. 20, 2006; amended April 23, 2010; amended Aug. 19, 2016; amended June 2, 2023.)

Kan. Admin. Regs. § 68-1-1c Revoked

Publisher status: INEFFECTIVE (not currently effective).

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History

History: (Authorized by and implementing K.S.A. 1982 Supp. 65-1631; effective May 1, 1983; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-1-1d Approved schools

The following may be recognized and approved by the board: (a) Any school or college of pharmacy or department of a university accredited by the accreditation council for pharmacy education; and

(b) any other school or college of pharmacy or department of a university that, as determined by the board, has a standard of education not below that of the university of Kansas school of pharmacy.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; effective May 1, 1983; amended May 1, 1987; amended Oct. 20, 2006.)

Kan. Admin. Regs. § 68-1-1e Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; effective May 1, 1983; amended May 1, 1987; revoked March 22, 2002.)

Kan. Admin. Regs. § 68-1-1f Foreign graduates

(a) Each applicant who has graduated from a school or college of pharmacy or a pharmacy department of a university located outside of the United States or who is not a citizen of the United States shall provide proof that the applicant has reasonable ability to communicate verbally and in writing with the general public in English as specified in this regulation.

(b) Each foreign applicant shall be required to meet the English language requirements for licensure under the pharmacy act of the state of Kansas by passing the internet-based test of English as a foreign language (TOEFL iBT) with at least the following minimum scores:

(1) 22 in reading;

(2) 21 in listening;

(3) 26 in speaking; and

(4) 24 in writing.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-1631; implementing K.S.A. 65-1631; effective May 1, 1983; amended June 6, 1994; amended March 20, 1995; amended Aug. 1, 1997; amended Oct. 20, 2006; amended Aug. 19, 2016.)

Kan. Admin. Regs. § 68-1-1g Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; effective Oct. 20, 2006; revoked Aug. 19, 2016.)

Kan. Admin. Regs. § 68-1-1h Foreign pharmacy graduate equivalency examination

In addition to meeting the requirements of K.A.R. 68-1-1f, each foreign applicant shall meet the following requirements for licensure under the pharmacy act of the state of Kansas:

(a) Pass the foreign pharmacy graduate equivalency examination (FPGEE) with a score of at least 75;

(b) obtain foreign pharmacy graduate examination committee (FPGEC) certification from the national association of boards of pharmacy (NABP); and

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; effective Oct. 23, 2009.)

Kan. Admin. Regs. § 68-1-2 Grades required

(a) Each successful applicant for licensure by examination under the pharmacy act of the state of Kansas shall:

(1) pass an examination approved by the board; and

(2) obtain a grade of not less than 75% on the law examination administered by the board.

(b) Each successful applicant for licensure by reciprocity from another state shall score not less than 75% on the law examination administered by the board.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 1987 Supp. 65-1631(c), as amended by L. 1988, Ch. 243, Sec. 7; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; amended May 1, 1980; amended May 1, 1985; amended May 1, 1986; amended May 1, 1989.)

Kan. Admin. Regs. § 68-1-2a Pharmacist-in-charge acknowledgement; notice of designation

(a) Each pharmacy or registrant required to have a pharmacist-in-charge that operates for more than 30 days without a designated pharmacist-in-charge who meets the requirements of this regulation shall be deemed to be in violation of K.S.A. 65-1627, and amendments thereto.

(b) Each prospective pharmacist-in-charge shall, at the time of assuming these duties, sign an acknowledgment that states the pharmacist has reviewed the pharmacy act and the board's regulations and is aware of the responsibilities of a pharmacist-in-charge. The pharmacist-in-charge shall provide this acknowledgment to the board within 30 days of assuming the duties of a pharmacist-in-charge.

(c) Except as specified in subsection (d), each pharmacy owner shall submit to the board, on a form provided by the board, notice of designation of a new pharmacist-in-charge at the pharmacy or facility required to have a pharmacist-in-charge no later than 30 days after the previous pharmacist-in-charge has ceased to serve as the pharmacist-in-charge.

(d) Any pharmacy owner that is unable to designate a new pharmacist-in-charge within 30 days may submit to the board, on a form provided by the board, a request for a 30-day extension to designate a new pharmacist-in-charge. The request shall be submitted to the board no more than 30 days after the previous pharmacist-in-charge has ceased to serve as pharmacist-in-charge and shall provide the reason for the request.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 2022 Supp. 65-1626 and K.S.A. 65-1630; implementing K.S.A. 2022 Supp. 65-1626, and K.S.A. 65-1637c; effective Aug. 1, 1997; amended May 31, 2002; amended June 2, 2023.)

Kan. Admin. Regs. § 68-1-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630; effective Jan. 1, 1966; amended Jan. 1, 1967; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; amended May 1, 1983; revoked March 22, 2002.)

Kan. Admin. Regs. § 68-1-3a Qualifying pharmaceutical experience

(a) Pharmaceutical experience that qualifies as one year of experience shall consist of 1,740 clock-hours as a pharmacy student or registered intern while being supervised by a preceptor. A preceptor may supervise at any time no more than two individuals who are pharmacy students or interns. All hours worked when the pharmacy student or intern is in regular attendance at an approved school of pharmacy and during vacation times and other times when the pharmacy student or intern is enrolled but not in regular attendance at an approved school of pharmacy may be counted as qualified hours. However, not more than 60 hours of work shall be acquired in any one week.

(b) No time may accrue to a pharmacy student before acceptance in an approved school of pharmacy or before being registered as an intern with the board. However, any foreign pharmacy graduate who has passed equivalent examinations as specified in K.A.R. 68-1-1f and K.A.R. 68-1-1h may apply for registration as an intern.

(d) Reciprocity shall not be denied to any applicant who is otherwise qualified and who meets either of the following conditions:

(1) Has met the internship requirements of the state from which the applicant is reciprocating; or

(2) has at least one year of experience as a registered pharmacist.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1631; effective, E-76-31, Aug. 11, 1975; effective May 1, 1976; amended May 1, 1983; amended May 1, 1985; amended May 31, 2002; amended Jan. 14, 2005; amended Oct. 23, 2009; amended Dec. 15, 2017.)

Kan. Admin. Regs. § 68-1-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-1-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-1-6 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-1-7 Reinstatement after lapse

Upon failure of a pharmacist to renew a registration under the provisions of K.S.A. 65-1632 for three consecutive years or more, the board shall require the applicant to take a written or oral examination prior to reinstatement. Upon satisfactory completion of that examination and compliance with the provisions of K.S.A. 65-1632, the applicant shall be entitled to a renewal of registration if no grounds exist for denying the renewal.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1983.)

Kan. Admin. Regs. § 68-1-8 Registered pharmacist to be on duty

It shall be the duty of the pharmacist in charge of every premise having a pharmacy registration, to ensure that a registered pharmacist is on duty at all times during which the pharmacy is open.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; amended May 1, 1983.)

Kan. Admin. Regs. § 68-1-9 Pharmacist-in-charge; responsibilities

(a) Each pharmacist-in-charge shall develop, supervise, and coordinate all pharmaceutical services performed within the pharmacy to ensure compliance with the Kansas pharmacy act, the state and federal uniform controlled substances act, the state and federal food, drug, and cosmetic act, and all applicable regulations.

(b) Each pharmacist-in-charge shall be personally available to the extent required to ensure comprehensive pharmaceutical services within the pharmacy and to develop a staff of additional licensed pharmacists and supportive personnel as necessary to serve the needs of the pharmacy. Each pharmacist-in-charge shall maintain records in the pharmacy describing the training and education regarding work functions performed by all pharmacy personnel. Each pharmacist-in-charge shall maintain in the pharmacy written procedures for the following:

(1) Designating the person or persons functioning as pharmacy technicians and supportive personnel;

(2) describing the job duties of all personnel;

(3) documenting the procedural steps taken by the pharmacist-in-charge to limit the functions of all personnel to their respective pharmacy work functions; and

(4) documenting training and related education for nondiscretionary tasks performed by pharmacy technicians.

(c) Each pharmacist-in-charge shall be responsible for direct supervision of all pharmacy personnel, for the security of the pharmacy, and for the security of all drugs in the pharmacy.

(d) Each pharmacist-in-charge shall ensure that the pharmacy maintains adequate drug information references commensurate with services offered and a current copy of the state laws and regulations listed in subsection (a).

(e) Each pharmacist-in-charge shall be responsible for establishing a drug recall procedure that can be effectively implemented.

(f) Each pharmacist-in-charge shall be responsible for developing written procedures for maintaining records of drug distribution, prepackaging, repackaging, and compounding. Prepackaging and repackaging of drugs shall be done in accordance with K.A.R. 68-7-15 and labeled in accordance with K.A.R. 68-7-16.

(g) Each pharmacist-in-charge shall be responsible for reviewing each published board newsletter and posting the newsletter in a conspicuous area within the pharmacy until publication of the next board newsletter.

(h)(1) Each pharmacist shall submit to the board, on a form provided by the board, notice of ceasing to serve as the pharmacist-in-charge at a pharmacy or facility required to have a pharmacist-in-charge no later than five days after ceasing to serve as the pharmacist-in-charge.

(2) Each pharmacist ceasing to serve as the pharmacist-in-charge shall inventory all controlled substances and drugs of concern, as defined by K.S.A. 65-1682 and amendments thereto, in the pharmacy or facility in accordance with the inventory requirements of K.A.R. 68-20-16 no more than two days before ceasing to serve as the pharmacist-in-charge and no later than the day ceasing to serve as the pharmacist-in-charge.

(3) Each pharmacist beginning to serve as the pharmacist-in-charge shall inventory all controlled substances and drugs of concern, as defined by K.S.A. 65-1682 and amendments thereto, in the pharmacy or facility in accordance with the requirements of K.A.R. 68-20-16 after beginning to serve as the pharmacist-in-charge but no more than two days after beginning to serve as the pharmacist-in-charge. The inventory may be taken simultaneously with the previous pharmacist-in-charge on the last day of the previous pharmacist-in-charge if both pharmacists are present in the pharmacy, actively participate in the inventory, and sign the inventory.

(4) If a pharmacist ceasing to serve as pharmacist-in-charge is unable to complete the inventory specified in paragraph (2) of this subsection or is terminated for a suspected or known violation of the Kansas pharmacy act, the pharmacy or facility owner shall request approval from the board to designate another pharmacist to conduct the inventory. If the board approves the request, the pharmacy or facility owner may designate another pharmacist to conduct the inventory specified in paragraph (2) of this subsection within the designated time frame.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 2022 Supp. 65-1626 and K.S.A. 65-1630; implementing K.S.A. 2022 Supp. 65-1626, K.S.A. 65-1637c, K.S.A. 65-1642, and K.S.A. 65-1648; effective June 2, 2023.)

Article 2 Drugstores

Kan. Admin. Regs. § 68-2-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2019 Supp. 65-1626, K.S.A. 65-1637c, and K.S.A. 65-1643; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; amended May 1, 1988; amended Aug. 1, 1997; amended March 22, 2002; amended Feb. 7, 2020; revoked Aug. 16, 2024.)

Kan. Admin. Regs. § 68-2-6 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-7 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-8 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-9 Change of ownership; duty of registrant to notify board

Each registrant shall notify the executive secretary of the board in writing of any change in majority ownership of the operation for which the registration was issued within five days after the date the change in ownership becomes effective.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2001 Supp. 65-1643; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; amended Aug. 1, 1997; amended Feb. 7, 2003.)

Kan. Admin. Regs. § 68-2-10 Cessation of operations

(a) When any pharmacy ceases operations at the location for which the registration was received, the pharmacist-in-charge shall meet the following requirements:

(1) Within five days after ceasing operations at that location, submit to the board, on a form provided by the board, notice of cessation of pharmacy operations, which shall include the following:

(A) The date the pharmacy ceased operations;

(B) a signed statement attesting that an inventory of all controlled substances was conducted;

(C) the location, pharmacy registration number, contact information, and manner of disposition of the remaining stocks of drugs; and

(D) the location, pharmacy registration number, contact information, and manner of disposition of all records required by the Kansas pharmacy practice act to be maintained; and

(2) no more than 10 days after ceasing operations at that location, notify each patient household that has received a prescription from the pharmacy within the previous two-year period, by U.S. mail, phone, text message, or electronic mail, of the cessation of operations of the pharmacy and the contact information and location for obtaining copies of patient records.

(b) The pharmacist-in-charge of any pharmacy that acquires patient records from a pharmacy that ceases operation shall be responsible for the preservation of the acquired records for the remainder of the term that the records are required by the Kansas pharmacy practice act to be preserved.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1642 and K.S.A. 65-1643; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended Feb. 7, 2003; amended Jan. 3, 2020.)

Kan. Admin. Regs. § 68-2-11 Security

Each premises for which a pharmacy registration is issued, except medical care facilities, shall be constructed so that the pharmacy can be secured to prevent access to prescription-only drugs when a pharmacist is not on duty.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2001 Supp. 65-1637 and K.S.A. 2001 Supp. 65-1643; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended Feb. 7, 2003.)

Kan. Admin. Regs. § 68-2-12 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-2-12a Minimum requirements for library, equipment, and supplies

(a) Each registered pharmacy, other than a medical care facility pharmacy, shall have a reference library, either immediately accessed by a computer or printed, that is updated at least annually and that includes the following:

(1) A current copy of the Kansas pharmacy practice act, the Kansas uniform controlled substances act, and the regulations under both acts;

(2) a drug information reference specifically drafted for patients, which may include the "professional's guide to patient drug facts," published by facts and comparisons, or "United States pharmacopeia dispensing information," volume II;

(3) one recognized reference in toxicology, pharmacology, and drug interactions;

(4) one recognized reference in drug equivalencies; and

(5) a medical dictionary.

(b) Each registered pharmacy shall also have on the premises the equipment and supplies necessary to compound, dispense, label, administer, and distribute drugs. The equipment shall be in good repair and shall be available in sufficient quantities to meet the needs of the practice of pharmacy conducted there.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2001 Supp. 65-1642; effective May 1, 1983; amended May 1, 1986; amended May 1, 1987; amended April 30, 1990; amended March 20, 1995; amended Dec. 27, 1999; amended Feb. 7, 2003.)

Kan. Admin. Regs. § 68-2-13 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-14 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-2-15 Nametags

(a) The following individuals shall wear a visible nametag under the following conditions:

(1) Each pharmacist, pharmacy student, and intern, while performing pharmacist functions in a pharmacy; and

(2) each pharmacy technician, while performing pharmacy technician functions in a pharmacy.

(b) Each nametag shall include the person's name and the designation of whether the person is a pharmacist, a pharmacy student, an intern, or a pharmacy technician.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2001 Supp. 65-1642; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended April 18, 2003.)

Kan. Admin. Regs. § 68-2-16 Branches, agents and pickup stations

No pharmacy nor pharmacist shall have, participate in, or permit an arrangement, branch, connection or affiliation whereby prescriptions are solicited, accepted, collected, or picked up, or advertised to be such, from or at any location other than a pharmacy for which a registration in good standing has been issued by the board.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976.)

Kan. Admin. Regs. § 68-2-17 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-2-18 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; effective Jan. 1, 1966; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-2-19 Prescription copies

(A) No registered pharmacist shall fill, and no pharmacy shall permit the filling of, a copy of a prescription. (B) Every reference copy of a prescription shall bear the following legend—"This prescription copy is issued for reference only."

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976.)

Kan. Admin. Regs. § 68-2-20 Pharmacist's function in filling a prescription

(a) As used in this regulation, each of the following terms shall have the meaning specified in this subsection:

(1) "Prescriber" means a "practitioner" as defined by K.S.A. 65-1626 and amendments thereto, a "mid-level practitioner" as defined by K.S.A. 65-1626 and amendments thereto, or a person authorized to issue a prescription by the laws of another state.

(2) "Legitimate medical purpose," when used regarding the dispensing of a prescription drug, means that the prescription for the drug was issued with a valid preexisting patient-prescriber relationship rather than with a relationship established through an internet-based questionnaire.

(b) Except as provided in subsection (c), judgmental functions that constitute the filling or refilling of a prescription shall be performed only by a pharmacist or by a pharmacist intern under the direct supervision of a licensed pharmacist and shall consist of the following steps:

(1) Read and interpret the prescription of the prescriber;

(2) limit any filling or refilling of a prescription to one year from the date of origin, except as provided by K.S.A. 65-1637 and K.S.A. 65-4123, and amendments thereto;

(3) verify the compounding, counting, and measuring of ingredients and document the accuracy of the prescription;

(4) personally offer to counsel each patient or the patient's agent with each new prescription dispensed, once yearly on maintenance medications and, if the pharmacist deems appropriate, with prescription refills in accordance with subsection (e);

(5) ensure the proper selection of the prescription medications, devices, or suppliers as authorized by law; and

(6) interpret and verify patient medication records and perform drug regimen reviews.

(c) The pharmacist-in-charge shall prohibit all other pharmacy personnel from performing those judgmental functions restricted to the pharmacist. The following judgmental functions shall be performed only by a pharmacist and shall not be delegated:

(1) Final verification of the accuracy of a completed compound or prescription;

(2) documentation of the pharmacist's final verification in the pharmacy record; and

(3) direct supervision of a pharmacist intern or pharmacy technician.

(d) Any pharmacist may delegate nonjudgmental functions to a pharmacist intern or pharmacy technician. Each pharmacist shall conduct in-process and final checks associated with the preparation of medications, except as provided by K.A.R. 68-7-11.

(e) In order to comply with subsection (b), the pharmacist or the pharmacist intern under the pharmacist's direct supervision shall perform the following:

(1) Personally offer to counsel each patient or the patient's agent with each new prescription dispensed, once yearly on maintenance medications and, if the pharmacist deems appropriate, with prescription refills. Any pharmacist may authorize an exception to the verbal counseling requirement on a case-by-case basis for the continuation of therapy prescriptions issued more frequently than once yearly;

(2) provide the verbal counseling required by this regulation in person or by the utilization of a telephone or other communication service available to the patient or patient's agent if the prescription is not collected at the pharmacy;

(3) when appropriate, provide alternative forms of patient information to supplement verbal patient counseling. These supplemental forms of patient information may include written information, leaflets, pictogram labels, video programs, and auxiliary labels on the prescription vials. However, the supplemental forms of patient information shall not be used as a substitute for the verbal counseling required by this regulation;

(4) encourage proper patient drug utilization and medication administration. The pharmacist shall counsel the patient or patient's agent on those elements that, in the pharmacist's professional judgment, are significant for the patient. These elements may include the following:

(A) The name and a description of the prescribed medication or device;

(B) the dosage form, dosage, route of administration, and duration of therapy;

(D) common side effects, adverse effects or interactions, or therapeutic contraindications that could be encountered; the action required if these effects, interactions, or contraindications occur; and any activities or substances to be avoided while using the medication;

(E) techniques for self-monitoring drug therapy;

(F) proper storage requirements and disposal instructions; and

(G) action to be taken in the event of a missed dose; and

(5) expressly notify the patient or the patient's agent if a brand exchange has been exercised.

(f) Except as required by K.S.A. 65-16,127 and amendments thereto for the dispensing of an emergency opioid antagonist, nothing in this regulation shall be construed to require a pharmacist to provide the required patient counseling if either of the following occurs:

(1) The patient or the patient's agent refuses counseling.

(2) The pharmacist, based upon professional judgment, determines that the counseling could be detrimental to the patient's care.

(g) Each pharmacist shall make a reasonable effort to ensure that any prescription, regardless of the means of transmission, has been issued for a legitimate medical purpose by a prescriber.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2021 Supp. 65-1626 and 65-1637; effective, E-77-39, July 22, 1976; effective Feb. 15, 1977; amended May 1, 1978; amended May 1, 1988; amended Nov. 30, 1992; amended March 20, 1995; amended Aug. 14, 1998; amended Dec. 27, 1999; amended Feb. 7, 2003; amended Jan. 8, 2010; amended June 2, 2023.)

Kan. Admin. Regs. § 68-2-21 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1984 Supp. 65-1642; effective May 1, 1986; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-2-22 Electronic transmission of a prescription

(a) Each prescription drug order transmitted electronically shall be issued for a legitimate medical purpose by a prescriber acting within the course of legitimate professional practice.

(b) Each prescription drug order communicated by way of electronic transmission shall meet these requirements:

(1) Be transmitted to a pharmacist in a licensed pharmacy of the patient's choice, exactly as transmitted by the prescriber;

(2) identify 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 and state laws and regulations;

(3) be transmitted by an authorized prescriber or the prescriber's designated agent; and

(4) be deemed the original prescription drug order, if the order meets the requirements of this regulation.

(c) Any prescriber may authorize an agent to communicate a prescription drug order orally or electronically to a pharmacist in a licensed pharmacy if the identity of the transmitting agent is included in the order.

(d) Each pharmacist shall exercise professional judgment regarding the accuracy, validity, and authenticity of the prescription drug order communicated by way of electronic transmission, consistent with existing federal and state laws and regulations.

(e) All electronic equipment for receipt of prescription drug orders communicated by way of electronic transmission shall be maintained so as to ensure against unauthorized access.

(f) Persons other than those bound by a confidentiality agreement shall not have access to pharmacy records containing confidential information or personally identifiable information concerning the pharmacy's patients.

(g) If communicated by electronic transmission, the prescription drug order shall be maintained in hard copy or as an electronic document for the time required by existing federal or state laws and regulations, whichever is longer.

(h) Any prescription drug order, including that for any controlled substance listed in schedules II, III, IV, and V, may be communicated by way of electronic transmission, if all requirements of K.A.R. 68-20-10a are met.

(i) After the pharmacist views the prescription drug order, this order shall be immediately reduced to a hard copy or an electronic document and shall contain all information required by federal and state laws and regulations.

(j) Each electronic prescription drug order created and transmitted in conformance with 21 C.F.R. part 1311 shall be considered an original, written, signed prescription drug order.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 2014 Supp. 65-1642; implementing K.S.A. 2014 Supp. 65-1637b and K.S.A. 2014 Supp. 65-1642; effective Feb. 5, 1999; amended Dec. 27, 1999; amended June 2, 2006; amended Oct. 23, 2009; amended May 20, 2011; amended Feb. 13, 2015.)

Kan. Admin. Regs. § 68-2-23 Notification to board; disciplinary action

Each pharmacy owner shall notify the board in writing within 30 days of any denial, limitation, suspension, revocation, voluntary surrender, or other disciplinary action taken by the state of Kansas or another jurisdiction against the pharmacy or the pharmacy owner or any application, license, registration, or permit held by the pharmacy owner.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2017 Supp. 65-1627; effective Jan. 4, 2019.)

Kan. Admin. Regs. § 68-2-24 Pharmacy owner responsibilities

(a) Each pharmacy owner shall ensure that the pharmacy is operated in compliance with the Kansas pharmacy act, the state and federal uniform controlled substances act, the state and federal food, drug, and cosmetic act, the state prescription monitoring program act, and all applicable regulations.

(b) Each pharmacy owner shall ensure that all policies and procedures of the pharmacy are in compliance with the Kansas pharmacy act, the state and federal uniform controlled substances act, the state and federal food, drug, and cosmetic act, the state prescription monitoring program act, and all applicable regulations.

(c) Each pharmacy owner shall not prohibit or prevent a pharmacist, pharmacist intern, or pharmacy technician from complying with the Kansas pharmacy act, the state and federal uniform controlled substances act, the state and federal food, drug, and cosmetic act, the state prescription monitoring program act, and all applicable regulations.

(d) Each pharmacy owner shall not penalize, prohibit, or prevent a pharmacist from conducting an in-person inspection of a prescription, drug or device, or product verification.

(e) Each pharmacy owner shall not permit an individual to be in the pharmacy that has had a license or registration denied, revoked, or suspended by the board, unless the licensee or registrant has subsequently been issued an active license or registration by the board.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 2022 Supp. 65-1643; implementing K.S.A. 2022 Supp. 65-1626, K.S.A. 2022 Supp. 65-1627, K.S.A. 65-1642, K.S.A. 2022 Supp. 65-1643, K.S.A. 65-1648, K.S.A. 65-1663, and K.S.A. 65-1676; effective Oct. 27, 2023.)

Kan. Admin. Regs. § 68-2-25 Minimum requirements of a prescription for a non-controlled substance

(a) Each pharmacist shall ensure the following requirements are met before dispensing each prescription for a non-controlled substance. The prescription shall:

(1) Contain, at a minimum, the following information:

(A) date the prescription is issued;

(B) name of the prescriber;

(D) first and last name of the patient;

(E) drug name;

(F) quantity prescribed;

(G) directions for use;

(H) first and last name of the agent of the prescriber if the prescription is transmitted by a person other than the prescriber; and

(2) Contain the name or initials of the pharmacist, or pharmacist intern, receiving the prescription if the prescription is received verbally.

(b) The pharmacist shall document any additions, changes, corrections, or updates made to the prescription on the prescription or in the prescription record as a result of any:

(1) Consultation with the prescriber or the prescriber's agent; or

(2) adaptation as authorized by K.S.A. 65-1637(g)(3) and amendments thereto.

(c) All records and documentation required by this regulation shall be maintained and readily retrievable for a period of five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-1656; implementing K.S.A. 65-1637, K.S.A. 65-1637d, K.S.A. 65-1642, and K.S.A. 65-1657; effective Aug. 16, 2024.)

Article 3 Retail Dealer's Permit

Kan. Admin. Regs. § 68-3-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-3-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1978.)

Kan. Admin. Regs. § 68-3-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-3-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-3-5 Retail dealer permit required

A retail dealer may engage in the selling in Kansas of nonprescription drugs that are prepackaged, fully prepared by the manufacturer or distributor for use by the consumer, and labeled in accordance with the requirements of the state and federal food, drug, and cosmetic acts only if the retail dealer has obtained a permit to do so from the board.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1998 Supp. 65-1643; effective Sept. 24, 1999.)

Kan. Admin. Regs. § 68-3-6 Minimum required information for permit

(a) Each retail dealer shall provide the board with the following minimum information as part of the application for the permit required by K.S.A. 65-1643(f), and amendments thereto, and as part of any renewal of this permit:

(1) The name, full business address, and telephone number of the permit holder;

(2) each trade or business name used by the permit holder; and

(3) the address, telephone number, and name of the contact person for each facility used by the permit holder for the storage, handling, and distribution of drugs.

(b) Each permit holder shall submit all revised information required by subsection (a) within 30 days after any change in that information.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1998 Supp. 65-1643; effective Sept. 24, 1999.)

Article 4 Manufacturers (not in active use)

Kan. Admin. Regs. § 68-4-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-4-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-4-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-4-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-4-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1986.)

Article 5 General Rules

Kan. Admin. Regs. § 68-5-1 Definitions

The following words and phrases as used throughout these rules and regulations shall have the meanings specified below, unless otherwise indicated by the context of the specific regulation.

(a) Beyond-use date. The term "beyond-use date" means a date placed on a prescription label at the time of dispensing, repackaging, or prepackaging that is intended to indicate to the patient or caregiver a time beyond which the contents of the prescription are not recommended to be used.

(b) Intern. The word "intern" means an individual who is a prospective candidate for examination as a licensed pharmacist and who is qualified to receive and is obtaining pharmaceutical experience as set forth in the pharmacy act of the state of Kansas and its rules and regulations.

(c) Medication order. The term "medication order" means an order by a prescriber for a registered patient of a Kansas licensed medical care facility.

(d) Prescriber. The word "prescriber" means a person who is authorized to issue a prescription order.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630; effective Jan. 1, 1966; amended Jan. 1, 1967; amended Jan. 1, 1968; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1988; amended April 28, 2000.)

Kan. Admin. Regs. § 68-5-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1980.)

Kan. Admin. Regs. § 68-5-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-6 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-5-7 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-8 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-9 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1986.)

Kan. Admin. Regs. § 68-5-10 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; amended Jan. 1, 1968; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-5-11 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; revoked April 10, 1989.)

Kan. Admin. Regs. § 68-5-12 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-13 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1966; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-5-14 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-1630; effective Jan. 1, 1966; amended, E-76-31, Aug. 11, 1975; amended May 1, 1976; amended May 1, 1978; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-5-15 Training of pharmacy technicians

(a) The pharmacist-in-charge of any pharmacy in which one or more pharmacy technicians peform any tasks authorized by the pharmacy act shall insure that each pharmacy technician complies with the training requirements in this regulation.

(b) The pharmacist-in-charge of any pharmacy in which one or more pharmacy technicians perform any tasks authorized by the pharmacy act shall insure that there exists for the pharmacy a current pharmacy technician training course, designed for the functioning of that pharmacy and addressing at least the following:

(1) Knowledge and understanding of the different pharmacy practice settings;

(2) knowledge and understanding of the duties and responsibilities of a pharmacy technician in relationship to other pharmacy personnel and knowledge of standards, ethics, laws, and regulations governing the practice of pharmacy;

(3) knowledge and ability to identify and employ pharmaceutical and medical terms, abbreviations, and symbols commonly used in prescribing and dispensing drugs and in record keeping;

(4) knowledge of and the ability to carry out calculations required for common dosage determinations;

(5) knowledge and understanding of the identification of drugs, drug dosages, routes of administration, dosage forms, storage requirements, and manufacturer recalls;

(6) knowledge of and the ability to perform the manipulative and record-keeping functions involved in and related to dispensing prescriptions or other drug distribution systems; and

(7) knowledge of and the ability to perform procedures and techniques, including aseptic techniques, relating to the compounding, packaging, and labeling of drugs.

(c) The pharmacist-in-charge of any pharmacy shall permit a pharmacy technician to perform tasks authorized by the pharmacy act only if the pharmacy technician has successfully completed, within 180 days of the effective date of this regulation or the effective date of the technician's employment in the pharmacy, whichever is later, a training course that meets the requirements of subsection (b) and was designed for the pharmacy in which the tasks are performed.

(d) The pharmacist-in-charge of any pharmacy in which one or more pharmacy technicians perform any tasks authorized by the pharmacy act shall also insure that the following requirements are met:

(1) There is an annual review of the pharmacy technician training course developed for the pharmacy.

(2) Adequate records are maintained documenting the training of each pharmacy technician as required by this regulation. These records shall be maintained at the pharmacy in a manner available for inspection by a board representative.

(3) The board is notified, within 30 days of the effective date of this regulation or the effective date of the employment of a pharmacy technician, of the following:

(i) The full name and current residence address of pharmacy technicians working in a pharmacy for which the pharmacist-in-charge has responsibility;

(ii) the date on which the pharmacy technician began the pharmacy technician training course or courses designed for the pharmacy or pharmacies in which the pharmacy technician is working; and

(iii) the name and address of the pharmacy or pharmacies in which the pharmacy technician is working.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 1998 Supp. 65-1642; implementing K.S.A. 1998 Supp. 65-1642; effective July 23, 1999.)

Kan. Admin. Regs. § 68-5-16 Ratio of pharmacy technicians to pharmacists

The ratio of pharmacy technicians to pharmacists in any pharmacy shall not exceed four to one. A pharmacist shall not supervise at any time more than two pharmacy technicians who have not passed a certification examination approved by the board pursuant to K.A.R. 68-5-17.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1663; effective, T-68-8-22-05, Aug. 22, 2005; effective May 26, 2006; amended April 27, 2007; amended Feb. 7, 2020.)

Kan. Admin. Regs. § 68-5-17 Pharmacy technicians; certification examination; request for extension

The following requirements shall apply to each individual who applies for a new pharmacy technician registration on or after July 1, 2017:

(a) Each pharmacy technician shall be required to pass either the pharmacy technician certification board (PTCB) certification examination or the national healthcareer association (NHA) ExCPT certification examination before the first renewal of the pharmacy technician's registration.

(1) Each pharmacy technician shall be required to attain a scaled score of at least 1400 on the PTCB certification examination in order to pass.

(2) Each pharmacy technician shall be required to attain a score of at least 390 on the NHA ExCPT certification examination in order to pass.

(b) Any pharmacy technician who is unable to take or pass an approved certification examination before the first renewal of the pharmacy technician's registration may submit to the board, on a form provided by the board, a request for a six-month extension to pass an approved certification examination. The request shall be submitted to the board before the pharmacy technician's registration expiration date.

(c) Within 30 days after passing an approved certification examination or before the first renewal, whichever is earlier, each pharmacy technician shall submit to the board proof of successful completion of the examination.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1663 and K.S.A. 65-1692; implementing K.S.A. 65-1663; effective May 11, 2018; amended Jan. 30, 2026.)

Kan. Admin. Regs. § 68-5-18 Pharmacy technicians; continuing education

(a)(1) "Continuing education" shall mean an organized and systematic education experience beyond basic preparation that is designed to achieve the following:

(A)(i) Increase knowledge, improve skills, or enhance the practice of pharmacy; or

(ii) improve protection of the public health and welfare; and

(B) ensure continued competence.

(b) Twenty clock-hours of continuing education shall be required for renewal of a pharmacy technician registration during each registration period. Continuing education clock-hours may be prorated for registration periods that are less than biennial at a rate of 0.8 clock-hours per month.

(c)(1) Each continuing education program shall be approved by the board. Each provider or registrant shall submit the continuing education program to the board at least 10 days in advance for consideration for approval. Each provider shall advertise the continuing education program as having only pending approval until the provider is notified of approval by the board.

(3) Each provider shall furnish a certificate of completion to the pharmacy technician for each continuing education program that the registrant has successfully completed. Each certificate shall be in a format approved by the board and shall include the following:

(A) The registrant's name;

(B) the title and date of the approved continuing education program;

(D) the number of continuing education clock-hours approved by the board;

(E) the number of continuing education clock-hours completed by the registrant;

(F) the approved program number issued by the board; and

(G) the provider's dated signature, certifying program completion.

(d) Within 30 days of completion, each pharmacy technician shall submit to the board proof of completion of any approved continuing education program not reported to the ACPE-NABP CPE monitor service. No credit shall be given for any certificate of completion received by the board after the October 31 expiration date of each registration period.

(e) A licensee shall not be allowed to carry forward excess clock-hours earned in one registration period into the next registration period.

(f) The required continuing education shall be obtained in the two-year registration period ending on the October 31 expiration date of each registration.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 2015 Supp. 65-1663; implementing K.S.A. 2015 Supp. 65-1663; effective Aug. 19, 2016.)

Article 6 Poisons; Additions and Deletions to Statutory List (not in active use)

Kan. Admin. Regs. § 68-6-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-1638; effective Jan. 1, 1966; revoked May 1, 1978.)

Kan. Admin. Regs. § 68-6-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1638; effective Jan. 1, 1966; revoked May 1, 1980.)

Article 7 Miscellaneous Provisions

Kan. Admin. Regs. § 68-7-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1968; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-7-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1968; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-7-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1968; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-7-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1968; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-7-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1968; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-7-6 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1975 Supp. 65-1630; effective Jan. 1, 1968; revoked, E-76-31, Aug. 11, 1975; revoked May 1, 1976.)

Kan. Admin. Regs. § 68-7-7 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-1630; effective, E-76-31, Aug. 11, 1975; effective May 1, 1976; revoked May 1, 1978.)

Kan. Admin. Regs. § 68-7-8 Records

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) "Digital image" means the electronic record produced when a hard-copy prescription is scanned by a computer and converted from human-readable format to a computer-readable digital format and maintained as part of the prescription record in a pharmacy prescription application.

(2) "Electronic annotation" means a method to mark up a digital image or electronic prescription to allow both notes and clarifications to be added to the prescription record without altering the original digital image.

(b) Each pharmacy owner and pharmacist-in-charge shall keep a book or file that records every prescription order filled at the pharmacy.

(c)(1) A digital image of the prescription may constitute the original prescription order. A hard copy of the prescription order shall not be required to be maintained if all of the following conditions are met:

(A) The prescription is not for a controlled substance.

(B) The pharmacy prescription application can capture and store an exact and legible image of the original prescription.

(C) The digital image includes the front and back of the prescription and retains all colors and graphics on the prescription.

(D) The digital image is unalterable.

(E) The digital image and all electronic annotations are readily retrievable and can be immediately reproduced by the pharmacy prescription application in electronically viewable and paper formats. In lieu of reproducing the digital image in a color paper format, the digital image may be provided in color in an electronic portable document format (PDF).

(F) Policies and procedures for the use of digital images are developed and implemented to include capturing, making, storing, retrieving, and recovering digital images and electronic annotations, and destruction of the original hard-copy prescription.

(G) The pharmacy maintains a back-up copy of the digital image and all electronic annotations stored in the pharmacy prescription application and updates the back-up copy at least once every seven days.

(H) A secure destruction method is used to dispose of the hard-copy prescription to ensure privacy and confidentiality.

(2) If the pharmacy prescription application data is automatically entered by a prescription order received by electronic transmission, the automated record shall constitute the original prescription order and a hard copy shall not be required if all of the following conditions are met:

(A) The electronic prescription and its means of transmission meet all requirements of the pharmacy act of the state of Kansas and the state and federal controlled substance acts, and amendments thereto.

(B) The pharmacy prescription application can capture and store all prescription information received.

(C) The prescription information is readily retrievable, and the pharmacy prescription application can immediately reproduce all prescription information received in both electronically viewable and paper formats.

(D) The pharmacy maintains a back-up copy of the electronic prescription record and all electronic annotations stored in the pharmacy prescription application and updates the back-up copy at least once every seven days.

(3) Nothing in paragraph (c)(1) shall be construed as requiring a pharmacy to maintain a digital image in lieu of hard-copy prescription.

(d) Any digital image may contain electronic annotations if the original image is still available for review and the name of the individual who made the annotations is documented.

(e) The pharmacist shall ensure that each printout of a digital image provided to a patient or the patient's representative is conspicuously marked "Copy Only" or "Not Valid for Dispensing Purposes."

(f) Each pharmacy owner shall establish policies and procedures in accordance with this regulation and shall ensure that all policies and procedures comply with the pharmacy act of the state of Kansas, and amendments thereto, and the implementing regulations. Each pharmacist-in-charge shall document an annual review of the policies and procedures for compliance with the pharmacy act, and amendments thereto, and the implementing regulations.

(g) Each of the following individuals shall be responsible for ensuring that each digital image is a complete, accurate, and legible representation of the corresponding hard-copy prescription:

(1) The pharmacist, pharmacist intern, or pharmacy technician who generates the digital image;

(2) the pharmacist, pharmacist intern, or pharmacy technician who enters the prescription information into the pharmacy prescription application; and

(3) the pharmacist who verifies the prescription.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1626a, as amended by L. 2022, ch. 74, sec. 2, K.S.A. 2021 Supp. 65-1637, K.S.A. 65-1642, and K.S.A. 2021 Supp. 65-1656; effective, E-76-31, Aug. 11, 1975; effective May 1, 1976; amended June 2, 2023.)

Kan. Admin. Regs. § 68-7-9 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 74-1606; effective, E-76-31, Aug. 11, 1975; effective May 1, 1976; amended May 1, 1978; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-7-10 Emergency medication kits in long-term care facilities

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) "Automated drug delivery system" means an automated dispensing system, as defined by K.S.A. 2023 Supp. 65-1626, and amendments thereto, that is located in a long-term care facility, uses a robotic, mechanical, or computerized device to supply each drug to an individual licensed by the board of healing arts or the board of nursing, who shall administer the drug to a patient, and meets the requirements of K.A.R. 68-9-3.

(2) "E-kit" means an emergency medication kit.

(3) "Recognized technician" means a pharmacy technician who has passed a certification examination approved by the board in accordance with K.A.R. 68-5-17.

(b) Each pharmacist providing consulting services for a long-term care facility shall ensure that each e-kit contains only the drugs that are generally regarded by practitioners as essential to the prompt treatment of sudden and unforeseen changes in a patient's condition that present an imminent threat to the patient's life or well-being. Each pharmacy that supplies an e-kit to a long-term care facility shall have a written agreement that states:

(1) Drugs in the e-kit shall be used for administration in emergency situations and not for routine care.

(2) The e-kit contents shall only be administered by authorized personnel acting on the order of a prescriber which includes compliance with 21 C.F.R. 1306.11 and 21 C.F.R. 1306.21 for controlled substances.

(c) Each pharmacist providing consulting services for the long-term care facility shall ensure that the long-term care facility has policies and procedures that meet the following requirements:

(1) Each pharmacy supplying an e-kit shall retain ownership of each drug until it is administered to the patient pursuant to the order of a prescriber.

(2) If the e-kit is not in an automated drug delivery system,

(A) The e-kit shall be locked or sealed in a manner that indicates when the e-kit has been opened or tampered with; and

(B) within 96 hours after the e-kit has been opened, a pharmacist or a recognized technician shall audit each drug in the e-kit.

(3) If the e-kit is in an automated drug delivery system, the pharmacy shall audit the e-kit at least once every month.

(4) The e-kit shall be securely locked in a sufficiently well-constructed cabinet, closet, or cart according to the pharmacist-in-charge's professional judgment or in an automated drug delivery system, with drugs properly stored according to the manufacturer's recommendations.

(5) Each nurse identified by the pharmaceutical services committee, or its equivalent, may access the e-kit in accordance with a prescriber's order.

(d) Each automated drug delivery system shall be registered and operated by a pharmacy located in Kansas.

(e) The pharmacist-in-charge or owner shall ensure the following e-kit requirements are met:

(1) The e-kit shall have an expiration date equivalent to the earliest expiration date of any drugs within the kit.

(2) At least once every six months, the pharmacist-in-charge or a pharmacist or recognized technician designated by the pharmacist-in-charge shall conduct an audit of each drug placed in the e-kit. Documentation of the audit shall be maintained in a readily retrievable format for a period of at least five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2024 Supp. 65-1637, K.S.A. 65-1642, and K.S.A. 65-1648; effective May 1, 1978; amended May 1, 1983; amended Sept. 9, 1991; amended Aug. 19, 2016; amended Jan. 4, 2019; amended Aug. 29, 2025.)

Kan. Admin. Regs. § 68-7-10a Pharmacy based drug dispensing systems in a facility

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) "Facility" means any of the following:

(A) Crisis intervention centers, as defined in K.S.A. 39-2002, and amendments thereto;

(B) Long-term care facility, as defined in K.A.R. 68-9-3; and

(2) "Out-of-house pharmacy" means a pharmacy providing services to a facility at a different location.

(b) Each out-of-house pharmacy shall create and implement policies and procedures for dispensing drugs to the residents of a facility.

(1) Provided within a time period that meets the needs of the patient, considering the following factors:

(A) the need for the drug as an emergency;

(B) the availability of the drug; and

(2) delivered safely to a designee of the facility;

(3) packaged in a unit-dose container or blister package unless the drug manufacturer specifies a different type of packaging. The packaging shall meet the requirements of K.A.R. 68-7-15 and 68-7-16; and

(4) filled or refilled pursuant to the original prescription or medication order, or a copy thereof.

(A) Each medication order shall expire either pursuant to the facility's stop order policy, pursuant to the prescriber's order, or after one year, whichever is less.

(B) Each medication order received from the facility shall be dispensed as a prescription order and shall meet the requirements of subsections (a)(1)(A) through (a)(1)(E), (a)(1)(G), and (a)(1)(H) of K.A.R. 68-2-25, except as outlined in subsection (c)(4)(C).

(d) No out-of-house pharmacy providing services to a facility shall package medication for another pharmacy unless shared services are utilized.

(e) No out-of-house pharmacy shall change the packaging of a medication dispensed by another pharmacy.

(f) Dispensed controlled substances shall not be returned to the pharmacy.

(g) Dispensed drugs returned to the pharmacy shall not be redispensed if the drugs were removed from the packaging at the facility or comingled with other drugs.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2024 Supp. 65-1637 and K.S.A. 65-1642; effective Aug. 29, 2025.)

Kan. Admin. Regs. § 68-7-11 Medical care facility pharmacy

The scope of pharmaceutical services within a medical care facility pharmacy shall meet the following requirements:

(a) The pharmacist-in-charge shall be responsible for developing programs and supervising all personnel in the distribution and control of drugs and all pharmaceutical services in the medical care facility.

(b) The pharmacist-in-charge shall develop a policy and procedure manual governing the storage, control, and distribution of drugs within the medical care facility. The pharmacist-in-charge shall submit the policy and procedure manual for approval to the pharmacy and therapeutics committee or an equivalent committee governing the security, control, and distribution of drugs within the facility.

(d) The pharmacist-in-charge shall be responsible for developing procedures for the distribution and control of drugs within the medical care facility when a pharmacist is not on the premises. These procedures shall be consistent with the following requirements:

(1) Drugs may be obtained upon a prescriber's medication order for administration to the inpatient by a physician's assistant, designated registered professional nurse, or nurses with approval and supervision of the pharmacist-in-charge. Adequate records of these withdrawals shall be maintained.

(2)(A) An interim supply of prepackaged drugs shall be supplied to an outpatient on an emergency basis only by a designated registered professional nurse or nurses pursuant to a prescriber's medication order when a pharmacist is not on the premises and a prescription cannot be filled. The interim supply shall be labeled in accordance with K.A.R. 68-7-14.

(B) The interim supply shall be limited in quantity to an amount sufficient to supply the outpatient's needs until a prescription can be filled. Adequate records of the distribution of the interim supply shall be maintained and shall include the following information:

(i) The original or a copy of the prescriber's order or, if an oral order, a written record prepared by a designated registered professional nurse or nurses that reduces the oral order to writing. The written record shall be signed by the designated registered professional nurse or nurses and the prescriber; and

(ii) the name of the patient; the date supplied; the drug or device, strength, and quantity distributed; directions for use; the prescriber's name; and, if appropriate, the DEA number.

(3) The designated registered professional nurse or physician's assistant may enter the medical care facility pharmacy and remove properly labeled pharmacy stock containers, commercially labeled packages, or properly labeled prepackaged units of drugs. The registered professional nurse or physician's assistant shall not transfer a drug from one container to another for future use, but may transfer a single dose from a stock container for immediate administration to the ultimate user.

(e) The pharmacist-in-charge of the medical care facility pharmacy shall maintain documentation of at least quarterly checks of drug records and conditions of drug storage, in all locations within the facility, including nursing stations, emergency rooms, outpatient departments, and operating suites.

(f) The pharmacist-in-charge shall participate with the pharmacy and therapeutics committee or an equivalent committee in formulating broad professional policies regarding the evaluation, appraisal, selection, procurement, storage, distribution, use, and safety procedures for drugs within the medical care facility.

(g) The pharmacist-in-charge shall be responsible for establishing policies and procedures for the mixing or preparation of parenteral admixtures. Whenever drugs are added to intravenous solutions, distinctive supplemental labels shall be affixed that indicate the name and amount of the drug added, the date and the time of addition, the beyond-use date, storage instructions, and the name or initials of the person who prepared the admixture. The pharmacist-in-charge shall comply with all requirements of article 13 of the board's regulations. Before the parenteral admixture is released from the pharmacy, the pharmacist shall verify the accuracy of all parenteral admixtures prepared by pharmacy technicians.

(h) The pharmacist shall interpret the prescriber's original order, or a direct copy of it, before the drug is distributed and shall verify that the medication order is filled in strict conformity with the direction of the prescriber. This requirement shall not preclude orders transmitted by the prescriber through electronic transmission. Variations in this procedure with "after-the-fact" review of the prescriber's original order shall be consistent with medical care facility procedures established by the pharmacist-in-charge. Each medication order shall be reviewed by a pharmacist within three days of the date it was written.

(i)(1) When a pharmacist is on the premises but not in the pharmacy, a pharmacy technician may be in the pharmacy. A pharmacy technician shall not distribute any drug or device out of the pharmacy when a pharmacist is not physically in the pharmacy unless authorized by the pharmacist.

(2) When a pharmacist is not on the premises, no one shall be permitted in the pharmacy except the designated registered professional nurse or nurses or a physician's assistant.

(j) Except with regard to drugs that have not been checked for accuracy by a pharmacist after having been repackaged, prepackaged, or compounded in a medical care facility pharmacy, a pharmacy technician in a medical care facility may check the work of another pharmacy technician in filled floor stock, a crash cart tray, a unit-dose cart, or an automated dispensing machine if the checking pharmacy technician meets each of the following requirements:

(1) Has passed a certification examination approved by the board;

(2) has either of the following experience levels:

(A) One year of experience working as a pharmacy technician plus at least six months of experience working as a pharmacy technician in the medical care facility at which the checking will be performed; or

(B) one year of experience working as a pharmacy technician in the medical care facility at which the checking will be performed; and

(3) has successfully completed a written training program and related examination designed by the pharmacist-in-charge of the medical care facility pharmacy to demonstrate competency in accurately checking whether floor stock, a crash cart tray, and an automated dispensing machine have been properly filled.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2022 Supp. 65-1626, K.S.A. 65-1642, and K.S.A. 65-1648; effective, E-77-39, July 22, 1976; effective Feb. 15, 1977; amended May 1, 1978; amended May 1, 1988; amended May 1, 1989; amended Dec. 27, 1999; amended April 28, 2000; amended July 20, 2007; amended July 16, 2010; amended June 2, 2023.)

Kan. Admin. Regs. § 68-7-12 Responsibility of pharmacist-in-charge in other than a medical care facility pharmacy

Each pharmacist-in-charge for premises having a pharmacy registration, other than a medical care facility pharmacy, shall be responsible for the following functions:

(a) Each pharmacist-in-charge shall develop or approve written policies and procedures for the pharmacy that meet the following conditions:

(1) Provide adequate accountability and control of drugs in compliance with the Kansas pharmacy act, the state and federal uniform controlled substances act, and the state and federal food, drug, and cosmetic act; and

(2) ensure that any incident that occurs as a result of an alleged or real error in filling or dispensing a prescription or medication order is brought to the attention of the pharmacist-in-charge and completely documented in accordance with K.A.R. 68-7-12b.

(b) Each pharmacist-in-charge shall develop written procedures for maintaining records of the pharmacy's dispensing, prepackaging, and bulk compounding actions and shall ensure that prepackaged medication is packaged in suitable containers and properly labeled.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2022 Supp. 65-1626 and 65-1637; effective, E-77-39, July 22, 1976; effective Feb. 15, 1977; amended May 1, 1978; amended May 1, 1989; amended Nov. 30, 1992; amended Feb. 27, 1998; amended Dec. 27, 1999; amended Feb. 7, 2003; amended July 20, 2007; amended June 2, 2023.)

Kan. Admin. Regs. § 68-7-12a Nonresident pharmacies

Each nonresident pharmacy shall meet the requirements of this regulation to be and remain registered in Kansas by the board.

(a)(1) Each pharmacy shall be currently licensed or registered in good standing in the state in which it is located.

(2) Each practicing pharmacist employed by or under contract with the pharmacy shall be licensed as a pharmacist in the state where the pharmacist practices.

(3) Each pharmacy shall provide and maintain, in readily retrievable form, the record of a satisfactory inspection conducted within the previous 18-month period by the licensing entity of the state where the pharmacy is located. If no such inspection record is readily available, the record of a satisfactory inspection conducted at the expense of the pharmacy within the previous 18-month period by a third party recognized by the board to inspect may be accepted.

(4) Each pharmacy shall designate a pharmacist-in-charge, as defined by K.S.A. 65-1626 and amendments thereto, who shall be named in the application and who shall be responsible for receiving communications from the board.

(A) The pharmacist-in-charge shall timely respond to any lawful request for information from the board or law enforcement authorities.

(B) The pharmacist-in-charge shall be responsible for receiving and maintaining publications distributed by the board.

(b) The owner or the owner's authorized representative of the nonresident pharmacy shall apply for registration and renewal on forms approved by the board. The information reasonably necessary to carry out the provisions of K.S.A. 65-1657 and amendments thereto, including the name, address, and position of each officer and director of a corporation or of the owners if the pharmacy is not a corporation, shall be required by the board.

(c) An exemption for registration may be granted by the board under K.S.A. 65-1657 and amendments thereto, upon application by any nonresident pharmacy that confines its dispensing activity to isolated transactions. The following shall be considered to determine whether to grant an exemption:

(1) The number of prescriptions dispensed or reasonably expected to be dispensed into Kansas;

(2) the number of patients served or reasonably expected to be served in Kansas;

(3) any efforts to promote the pharmacy's services in Kansas;

(4) any contract between the pharmacy and either an employer or organization to provide pharmacy services to employees or other beneficiaries in Kansas;

(5) medical necessity;

(6) the effect on the health and welfare of persons in Kansas; and

(7) any other relevant matters.

(d) The pharmacy owner shall pay an annual registration fee as specified in K.A.R. 68-11-2.

(e) The pharmacy records of drugs dispensed to Kansas addresses shall be maintained so that the records are readily retrievable upon request. These records shall be made available for inspection by the board or by Kansas law enforcement authorities upon request.

(f) The pharmacy shall maintain an incoming toll-free telephone number for use by Kansas customers to facilitate personal communication with a pharmacist with access to patient records.

(1) This service shall be available during normal business hours for at least 40 hours and six days per week.

(2) This telephone number and any others available for use shall be printed on each container of drugs dispensed in Kansas.

(3) The toll-free number shall have a sufficient number of extensions to provide reasonable access to incoming callers.

(g) Generic drugs shall be dispensed into Kansas only pursuant to K.S.A. 65-1637, and amendments thereto.

(h) The facilities and records of the pharmacy shall be subject to inspection by the board. Satisfactory inspections conducted within the previous 18-month period by the licensing entity of the state where the pharmacy is located or a third party recognized by the board to inspect may be accepted in lieu of inspection by the board.

(i) Each owner or owner's authorized representative of the nonresident pharmacy either doing business in Kansas or providing pharmacy services, dispensing, or either delivering or causing to be delivered prescription drugs to Kansas consumers shall designate a resident agent in Kansas for service of process and file this information with the secretary of state.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2016 Supp. 65-1657; effective March 29, 1993; amended March 20, 1995; amended Feb. 7, 2003; amended Jan. 12, 2018.)

Kan. Admin. Regs. § 68-7-12b Incident reports

(a) For purposes of this regulation, "reportable incident" and "incident" shall mean a preventable medication error involving a prescription drug and resulting in any of the following:

(1) The patient receiving the wrong drug;

(2) the patient receiving an incorrect drug strength;

(3) the patient receiving an incorrect dosage form;

(4) the drug being received by the wrong patient;

(5) inadequate or incorrect packaging, labeling, or directions; or

(6) the dispensing of a drug to a patient in a situation that results in or has the potential to result in serious harm to the patient.

(b) For each pharmacy other than a medical care pharmacy, the pharmacist-in-charge shall ensure that procedures exist requiring each pharmacist who becomes aware of a reportable incident to report the incident to the pharmacist-in-charge as soon as practical.

(c) As soon as possible after discovery of the incident, the pharmacist shall prepare a report containing the following information:

(1) The name, address, age, and phone number of any complainant, if available;

(2) the name of each pharmacy employee and the license number of each licensee involved;

(3) the date of the incident and the date of the report;

(4) the pharmacist's description of the incident;

(5) the prescriber's name and whether or not the prescriber was contacted; and

(6) the signatures of all pharmacy employees involved in the incident.

For each pharmacy, the pharmacist-in-charge shall ensure that procedures exist requiring that the incident report be maintained in the pharmacy for at least five years in a manner so that the report can be provided to the board or its representative within three business days, upon request.

(d) The preparation of an incident report that meets the requirements of this regulation shall be the responsibility of each pharmacist involved in the incident and the pharmacist-in-charge. The maintenance of incident reports as required by this regulation shall be the responsibility of the pharmacist-in-charge.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2007 Supp. 65-1626 and K.S.A. 2007 Supp. 65-1626d; effective Feb. 7, 2003; amended Oct. 24, 2008.)

Kan. Admin. Regs. § 68-7-13 Pharmacist in charge of more than one location

No pharmacist shall be a pharmacist in charge of more than one full-time pharmacy operation, which is defined as being one where the on-premises pharmacist services total 30 hours or more weekly.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630; effective, E-77-39, July 22, 1976; effective Feb. 15, 1977; amended May 1, 1988.)

Kan. Admin. Regs. § 68-7-14 Prescription labels.

Kansas Administrative Regulations

State Board of Pharmacy

Article 7.—Miscellaneous Provisions

68-7-14. Prescription labels.

(a) The label of each drug or device shall be typed or machine-printed and shall include the following information:

(1) The name, address, and telephone number of the pharmacy or registered facility dispensing the prescription;

(2) the name of the prescriber;

(3) the full name of the patient;

(4) the identification number assigned to the prescription by the dispensing pharmacy or registered facility;

(5) the date the prescription was filled or refilled, whichever is most recent;

(6) adequate directions for use of the drug or device;

(7) the beyond-use date of the drug or device dispensed. If the drug is removed from the original manufacturer’s packaging, the beyond-use date shall not exceed:

(A) one year from the date of dispensing;

(B) the manufacturer’s expiration date; or

whichever is less.

(8) the name of the drug or device dispensed;

(9) if a generic drug or device is dispensed, the name of the manufacturer or an easily identified abbreviation of the manufacturer's name;

(10) the strength of the drug;

(11) the contents in terms of weight, measure, or numerical count; and

(12) necessary auxiliary labels and storage instructions, if needed.

(b) A registered facility shall be permitted to label or relabel only those drugs or devices originally dispensed from the registered facility’s location.

(Authorized by K.S.A. 65-1630; implementing K.S.A. 2025 Supp. 65-1626a; effective,

E-77-39, July 22, 1976; effective Feb. 15, 1977; amended May 1, 1978; amended May 1, 1980; amended May 1, 1988; amended June 6, 1994; amended March 20, 1995; amended April 28, 2000; amended Oct. 23, 2009; amended Aug. 14, 2026.)

***** Authenticated Kansas Administrative Regulation *****

Kan. Admin. Regs. § 68-7-15 Packaging of drugs or devices in advance of immediate need

All drugs or devices, whether in a unit-dose container or multiple-dose container, packaged in advance of immediate need shall meet the requirements of this regulation.

(a) Packaging shall be done by a pharmacist or under the pharmacist's direct supervision. The pharmacist shall verify and document verification of the packaged drugs or devices before the packaged drugs or devices are released from a facility registered with the board.

(b) Packaging shall be limited to the drugs or devices dispensed from or supplied by the facility registered with the board or in accordance with a shared services agreement.

(c) All containers used for packaging shall preserve the stability and integrity of the drug or device. The storage conditions of each packaged drug or device shall be maintained according to the manufacturer's recommendations to preserve the stability and integrity of the drug. The beyond-use date assigned to each packaged drug or device shall be the manufacturer's expiration date, the maximum allowable beyond-use date for the type of packaging material used, or not more than 12 months from the date of packaging, whichever is earlier.

(d) An electronic or a written record shall be established for lot numbers for recall purposes and shall be kept readily retrievable in the facility registered with the board.

(e) If an area apart or separated from the prescription drug area is used for packaging, the area shall be enclosed and locked when a pharmacist is not in attendance in that area.

(f) In lieu of separately dispensing a drug and an ingestible event marker approved by the food and drug administration to monitor whether a patient is taking the drug as prescribed, any pharmacist may use an ingestible event medication adherence package pursuant to a valid prescription order or after obtaining the consent of the practitioner, caregiver, or patient.

(g) For purposes of this regulation, "ingestible event medication adherence package" shall mean an ingestible unit-dose package designed to ensure medication adherence that contains drugs from a manufacturer's original container and an ingestible event marker, as defined by 21 C.F.R. 880.6305, effective February 1, 2022 and hereby adopted by reference.

(h) In addition to meeting the requirements of this regulation, all packaging of sterile preparations shall meet the requirements of K.A.R. 68-13-4.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2022 Supp. 65-1626a and K.S.A. 65-1634; effective May 1, 1978; amended Dec. 15, 2017; amended Nov. 29, 2019; amended June 2, 2023.)

Kan. Admin. Regs. § 68-7-16 Labels for drugs or devices packaged in advance of immediate need

(a) Except as specified in subsection (b), each label for a drug or device packaged in advance of immediate need shall contain the following:

(1) The generic name of the drug or device and the manufacturer's name. If the packaged drug or device bears a brand name, the brand name may be substituted for the generic name of the drug or device;

(2) the strength and quantity of the drug or device;

(3) the lot number, date of packaging, and the name of the individual responsible for packaging;

(4) the beyond-use date; and

(5) necessary auxiliary labels.

(b) If the owner of a facility registered with the board maintains a record system that includes the manufacturer's name, lot numbers, date of packaging, and the name of the individual responsible for packaging the drug or device, this information may be deleted from the label.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2022 Supp. 65-1626a and K.S.A. 65-1634; effective May 1, 1978; amended June 2, 2023.)

Kan. Admin. Regs. § 68-7-17 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-1630; effective Feb. 15, 1977; revoked May 1, 1978.)

Kan. Admin. Regs. § 68-7-18 Health departments, private not-for-profit family planning clinics, federally qualified health centers, and indigent healthcare clinics

The supply and control of drugs provided by health departments, private not-for-profit family planning clinics, federally qualified health centers, and indigent healthcare clinics authorized under K.S.A. 65-1648(d)(1), and amendments thereto, shall conform to the following requirements:

(a) The approved drugs that may be stored and supplied by health departments, not-for-profit family planning clinics, and indigent healthcare clinics shall be only noncontrolled drugs that are approved by the food and drug administration.

(b) The approved drugs that may be stored and supplied by a federally qualified health center shall be only drugs that are approved by the food and drug administration.

(c)(1) The pharmacist-in-charge shall ensure that health departments, family planning clinics, federally qualified health centers, and indigent healthcare clinics maintain and implement written policies and procedures for the following:

(A) Supervision of all personnel in the supply and control of drugs;

(B) storage, control, supply, labeling, and prepacking of drugs;

(C) documentation of at least quarterly checks of drug records, drug storage conditions, and drugs stored in all locations within the facility by a pharmacist;

(D) drug recall procedure that can be effectively implemented; and

(E) maintaining records of supplying and prepacking of drugs.

(2) Drugs packaged in advance of immediate need shall meet the requirements of K.A.R. 68-7-15 and 68-7-16.

(d) The procedures for the control and supplying of drugs within health department facilities, family planning clinics, federally qualified health centers, and indigent healthcare clinics shall be consistent with the following requirements:

(1) Adequate records of the drugs supplied by the designated registered professional nurse or nurses shall be maintained and shall include the prescriber's order or written protocol.

(A) If the prescriber's order was given verbally, the designated registered professional nurse or nurses shall reduce that order to writing. The written copy of the order shall be maintained in a permanent patient file.

(B) The records shall include the following:

(i) The full name of the patient;

(ii) the date ordered;

(iii) the name of the drug, strength, and the quantity supplied;

(iv) the directions for use;

(v) the prescriber's name and the name of the supervising physician if the prescriber is a physician's assistant; and

(vi) if the order is received verbally, the first and last name of the registered professional nurse that received that order.

(i) The full name of the patient;

(ii) the name of the drug, strength, and quantity supplied;

(iii) the date supplied;

(iv) the internal ID number assigned to the supply of the drug provided.

(2) A supply of drugs shall be provided to a patient by a designated registered professional nurse or nurses pursuant to a prescriber's order. Only a designated registered professional nurse or nurses may access the pharmacy area and remove the supply of the drugs. The supply shall conform with the labeling requirements of K.A.R. 68-7-14.

(e) The designation of a pharmacist-in-charge of a health department, family planning clinic, federally qualified health center, or indigent healthcare clinic shall be subject to the provisions of K.A.R. 68-1-2a and 68-7-13.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1648; effective, T-84-3, Feb. 10, 1983; effective May 1, 1984; amended July 23, 1999; amended April 28, 2000; amended Aug. 16, 2024.)

Kan. Admin. Regs. § 68-7-19 Transfer of a refillable prescription between pharmacies

(a) As used in K.S.A. 65-1656 and amendments thereto, the requested or transferring pharmacy shall mean the pharmacy that has on file the original refillable prescription that the patient wants to transfer to a second pharmacy. The dispensing or requesting pharmacy shall mean the pharmacy that is wanting the information transferred from the original refillable prescription so that the patient may obtain the medication at this second pharmacy or the pharmacy receiving the transferred prescription.

(b) Before any prescription is transferred, the prescription information at the transferring pharmacy shall meet all of the following conditions:

(1) The prescription information indicates authorization for refilling by the prescriber.

(2) The drug on the prescription information is not a schedule II controlled substance.

(3) The number of lawfully allowable refills directed by the prescriber has not been exceeded.

(4) The maximum allowable time limit from the original dating of the prescription has not been exceeded.

(1)(A) The transferring pharmacy shall cancel the transferred prescription by writing the word "void" on its face and shall record the following on the prescription:

(i) The name, address, and phone number of the receiving pharmacy;

(ii) the DEA registration number of the receiving pharmacy, if the drug is a schedule III, IV, or V controlled substance;

(iii) the date of the transfer request and the date of the prescription transfer;

(iv) the first name and last name of the person providing the requested prescription transfer information at the transferring pharmacy and, if applicable, the first name and last name of the pharmacist supervising the transfer; and

(v) the first name and last name of the person receiving the prescription transfer information at the requesting pharmacy and, if applicable, the first name and last name of the pharmacist supervising the transfer.

(B) If the pharmacy from which the prescription is transferred utilizes a computerized prescription recordkeeping system adequate to do so, the information required by this regulation shall be documented in the computer record of the prescription and shall not be required to be manually recorded on the prescription.

(2)(A) The prescription record at the pharmacy receiving the transferred prescription shall show the following, in addition to all other lawfully required information for an original prescription:

(i) The word "transfer" written on the face of the prescription record;

(ii) the date issued, the date of original filling, and the date of the last fill;

(iii) the original number of refills authorized and the number of remaining authorized refills;

(iv) the original prescription number;

(v) the name, address, and telephone number of the transferring pharmacy;

(vi) the first name and last name of the person providing the requested prescription transfer information at the transferring pharmacy and, if applicable, the first name and last name of the pharmacist supervising the transfer; and

(vii) the first name and last name of the person receiving the prescription transfer information at the requesting pharmacy and, if applicable, the first name and last name of the pharmacist supervising the transfer;

(viii) the name, address, and telephone number of the prescriber; and

(ix) if the transfer involves a schedule III, IV, or V controlled substance, the DEA registration number of the prescriber and of the transferring pharmacy.

(B) If the pharmacy receiving the prescription transfer utilizes a computerized prescription recordkeeping system adequate to do so, the information required by this regulation shall be documented in the computer record of the prescription and shall not be required to be manually recorded on the prescription.

(d) Pharmacies sharing a common computerized recordkeeping system that permits the electronic transfer of prescriptions and prescription information from the transferring pharmacy to the requesting pharmacy shall be required to do the following:

(1) Establish procedures to permit these transfers only in instances of valid and legal requests;

(2) ensure that at the time of the transfer there is a sufficient electronic record left at the transferring pharmacy so that a pharmacist at the transferring pharmacy can comply with the recordkeeping requirements of K.S.A. 65-1656, and amendments thereto, and this regulation; and

(3) ensure that the common files contain the following information in a manner readily available to any person accessing the files:

(A) Any authorization for refilling by the prescriber;

(B) an indication of whether or not the number of lawfully allowable refills authorized by the prescriber has been exceeded;

(C) an indication of whether the maximum allowable time limit from the original date of the prescription has been exceeded;

(D) any other information provided by the original prescription or prescription order; and

(E) the name and address of the pharmacy last dispensing the drug pursuant to the prescription.

(e) The dispensing pharmacy shall advise the patient and notify the transferring pharmacy that the original prescription shall be canceled in the transferring pharmacy.

(f) Any pharmacist may transfer a valid, refillable prescription from or to another pharmacy in or outside Kansas. Noncontrolled substance prescriptions may be transferred more than once, but schedule III, IV, and V controlled substance prescriptions shall not be transferred more than one time.

(g) Drugs shall not be dispensed more frequently or in larger amounts, except as allowed by K.S.A. 65-1637 and amendments thereto, than the prescriber ordered without direct prescriber authorization by way of a new prescription order.

(h) Valid refillable prescription transfers for prescription drugs not listed in schedule II of the uniform controlled substances act may be received or transferred by a pharmacist, or a pharmacist intern under the direct supervision of a pharmacist, utilizing any of the following methods of communication:

(1) Direct verbal communication;

(2) facsimile; or

(3) automated computer software.

(i) Valid refillable prescription transfers for noncontrolled substances may be received or transferred by a pharmacy technician that has passed a national certification exam approved by the board and has been authorized by the supervising pharmacist to perform this function by means of automated computer pharmacy software or by facsimile of a transfer document created by the transferring pharmacy's prescription processing software.

(j) A pharmacy technician shall not forward or transfer an original, unfilled prescription.

(k) Any pharmacist or pharmacist intern may forward or transfer an original, unfilled prescription to a receiving pharmacy.

(l) A pharmacy shall not initiate the transfer of a prescription without authorization from the patient or the patient's caregiver.

(m) All records required by this regulation shall be kept readily retrievable for five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2021 Supp. 65-1656; effective March 29, 1993; amended July 23, 1999; amended June 2, 2023.)

Kan. Admin. Regs. § 68-7-20 Shared services

(a)(1) "Order" shall mean either of the following:

(A) A prescription order as defined in K.S.A. 65-1626, and amendments thereto; or

(B) a medication order as defined in K.A.R. 68-5-1.

(2) "Shared order filling" shall mean the following:

(A) Preparing, packaging, compounding, or labeling an order, or any combination of these functions, by a person authorized by the pharmacy act to do so and located at a pharmacy on behalf of and at the request of another pharmacy; and

(B) returning the filled order to the requesting pharmacy for delivery to the patient or patient's agent or, at the request of the requesting pharmacy, directly delivering the filled order to the patient.

(3) "Shared order processing" shall mean the following order-processing functions that are performed by a person authorized by the pharmacy act and located at a pharmacy, on behalf of and at the request of another pharmacy:

(A) Interpreting and entering the order; and

(B) performing drug utilization reviews, claims adjudication, refill authorizations, or therapeutic interventions, or any combination of these functions.

(4) "Shared services" shall mean shared order filling or shared order processing, or both.

(b) Each pharmacy participating in shared services shall be registered by the board as either a resident or a nonresident pharmacy.

(c) Pharmacies may provide or utilize shared services functions only if the pharmacies involved meet the following requirements:

(1) Share a common electronic file or appropriate technology to allow access to sufficient information necessary to fill, refill, or perform shared services in conformance with the pharmacy act and the board's regulations; and

(2)(A) Have the same owner; or

(B) have a written contract outlining the services provided and the shared responsibilities of each party in complying with the pharmacy act and the board's regulations.

(d) Each pharmacy engaged in shared services shall meet the following requirements:

(1) Maintain records identifying, individually for each order processed, the name of each pharmacist, technician, pharmacy student, and intern who took part in the drug utilization review, refill authorization, or therapeutic intervention functions performed at that pharmacy;

(2) maintain records identifying, individually for each order filled or dispensed, the name of each pharmacist, technician, pharmacy student, and intern who took part in the filling, dispensing, and counseling functions performed at that pharmacy;

(3) report to the board within 30 days the results of any disciplinary action taken by another state's pharmacy board;

(4) maintain a mechanism for tracking the order during each step of the processing and filling procedures performed at the pharmacy;

(5) maintain a mechanism to identify on the prescription label all pharmacies involved in filling the order;

(6) provide for adequate security to protect the confidentiality and integrity of patient information; and

(7) be able to obtain for inspection any required record or information within 72 hours of any request by a board representative.

(e) Each pharmacy providing or utilizing shared services shall adopt and maintain a joint policies and procedures manual that meets both of the following conditions:

(1) The manual describes how compliance with the pharmacy act and the board's regulations will be accomplished while engaging in shared services.

(2) A copy of the manual is maintained in each pharmacy.

(f) Nothing in this regulation shall prohibit an individual pharmacist licensed in Kansas who is an employee of or under contract with the pharmacy from accessing the pharmacy's electronic database from inside or outside the pharmacy and performing the order-processing functions permitted by the pharmacy act and the board's regulations, if both of the following conditions are met:

(1) The pharmacy establishes controls to protect the privacy and security of confidential records.

(2) None of the database is duplicated, downloaded, or removed from the pharmacy's electronic database.

(g) Nothing in this regulation shall permit a pharmacy, physician, physician assistant, or mid-level practitioner to utilize shared services to operate a requesting pharmacy that is not actively engaged in the practice of pharmacy.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-1656; implementing K.S.A. 2016 Supp. 65-1626, as amended by L. 2017, ch. 34, sec. 1, K.S.A. 2016 Supp. 65-1626a, K.S.A. 2016 Supp. 65-1637, as amended by L. 2017, ch. 34, sec. 6, K.S.A. 2016 Supp. 65-1642, as amended by L. 2017, ch. 34, sec. 8, and K.S.A. 65-1656; effective April 16, 2004; amended April 18, 2008; amended Dec. 15, 2017.)

Kan. Admin. Regs. § 68-7-20a Delivery of prescriptions dispensed to an alternate site for administration

(a) Definitions. Each of the following terms shall have the meaning specified in this regulation:

(1) "Administering facility" means a registered administering facility or a non-registered administering facility.

(2) "Non-registered administering facility" means a facility that is not registered with the board and is authorized to administer prescription-only drugs under the direction of a practitioner or mid-level practitioner.

(3) "Registered administering facility" means a facility registered with the board that is authorized to administer prescription-only drugs pursuant to state or federal authority.

(b) Any pharmacist may fill a prescription at an originating pharmacy and cause the prescription to be delivered to an administering facility for preparation and administration to the patient.

(c) Each owner and pharmacist-in-charge of an originating pharmacy participating in drug delivery for administration under subsection (b) shall maintain and comply with a policies and procedures manual that includes the following:

(1) Maintaining and retrieving dispensing records that include the following:

(A) The manner in which the pharmacy will access prescription information necessary to complete assigned responsibilities;

(B) a method of recordkeeping that identifies the pharmacist responsible for dispensing the prescription and counseling the patient; and

(C) a method of recordkeeping that documents all required elements of medication preparation specified in article 13 of the board's regulations;

(2) the mechanism for the administering facility to track the prescription during each stage of the delivery process;

(3) controls to protect the privacy and security of confidential records;

(4) ensuring accuracy, security, integrity, and accountability in the delivery process from the time the prescription leaves the originating pharmacy until the prescription is received by staff at the administering facility;

(5) recordkeeping requirements for handling any unopened prescription medication not administered to the patient; and

(6) informing and obtaining consent from the patient for using this dispensing and delivery process.

(d) Each owner and pharmacist-in-charge of an originating pharmacy participating in drug delivery for administration under subsection (b) shall ensure that the following requirements are met:

(1) Each prescription waiting to be picked up or in the process of being delivered to the administering facility shall be stored according to the manufacturer's requirements and relevant laws and regulations.

(2) The pharmacist responsible for filling the prescription shall meet the following requirements:

(A) Notify the administering facility of the anticipated arrival date of the shipment to the administering facility, the exact address where the prescription will be shipped, the name of the patient to whom the drug is being dispensed, and any special storage requirements for the prescription;

(B) provide counseling to the patient or ensure that a process is in place for the patient to receive counseling from a practitioner or pharmacist;

(C) provide a procedure for returning to the originating pharmacy any unopened prescription medication not administered to the patient; and

(D) coordinate the preparation and delivery of the materials needed by the administering facility to administer the dispensed prescription.

(3) Each prescription shall be scheduled for delivery during the administering facility's normal business day unless otherwise agreed upon by the administering facility.

(e) Prescriptions for controlled substances shall not be delivered under this regulation unless the delivery is in compliance with state and federal law.

(f) Each owner and pharmacist-in-charge of a registered administering facility participating in drug delivery for administration under subsection (b) shall ensure each prescription waiting to be administered to the patient shall be stored according to the manufacturer's requirements and relevant laws and regulations in a room, cabinet, cart, or other device that is locked when not in use, cannot be easily moved, and is restricted to the practitioner, pharmacist, or their designee.

(g) A pharmacist shall only allow a prescription to be returned to stock at either the originating pharmacy or the registered administering facility by agreement with the originating pharmacy if it meets the following requirements:

(1) The prescription was delivered to a registered administering facility pursuant to subsection (b); and

(2) the prescription is unopened, unadulterated, and was continuously maintained in accordance with the manufacturer's requirements and relevant laws and regulations.

(h) All records required under this regulation shall be readily retrievable and maintained for five years at the pharmacy.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2023 Supp. 65-1626a, K.S.A. 65-1634, K.S.A. 2023 Supp. 65-1637, K.S.A. 65-1642, and K.S.A. 2023 Supp. 65-1656; effective Jan. 24, 2025.)

Kan. Admin. Regs. § 68-7-21 Institutional drug rooms.

Kansas Administrative Regulations

State Board of Pharmacy

Article 7.—Miscellaneous Provisions

68-7-21. Institutional drug rooms.

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) “Drugs of concern” means the same as defined in K.S.A. 65-1682, and amendments thereto.

(2) “Supervisor” means the pharmacist or practitioner, as that term is defined in K.S.A. 65-1637a and amendments thereto, who is responsible for supervising an institutional drug room.

(b) All prescription-only drugs supplied to patients from an institutional drug room shall be labeled in accordance with K.A.R. 68-7-14. All prepackaging of drugs in advance of immediate need in an institutional drug room shall meet the requirements of K.A.R. 68-7-15 and K.A.R. 68-7-16.

(1) Approve and implement a written manual of policies and procedures governing the following:

(A) training and supervision of personnel;

(B) storage, control, prepackaging, and provision of drugs;

(D) procedures for documenting all reportable incidents in accordance with K.A.R. 68-7-12b.

(2) Perform and document a quarterly review of drug records, drug storage conditions, and the drugs stored in all locations within the institutional drug room.

(3) Maintain documentation of the following:

(A) training of personnel;

(B) prepackaging;

(D) reportable incidents in accordance with K.A.R. 68-7-12b; and

(E) supply date, prescription identification number, and the name of the patient in a log separate from the patient’s medical chart for each prescription supplied by the institutional drug room.

(4) Inventory all controlled substances and drugs of concern in accordance with the inventory requirements of K.A.R. 68-20-16.

(5) Each pharmacist or practitioner who ceases to serve as supervisor shall inventory all controlled substances and drugs of concern in the institutional drug room in accordance with the inventory requirements of K.A.R. 68-20-16 no more than two days before and no later than the day the pharmacist or practitioner ceases to serve as the supervisor.

(6) Each pharmacist or practitioner beginning to serve as the supervisor shall inventory all controlled substances and drugs of concern in the institutional drug room in accordance with the requirements of K.A.R. 68-20-16 no more than two days after beginning to serve as the supervisor. The inventory may be taken simultaneously with the previous supervisor on the previous supervisor’s last day if both the incoming and outgoing supervisors are present, actively participate in the inventory, and sign the inventory.

(d) If the order is recorded in the patient’s file by anyone other than the prescriber, then the order shall include the first and last name of the person that received the order.

(e) The records maintained in each patient's file for supplied drugs shall include the following information:

(1) The full name of the patient;

(2) the date on which the drug was provided;

(3) the name of the drug, the quantity provided, and the strength of the drug provided;

(4) the directions for use of the drug; and

(5) the prescriber's name.

(f) All records required by this regulation shall be kept readily retrievable for five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-1637a; implementing K.S.A. 2025 Supp. 65-1626 and K.S.A. 65-1637a; effective April 23, 2010; amended Aug. 14, 2026.)

Kan. Admin. Regs. § 68-7-22 Collaborative practice

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) "Collaborative drug therapy management" and "CDTM" mean a practice of pharmacy in which a pharmacist performs certain pharmaceutical-related patient care functions for a specific patient, and the functions have been delegated to the pharmacist by a physician through a collaborative practice agreement.

(2) "Collaborative practice agreement" and "CPA" mean a signed agreement or protocol voluntarily entered into between one or more pharmacists and one or more physicians that provides for collaborative drug therapy management.

(3) "Pharmacist" means a person licensed, without limitation or restriction, to practice pharmacy in Kansas.

(4) "Physician" means a person who is licensed to practice medicine and surgery in Kansas and who is a signing party to the pharmacist's CPA or update.

(b) Any pharmacist may practice collaborative drug therapy management only pursuant to a collaborative practice agreement or update established and maintained in accordance with this regulation. Although a physician shall remain ultimately responsible for the care of the patient, each pharmacist who engages in CDTM shall be responsible for all aspects of the CDTM performed by the pharmacist.

A pharmacist shall not become a party to a CPA or update that authorizes the pharmacist to engage in any CDTM function that is not appropriate to the training and experience of the pharmacist or physician, or both. A pharmacist shall not provide CDTM to a patient if the pharmacist knows that the patient is not being treated by a physician who has signed the pharmacist's current CPA.

(c)(1) Each CPA and update shall be dated and signed by each physician and each pharmacist. Each CPA and update shall include the following:

(A) A statement of the general methods, procedures, and decision criteria that the pharmacist is to follow in performing CDTM;

(B) a statement of the procedures that the pharmacist is to follow to document the CDTM decisions made by the pharmacist;

(C) a statement of the procedures that the pharmacist is to follow to communicate to the physician either of the following:

(i) Each change in a patient's condition identified by the pharmacist; or

(ii) each CDTM decision made by the pharmacist;

(D) a statement identifying the situations in which the pharmacist is required to initiate contact with the physician; and

(E) a statement of the procedures to be followed by the pharmacist if an urgent situation involving a patient's health occurs, including identification of an alternative health care provider that the pharmacist should contact if the pharmacist cannot reach a physician.

(2) A CPA shall not authorize a pharmacist to administer influenza vaccine except pursuant to K.S.A. 65-1635a, and amendments thereto.

(d) Each CPA and update shall be reviewed and updated at least every two years. A signing pharmacist shall deliver a digital or paper copy of each CPA and update to the board within five business days after the CPA or update has been signed by all parties.

(e) Within 48 hours of making any drug or drug therapy change to a patient's treatment, the pharmacist shall initiate contact with a physician, identifying the change.

(f) This regulation shall not be interpreted to impede, restrict, inhibit, or impair either of the following:

(1) Current hospital or medical care facility procedures established by the hospital or medical care facility pharmacy and either the therapeutics committee or the medical staff executive committee; or

(2) the provision of medication therapy management as defined by the centers for medicare and medicaid services under the medicare part D prescription drug benefit.

(g) As part of each pharmacist's application to renew that individual's license, the pharmacist shall advise the board if the pharmacist has entered into a CPA.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2015 Supp. 65-1626a; effective May 27, 2016.)

Kan. Admin. Regs. § 68-7-23 Dispensing and administration of emergency opioid antagonist without a prescription

(a) Any pharmacist may dispense an emergency opioid antagonist and the necessary medical supplies needed to administer an emergency opioid antagonist to a patient, bystander, first responder agency, or school nurse without a prescription, in accordance with the opioid antagonist protocol and this regulation.

(b) Each pharmacist dispensing an emergency opioid antagonist pursuant to this regulation shall submit to the board a form provided by the board, within five days of signing the opioid antagonist protocol, and shall maintain a signed and dated copy of the opioid antagonist protocol, which shall be made available to the pharmacist-in-charge, the board, and the board's designee. Each pharmacist that no longer dispenses emergency opioid antagonists pursuant to the opioid antagonist protocol shall notify the board, in writing, within 30 days of discontinuation.

(c) Each emergency opioid antagonist dispensed by a pharmacist shall be labeled in accordance with the pharmacy practice act and any implementing regulations.

(d) Each pharmacist who dispenses an emergency opioid antagonist pursuant to this regulation shall perform the following:

(1) For each patient, bystander, first responder agency, or school nurse to whom the emergency opioid antagonist is dispensed, instruct that person or entity to summon emergency medical services as soon as practicable either before or after administering the emergency opioid antagonist;

(2) for each patient or bystander to whom the emergency opioid antagonist is dispensed, provide in-person counseling, training, and written educational materials appropriate to the dosage form dispensed, including the following:

(A) Risk factors of opioid overdose;

(B) strategies to prevent opioid overdose;

(D) steps in responding to an overdose;

(E) information on emergency opioid antagonists;

(F) procedures for administering an emergency opioid antagonist;

(G) proper storage, disposal, and expiration date of the emergency opioid antagonist dispensed; and

(H) information on where to obtain a referral for substance use disorder treatment; and

(3) for each first responder agency or school nurse to whom the emergency opioid antagonist is dispensed, provide that person or entity with written education and training materials that meet the requirements of paragraphs (d)(1) and (2) and include the requirements to keep inventory records and report any administration of the emergency opioid antagonist to the appropriate healthcare provider pursuant to this regulation.

(e) Each pharmacist shall document the dispensing of any emergency opioid antagonist pursuant to this regulation in a written or electronic prescription record for the patient, bystander, first responder agency, or school nurse to whom the emergency opioid antagonist is dispensed. The pharmacist shall record as the prescriber either that pharmacist or the physician who has signed the opioid antagonist protocol. The prescription record shall be maintained so that the required information is readily retrievable during the pharmacy's normal operating hours and shall be securely stored within the pharmacy for at least five years.

(f) Any of the following individuals or facilities licensed or registered with the board of pharmacy or the board of healing arts may sell emergency opioid antagonists at wholesale to a first responder agency or school nurse:

(1) A pharmacist;

(2) a physician medical director; or

(3) a pharmacy.

(g) Each first responder, scientist, and technician operating under a first responder agency administering an emergency opioid antagonist shall perform the following:

(1) Summon emergency medical services as soon as practicable either before or after administering the emergency opioid antagonist;

(2) immediately provide information related to the administration to any responding emergency medical services personnel, any emergency room personnel, or any treating physician; and

(3) notify the physician medical director for the first responder agency within 24 hours of administration.

(h) Each first responder agency that is dispensed an emergency opioid antagonist shall ensure that any first responder, scientist, or technician operating under the first responder agency is appropriately trained on the use of emergency opioid antagonists and meets the training requirements in subsection (d) and the opioid antagonist protocol.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing 2017 HB 2217, sec. 1; effective, T-68-6-19-17, July 1, 2017; effective Sept. 15, 2017.)

Kan. Admin. Regs. § 68-7-25 Notification to board; pharmacist, pharmacy technician, or pharmacy intern

Each pharmacist, pharmacy technician, and pharmacy intern shall notify the board in writing of any of the following circumstances within 30 days of the date of occurrence:

(a) Any conduct resulting in a charge of, arrest or indictment for, plea of guilty or no contest to, diversion agreement, or suspended imposition of sentence against the registrant or licensee that would constitute any of the following:

(1) Unprofessional conduct as defined by K.S.A. 65-1626, and amendments thereto;

(2) a violation of the federal or state food, drug, and cosmetic act; or

(3) a violation of the Kansas uniform controlled substances act;

(b) any conviction of any felony against the registrant or licensee; or

(c) any denial, limitation, suspension, revocation, voluntary surrender, or other disciplinary action taken by another jurisdiction against any pharmacy, pharmacist, pharmacy intern, or pharmacy technician application, license, registration, or permit held by the registrant or licensee.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2017 Supp. 65-1626, 65-1627, 65-1663, and 65-1676; effective Jan. 4, 2019.)

Kan. Admin. Regs. § 68-7-26 Application for licenses, registrations, or permits; withdrawal of application

After an application for a license, registration, or permit has been submitted, the failure of the applicant or authorized representative to respond to official correspondence from the board regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2024 Supp. 65-1631, K.S.A. 2024 Supp. 65-1643, K.S.A. 65-1663, and K.S.A. 65-1676; effective Jan. 30, 2026.)

Article 8 Advertising

Kan. Admin. Regs. § 68-8-1 Advertising

Licensees, registrants, and permit holders shall not use or allow to be used for their benefit any advertising that is false or misleading.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1630; implementing K.S.A. 65-1650; modified, L. 1978, ch. 466, May 1, 1978; amended May 1, 1985; amended May 1, 1988; amended April 18, 2003.)

Article 9 Automated Prescription Systems

Kan. Admin. Regs. § 68-9-1 Electronic data storage systems.

Kansas Administrative Regulations

State Board of Pharmacy

Article 9.—Automated Prescription Systems

68-9-1. Electronic data storage systems.

All electronic data storage systems operating within this state shall comply with the following requirements:

(a) The pharmacist-in-charge shall adopt and implement written policies and procedures for the following:

(1) Control, use, and operation of the system;

(2) pharmacy operations when the system is inoperable; and

(3) updating and restoring pharmacy data to the system after each time the system was inoperable.

(b) Each electronic data storage system shall:

(1) Maintain the confidentiality of prescriptions and have adequate security and safeguards to prevent unauthorized access, modification, or manipulation of patient medication profile data;

(2) contain accurate drug product information;

(3) only allow pharmacists to make decisions concerning judgmental functions as stated in K.A.R. 68-2-20;

(4) limit final verification of a prescription to pharmacists;

(5) provide a method of numerically identifying each patient's prescription;

(6) have a method for handling partial fillings and refillings of prescriptions;

(7) have a method for handling compounded prescriptions, if applicable;

(8) provide a label containing the information required under K.A.R. 68-7-14;

(9) maintain a record that preserves all information contained in the original prescription;

(10) maintain each patient's medication profile record in a format that is immediately available at the practice site and provides access to each patient’s medication profile record to each pharmacist employed at the practice site;

(11) document the individual pharmacist who has taken responsibility for:

(A) The accuracy of the information entered;

(B) authorizing each dispensing of the prescription; and

(12) maintain an electronic daily prescription log. The daily log shall include the following information for all new and refilled prescriptions filled on that day.

(A) The original prescription number;

(B) the date of the issuance of the original prescription order;

(D) the name and address of the prescriber;

(E) the prescriber’s DEA registration number if required; and

(F) the name, strength, dosage form, and quantity of the medication dispensed;

(13) maintain the following prescription information:

(A) exact refill data;

(B) dates of filling, refillings, and partial fillings; and

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-4102; implementing K.S.A. 2025 Supp. 65-1626, K.S.A. 65-1642, and K.S.A. 65-4121; effective May 1, 1980; amended May 1, 1989; amended April 3, 1990; amended Sept. 9, 1991; amended March 22, 2002; amended Aug. 14, 2026.)

Kan. Admin. Regs. § 68-9-2 Automated drug delivery systems in pharmacies

(a) For purposes of this regulation, "automated drug delivery system" shall mean an automated dispensing system, as defined by K.S.A. 65-1626 and amendments thereto, that is located in a Kansas pharmacy and uses a robotic, mechanical, or computerized device to perform operations or activities other than compounding or administration, involving the storage, packaging, or labeling of, or any other step before dispensing, drugs. Each prescription medication prepared by an automated drug delivery system shall be verified and documented by a Kansas-licensed pharmacist as part of the dispensing process.

(b) A pharmacist-in-charge of any licensed pharmacy, licensed health care facility, or other location that is required to be supervised by a pharmacist-in-charge and that uses an automated drug delivery system shall perform the following before allowing the automated drug delivery system to be used:

(1) Ensure that the automated drug delivery system is in good working order and accurately selects the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate recordkeeping and security safeguards;

(2) ensure that the automated drug delivery system has a mechanism for securing and accounting for all drugs removed from and subsequently returned to the system;

(3) ensure that the automated drug delivery system has a mechanism for securing and accounting for all wasted or discarded drugs, including a manual override for the pharmacist, pharmacy intern, or pharmacy technician to clear a jammed, blocked, or malfunctioning automated drug delivery system;

(4) ensure compliance with an ongoing continuous quality improvement program pursuant to K.S.A. 65-1695, and amendments thereto, or a risk management program that monitors total system performance and includes the requirement for accuracy in the drug and strength delivered;

(5) ensure that the automated drug delivery system is loaded accurately and according to the original manufacturer's storage requirements;

(6) approve and implement an operational policy that limits the personnel responsible for the loading and unloading of drugs to or from the automated drug delivery system to any of the following:

(A) A Kansas-licensed pharmacist;

(B) a Kansas-registered pharmacy intern;

(D) a nurse with a license issued pursuant to K.S.A. 65-1115, and amendments thereto;

(7) at the location of the automated drug delivery system, maintain a current list of those approved individuals who are authorized to unload any drug from the automated drug delivery system;

(8) approve and implement security measures that meet the requirements of all applicable state and federal laws and regulations in order to prevent unauthorized individuals from accessing or obtaining drugs;

(9) preapprove all individuals who are authorized to unload any drug from the automated drug delivery system;

(10) ensure that all drugs loaded in the automated drug delivery system are packaged in the manufacturer's original packaging or in repackaged containers, in compliance with K.A.R. 68-7-15 and K.A.R. 68-7-16, or in containers with the lot number and expiration date tracked by the automated drug delivery system;

(11) provide the board with prior written notice of the installation or removal of the automated drug delivery system; and

(12) ensure that a system of preventive maintenance and sanitation for the automated drug delivery system is established and followed.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2017 Supp. 65-1637 and 65-1642; effective July 6, 2001; amended Feb. 7, 2003; amended Aug. 19, 2016; amended Jan. 4, 2019.)

Kan. Admin. Regs. § 68-9-3 Automated drug delivery system to supply drugs for administration in certain facilities

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) "Automated drug delivery system" means an automated dispensing system, as defined by K.S.A. 2017 Supp. 65-1626 and amendments thereto, that is located in a facility outside of a managing pharmacy and uses a robotic, mechanical, or computerized device to supply each drug to an individual licensed by the board of healing arts or the board of nursing, who shall administer the drug to a patient.

(2) "Facility" means any of the following:

(A) A medical care facility, as defined in K.S.A. 65-1626 and amendments thereto;

(B) an institutional drug room, as defined in K.S.A. 65-1626 and amendments thereto; or

(i) A nursing facility, as defined in K.S.A. 39-923 and amendments thereto;

(ii) a nursing facility for mental health, as defined in K.S.A. 39-923 and amendments thereto; or

(iii) any other type of adult care home, as defined in K.S.A. 39-923 and amendments thereto, that is not specified in paragraphs (a)(2)(C)(i) and (ii) and, after submitting an application, is approved by the board for an automated drug delivery system.

(3) "Managing pharmacy" means a pharmacy located in Kansas.

(4) "Pharmacist-in-charge" means the pharmacist-in-charge of the managing pharmacy.

(b) Before the initial stocking and use of an automated drug delivery system to supply drugs for administration, the pharmacist-in-charge shall meet the following requirements:

(1) Provide the board with at least 14-day prior written notice, on a form provided by the board; and

(2) ensure that all necessary licenses, registrations, and authorizations, including a drug enforcement administration registration if supplying controlled substances, have been obtained.

(c) The pharmacist-in-charge shall consult with the pharmacy and therapeutics committee or an equivalent committee in establishing the criteria and process for determining a formulary of approved drugs that may be stored in the automated drug delivery system.

(d) A bar code verification, electronic verification, or similar verification process shall be utilized to ensure the correct selection of drugs placed or to be placed into each automated drug delivery system. The utilization of a bar code, electronic verification, or similar verification process shall require an initial quality assurance validation, followed by a quarterly assurance review by a pharmacist.

(e) The pharmacist-in-charge shall ensure that a policy exists requiring that if, at the time of loading any controlled substance, a discrepancy in the count of that drug in the automated drug delivery system exists, the discrepancy is immediately reported to the pharmacist-in-charge.

Whenever the pharmacist-in-charge becomes aware of a discrepancy regarding the count of a controlled substance in the automated drug delivery system, the pharmacist-in-charge shall be responsible for reconciliation of the discrepancy or proper reporting of the loss.

(f) The pharmacist-in-charge shall be responsible for the following:

(1) Controlling access to the automated drug delivery system;

(2) maintaining policies and procedures for the following:

(A) Operating the automated drug delivery system;

(B) providing prior training and authorization of personnel who are authorized to remove any drug from the automated drug delivery system;

(C) maintaining, at the location of the automated drug delivery system, a list of those individuals who are authorized to remove any drug from the automated drug delivery system;

(D) maintaining patient services whenever the automated drug delivery system is not operating; and

(E) defining a procedure for a pharmacist to grant access to the drugs in the automated drug delivery system;

(3) securing the automated drug delivery system;

(4) ensuring that each patient receives the pharmacy services necessary for appropriate pharmaceutical care;

(5) ensuring that the automated drug delivery system maintains the integrity of the information in the system and protects patient confidentiality;

(6) ensuring compliance with all requirements for packaging and labeling each medication pursuant to K.A.R. 68-7-15 and K.A.R. 68-7-16, unless the medication is already packaged in the manufacturer's original container or in repackaged containers;

(7) ensuring that a system of preventive maintenance and sanitation exists and is implemented for the automated drug delivery system;

(8) ensuring that a policy exists for securing and accounting for all drugs that are wasted or discarded from the automated drug delivery system;

(9) ensuring that inspections are conducted and documented at least monthly to ensure the accuracy of the contents of the automated drug delivery system; and

(10) ensuring the accurate loading and unloading of the automated drug delivery system by approving and implementing an operational policy that limits the personnel responsible for the loading and unloading of the automated drug delivery system to a Kansas-licensed pharmacist or any of the following, each of whom shall be under the supervision of a Kansas-licensed pharmacist:

(A) A Kansas-registered pharmacy intern;

(B) a Kansas-registered pharmacy technician; or

(g) A pharmacist shall comply with the medication order review and verification requirements specified in K.A.R. 68-7-11.

(h) Except in the event of a sudden and unforeseen change in a patient's condition that presents an imminent threat to the patient's life or well-being, any authorized individual at a facility may distribute patient-specific drugs utilizing an automated drug delivery system without verifying each individual drug selected or packaged by the automated drug delivery system only if both of the following conditions are met:

(1) The initial medication order has been reviewed and approved by a pharmacist.

(2) The drug is distributed for subsequent administration by a health care professional permitted by Kansas law to administer drugs.

(i) The pharmacist-in-charge shall be responsible for establishing a continuous quality improvement program for the automated drug delivery system. This program shall include written procedures for the following:

(1) Investigation of any medication error related to drugs supplied or packaged by the automated drug delivery system;

(2) review of any discrepancy or transaction reports and identification of patterns of inappropriate use of or access to the automated drug delivery system; and

(3) review of the operation of the automated drug delivery system.

(j) The pharmacist-in-charge shall ensure that the managing pharmacy maintains, in a readily retrievable manner and for at least five years, the following records related to the automated drug delivery system:

(1) Transaction records for all drugs or devices supplied by the automated drug delivery system; and

(2) any report or analysis generated as part of the continuous quality improvement program.

(k) A Kansas-registered pharmacy technician, a Kansas-registered pharmacy intern, or a nurse with a license issued pursuant to K.S.A. 65-1115, and amendments thereto, who the pharmacist-in-charge has determined is properly trained may be authorized by that pharmacist-in-charge to perform the functions of loading and unloading an automated drug delivery system utilizing a bar code verification, electronic verification, or similar verification process as specified in subsection (d).

(l) If any drug has been removed from the automated drug delivery system, that drug shall not be replaced into the automated drug delivery system unless either of the following conditions is met:

(1) The drug's purity, packaging, and labeling have been examined according to policies and procedures established by the pharmacist-in-charge to determine that the reuse of the drug is appropriate.

(2) The drug is one of the specific drugs, including multidose vials, that have been exempted by the pharmacy and therapeutics committee or an equivalent committee.

(m) Upon the removal of any automated drug delivery system, the pharmacist-in-charge shall provide the board with notification, on a form provided by the board.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2017 Supp. 65-1637, 65-1642, and 65-1648; effective Aug. 19, 2016; amended Jan. 4, 2019.)

Article 10 Nuclear Pharmacy (not in active use)

Kan. Admin. Regs. § 68-10-1 Rejected

68-10-1 to 68-10-3.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; rejected, L. 1983, Ch. 356, effective May 1, 1983.)

Kan. Admin. Regs. § 68-10-2 Rejected

68-10-1 to 68-10-3.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; rejected, L. 1983, Ch. 356, effective May 1, 1983.)

Kan. Admin. Regs. § 68-10-3 Rejected

68-10-1 to 68-10-3.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1631; rejected, L. 1983, Ch. 356, effective May 1, 1983.)

Article 11 Fees

Kan. Admin. Regs. § 68-11-1 Fees for examination and licensure as a pharmacist

The following fees shall be paid to the board by each applicant for examination and licensure as a pharmacist:

(a) Each applicant for examination shall pay a fee of $100.00.

(b) Each applicant for reciprocal licensure shall pay a fee of $125.00.

(c) An additional fee of $250.00 to evaluate the education and training shall be paid by each applicant for reciprocal licensure or examination who graduated from a school or college of pharmacy or department of a university not approved by the board.

(d) Each licensed pharmacist shall pay a renewal fee of $150.00.

(e) The penalty fee for a late renewal of a pharmacist license shall be $200.00.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-1645; implementing K.S.A. 65-1645; effective May 1, 1983; amended May 1, 1986; amended May 1, 1987; amended May 1, 1988; amended May 1, 1991; amended Nov. 30, 1992; amended June 6, 1994; amended July 31, 1998; amended Feb. 5, 1999; amended Feb. 7, 2003; amended Oct. 20, 2006; amended May 30, 2014; amended May 31, 2019.)

Kan. Admin. Regs. § 68-11-2 Fees for premises and service registrations and permits

(a) Pharmacy registration fees shall be as follows:

(1) Each new pharmacy registration shall be $150.00.

(2) Each renewal pharmacy registration shall be $125.00.

(b) Manufacturer registration fees shall be as follows:

(1) Each new registration shall be $350.00.

(2) Each renewal registration shall be $350.00.

(1) Each new registration shall be $350.00.

(2) Each renewal registration shall be $350.00.

(3) For each wholesale distributor who deals exclusively in nonprescription drugs, the registration fee shall be $50.00.

(4) For each wholesale distributor who deals exclusively in nonprescription drugs, the renewal fee shall be $50.00.

(d) For each institutional drug room or veterinary medical teaching hospital pharmacy, registration fees shall be as follows:

(1) Each new registration shall be $25.00.

(2) Each renewal registration shall be $20.00.

(e) Retail dealer permit fees shall be as follows:

(1) Each new permit shall be $10.00.

(2) Each renewal permit shall be $10.00.

(f) Each special auction permit shall be $28.00.

(g) Sample distribution fees shall be as follows:

(1) Each new permit shall be $30.00.

(2) Each renewal permit shall be $30.00.

(h) For each place of business that sells durable medical equipment, registration fees shall be as follows:

(1) Each new registration shall be $300.00.

(2) Each renewal registration shall be $300.00.

(i) Third-party logistics provider registration fees shall be as follows:

(1) Each new registration shall be $350.00.

(2) Each renewal registration shall be $350.00.

(3) For each third-party logistics provider who deals exclusively in nonprescription drugs, the registration fee shall be $50.00.

(4) For each third-party logistics provider who deals exclusively in nonprescription drugs, the renewal fee shall be $50.00.

(j) For each outsourcing facility or virtual outsourcing facility, registration fees shall be as follows:

(1) Each new registration shall be $350.00.

(2) Each renewal registration shall be $350.00.

(k) Repackager registration fees shall be as follows:

(1) Each new registration shall be $350.00.

(2) Each renewal registration shall be $350.00.

(l) For each place of business that operates an automated dispensing system for patient medication administration, registration fees shall be as follows:

(1) Each new registration shall be $20.00.

(2) Each renewal registration shall be $20.00.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 65-1645; implementing K.S.A. 65-1645; effective May 1, 1983; amended May 1, 1988; amended June 6, 1994; amended Feb. 7, 2003; amended Oct. 24, 2008; amended May 30, 2014; amended Dec. 15, 2017; amended May 31, 2019.)

Kan. Admin. Regs. § 68-11-3 Fees for registration as a pharmacy technician or pharmacy intern

The following fees shall be paid to the board:

(a) Each applicant for initial registration as a pharmacy technician shall pay a fee of $20.00.

(b) Each registered pharmacy technician shall pay a renewal fee of $20.00.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630, K.S.A. 2015 Supp. 65-1663, and K.S.A. 2015 Supp. 65-1676; implementing K.S.A. 2015 Supp. 65-1663 and 65-1676; effective Aug. 19, 2016.)

Article 12 Resale of medication

Kan. Admin. Regs. § 68-12-1 Rejected

68-12-1.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1637a; rejected, L. 1983, Ch. 356, effective May 1, 1983.)

Kan. Admin. Regs. § 68-12-2 Resale of dispensed prescription drugs

Except for prescription drugs in unit-dose systems that contain only one medication and in which the drug has not reached the patient and is still intact, prescription drugs that have been dispensed to the final consumer shall not be resold, redispensed, or distributed by a licensed pharmacist.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1634; effective May 1, 1988; amended Nov. 30, 1992; amended, T-68-11-19-92, Nov. 30, 1992; amended March 29, 1993; amended Feb. 7, 2003.)

Article 13 Parenteral Products

Kan. Admin. Regs. § 68-13-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2001 Supp. 65-1642; effective May 1, 1988; amended Feb. 7, 2003; revoked Jan. 4, 2019.)

Kan. Admin. Regs. § 68-13-2 Definitions

As used in this article of the board's regulations, each of the following terms shall have the meaning specified in this regulation:

(a) "Active ingredients" means chemicals, substances, or other components intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in humans or for use as nutritional supplements.

(b) "Added substances" and "inactive ingredients" mean the ingredients necessary to compound a sterile preparation or nonsterile preparation and not intended or expected to cause a human pharmacologic response if administered alone in the amount or concentration contained in a single dose of the drug product.

(c) "Antearea" means an area, separate from the buffer area, that meets the requirements of an ISO class eight environment and in which personal hygiene and garbing procedures, staging of components, order entry, and labeling are performed.

(d) "Batch" means multiple sterile dosage units in a quantity greater than 25 that are compounded in a discrete process by the same individual or individuals during one limited period.

(e) "Beyond-use date" means a date placed on a prescription label at the time of dispensing, repackaging, or prepackaging that is intended to indicate to the patient or caregiver a time beyond which the contents of the prescription are not recommended to be used.

(f) "Biological safety cabinet" and "BSC" mean a ventilated cabinet for sterile preparations and hazardous drugs to protect personnel, products, and the environment that has an open front with inward airflow for protection of personnel, downward-airflow LAFS for product protection, and HEPA-filtered exhausted air for environmental protection.

(g) "Buffer area" means an area that meets the requirements for an ISO class seven environment and in which the primary engineering control is located.

(h) "Clean room" means a room that meets the requirements for an ISO class five environment.

(i) "Complex nonsterile compounding" means making a nonsterile preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes. Nonsterile preparations made using complex nonsterile compounding shall include transdermal dosage forms, modified-release forms, and suppositories for systemic effects.

(j) "Component" means any active ingredient or added substance intended for use in the compounding of a drug product, including any ingredient that does not appear in the drug product.

(k) "Compounding" has the meaning specified in K.S.A. 2017 Supp. 65-1626, and amendments thereto.

(l) "Compounding area" means any area in a pharmacy or outsourcing facility where compounding is performed.

(m) "Compounding aseptic containment isolator" and "CACI" mean a compounding aseptic isolator designed to provide worker protection from exposure to undesirable levels of airborne drugs throughout the compounding and material transfer process and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment shall not occur unless the air is first passed through a HEPA filter capable of containing airborne concentrations of the physical size and state of the drug being compounded. Whenever volatile hazardous drugs are compounded, the exhaust air from the CACI shall be removed by the building's ventilation system.

(n) "Compounding aseptic isolator" and "CAI" mean a type of isolator specifically designed for compounding sterile preparations or nonsterile preparations and designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer process. Air exchange into the CAI from the surrounding environment shall not occur unless the air has first passed through a HEPA filter and an ISO class five environment is maintained.

(o) "Cytotoxic," when used to describe a pharmaceutical, means that the pharmaceutical is capable of killing living cells. This term is also used to describe components classified as cancer chemotherapeutic, carcinogenic, mutagenic, or antineoplastic.

(p) "Dosage unit" means the amount of a sterile preparation that would be administered to or taken by one patient at a time.

(q) "Endotoxin" means a potentially toxic, natural compound that is a structural component of bacterial cell walls and that is released mainly when bacteria undergo destruction or decomposition.

(r) "Essentially a copy" means any sterile preparation or nonsterile preparation that is comparable in active ingredients to a commercially available drug product, unless either of the following conditions is met:

(1) There is a change made for an identified individual patient that produces a clinically significant difference for the patient, as determined by the prescribing practitioner, between the comparable commercially available drug product and either the sterile preparation or the nonsterile preparation.

(2) The drug appears on the drug shortage list in section 506E of the federal food, drug, and cosmetic act, 21 U.S.C. 356e, at the time of compounding, distribution, and dispensing.

(s) "Excursion" means a deviation from the range of temperatures specified by the manufacturer for storage or transport of a pharmaceutical based on stability data.

(t) "Glove fingertip test" means a test in which a gloved fingertip is pressed to and cultured on a microbiological growth media plate. Each successful glove fingertip test shall yield no more than three colony-forming units per contact plate for the annual competency evaluation and shall yield zero colony-forming units at least three times for the initial competency evaluation.

(u) "Hazardous drug" means any drug or compounded drug identified by at least one of the following criteria:

(1) Carcinogenicity;

(2) teratogenicity or developmental toxicity;

(3) reproductive toxicity;

(4) organ toxicity at low doses;

(5) genotoxicity; or

(6) drug product structure or toxicity that mimics that of existing hazardous drugs.

(v) "HEPA" means high-efficiency particulate air.

(w) "ISO class eight environment" means an atmospheric environment containing less than 3,520,000 airborne particles measuring at least 0.5 micron in diameter per cubic meter of air.

(x) "ISO class five environment" means an atmospheric environment containing less than 3,520 airborne particles measuring at least 0.5 micron in diameter per cubic meter of air.

(y) "ISO class seven environment" means an atmospheric environment containing less than 352,000 airborne particles measuring at least 0.5 micron in diameter per cubic meter of air.

(z) "Laminar airflow system" and "LAFS" mean an apparatus designed to provide an ISO class five environment for the compounding of sterile preparations using air circulation in a defined direction that passes through a HEPA filter.

(aa) "Manufacturing" means manufacture as defined in K.S.A. 65-1626, and amendments thereto.

(bb) "Media fill test" means a test in which a microbiological growth medium, which may consist of a soybean-casein digest medium, is substituted for an actual drug product to simulate admixture compounding. The media fill test shall be successful if it produces a sterile preparation without microbial contamination.

(cc) "Moderate nonsterile compounding" means making a nonsterile preparation that requires special calculations or procedures to determine quantities of components per nonsterile preparation or per dosage unit or making a nonsterile preparation for which stability data is not available. Nonsterile preparations made using moderate nonsterile compounding shall include morphine sulfate suppositories, diphenhydramine troches, and a mixture of two or more manufactured creams if stability of the mixture is not known.

(dd) "Multiple-dose container" means a multiple-unit container for any sterile preparation intended only for parenteral administration, usually containing antimicrobial preservatives.

(ee) "Nonsterile preparation" means a pharmaceutical made using simple nonsterile compounding, moderate nonsterile compounding, or complex nonsterile compounding.

(ff) "Official compendium" has the meaning specified in K.S.A. 65-656, and amendments thereto.

(gg) "Order" means either a prescription order as defined in K.S.A. 65-1626, and amendments thereto, or a medication order as defined in K.A.R. 68-5-1.

(hh) "Parenteral," when used to refer to a solution, means that the solution is administered by injection through one or more layers of skin or by other routes of administration that bypass the gastrointestinal tract.

(ii) "Parenteral product" means a sterile preparation administered by injection through one or more layers of skin or by other routes of administration that bypass the gastrointestinal tract.

(jj) "Practitioner-patient-pharmacist relationship" means a relationship that meets all of the following conditions:

(1) The practitioner has assumed the responsibility for making medical judgments regarding the health of the patient and the need for medical treatment.

(2) The practitioner has sufficient knowledge of the patient to initiate at least a general or preliminary diagnosis of the medical condition, and the practitioner has examined the patient and is available for follow-up.

(3) The practitioner has communicated the necessary prescriptions to the pharmacist, who is able to provide pharmaceutical care to the patient and, if needed, communicate with the practitioner.

(kk) "Primary engineering control" means a clean room or an apparatus for compounding sterile preparations, including an LAFS, a BSC, a CAI, or a CACI, designed to provide an ISO class five environment for compounding sterile preparations.

(ll) "Purified water" means water that meets the requirements for ionic and organic chemistry purity and protection from microbial contamination specified in section 1231 of the official compendium.

(mm) "Refrigeration" and "controlled cold temperature" mean a temperature maintained thermostatically between 2° and 8°C (36° to 46°F) that allows for excursions between 0° and 15°C (32° to 59°F) that are experienced during storage, shipping, and distribution, such that the allowable calculated mean kinetic temperature is not more than 8°C (46°F).

(nn) "Room temperature" means a temperature maintained thermostatically that meets the following criteria:

(1) Encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F);

(2) results in a mean kinetic temperature calculated to be not more than 25°C (77°F); and

(3) allows for excursions between 15° and 30°C (59° to 86°F) experienced in pharmacies, hospitals, and storage facilities, such that the allowable calculated mean kinetic temperature remains in the allowed range.

(oo) "Segregated compounding area" means a designated, demarcated area or room that is restricted to compounding low-risk sterile preparations, which shall contain a primary engineering control providing unidirectional airflow that maintains an ISO class five environment and shall be void of all activities and materials extraneous to the sterile compounding process.

(pp) "Simple nonsterile compounding" means either of the following:

(1) Making a nonsterile preparation that has a compounding monograph listed in the official compendium or that appears in a peer-reviewed journal containing specifics on component quantities, compounding procedure, equipment, and stability data for the formulation and appropriate beyond-use dates; or

(2) reconstituting or manipulating commercially available products that require the addition of one or more ingredients as directed by the manufacturer.

Nonsterile preparations made using simple nonsterile compounding shall include captopril oral solution, indomethacin topical gel, and potassium bromide oral solution.

(qq) "Single-dose container" means a single-unit container for any sterile preparation intended for parenteral administration that is accessed once for one patient.

(rr) "Specific medical need" means a medical reason why a commercially available drug product cannot be used, excluding cost and convenience.

(ss) "Sterile preparation" means any dosage form of a drug, including parenteral products free of viable microorganisms, made using currently accepted aseptic compounding techniques under acceptable compounding conditions. This term shall include any commercially compounded sterile drug dosage form that has been altered in the compounding process.

(tt) "Sufficient documentation" means either of the following:

(1) A prescription documenting a specific medical need; or

(2) a notation in a pharmacy's or an outsourcing facility's records that verbal or other documentation of the specific medical need was received for each prescription, including the name of the person verifying the specific medical need, the date, and the specific medical need.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 2017 Supp. 65-1637e; implementing K.S.A. 2017 Supp. 65-1626, K.S.A. 2017 Supp. 65-1626a, K.S.A. 65-1634, K.S.A. 2017 Supp. 65-1637c, and K.S.A. 2017 Supp. 65-1642; effective May 11, 2018.)

Kan. Admin. Regs. § 68-13-3 Nonsterile preparations

(a) This regulation shall apply to the following:

(1) Nonsterile preparations that are compounded in Kansas; and

(2) nonsterile preparations that are shipped or delivered into Kansas by a pharmacy and are to be administered to a patient in Kansas.

(b) "Pharmacy," as used in this regulation, shall mean a pharmacy, nonresident pharmacy, or outsourcing facility as defined by K.S.A. 2017 Supp. 65-1626, and amendments thereto.

(c) Any pharmacist may compound a nonsterile preparation that is commercially available only if it is different from a product approved by the FDA and there is sufficient documentation of a specific medical need for an individual patient.

(d) A pharmacist shall not compound a nonsterile preparation by any of the following methods:

(1) Using any component withdrawn from the market by the FDA for safety reasons;

(2) receiving, storing, or using any drug component that is not guaranteed or otherwise determined to meet the requirements of an official compendium;

(3) compounding finished drugs from bulk active ingredients that do not meet the requirements of a monograph listed in the official compendium; or

(4) compounding finished drugs from bulk active ingredients that are not components of FDA-approved drugs.

(e) For the convenience of any patient, any pharmacist may compound a nonsterile preparation before receiving an order based on routine, regularly observed prescribing patterns.

(f) Compounding for non-human animals shall meet the same requirements as those for human prescriptions, except that a pharmacist shall not compound bulk chemicals for food-producing animals.

(g) Each nonsterile preparation sold by a pharmacy to a practitioner for administration to a patient shall be packaged with a label that includes the following text: "For Office Use Only — Not for Resale."

(h) Any pharmacy may distribute nonsterile preparations without a prescription, including providing limited quantities to a practitioner in the course of professional practice to administer limited quantities to an individual patient, if the nonsterile preparations are not intended for resale.

(i) Each pharmacy selling any prescription nonsterile preparation to a practitioner for office use shall maintain an invoice documenting the following:

(1) The name and address of the practitioner;

(2) the drug compounded, including the lot number and expiration date of each component;

(3) the quantity sold; and

(4) the date of the transaction.

The invoice shall be maintained in the pharmacy and shall be made readily available to the pharmacist-in-charge, the board, and the board's designee.

(j) Within each pharmacy in which compounding occurs, one area shall be designated as the principal compounding area, where all nonsterile compounding shall take place.

(1) Each compounding area shall be well-lighted and well-ventilated, with clean and sanitary surroundings, and shall be free of food and beverages.

(2) Each compounding area shall provide the drugs, chemicals, and devices with necessary protection from deterioration due to light, heat, and evaporation and shall be arranged to protect all prescription drugs and devices from theft and any other unauthorized removal.

(3) All components used in compounding nonsterile preparations shall be stored in labeled containers in a clean, dry area and, if required, under proper refrigeration.

(4) Each compounding area shall include a sink that is equipped with hot and cold running water for hand and equipment washing.

(k) Each pharmacist compounding nonsterile preparations shall use purified water if the formulations indicate the inclusion of water.

(l) Each pharmacist-in-charge shall maintain a uniform formulation record for each nonsterile preparation, documenting the following:

(1) The ingredients, quantities, strength, and dosage form of the nonsterile preparation;

(2) the equipment used to compound the nonsterile preparation and the mixing instructions;

(3) the container used in dispensing;

(4) the storage requirements;

(5) the beyond-use date to be assigned;

(6) quality control procedures, which shall include identification of each person performing or either directly supervising or checking each step in the compounding process and which may include monitoring the following:

(A) Capsule weight variation;

(B) adequacy of mixing to ensure uniformity and homogeneity; and

(7) the source of the formulation, including the name of the person, entity, or publication; and

(8) the name or initials of the person creating the formulation record and the date on which the formulation record was established at the pharmacy.

(m) Each pharmacist-in-charge shall maintain on the original order or on a separate, uniform record a compounding record for each nonsterile preparation, documenting the following:

(1) The name and strength of the nonsterile preparation;

(2) the identifier used to distinguish the nonsterile preparation's formulation record from other formulation records;

(3) the name of the manufacturer or repackager and, if applicable, the lot number and expiration date of each component;

(4) the total number of dosage units or total quantity compounded;

(5) the name of each person who compounded the nonsterile preparation;

(6) the name of the pharmacist, or the pharmacy student or intern working under the direct supervision and control of the pharmacist, who verified the accuracy of the nonsterile preparation;

(7) the date of compounding;

(8) the assigned internal identification number, if used;

(9) the prescription number, if assigned;

(10) the results of quality control procedures; and

(11) the assigned beyond-use date. In the absence of valid scientific stability information that is applicable to a specific drug or nonsterile preparation, the beyond-use date shall not be later than the expiration date of any component of the formulation and shall be established in accordance with the following criteria:

(A) For nonaqueous and solid formulations, either of the following:

(i) If a manufactured drug product is the source of the active ingredient, six months from the date of compounding or the time remaining until the manufactured drug product's expiration date, whichever is earlier; or

(ii) if a substance listed in an official compendium is the source of an active ingredient, six months from the date of compounding or the time remaining until the expiration date of any component of the formulation, whichever is earlier;

(B) for water-containing oral formulations, not more than 14 days when stored under refrigeration; and

(C) for water-containing non-oral formulations, not longer than the intended duration of therapy or 30 days, whichever is earlier.

(n) The compounding record and the corresponding formulation record specified in subsections (m) and (l), respectively, shall be retained at the pharmacy for at least five years and shall be made readily available to the pharmacist-in-charge, the board, and the board's designee.

(o) If a patient requests a transfer of the patient's prescription, a copy of the original prescription shall be transmitted upon the request of the receiving pharmacist. The transferring pharmacist shall also transfer the following written information with the prescription:

(1) Active ingredients;

(2) concentration;

(3) dosage form;

(4) route of delivery;

(5) delivery mechanism;

(6) dosing duration; and

(7) details about the compounding procedure.

(p) The pharmacist-in-charge shall ensure that all support personnel are trained and successfully demonstrate the following before performing delegated compounding:

(1) Comprehensive knowledge of the pharmacy's standard operating procedures with regard to compounding as specified in the policy and procedure manual; and

(2) familiarity with the compounding techniques used at the pharmacy.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 2017 Supp. 65-1637e; implementing K.S.A. 2017 Supp. 65-1626a, K.S.A. 65-1634, K.S.A. 65-1637c, and K.S.A. 2017 Supp. 65-1642; effective May 11, 2018.)

Kan. Admin. Regs. § 68-13-4 Sterile preparations

(a) This regulation shall apply to the following:

(1) Sterile preparations that are compounded in Kansas; and

(2) sterile preparations that are shipped or delivered into Kansas by a pharmacy to be administered to a patient in Kansas.

(b) As used in this regulation, each of the following terms shall have the meaning specified in this subsection:

(1)(A) "High-risk," when used to describe a sterile preparation, means that the sterile preparation meets at least one of the following conditions:

(i) The sterile preparation is compounded from nonsterile ingredients or with nonsterile containers or equipment before terminal sterilization.

(ii) The sterile ingredients or components of the sterile preparation are exposed to air quality inferior to that of an ISO class five environment for more than one hour.

(iii) The sterile preparation contains nonsterile water and is stored for more than six hours before being sterilized.

(iv) The compounding pharmacist cannot verify from documentation received from the supplier or by direct examination that the chemical purity and content strength of the ingredients meet the specifications of an official compendium.

(v) The sterile preparation has been stored at room temperature and administered more than 24 hours after compounding, stored under refrigeration more than three days, or stored frozen from 0° to -20°C (32° to -4°F) or colder for 45 or fewer days, and sterility has not been confirmed by testing.

(B) This term shall apply to sterile preparations including the following:

(i) Alum bladder irrigation solution;

(ii) any morphine preparation made for parenteral administration from nonsterile powder or tablets;

(iii) any total parenteral nutrition solution made from dried amino acids;

(iv) any total parenteral nutrition solution sterilized by final filtration; and

(v) any autoclaved intravenous solution.

(2) "Immediate use" means a situation in which a sterile preparation is compounded pursuant to an order in a medical care facility for administration to the patient within one hour of the start of compounding the sterile preparation.

(3) "Low-risk," when used to describe a sterile preparation, means that the sterile preparation meets the following conditions:

(A) In the absence of sterility testing, is stored at room temperature and administration to the patient has begun not more than 48 hours after compounding, is stored under refrigeration for 14 or fewer days before administration to the patient over a period not to exceed 24 hours, or is stored frozen at -20°C (-4°F) or colder for 45 or fewer days before administration to the patient over a period not to exceed 24 hours;

(B) is prepared for administration to one patient or is batch-prepared and contains suitable preservatives for administration to more than one patient; and

(C) is prepared by a simple or closed-system aseptic transfer of no more than three sterile, nonpyrogenic, finished pharmaceuticals obtained from licensed manufacturers into sterile final containers obtained from licensed manufacturers with no more than two instances in which a transfer device passes through the designated access point into any one sterile container or package.

(4)(A) "Medium-risk," when used to describe a sterile preparation, means that the sterile preparation meets at least one of the following conditions:

(i) In the absence of sterility testing, is stored at room temperature and administered to the patient not more than 30 hours after compounding, is stored under refrigeration for nine or fewer days, or is stored frozen at -20°C (-4°F) or colder for 45 or fewer days;

(ii) is batch-prepared and intended for use by more than one patient or by one patient on multiple occasions;

(iii) is created by a compounding process that includes complex aseptic manipulations other than a single-volume transfer; or

(iv) is compounded by at least four manipulations of sterile ingredients obtained from licensed manufacturers in a sterile container obtained from a licensed manufacturer by using a simple or closed-system aseptic transfer.

(B) This term shall apply to the following:

(i) Sterile preparations for use in a portable pump or reservoir over multiple days;

(ii) batch-reconstituted sterile preparations;

(iii) batch-prefilled syringes; and

(iv) total parenteral nutrient solutions that are compounded by the gravity transfer of carbohydrates and amino acids into an empty container with the addition of sterile additives using a syringe and needle or that are mixed with an automatic compounding device.

(5) "Pharmacy" means a pharmacy, nonresident pharmacy, or outsourcing facility as defined by K.S.A. 2017 Supp. 65-1626, and amendments thereto.

(c) Any sterile preparation for immediate use may be compounded outside a primary engineering control if both of the following conditions are met:

(1) Administration to the patient begins within one hour of the start of compounding the sterile preparation.

(2) The sterile preparation is compounded by a simple or closed-system aseptic transfer of sterile, nonpyrogenic, finished pharmaceuticals obtained from licensed manufacturers into sterile final containers obtained from licensed manufacturers.

(d) When a multiple-dose container with antimicrobial preservatives has been opened or entered, the container shall be labeled with a beyond-use date not to exceed 28 days, unless otherwise specified by the manufacturer.

(e) Each compounding area shall contain a primary engineering control providing unidirectional airflow that will maintain an ISO class five environment for compounding sterile preparations and shall be void of all activities and materials that are extraneous to compounding.

(f) Each sterile preparation compounded in a segregated compounding area shall be labeled with a beyond-use date of no more than 12 hours.

(g) Each single-dose container shall be labeled as such.

(h) The contents of each single-dose container shall be used within one hour if the container is opened or entered in an area with air quality that does not meet the requirements of an ISO class five environment.

(i) The contents of each single-dose container shall be used within six hours if the container is opened or entered in an area that meets the requirements of an ISO class five environment.

(j) For the convenience of any patient, any pharmacist may compound a sterile preparation before receiving an order if the pharmacist has previously filled orders for the sterile preparation and the sterile preparation is based on routine, regularly observed prescribing patterns.

(k) Compounding for non-human animals shall meet the same requirements as those for human prescriptions, except that a pharmacist shall not compound bulk chemicals for food-producing animals.

(l) Each sterile preparation sold by a pharmacy to a practitioner for administration to a patient shall be packaged with a label that includes the following text: "For Office Use Only — Not For Resale."

(m) Any pharmacy may distribute sterile preparations without a prescription, including providing limited quantities to a practitioner in the course of professional practice to administer limited quantities to an individual patient, if the sterile preparations are not intended for resale.

(n) A pharmacist shall not compound a sterile preparation that is essentially a copy.

(o) Any pharmacist may compound a sterile preparation that is commercially available only if there is sufficient documentation of a specific medical need for the prescription or the product is temporarily unavailable due to problems other than safety or effectiveness. Each pharmacist shall document any unavailability in the patient's prescription record, including the date the product was unavailable, and shall maintain documentation from the manufacturer or distributor demonstrating the product's unavailability. The pharmacist shall cease compounding the sterile preparation as soon as the product becomes commercially available.

(p) A pharmacist shall not compound a sterile preparation by any of the following methods:

(1) Using any component withdrawn from the market by the FDA for safety reasons;

(2) receiving, storing, or using any drug component that is not guaranteed or otherwise determined to meet the requirements of an official compendium; or

(3) compounding finished drugs through manufacturing, as defined in K.S.A. 65-1626 and amendments thereto, without first receiving an FDA-sanctioned investigational new drug application in accordance with 21 U.S.C. 355(i) and 21 C.F.R. Part 312.

(q) Each pharmacist or pharmacy compounding sterile preparations shall have the following resources:

(1) A primary engineering control that is currently certified by an inspector certified by the controlled environmental testing association to ensure aseptic conditions within the working area and that has the required documentation. The certification shall be deemed current if the certification occurred within the previous six months or on the date the device was last moved to another location, whichever is more recent. The required documentation shall include the following:

(A) Inspection certificates for the past five years or since the date of installation, whichever is more recent;

(B) records of all filter maintenance for the past five years or since the date of installation, whichever is more recent;

(C) records of all HEPA filter maintenance for the past five years or since the date of installation, whichever is more recent; and

(D) records of all disinfecting and cleaning for the past year or since the date of installation, whichever is more recent;

(2) a sink with hot and cold running water;

(3) a refrigerator capable of maintaining a temperature of 2° to 8°C (36° to 46°F) and, if needed, a freezer capable of maintaining a temperature of -25° to -10°C (-13° to 14°F). The temperature shall be monitored and recorded each business day. Each pharmacy with an electronic system that alerts the pharmacist to noncompliant temperatures shall be exempt from daily recording;

(4) the reference materials required by K.A.R. 68-2-12a and a current copy of a reference text on intravenous incompatibilities and stabilities. If an electronic library is provided, a workstation shall be readily available for use by pharmacy personnel, students, interns, and board personnel;

(5) a policy and procedure manual, with a documented review at least every two years by the pharmacist-in-charge or designee, which shall include the following subjects:

(A) Sanitation;

(B) storage;

(D) labeling;

(E) destruction and return of controlled substances;

(F) recordkeeping;

(G) recall procedures;

(H) responsibilities and duties of supportive personnel;

(I) aseptic compounding techniques; and

(J) ongoing evaluation of all staff compounding sterile preparations; and

(6) supplies necessary for compounding sterile preparations.

(r) Each pharmacist-in-charge shall maintain a uniform formulation record for each sterile preparation, documenting the following:

(1) The quantities, strength, and dosage form of all components of the sterile preparation;

(2) the equipment used to compound the sterile preparation and the mixing instructions;

(3) the container used in dispensing;

(4) the storage requirements;

(5) the beyond-use date to be assigned;

(6) quality control procedures, which may include monitoring the following, if applicable:

(A) Adequacy of mixing to ensure uniformity and homogeneity; and

(B) the clarity, completeness, or pH of solutions;

(7) the sterilization methods;

(8) the source of the formulation; and

(9) the name of the pharmacist who verified the accuracy of the formulation record and the date of verification.

(s) Each pharmacist-in-charge shall maintain on the original order or on a separate, uniform record a compounding record for each sterile preparation, documenting the following:

(1) The name and strength of the sterile preparation;

(2) the formulation record reference for the sterile preparation;

(3) the name of the manufacturer or repackager and, if applicable, the lot number and the expiration date of each component;

(4) the total number of dosage units or total quantity compounded;

(5) the name of the person or persons who compounded the sterile preparation;

(6) the name of the pharmacist, or the pharmacy student or intern working under the direct supervision and control of the pharmacist, who verified the accuracy of the sterile preparation;

(7) the date of compounding;

(8) the assigned internal identification number, if applicable;

(9) the prescription number, if assigned;

(10) the results of quality control procedures;

(11) the results of the sterility testing and, if applicable, pyrogen testing for the batch; and

(12) the assigned beyond-use-date. In the absence of valid scientific stability information that is applicable to a component or the sterile preparation, the beyond-use date shall be established in accordance with the following criteria:

(A) For nonaqueous and solid formulations, one of the following:

(i) If the manufactured drug product is the source of the active ingredient, six months from the date of compounding or the time remaining until the manufactured drug product's expiration date, whichever is earlier; or

(ii) if the substance listed in an official compendium is the source of an active ingredient, six months from the date of compounding or the time remaining until the expiration date of any component of the formulation, whichever is earlier;

(B) for formulations containing water and made from ingredients in solid form, not more than 14 days when stored under refrigeration; and

(t) The compounding record and corresponding formulation record specified in subsections (s) and (r), respectively, shall be retained at the pharmacy for at least five years and shall be made readily available to the pharmacist-in-charge, the board, and the board's designee.

(u) Medical care facility pharmacies shall generate a compounding record and a corresponding formulation record only for batch compounding or for any sterile preparation with a beyond-use date of more than seven days.

(v) Except when compounding in any CAI, each person involved in compounding a sterile preparation shall follow personal garbing and washing procedures that include the following minimum requirements:

(1) Preparing for garbing by removing any outer garments, cosmetics, jewelry, and artificial nails;

(2) performing the following procedures, in the order listed:

(A) Donning dedicated shoes or shoe covers;

(B) donning head and facial hair covers;

(C) either washing the hands with soap for at least 20 seconds or using an antiseptic hand scrub in accordance with the manufacturer's instructions; and

(D) donning a nonshedding gown; and

(3) entering the work area and immediately performing an antiseptic hand-cleaning procedure using an alcohol-based surgical hand scrub and successively donning sterile, powder-free gloves. Sterile gloves shall be disinfected after touching any nonsterile area.

(w) All sterile preparations shall be stored and delivered in a manner that is designed to maintain parenteral product stability and sterility.

(x) All sterile preparations, except for sterile preparations for immediate use, shall be compounded under aseptic conditions as follows:

(1) Each low-risk sterile preparation labeled with a beyond-use date of 12 hours or longer shall be compounded in an ISO class five environment using techniques that ensure sterility. Each low-risk sterile preparation labeled with a beyond-use date of less than 12 hours shall, at a minimum, be made in a segregated compounding area.

(2) Each medium-risk sterile preparation shall be compounded in an ISO class five environment using techniques that ensure sterility.

(3) Each high-risk sterile preparation made with nonsterile components shall be sterilized before being administered to a patient and shall have a certificate of analysis indicating that all nonsterile components meet the standards of the "United States pharmacopeia" and the FDA for identity, purity, and endotoxin levels as verified by a pharmacist.

(y) Each pharmacist engaged in the dispensing of sterile preparations shall meet all labeling requirements under state and federal law. In addition, the label of each sterile preparation shall contain the following information:

(1) The name and quantity of each component;

(2) the beyond-use date;

(3) the prescribed flow rate;

(4) the name or initials of each person who compounded the sterile preparation; and

(5) any special storage instructions.

(z)(1) The pharmacist-in-charge and all personnel involved in compounding sterile preparations shall have practical or academic training in sterile compounding, clean room technology, laminar flow technology, and quality assurance techniques. The training shall include the following:

(A) At least one successful media fill test; and

(B) a successful glove fingertip test.

(2) The pharmacist-in-charge shall ensure that all supportive personnel are trained and successfully demonstrate the following before performing any delegated sterile admixture services:

(A) Comprehensive knowledge of the pharmacy's standard operating procedures with regard to sterile admixture services, as specified in the policy and procedure manual;

(B) familiarity with the compounding techniques; and

(3) The pharmacist-in-charge shall be responsible for testing the aseptic technique of all personnel involved in compounding sterile preparations annually by means of a media fill test. All personnel involved in compounding high-risk sterile preparations shall undergo this testing twice each year. Each individual who fails to demonstrate acceptable aseptic technique shall be prohibited from compounding sterile preparations until the individual demonstrates acceptable technique by means of a media fill test.

(aa) The pharmacist-in-charge shall document all training and test results for each person before that person begins compounding sterile preparations. This documentation shall be maintained by the pharmacy for at least five years and shall be made available to the board upon request.

(bb) The pharmacist-in-charge shall be responsible maintaining records documenting the frequency of cleaning and disinfection of all compounding areas, according to the following minimum requirements:

(1) Each ISO class five environment shall be cleaned and disinfected as follows:

(A) At the beginning of each shift;

(B) every 30 minutes during continuous periods of compounding individual sterile preparations;

(D) after a spill or known contamination.

(2) All counters, work surfaces, and floors shall be cleaned and disinfected daily.

(3) All walls, ceilings, and storage shelves shall be cleaned and disinfected monthly.

(cc) The pharmacist-in-charge shall be responsible for maintaining records documenting the monitoring of the air pressure and air flow and shall initiate immediate corrective action if indicated. The air pressure of the antearea shall be maintained at five pascals, and the air flow shall be maintained at 0.2 meters per second. The air pressure and air flow values shall be checked and recorded at least once daily.

(dd) The pharmacist-in-charge shall be responsible for maintaining records documenting the monitoring of the cleanliness and sterility of the sterile compounding environment. Environmental sampling shall be performed in each new facility before any sterile preparation in that facility is provided to a patient and, at a minimum, every six months thereafter. The environmental sampling shall include the primary engineering control, antearea and buffer area, and equipment and shall be performed following any repair or service performed at the facility and in response to any identified problem or concern.

Environmental sampling shall consist of the following, at a minimum:

(1) Environmental nonviable particle counts;

(2) environmental viable airborne particle testing by volumetric collection;

(3) environmental viable surface sampling; and

(4) certification of operational efficiency of the primary engineering control by an independent contractor according to the international organization of standardization classification of particulate matter in room air, at least once every six months.

(ee) The environmental sampling records specified in subsection (dd) shall be retained at the pharmacy for at least five years and shall be made readily available to the pharmacist-in-charge, the board, and the board's designee.

(ff) If a microbial growth above acceptable levels is detected in an ISO class five environment, ISO class seven environment, or ISO class eight environment, an immediate reevaluation of the adequacy of compounding practice, cleaning procedures, operational procedures, and air filtration efficiency with the aseptic compounding location shall be conducted and documented. Each investigation into the source of the contamination shall include air sources, personnel garbing, and all filters, at a minimum. The ISO class five environment, ISO class seven environment, or ISO class eight environment shall be cleaned three times and environmental sampling shall be performed and reevaluated. Sterile preparations may be compounded and labeled with a beyond-use date according to subsection (gg) until microbial growth has decreased to acceptable levels.

(1) An ISO class five environment shall have acceptable levels of microbial growth if both of the following conditions are met:

(A) An airborne sample demonstrates no more than one colony-forming unit per cubic meter of air.

(B) A surface sample demonstrates no more than three colony-forming units per contact plate.

(2) An ISO class seven environment shall have acceptable levels of microbial growth if both of the following conditions are met:

(A) An airborne sample demonstrates no more than 10 colony-forming units per cubic meter of air.

(B) A surface sample demonstrates no more than five colony-forming units per contact plate.

(3) An ISO class eight environment shall have acceptable levels of microbial growth if both of the following conditions are met:

(A) An airborne sample demonstrates no more than 100 colony-forming units per cubic meter of air.

(B) A surface sample demonstrates no more than 100 colony-forming units per contact plate.

(gg) Unless sterility has been confirmed by testing, each high-risk sterile preparation shall be administered according to the following:

(1) Within 24 hours of compounding if stored at room temperature;

(2) within three days of compounding if stored under refrigeration; or

(3) within 45 days of compounding if stored frozen at -20°C (-4°F) or colder.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630 and K.S.A. 2017 Supp. 65-1637e; implementing K.S.A. 2017 Supp. 65-1626a, K.S.A. 65-1634, K.S.A. 2017 Supp. 65-1637c, and K.S.A. 2017 Supp. 65-1642; effective May 11, 2018.)

Article 14 Wholesale Distributors

Kan. Admin. Regs. § 68-14-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1998 Supp. 65-1643; effective June 15, 1992; amended March 20, 1995; amended July 30, 1999; revoked Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-2 Definitions

As used in this article of the board's regulations and the pharmacy practice act, each of the following terms shall have the meaning specified in this regulation:

(a) "Blood" means whole blood collected from a single donor and processed either for transfusion or for further manufacturing.

(b) "Blood component" means that part of blood separated by physical or mechanical means.

(c) "Common ownership and 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, by voting rights, by contract, or by other means.

(d) "Drug sample" means a unit of a prescription-only drug that is not intended to be sold, is intended to promote the sale of the drug, and is distributed on a gratuitous basis.

(e) "Device" has the meaning specified in K.S.A. 65-656, and amendments thereto.

(f) "Emergency medical reasons" shall include transfers of prescription-only drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, except that the gross dollar value of these transfers shall not exceed five percent of the total prescription-only drug sales revenue of either the transferor or transferee pharmacy during any period of 12 consecutive months.

(g) "Excursion" means a deviation from the range of temperatures specified by the manufacturer for storage or transport of a prescription-only drug or device based on stability data.

(h) "Intracompany sales" and "intracompany distribution" mean any transaction or transfer between any division, subsidiary, parent, affiliated, or related company under the common ownership and control of a corporate entity.

(i) "Primary owner" means any person owning or controlling more than 50 percent of the wholesaler's business.

(j) "Room temperature" means a temperature that is maintained thermostatically and meets the following requirements:

(1) Encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F);

(2) results in a mean kinetic temperature calculated to be not more than 25°C (77°F); and

(3) allows for excursions between 15° and 30°C (59° to 86°F) experienced in facilities, such that the allowable calculated mean kinetic temperature remains in the allowed range.

(k) "Virtual wholesale distribution" means arranging for the distribution of a drug or device, which may include taking actual possession of the drug or device and shall include contracting with another entity for the distribution, purchase, and sale of the drug or device.

(l) "Virtual wholesale distributor" means a business entity that arranges for the distribution of a drug or device, with or without taking actual possession of the drug or device, and contracts with others for the distribution, purchase, and sale.

(m) "Wholesale distribution" means distribution of prescription-only drugs or devices to persons other than a consumer or patient and shall include virtual wholesale distribution and virtual wholesale distributors, but this term shall not include either of the following:

(1) The distribution of drug samples by manufacturers' representatives or representatives of the authorized distributor of record, in accordance with 21 U.S.C. 353; or

(2) the sale, purchase, or trade of blood and blood components intended for transfusion.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1626, as amended by L. 2019, ch. 52, sec. 7, K.S.A. 65-1643, K.S.A. 65-1655, K.S.A. 65-1655a, and K.S.A. 65-1655b; effective June 15, 1992; amended July 23, 1999; amended Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 1998 Supp. 65-1655 and 65-1643; effective June 15, 1992; amended July 23, 1999; revoked Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-4 Minimum required information for registration

(a) Each wholesale distributor, virtual wholesale distributor, third-party logistics provider, or outsourcing facility shall provide the board with the following minimum information as part of the registration requirements described in K.S.A. 65-1645, and amendments thereto, and as part of any renewal of any registration:

(1) The name, commercial business address, and telephone number of the registrant;

(2) each trade or business name used by the registrant;

(3) the address, telephone number, and name of the contact person for each facility used by the registrant for the storage, handling, and distribution of prescription-only drugs or devices;

(4) the type of ownership or operation, including partnership, corporation, or sole proprietorship;

(5) the name of each owner, operator, facility manager, and designated representative of the registrant, including the following:

(A) If a person, the name, address, and date of birth of the person;

(B) if a partnership, the name, address, and date of birth of each partner and the name of the partnership;

(C) if a corporation, the name, title, address, and date of birth of each corporate officer and director, the corporate name, and the name of the state of incorporation; and

(D) if a sole proprietorship, the name, address, and date of birth of the sole proprietor and the name of the business entity;

(6) a list of all states where the registrant is registered as a wholesale distributor, virtual wholesale distributor, third-party logistics provider, or outsourcing facility;

(7) a copy of any current DEA registration;

(8) all disciplinary actions or sanctions by any state or federal agency against the registrant or any principal, owner, director, officer, facility manager, or designated representative thereof;

(9) if the facility is located outside of Kansas, a record of the following:

(A) A current registration in the state where the registrant is located;

(B) a satisfactory inspection conducted within the previous 36-month period by the registering entity of the state where the registrant is located. If no such inspection record is readily available, the record of a satisfactory inspection conducted at the expense of the registrant within the previous 36-month period by a third party recognized by the board to inspect may be accepted; and

(C) a designated resident agent in Kansas for service of process, the record of whom shall also be on file with the secretary of state; and

(10) if the registrant is an outsourcing facility, a record of the following:

(A) A current outsourcing facility registration from the food and drug administration (FDA); and

(B) a current inspection report from an FDA inspection conducted within the previous 24-month period that indicates compliance with the requirements of the federal food, drug and cosmetic act, including guidance documents and current good manufacturing practices established by the FDA. If no such inspection record is readily available, the record of a satisfactory inspection conducted at the expense of the registrant within the previous 36-month period by a third party recognized by the board to inspect may be accepted.

(b) Each registrant shall provide the board with a surety bond that meets the requirements of 21 U.S.C. 360eee-2.

(c) Each registrant shall provide and maintain, in readily retrievable form, a list of all manufacturers, wholesale distributors, third-party logistics providers, outsourcing facilities, and dispensers with which the registrant is transacting business.

(d) Each registrant shall submit revised information requested by subsection (a) within 30 days after any change in that information.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1643, K.S.A. 65-1645, K.S.A. 65-1655, K.S.A. 65-1655a, and K.S.A. 65-1655b; effective June 15, 1992; amended July 23, 1999; amended Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-5 Personnel

(a) Each wholesale distributor registrant, virtual wholesale distributor registrant, third-party logistics registrant, or outsourcing facility registrant shall require each person employed in any wholesale distribution, virtual wholesale distribution, third-party logistics, or outsourcing activity, or any combination of these activities, to receive education, training, and experience sufficient for that person to perform the assigned functions in a manner providing assurance that the drug product quality, safety, and security will at all times be maintained as required by law. Each registrant shall maintain records of the training, education, and experience for five years.

(b) Each wholesale distributor registrant, virtual wholesale distributor registrant, or third-party logistics provider registrant shall designate an individual as the facility manager, who shall be responsible for all aspects of the registrant's operation.

(c) Each outsourcing facility registrant shall designate a pharmacist-in-charge, as defined by K.S.A. 65-1626 and amendments thereto, who shall be responsible for all aspects of the registrant's operation.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1655, K.S.A. 65-1655a, and K.S.A. 65-1655b; effective June 15, 1992; amended July 23, 1999; amended Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-6 Violations and penalties

Any license or registration granted under this article may be suspended or revoked by the board for willful and serious violation of these regulations.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 1991 Supp. 65-1655; effective June 15, 1992.)

Kan. Admin. Regs. § 68-14-7 Wholesale distributors; minimum requirements for the storage and handling of prescription-only drugs and devices and for the establishment and maintenance of prescription-only drug and device distribution records

Each wholesale distributor registrant shall meet the following minimum requirements for the storage and handling of prescription-only drugs and devices and for the establishment and maintenance of prescription-only drug and device distribution records by the registrant and its officers, agents, representatives, and employees:

(a) Facilities. Each facility at which prescription-only drugs and devices are stored, warehoused, handled, held, offered, marketed, transported from, or displayed shall meet the following requirements:

(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) have a quarantine area for storage of prescription-only drugs and devices that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, or suspected of being counterfeit, or that are in immediate or sealed, secondary containers that have been opened or deemed unfit for distribution;

(4) be maintained in a clean and orderly condition;

(5) be free from infestation by insects, rodents, birds, or vermin of any kind;

(6) be a commercial location and not a personal dwelling or residence;

(7) have sufficient storage space to maintain records of all transactions for at least five years; and

(8) be in a location separate from any other wholesale distributor or pharmacy registered by the board or another state.

(b) Security.

(1) Each facility used for wholesale distribution shall be secure from unauthorized entry.

(A) Access from outside the premises shall be kept to a minimum and be well controlled.

(B) The outside perimeter of the premises shall be well lighted.

(2) Each facility shall be equipped with an alarm system to detect entry after hours.

(3) Each facility 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.

(4) Each registrant shall ensure adequate accountability and control of all controlled substances in compliance with the Kansas uniform controlled substances act, federal drug laws, and all applicable regulations.

(5) Each registrant shall verify that all persons or entities who undertake, either directly or by any other arrangement, to transport prescription-only drugs or devices on behalf of the registrant ensure security.

(c) Storage. All prescription-only drugs and devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with manufacturer's recommendations to preserve the stability of these drugs and devices.

(1) If no storage requirements are established for a prescription-only drug or device, the drug or device may be held at room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(2) Appropriate manual, electromechanical, or electronic temperature and humidity-recording equipment, devices, logs, or a combination of these means shall be utilized to document proper storage of prescription-only drugs and devices at least once during each 24-hour period.

(3) The recordkeeping requirements in subsection (f) shall be followed for all stored prescription-only drugs and devices.

(d) Examination of materials.

(1) Upon receipt, each outside shipping container shall be visually examined to identify and to prevent the acceptance of prescription-only drugs or devices that are contaminated or otherwise unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(2) Each outgoing shipment shall be carefully inspected to identify the prescription-only drugs or devices and to ensure that there is no delivery of prescription-only drugs or devices that have been damaged in storage or held under improper conditions.

(3)(A) No registrant shall engage in the wholesale distribution of prescription-only drugs or devices that are purchased or received from pharmacies or practitioners or from wholesale distributors that obtained the drugs or devices from pharmacies or practitioners.

(B) Any registrant may receive for redistribution prescription-only drugs or devices returned from pharmacies or practitioners that were distributed by the registrant. Before redistribution, the registrant shall examine the prescription-only drug or device to ensure that it has not been opened or used. If the prescription-only drug or device has been opened, it shall be quarantined and physically separated from other prescription-only drugs or devices until the prescription-only drug or device is destroyed.

(C) Any registrant that also operates as a reverse logistics provider or returns processor may receive prescription-only drugs or devices for destruction from pharmacies and practitioners regardless of where the drugs or devices are obtained. Each registrant shall maintain documentation for the disposition of prescription-only drugs or devices sent for destruction with proof of destruction, including a certificate of destruction, for inventory accountability and shall maintain records documenting any return to the supplier.

(4) The recordkeeping requirements in subsection (f) shall be followed for all incoming and outgoing prescription-only drugs or devices.

(e) Returned, damaged, and outdated prescription-only drugs or devices.

(1) Prescription-only drugs or devices that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription-only drugs and devices until they are destroyed or returned to their supplier.

(2) Each prescription-only drug or device whose immediate or sealed outer or sealed secondary container has been opened or used shall be identified as such and shall be quarantined and physically separated from other prescription-only drugs or devices until the drug or device is either destroyed or returned to the supplier.

(3) If the conditions under which a prescription-only drug or device has been returned cast doubt on the drug's or device's safety, identity, strength, quality, or purity, then the drug or device shall be destroyed or returned to the supplier, unless examination, testing, or other investigations prove that the drug or device meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether or not the conditions under which a drug or device has been returned cast doubt on the drug's or device's safety, identity, strength, quality, or purity, the registrant shall consider, among other factors, the conditions under which the drug or device has been held, stored, or shipped before or during its return and the condition of the drug or device and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in subsection (f) shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription-only drugs or devices.

(f) Recordkeeping.

(1) Each registrant shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription-only drugs and devices. These records shall include the following information:

(A) The source of the drugs and devices, including the name and principal address of the seller or transferor, and the address of the location from which the drugs or devices were shipped;

(B) the identity and quantity of the drugs and devices received and either distributed or disposed of; and

(2) Each record related to the wholesale distribution of prescription-only drugs or devices, including invoices of purchase or sale, packing slips, and shipment records, shall accurately reflect the name of the registrant as that name appears on the registration issued by the board.

(3) Inventories and records shall be made available for inspection and photocopying by an authorized representative of the board for five years following disposition of the prescription-only drugs or devices.

(4) Records described in this regulation 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 representative of the board.

(5) Each registrant shall post all current federal and state registrations in a conspicuous place.

(g) Written policies and procedures. Each registrant shall establish, maintain, and adhere to written policies and procedures concerning the receipt, security, storage, inventory, and distribution of prescription-only drugs and devices, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. In addition, each registrant shall establish, maintain, and adhere to the following written policies and procedures:

(1) A procedure by which the oldest approved stock of a prescription-only drug or device is distributed first. The procedure may permit deviation from this requirement, if the deviation is temporary and appropriate to meet the needs of the receiving facility;

(2) a procedure to be followed for handling recalls and withdrawals of prescription-only drugs and devices. This procedure shall be adequate to deal with recalls and withdrawals due to any of the following:

(A) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other government agency, including the board;

(B) any voluntary action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or

(C) any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(3) a procedure to ensure that wholesale distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency;

(4) a procedure to ensure that all outdated prescription-only drugs or devices are segregated from other drugs or devices and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription-only drugs and devices. This documentation shall be maintained for five years after disposition of the outdated prescription-only drugs or devices; and

(5) a procedure to ensure that prescription-only drugs and devices are distributed only to registered entities with the authority to possess prescription-only drugs or devices in Kansas and to maintain documentation of this authority as part of the distribution record.

(h) Responsible persons. Each registrant shall establish and maintain a list of officers, directors, managers, and other persons in charge of wholesale prescription-only drug and device distribution, storage, and handling, including a description of their duties and a summary of their qualifications. This list shall be made available for inspection by the board.

(i) Compliance with federal, state, and local law.

(1) Each registrant that deals in controlled substances shall register with the DEA.

(2) Each registrant shall permit the board's authorized personnel to enter and inspect the registrant's premises and delivery vehicles and to audit the records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.

(3) Each registrant shall operate in accordance with the requirements of 21 U.S.C. 353, 21 U.S.C. 360eee-1, 21 U.S.C. 360eee-2, and any implementing regulation.

(j) Salvaging and reprocessing. Each registrant shall be subject to the provisions of any applicable federal, state, or local laws or regulations that relate to prescription-only drug or device salvaging or reprocessing.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1634 and K.S.A. 65-1655; effective June 15, 1992; amended July 23, 1999; amended Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-7a Third-party logistics providers; minimum requirements for operation and maintenance of records

Each third-party logistics provider registrant shall meet the following minimum requirements for operation and the maintenance of records:

(a) Facilities. Each facility at which a third-party logistics provider is located shall meet the following requirements:

(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) have a quarantine area for storage of prescription-only drugs and devices that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, or suspected of being counterfeit or that are in immediate or sealed, secondary containers that have been opened or deemed unfit for distribution;

(4) be maintained in a clean and orderly condition;

(5) be free from infestation by insects, rodents, birds, or vermin of any kind;

(6) be in a location separate from any pharmacy registered by the board or another state;

(7) be a commercial location and not a personal dwelling or residence; and

(8) have sufficient storage space to maintain records of all shipments pertaining to third-party logistics for at least five years.

(b) Security.

(1) Each facility used for third-party logistics shall be secure from unauthorized entry.

(A) Access from outside the premises shall be kept to a minimum and be well controlled.

(B) The outside perimeter of the premises shall be well lighted.

(2) Each facility shall be equipped with an alarm system to detect entry after hours.

(3) The recordkeeping requirements in subsection (f) shall be followed for all stored prescription-only drugs and devices.

(d) Examination of materials.

(3) The recordkeeping requirements in subsection (f) shall be followed for all incoming and outgoing prescription-only drugs or devices.

(e) Returned, damaged, and outdated prescription-only drugs or devices.

(2) Each prescription-only drug or device whose immediate or sealed outer or sealed secondary container has been opened or used shall be identified as such and shall be quarantined and physically separated from other prescription-only drugs and devices until the drug or device is either destroyed or returned to the supplier.

(4) The recordkeeping requirements in subsection (f) shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription-only drugs or devices.

(f) Recordkeeping.

(A) The source of the drugs and devices, including the name and principal address of the seller or transferor, and the address of the location from which the drugs or devices were shipped;

(B) the identity and quantity of the drugs and devices received and either distributed or disposed of; and

(2) Inventories and records shall be made available for inspection and photocopying by an authorized representative of the board for five years following disposition of the prescription-only drugs or devices.

(3) The records described in this regulation 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 representative of the board.

(4) Each registrant shall post all current federal and state registrations in a conspicuous place.

(A) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other government agency, including the board;

(B) any voluntary action by the manufacturer to remove defective or potentially defective drugs or devices from the market; or

(C) any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(3) a procedure to ensure that the registrant prepares for, protects against, and handles any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency; and

(4) a procedure to ensure that all outdated prescription-only drugs or devices are segregated from other drugs and devices and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription-only drugs or devices. Each registrant shall maintain this documentation for five years after disposition of each outdated prescription-only drug or device.

(h) Responsible persons. Each registrant shall establish and maintain a list of officers, directors, managers, and other persons in charge of prescription-only drug and device distribution, storage, and handling, including a description of their duties and a summary of their qualifications. This list shall be made available for inspection by the board.

(i) Compliance with federal, state, and local law.

(1) Each registrant that deals in controlled substances shall register with the DEA.

(3) Each registrant shall operate in accordance with the requirements of 21 U.S.C. 360eee, or any implementing regulation.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1634 and K.S.A. 65-1655a; effective Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-7b Outsourcing facilities; minimum requirements for operation and maintenance of records

Each registrant who is the owner of an outsourcing facility shall meet the following minimum requirements for operation and the maintenance of records:

(a) Facilities. Each outsourcing facility shall meet the following requirements:

(1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) have a quarantine area for storage of prescription-only drugs and devices that are outdated, damaged, deteriorated, misbranded, adulterated, or deemed unfit for distribution;

(4) have a quarantine area designated for holding products waiting for testing data before being released for distribution;

(5) be maintained in a clean and orderly condition;

(6) be free from infestation by insects, rodents, birds, or vermin of any kind;

(7) be a commercial location and not a personal dwelling or residence; and

(8) have sufficient storage space to maintain records of all shipments pertaining to outsourcing for at least five years.

(b) Security.

(1) Each facility used for outsourcing shall be secure from unauthorized entry.

(A) Access from outside the premises shall be kept to a minimum and be well controlled.

(B) The outside perimeter of the premises shall be well lighted.

(2) Each facility shall be equipped with an alarm system to detect entry after hours.

(3) The recordkeeping requirements in subsection (f) shall be followed for all stored prescription-only drugs and devices.

(d) Examination of materials.

(3) The recordkeeping requirements in subsection (f) shall be followed for all incoming and outgoing prescription-only drugs and devices.

(e) Returned, damaged, and outdated prescription-only drugs and devices.

(2) Each prescription-only drug or device whose immediate or sealed outer or sealed secondary container has been opened or used shall be identified as such and shall be quarantined and physically separated from other prescription-only drugs until the drug or device is either destroyed or returned to the supplier.

(3) If the conditions under which a prescription-only drug or device has been returned cast doubt on the drug's or device's safety, identity, strength, quality, or purity, then the drug or device shall be destroyed, unless examination, testing, or other investigations prove that the drug or device meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether or not the conditions under which a drug or device has been returned cast doubt on the drug's or device's safety, identity, strength, quality, or purity, the registrant shall consider, among other factors, the conditions under which the drug or device has been held, stored, or shipped before or during its return and the condition of the drug or device and its container, carton, or labeling, as a result of storage or shipping.

(4) The recordkeeping requirements in subsection (f) shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription-only drugs and devices.

(f) Recordkeeping.

(1) Each registrant shall establish and maintain records of all transactions regarding the receipt and distribution or other disposition of prescription-only drugs and devices and any bulk active pharmaceutical ingredients used in compounding or manufacturing. These records shall include the following information:

(A) The source of the drugs and devices or the active pharmaceutical ingredients, including the name and principal address of the seller or transferor, the address of the location from which the drugs or devices were shipped, and the certificate of analysis if an active pharmaceutical ingredient was received;

(B) the identity and quantity of the drugs and devices or the active pharmaceutical ingredients received and either distributed or disposed of; and

(C) the date of receipt of the drugs and devices and the date of distribution or any other disposition of the drugs and devices.

(2) Records shall be made available for inspection and photocopying by an authorized representative of the board for five years following disposition of the prescription-only drugs or devices.

(4) Each registrant shall post all current federal and state registrations in a conspicuous place.

(2) a procedure to be followed for handling recalls and withdrawals of prescription-only drugs and devices including written notification to the board within 24 hours. This procedure shall be adequate to deal with recalls and withdrawals due to any of the following:

(A) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other government agency, including the board;

(B) any voluntary action by the registrant to remove defective or potentially defective drugs or devices from the market; or

(C) any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(4) a procedure to ensure that all outdated prescription-only drugs or devices are segregated from other drugs or devices and destroyed. This procedure shall provide for written documentation of the disposition of outdated prescription-only drug or device. This documentation shall be maintained for five years after disposition of the outdated prescription-only drug or device; and

(5) a procedure to ensure that prescription-only drugs and devices are sold only to registered entities with the authority to possess prescription-only drugs and devices in Kansas and to maintain documentation of this authority as part of the distribution record.

(h) Responsible persons. Each registrant shall establish and maintain a list of officers, directors, managers, pharmacists, pharmacy technicians, and other persons in charge of drug compounding, distribution, storage, and handling, including a description of their duties and a summary of their qualifications. This list shall be made available for inspection by the board.

(i) Compliance with federal, state, and local law.

(1) Each registrant that deals in controlled substances shall register with the DEA.

(3) Each registrant shall operate in accordance with section 503B of the federal food, drug, and cosmetic act, 21 U.S.C. 353b.

(4) Each drug manufactured, prepared, propagated, compounded, or processed by an outsourcing facility without a registration issued by the board shall be deemed misbranded.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 65-1634 and K.S.A. 65-1655b; effective Jan. 3, 2020.)

Kan. Admin. Regs. § 68-14-8 Wholesale distributors transaction

(a) Notwithstanding any other provision of these regulations under article 14, a wholesale distributor, duly registered with the board, may sell or deliver to a layperson responsible for the control of an animal, a prescription-only drug to be administered to the animal only if a licensed veterinarian practitioner has issued, before the sale or delivery, a lawful written prescription or order for the prescription-only drug in the course of an existing, valid veterinarian-client-patient relationship as defined in K.S.A. 47-816 and amendments thereto. As used in these regulations under article 14, "wholesale distribution" shall include this transaction.

(1) Except as otherwise provided in this regulation, at the time the prescription-only drug leaves the registered location of the wholesale distributor, the wholesale distributor shall possess, at the registered location, a copy of the written prescription or order for the drug.

(2) Except as otherwise provided in this regulation, at the time the prescription-only drug is delivered to the layperson, the person making the delivery shall possess a copy of the written prescription or order for the drug.

(3) The wholesale distributor shall retain, for a period of five years, a copy of the written prescription or order in a manner that makes it readily available for review by a board representative.

(b) In lieu of receiving a written prescription or order from a licensed veterinarian practitioner before a prescription-only drug leaves the registered location, the wholesale distributor may accept a verbal order from a licensed veterinarian practitioner if all of the following conditions are met:

(1) The licensed veterinarian practitioner has created a written prescription or order, but advised the wholesale distributor that, under the circumstances, it is not reasonably possible for the licensed veterinarian practitioner to provide the written prescription or order to the wholesale distributor before the prescription-only drug leaves the registered location.

(2) The licensed veterinarian practitioner provides to the wholesale distributor all of the information required by K.A.R. 70-7-1(n) to be included in a written order for a prescription of legend drugs.

(3) The verbal order is received in a communication directly with the licensed veterinarian practitioner.

(4) The wholesale distributor makes, at the time the verbal order is received, a written confirmation of the information provided by the licensed veterinarian practitioner and records the following information:

(A) The name of the licensed veterinarian practitioner;

(B) the date and time the verbal order was received; and

(5) At the time of receiving the verbal order, the wholesale distributor requests that the licensed veterinarian practitioner send a written prescription for the prescription-only drugs so that it is received by the wholesale distributor within 72 hours of receipt of the verbal order and, if it is not received, advises the Kansas board of veterinary examiners of this in writing.

(6) At the time the prescription-only drug leaves the registered location of the wholesale distributor, the wholesale distributor possesses, at the registered location, the original written confirmation.

(7) At the time the prescription-only drug is delivered to the layperson responsible for the control of the animal, the person making the delivery possesses a copy of the written confirmation.

(8) The original written confirmation is maintained by the wholesale distributor for five years in a manner that makes it readily available for review by a board representative.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1999 Supp. 65-1635(d); effective July 23, 1999; amended Nov. 27, 2000.)

Kan. Admin. Regs. § 68-14-9 Requirements.

Kansas Administrative Regulations

State Board of Pharmacy

Article 14.—Wholesale Distributors

68-14-9. Requirements.

(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:

(1) “Registrant” means a trading partner as defined by K.S.A. 65-1626.

(2) “High risk product” means a product that has at least one of the following factors:

(A) Within 24 hours after determining or being notified by the FDA or a trading partner that there is a high risk that a product that the manufacturer has reason to believe is in an immediate trading partner’s possession is an illegitimate product.

(B) Within 24 hours after determining or being notified by the FDA or a trading partner that there is a specific high risk that could increase the likelihood that an illegitimate product will enter the U.S. pharmaceutical distribution supply chain.

(C) Within 24 hours after determining or being notified by the FDA or a trading partner that there exists an “other high risk” as determined by the FDA in guidance pursuant to 21 U.S.C. 360eee-1 subsection (h).

(3) “Illegitimate product” means a product for which credible evidence shows that the product:

(A) is counterfeit, diverted, or stolen;

(B) is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;

(D) appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.

(b) Each registrant shall operate in accordance with the requirements specified in 21 U.S.C. 353, 21 U.S.C. 360eee, 21 U.S.C. 360eee-1, 21 U.S.C. 360eee-2, 21 U.S.C. 360eee-3, and any implementing regulations.

(c) Each registrant shall adopt policies and procedures to ensure that each trading partner the registrant trades with is properly licensed or registered with Kansas and the state from which the trading partner is conducting business or if the state where the trading partner is conducting business from has not established a licensure requirement, is licensed by the secretary of health and human services.

(d) Each registrant shall notify the board in writing and provide the board with a copy of the completed form 3911, as issued by the FDA, within 24 hours of determining that a product in the possession or control of the registrant is an illegitimate product.

(e) Each manufacturer shall notify the board in writing and provide the board with a copy of the completed form 3911, as issued by the FDA, within 24 hours if the manufacturer has reason to believe that a trading partner may have in their possession a high risk product manufactured by or purported to be manufactured by the manufacturer.

(f) Each registrant shall not be required to meet the applicable requirements of subsection (b) if they have a waiver or exemption from the federal government or meet the exception specified in subsection (a)(3) of 21 U.S.C. 360eee-1.

(g) Each registrant shall notify the board in writing within 30 days of discovery if any of the following occur:

(1) The registrant identifies a trading partner that is not properly licensed or registered with Kansas and the state from which the trading partner is conducting business or if the state where the trading partner is conducting business from has not established a licensure requirement, is not licensed by the secretary of health and human services; or

(2) the registrant receives approval from the FDA granting the registrant a waiver, exception, or exemption from the requirements of subsection (a)(3) of 21 U.S.C. 360eee-1.

(h) Each registrant shall utilize a system approved by the board to respond to requests from the board for information required by subsection (b).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630, K.S.A. 2025 Supp. 65-1643d, K.S.A. 65-1655, and K.S.A. 65-1655a; implementing K.S.A. 65-1642, K.S.A. 2025 Supp. 65-1643, K.S.A. 2025 Supp. 65-1643d, K.S.A. 65-1648, K.S.A. 65-1655, and K.S.A. 65-1655a; effective Aug. 14, 2026.)

Article 15 Nonprescription Wholesale Distributors

Kan. Admin. Regs. § 68-15-1 Nonprescription wholesale distributors

"Nonprescription wholesale distributor" shall mean any person, partnership, corporation, or business firm registered in this state and engaging in the distribution of drugs that are not prescription-only drugs to persons or entities other than a consumer or patient.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1998 Supp. 65-1643(c); effective July 23, 1999.)

Kan. Admin. Regs. § 68-15-2 Nonprescription wholesale distributor registration required

A nonprescription wholesale distributor may engage in the distribution of nonprescription drugs to persons or entities, other than a consumer or patient in Kansas, if both of the following conditions are met:

(a) The drugs are prepackaged, fully prepared by the manufacturer or distributor for use by a consumer, and appropriately labeled.

(b) The distributor has first obtained a registration to do so from the board.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1998 Supp. 65-1643(c) and K.S.A. 65-1634; effective Sept. 24, 1999.)

Kan. Admin. Regs. § 68-15-4 Minimum requirements for storage

All drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with any requirements in the labeling or packaging of the drugs, or with any requirements in the United States pharmacopeia: the national formulary (USP/NF), as in effect on March 15, 1999 and published January 1, 1995.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 1998 Supp. 65-1643(c) and K.S.A. 65-1634; effective Sept. 24, 1999.)

Article 16 Cancer Drug Repository Program (not in active use)

Kan. Admin. Regs. § 68-16-1 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2007 Supp. 65-1667; effective Dec. 1, 2006; amended April 10, 2009; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1665 and K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-6 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-7 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-8 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Kan. Admin. Regs. § 68-16-9 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2005 Supp. 65-1667; effective Dec. 1, 2006; revoked Feb. 13, 2015.)

Article 18 Utilization of Unused Medications

Kan. Admin. Regs. § 68-18-1 Transferring unused medications

(a) Each administrator or operator of an adult care home, pharmacist-in-charge of a mail service pharmacy, and administrator of a medical care facility who wants to become a donating entity, as defined in L. 2008, ch. 9, sec. 2 and amendments thereto, shall submit to the board written notification of intent to participate in the unused medications program. The notification shall be submitted on a form approved by the board.

(b) Before the transfer of each unused medication to a qualifying center or clinic, each mail service pharmacy and medical care facility that has become a donating entity as specified in subsection (a) shall perform the following:

(1) Determine the quality and suitability of each unused medication by a pharmacist's verification that the unused medication meets the following requirements:

(A) Can be identified;

(B) is in the manufacturer's sealed container, a pharmacy unit-dose package, or a hermetically sealed tamper-evident package from the pharmacy;

(D) is not a controlled substance;

(E) has not been adulterated; and

(F) is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer;

(2) remove the name of the patient or resident and all of the patient's or resident's personal identifiers in order to protect confidentiality;

(3) consult with the qualifying center or clinic to determine whether the qualifying center or clinic is willing to accept each unused medication; and

(4) ensure that the qualifying center or clinic has a consulting pharmacist and is registered with the board to accept unused medications.

(c) Before the transfer of each unused medication to a qualifying center or clinic, each adult care home that has become a donating entity as specified in subsection (a) shall meet the requirements specified in paragraphs (b)(2), (3), and (4).

(d) When a donating entity transfers an unused medication to a qualifying center or clinic, the donating entity shall meet the following requirements:

(1) Complete a manifest on a form approved by the board; and

(2) include a copy of the manifest with the unused medications.

(e) Each donating entity shall maintain a copy of the manifest that the donating entity provided to the qualifying center or clinic for at least five years. The donating entity shall also maintain a copy of the manifest that was signed and returned by the qualifying center or clinic for at least five years.

(f) A donating entity shall not transfer an unused medication that can be dispensed only to a patient or resident registered with the drug manufacturer.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing L. 2008, ch. 9, §7; effective Jan. 2, 2009.)

Kan. Admin. Regs. § 68-18-2 Accepting unused medications

(a) Each qualifying center or clinic that elects to participate in the unused medications program shall submit to the board written notification of intent to participate on a form approved by the board.

(b) Each qualifying center or clinic shall maintain all unused medications in a storage unit with controlled access.

(c) After the acceptance of each unused medication from an adult care home that has become a donating entity as specified in K.A.R. 68-18-1(a), each qualifying center or clinic shall perform the following:

(1) Determine the quality and suitability of each unused medication by verification of a pharmacist that the unused medication meets the following requirements, in addition to the requirements of L. 2008, ch. 9, sec. 4 and amendments thereto:

(A) Can be identified; and

(B) is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer;

(2) ensure that the name of the patient or resident and all of the patient's or resident's personal identifiers have been removed in order to protect confidentiality;

(3) check each unused medication against the manifest to resolve any discrepancies with the donating entity; and

(4) complete the manifest and return a copy of the manifest to the donating entity.

(d) After the acceptance of each unused medication from a mail service pharmacy or a medical care facility that has become a donating entity as specified in K.A.R. 68-18-1(a), each qualifying center or clinic shall perform the following:

(1) Determine the quality and suitability of each unused medication by the verification of a pharmacist or practitioner that the unused medication meets the following requirements, in addition to the requirements of L. 2008, ch. 9, sec. 4 and amendments thereto:

(A) Can be identified; and

(B) is not a medication that can be dispensed only to a patient or resident registered with the drug manufacturer; and

(2) meet all of the requirements specified in paragraphs (c)(2), (3), and (4).

(e) Each qualifying center or clinic shall maintain a copy of the manifest that was provided by the donating entity for at least five years. The qualifying center or clinic shall also maintain a copy of the manifest signed and returned to the donating agency for at least five years.

(f) A qualifying center or clinic shall not accept or dispense an unused medication that can be dispensed only to a patient or resident registered with the drug manufacturer.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing L. 2008, ch. 9, §7; effective Jan. 2, 2009.)

Kan. Admin. Regs. § 68-18-3 Recall of unused medications

(a) If an unused medication is recalled and the qualifying center or clinic does not have the lot number on the label to differentiate between the recalled medications and the nonrecalled medications, all of the unused medications shall be destroyed.

(b) If a donating entity has transferred an unused medication to a qualifying center or clinic, the medication is subsequently recalled, and the donating entity has been notified of the recall, the donating entity shall be responsible for notifying the qualifying center or clinic of the recall.

(c) Each qualifying center or clinic in possession of any unused medication that is expired, adulterated, or recalled shall make a manifest for and destroy that medication.

(d) Following the destruction of any unused medications, the manifest shall be signed by the consulting pharmacist and a witness to verify the destruction. Each drug destruction manifest shall be maintained for at least five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing L. 2008, ch. 9, §7; effective Jan. 2, 2009.)

Article 19 Continuous Quality Assurance Programs

Kan. Admin. Regs. § 68-19-1 Minimum program requirements

Each pharmacy's continuous quality improvement program shall meet the following minimum requirements:

(a) The pharmacist-in-charge or the pharmacist-in-charge's designee shall start reviewing each incident report within seven days, and the pharmacist-in-charge shall complete the review of each incident report within 30 days of the incident report's creation. The pharmacist-in-charge shall document and perform the following as part of the review process:

(1) Communicate with each employee involved in the incident;

(2) complete a root cause analysis of the incident report; and

(3) create a corrective action plan for the incident.

(b) No later than the 15th day of each February, April, June, August, October, and December, the pharmacist-in-charge shall create a summary and communicate the information from the summary to each licensee and registrant under the pharmacist-in-charge's supervision. The summary shall include the following information from the two previous calendar months:

(1) Each type of incident reported, including each identified prescription number involved;

(2) each root cause analysis completed;

(3) each corrective action plan created; and

(4) evaluation of the outcomes and effectiveness of each correction action plan from the monthly summaries for the previous four months.

If the pharmacy did not have any new incident report, root cause analysis, or corrective action plan since the last summary, the pharmacist-in-charge shall create a null report. "Null report" means a report that states that the pharmacy did not have any new incident reports, root cause analyses, or corrective action plans.

(c) The pharmacy shall maintain a copy of each summary and null report in a readily retrievable format for a period of at least five years.

(d) Any pharmacy that actively reports to a patient safety organization certified by the secretary pursuant to 42 U.S.C. § 299b-24, and amendments thereto, that has a primary mission of continuous quality improvement, shall be exempt from the requirements set forth in paragraphs (a)(2), (a)(3), (b)(2), and (b)(3) of this regulation. The pharmacy shall maintain a record of the pharmacy's membership with the patient safety organization in a readily retrievable format for a period of five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-1695; effective April 10, 2009; amended Nov. 29, 2019; amended Aug. 16, 2024.)

Article 20 Controlled Substances

Kan. Admin. Regs. § 68-20-1 Definitions

As used in this article of the board's regulations, each of the following terms shall have the meaning specified in this regulation:

(a) "Act" means the uniform controlled substances act of Kansas, K.S.A. 65-4101 et seq., and amendments thereto.

(b) "Basic class," when referring to controlled substances listed in K.S.A. 65-4105 and K.S.A. 65-4107 and amendments thereto, means any of the following:

(1) Each of the opiates, including its isomers, esters, ethers, and salts, and salts of isomers, esters, and ethers, whenever the existence of the isomers, esters, ethers and salts is possible within the specific chemical designation listed in K.S.A. 65-4105(b) and amendments thereto;

(2) each of the opium derivatives, including its salts and isomers, and salts of isomers, whenever the existence of the salts, isomers, and salts of isomers is possible within the specific chemical designation listed in K.S.A. 65-4105(c) and amendments thereto;

(3) each of the hallucinogenic substances, including its salts and isomers, and salts of isomers, whenever the existence of the salts, isomers, and salts of isomers is possible within the specific chemical designation listed in K.S.A. 65-4105(d) and amendments thereto;

(4) each of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(A) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium, and tincture of opium;

(B) apomorphine;

(D) ethylmorphine;

(E) hydrocodone;

(F) hydromorphone;

(G) metopon;

(H) morphine;

(I) oxycodone;

(J) oxymorphone;

(K) thebaine;

(L) mixed alkaloid of opium listed in K.S.A. 65-4107(b)(1) and amendments thereto;

(M) cocaine; and

(N) ecgonine;

(5) each of the opiates, including its isomers, esters, ethers, and salts, whenever the existence of the isomers, esters, ethers, and salts is possible within the specific chemical designation listed in K.S.A. 65-4107(c) and amendments thereto;

(6) methamphetamine, including its salts, isomers, and salts of isomers, when contained in any injectable liquid;

(7) amphetamine, its salts, optical isomers and salts of its optical isomers;

(8) phenmetrazine and its salts; or

(9) methylphenidate.

(c) "Controlled premises" means a facility registered with the board and any conveyance operated by the facility where controlled substances or original or copies of records or documents required under the act are kept or required to be kept and where registrants or persons who are exempted from registration under the act may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances.

(d) "Drug of concern" has the meaning specified in K.S.A. 65-1682, and amendments thereto.

(e) "Prescription" means an order for medication that is dispensed to or for an ultimate user. This term shall not include an order for medication that is dispensed for immediate administration to the ultimate user. An order for a single dose of a drug for immediate administration to a bed patient in a medical care facility shall not be construed to be a prescription.

(f) "Readily retrievable" has the meaning specified in K.S.A. 65-1626 and K.S.A. 65-4101, and amendments thereto.

(g) "Registrant" means any person who is registered pursuant to K.S.A. 65-4117, and amendments thereto.

(h) "Secretary" means executive secretary of the Kansas state board of pharmacy.

(i) Each term used in this article of the board's regulations that is not defined in this regulation shall have the meaning specified in the act, the Kansas pharmacy act, or the Kansas prescription monitoring program act, and amendments thereto.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4102; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1985; amended May 1, 1989; amended June 2, 2023.)

Kan. Admin. Regs. § 68-20-2 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-4 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-5 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-4115; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-6 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-4115; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended, E-77-42, Sept. 9, 1976; amended Feb. 15, 1977; amended May 1, 1978; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-7 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-8 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1976 Supp. 65-4102; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked, E-77-42, Sept. 9, 1976; revoked Feb. 15, 1977.)

Kan. Admin. Regs. § 68-20-8a Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1977 Supp. 65-4115; effective May 1, 1978; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-8b Rejected

68-20-8b and 68-20-8c.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1976 Supp. 65-4115; effective, E-77-42, Sept. 9, 1976; effective Feb. 15, 1977; rejected, L. 1977, ch. 320, May 13, 1977.)

Kan. Admin. Regs. § 68-20-8c Rejected

68-20-8b and 68-20-8c.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1976 Supp. 65-4115; effective, E-77-42, Sept. 9, 1976; effective Feb. 15, 1977; rejected, L. 1977, ch. 320, May 13, 1977.)

Kan. Admin. Regs. § 68-20-9 Fees for registration and reregistration

(a) Fee amounts.

(1) For each registration or reregistration of a manufacturer for each additional location in this state where controlled substances are manufactured, the registrant shall pay a fee of $50.00.

(2) For each registration or reregistration of each additional location from which controlled substances are distributed, the registrant shall pay a fee of $50.00.

(3) For each registration or reregistration of each location within this state where research or instructional activities are conducted with controlled substances listed in schedules I through V, the registrant shall pay a fee of $50.00.

(4) For each registration or reregistration to conduct chemical analysis with controlled substances listed in schedules I through V, as set out in K.S.A. 65-4105, K.S.A. 65-4107, K.S.A. 65-4109, K.S.A. 65-4111, K.S.A. 65-4113 and amendments thereto, within this state, the registrant shall pay a fee of $50.00.

(b) Time and method of payment; refund.

(1) Registration and reregistration fees shall be paid at the time the application for registration or reregistration is submitted for filing.

(2) Payment shall be made in the form of a personal, certified, cashier's check or a money order payable to the state board of pharmacy.

(3) Payments made in the form of stamps, foreign currency or third party endorsement checks shall not be accepted.

(4) If the application is not accepted for filing or is denied, all payments made under paragraph (1) through (4) of subsection (a) shall be refunded to the applicant.

(1) Any official or agency of the U.S. army, navy, marine corps, air force, coast guard, veteran's administration or public health service authorized to procure or purchase controlled substances for official use shall be exempted by the board from the fees set forth in subsection (a), paragraphs (1) through (4).

(2) Any official, employee, or other civil service or agency of the United States, or any state, or any political subdivision or agency thereof, authorized to dispense or administer such substances, to conduct research, instructional activities, or chemical analysis with such substances, or any combination thereof, in the course of the official duties of employment, may be exempted by the board from the fees in subsection (a), paragraphs (1) through (4).

(d) In order to claim exemption from payment of a registration or reregistration fee, the registrant shall have completed the certification on the appropriate application forms. The registrant's superior shall certify the status and address of the registrant and shall certify to the authority of the registrant to acquire, possess, or handle controlled substances.

(e) Exemption from the payment of a registration or reregistration fee shall not relieve the registrant of any other requirements or duties prescribed by law.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4116; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1983; amended May 1, 1986; amended June 6, 1994.)

Kan. Admin. Regs. § 68-20-10 Requirements of registration

(a) Persons required to register. Every person who manufactures, distributes, or dispenses any controlled substances within this state, or who proposes to engage in the manufacture, distribution, or dispensing of any controlled substance in this state shall obtain annually a registration unless exempted by law or pursuant to subsections (d) through (g) of this regulation. Only persons actually engaged in these activities in this state shall be required to obtain a registration.

(b) Separate registration for independent activities.

(1) The following six groups of activities shall be deemed to be independent of each other:

(A) Manufacturing controlled substances;

(B) distributing controlled substances;

(C) dispensing, conducting research, other than research described in paragraph (b)(1)(D), with, and conducting instructional activities with, controlled substances listed in schedules II through V;

(D) conducting research with narcotic drugs listed in schedules II through V for the purpose of continuing the dependence on these drugs of a narcotic drug-dependent person in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program pursuant to a notice of claimed investigational exemption for a new drug approved by the food and drug administration;

(E) conducting research and instructional activities with controlled substances listed in schedule I; and

(F) conducting chemical analysis with controlled substances listed in any schedule.

(2) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this subsection (b). Any person, when registered to engage in the group of activities described in each paragraph in this subsection, shall be authorized to engage in the coincident activities described in that paragraph without obtaining a registration to engage in such coincident activities if, unless specifically exempted, the person complies with all requirements and duties prescribed by law for the following persons registered to engage in the coincident activities:

(A) A person registered to manufacture any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class that the person is not registered to manufacture.

(B) A person registered to manufacture any controlled substance listed in schedules II through V shall be authorized to conduct chemical analysis and preclinical research, including quality control analysis, with narcotic and nonnarcotic controlled substances listed in those schedules in which the person is authorized to manufacture.

(C) A person registered to conduct research with a basic class of controlled substances listed in schedule I shall be authorized to manufacture this class if and to the extent that the manufacture is set forth in the research protocol filed with the application for registration and to distribute this class to other persons registered to conduct research with this class or to conduct chemical analysis.

(D) A person registered to conduct chemical analysis with controlled substances shall be authorized to perform the following:

(i) Manufacture and import these substances for analytical or instructional purposes;

(ii) distribute these substances to other persons registered to conduct chemical analysis or instructional activities, to persons registered or authorized to conduct research with these substances, and to persons exempted from registration pursuant to subsection (c);

(iii) export these substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries; and

(iv) conduct instructional activities with controlled substances.

(E) A person registered or authorized to conduct research, other than the research described in paragraph (b)(2)(C), with controlled substances listed in schedules II through V shall be authorized to perform the following:

(i) Conduct chemical analysis with controlled substances listed in those schedules in which the person is authorized to conduct research to manufacture is set forth in a statement filed with the application for registration;

(ii) distribute these substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with these substances and to persons exempted from registration pursuant to subsection (c); and

(iii) conduct instructional activities with controlled substances.

(F) A person registered to dispense under the pharmacy act, or to conduct research, other than research described in paragraph (b)(2)(D), with controlled substances listed in schedules II through V shall be authorized to dispense and to conduct research and to conduct instructional research with those substances.

(3) A single registration to engage in any group of independent activities may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in schedule I may conduct research with any substance listed in schedule I for which the person has filed and had approved a research protocol.

(1) A separate registration shall be required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, or dispensed by a person.

(2) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

(A) A warehouse where controlled substances are stored by or on behalf of a registered person, unless these substances are distributed directly from the warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of the pharmacy act, K.S.A. 65-4116 and amendments thereto;

(B) an office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains these substances, other than substances for display purposes only, nor serves as a distribution point for filling sales orders; and

(C) an office used by a practitioner or mid-level practitioner who is registered at another location where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner or mid-level practitioner at this office, and where no supplies of controlled substances are maintained.

(d) Exemption of agents and employees; affiliated practitioners.

(1) Practitioners, mid-level practitioners, pharmacists, and other persons required to register under this act shall not be exempt from registration because of their status as an agent or employee of a person who is already registered to engage in any group of independent activities. The requirements of registration, however, shall be waived for any agent or employee of a person who is registered to engage in any group of independent activities, if the agent or employee is acting in the usual course of his business or employment.

(2) A practitioner who is an intern, resident, or foreign physician or medical graduate may dispense and prescribe controlled substances under the registration of the hospital or other institution that is registered and by whom the person is employed if all of the following conditions are met:

(A) The practitioner is authorized or permitted to do so by the laws of the state of Kansas.

(B) The dispensing or prescribing is done in the usual course of the practitioner's professional practice.

(C) The hospital or other institution by whom the person is employed has determined that the practitioner is permitted to dispense or prescribe drugs by the state of Kansas.

(D) The practitioner is acting only within the scope of employment in the hospital or institution.

(E) The hospital or other institution authorizes the intern, resident, or foreign physician or medical graduate to dispense or prescribe under the hospital registration and designates a specific internal registration code number for each intern, resident, or foreign physician or medical graduate so authorized. The code number shall consist of numbers, letters, or a combination of both and shall be a suffix to the institution's drug enforcement administration registration number, preceded by a hyphen.

(F) A current list of internal codes and the corresponding practitioners is kept by the hospital or other institution, and an updated copy is on file with the state board of pharmacy of the state of Kansas for the purposes of verifying the authority of the prescribing practitioner.

(e) Exemption of certain military and other personnel.

(1) The requirement of registration shall be waived for any official of the U.S. army, navy, marine corps, air force, coast guard, or public health service who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of official duties. These officials shall follow the procedures set forth in K.A.R. 68-20-18, 68-20-19, 68-20-20, and 68-20-21, but shall state the branch of service or agency and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a public health service employee is the person's social security identification number.

(2) If any official exempted by this subsection also engages as a private individual in any activity or group of activities for which registration is required, the official shall obtain a registration for these private activities.

(f) Exemption of law enforcement officials.

(1) The requirement of registration shall be waived for the following persons in the circumstances described in this subsection:

(A) Any officer or employee of the bureau, any officer of the U.S. bureau of customs, any officer or employee of the United States food and drug administration, and any other federal officer who is lawfully engaged in the enforcement of any federal law relating to controlled substances, drugs, or customs, and is duly authorized to possess controlled substances in the course of official duties; and

(B) any officer or employee of the state of Kansas, or any political subdivision or agency thereof, who is engaged in the enforcement of Kansas law or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of official duties.

(2) Any official exempted by this subsection may, when acting in the course of official duties, possess any controlled substance and distribute any such substance to any other official who is also exempted by this subsection and acting in the course of official duties.

(3) Any official exempted by this subsection may procure any controlled substance in the course of an inspection, in accordance with the controlled substances act, K.S.A. 65-4131(c) and amendments thereto, or in the course of any criminal investigation involving the person from whom the substance was procured.

(4) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use as standards in chemical analysis, these laboratories shall obtain annually a registration to conduct chemical analysis. These laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, shall be deemed to be officials exempted by this subsection and within the activities described in the controlled substances act, K.S.A. 65-4115 and amendments thereto. For purposes of this subsection, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this subsection.

(g) Exemption of civil defense officials.

(1) The requirement of registration shall be waived for any official of a civil defense or disaster relief organization who, in the course of official duties, is authorized to perform either of the following:

(A) Maintain, and distribute for maintenance, controlled substances held for emergency use; or

(B) procure controlled substances for the purposes of maintaining supplies for emergency use, if all procurement is from the U.S. general services administration and in accordance with the rules of the U.S. office of emergency preparedness.

(2) The requirement of registration shall be waived for any official of a civil defense or disaster relief organization during a state of emergency or disaster within the official's jurisdiction proclaimed by the president or by a concurrent resolution of the congress, which official, in the course of official duties during this emergency or disaster, is authorized to perform either of the following:

(A) Dispense controlled substances; or

(B) procure or distribute controlled substances, if all procurement is on a special "civil defense emergency order form," as described in this subsection.

(3) Civil defense emergency order forms shall be furnished by the U.S. office of emergency preparedness and shall contain the name of the civil defense or disaster relief organization. These forms may be used and shall be valid only during a state of emergency disaster proclaimed by the president or by a concurrent resolution of the congress for the area in which the organization using the forms has civil defense or disaster relief jurisdiction, who shall state the position and the nature and legal designation of the emergency or disaster. These forms may be filled by any person registered under the controlled substances act. The organization shall, upon the execution of a civil defense emergency order form, be deemed to be registered under the controlled substances act for purposes of record keeping pursuant to K.A.R. 68-20-16.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4116, as amended by L. 1999, Ch. 149, Sec. 9; implementing K.S.A. 65-4116, as amended by L. 1999, Ch. 149, Sec. 9, 65-4131; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended Dec. 27, 1999.)

Kan. Admin. Regs. § 68-20-10a Electronic transmission of a controlled substance prescription

(a) Each prescription drug order transmitted electronically shall be issued for a legitimate medical purpose by a prescriber acting within the course of legitimate professional practice.

(b) Each prescription drug order communicated by way of electronic transmission shall fulfill all the requirements of K.A.R. 68-2-22.

(c) A prescription drug order, including that for any controlled substance listed in schedules II, III, IV, and V, may be communicated by electronic transmission in accordance with 21 C.F.R. part 1311.

(d) Each electronic prescription drug order created and transmitted in conformance with 21 C.F.R. part 1311 shall be considered an original, written, signed prescription drug order.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630, K.S.A. 2014 Supp. 65-1642, and K.S.A. 2014 Supp. 65-4102; implementing K.S.A. 2014 Supp. 65-1642, 65-4102, and 65-4123; effective Feb. 5, 1999; amended Dec. 27, 1999; amended April 23, 2010; amended May 20, 2011; amended Feb. 13, 2015.)

Kan. Admin. Regs. § 68-20-11 Applications for registration

(a) The expiration date of all registrations shall be the last day of June in each year.

(b) Each application for the following types of registration shall include the controlled substances code number for each basic class or substance to be covered by the registration:

(1) Registration to handle any basic class of controlled substances listed in schedule I, except registration to conduct chemical analysis with such classes;

(2) registration to manufacture a basic class of controlled substances listed in schedules II through V; and

(3) registration to conduct research with any narcotic controlled substance in schedules II through V.

(1) the applicant, if an individual;

(2) the authorized representative, if the registration is for a location;

(3) a partner of the applicant, if a partnership; or

(4) by an officer of the applicant, if a corporation, corporate division, association, trust or other entity.

(d) Any applicant may authorize one or more individuals to sign applications for the applicant or location by filing, with the executive secretary of the board, a power of attorney for each such individual. The power of attorney shall contain the signature of the individual who shall be authorized to sign applications pursuant to that power of attorney. The power of attorney shall be valid until revoked by the applicant.

(e) Any person required to obtain more than one registration may submit all applications in one package. Each application shall be completed and should not refer to any accompanying application for required information.

(f) Applications submitted for filing shall be dated upon receipt. Completed applications shall be accepted for filing. If completed with only minor defects, the board may accept the application for filing and send a request to the applicant for additional information. A defective application shall be returned to the applicant within 10 days following its receipt with a statement of the reason for refusal to accept the application for filing. A defective application may be corrected and resubmitted for filing at any time.

(g) Additional information. The board may require any applicant or the applicant's authorized representative to submit such documents or written statements of fact relevant to the application as it deems necessary to determine whether the application should be granted. The failure of the applicant or authorized representative to provide the documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver of an opportunity to present the documents or facts for consideration by the board in granting or denying the application.

(h) Amendments to and withdrawal of applications.

(1) Any application may be amended or withdrawn without permission of the board at any time before the date on which the applicant or the applicant's authorized representative receives an order to show cause pursuant to K.S.A. 65-4119. Any application may be amended or withdrawn with permission of the board at any time good cause is shown by the applicant or the applicant's authorized representative, or when the amendment or withdrawal is in the public interest.

(2) After an application has been accepted for filing, a request by the applicant or the applicant's authorized representative for return of the application or failure of the applicant or authorized representative to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4116 as amended by L. 1987, Ch. 244, Sec. 3; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1985; amended May 1, 1988.)

Kan. Admin. Regs. § 68-20-12 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4116, 65-4117, 65-4118, 65-4119; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; revoked May 1, 1987.)

Kan. Admin. Regs. § 68-20-13 Hearings generally

In any case where the board shall hold a hearing on any registration or application therefor, the procedures for such hearing shall be conducted in accordance with the procedural provisions of the act and paragraph 68-20-13 of these regulations. Any hearing under this part shall be independent of and not in lieu of, criminal proceedings or other proceedings under the act or any other law of this state.

(A) Purpose of hearing—The board shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.

(B) Waiver or modification of rules—The board or its presiding officer (with respect to matters pending before him), may modify or waive any rule or regulation in paragraph 68-20-13 of these regulations by notice in advance of the hearing, if the board determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the records of the hearing.

(1) Any person entitled to a hearing may file with the board a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.

(2) If any person entitled to a hearing or to participate in a hearing waives his opportunity to participate in the hearing, the board may proceed without the presence of such person.

(D) Burden of proof.

(1) At any hearing for the denial of a registration, the board shall have the burden of proving that the requirements of such registration pursuant to the act (K.S.A. 65-4117, K.S.A. 65-4118) are not satisfied.

(2) At any hearing for the revocation or suspension of a registration, the board shall have the burden of proving that the requirements for such revocation or suspension in accordance with the provisions of the act (K.S.A. 65-4119).

(E) Time and place of hearing—The hearing will commence at the place and time designated in the order to show cause (unless expedited pursuant to paragraph 68-20-12D of these regulations) but thereafter, it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.

(F) Final order—As soon as practicable after the presiding officer has certified the record to the board, the board shall issue its order on the granting, denial, revocation or suspension of the registration. In the event that any application for registration is denied, or any registration is revoked or suspended, the order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. The board shall serve one copy of its order upon each party in the hearing by registered, return receipt requested mail.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4117, 65-4118, 65-4119; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973.)

Kan. Admin. Regs. § 68-20-14 Modification, transfer and termination of registration

(A) Modification in registration—Any registrant may apply to modify his registration to authorize the handling of additional controlled substances by submitting a letter of request to the state board of pharmacy. The letter shall contain the registrant's name, address, registration number and the substance and/or schedules to be added to his registration and shall be signed by the same person who signed the most recent application for registration or reregistration. If the registrant is seeking to handle additional controlled substances listed in schedule I for the purpose of research or instructional activities, he shall attach one copy of the federally approved research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent and duration of such instructional activities, as appropriate. One-half of the original fees shall be required to be paid for said modification. The request for modification shall be handled in the same manner as an application for registration.

(B) Termination of registration—The registration of any person or location shall terminate if and when such person or authorized representative of a location dies, ceases legal existence, discontinues business or professional practice or changes the location as shown on the certificate of registration. Any registrant who ceases legal existence, discontinues business or professional practice, or changes location as shown on the certificate of registration, shall notify the board promptly of such fact and forthwith deliver the certificate of registration directly to the secretary or executive secretary of the board. In the event of a change in name or mailing address the person or authorized representative of the location shall notify the board promptly in advance of the effective date of this change by filing the change of name or mailing address with the board. This change shall be noted on the original application on file with the board.

(C) Transfer of registration—No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the board may specifically designate and then only pursuant to its written consent.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4115; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973.)

Kan. Admin. Regs. § 68-20-15 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1976 Supp. 65-4115; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended, E-77-42, Sept. 9, 1976; amended Feb. 15, 1977; revoked May 1, 1983.)

Kan. Admin. Regs. § 68-20-15a Security requirements

(a) General security requirements. Each applicant and registrant shall provide effective controls and procedures to guard against theft and diversion of controlled substances in conformance with the security requirements of federal law, including the requirements of 21 CFR 1301.71 as in effect on April 1, 1999, which are hereby adopted by reference.

(b) Physical security controls for nonpractitioners shall comply with the requirements of 21 CFR 1301.72 and 1301.73 as in effect on April 1, 1999, which are hereby adopted by reference.

(1) Good faith inquiry. Before distributing a controlled substance to any person whom the registrant does not know to be registered to possess a controlled substance, each registrant shall make a good faith inquiry with the board to determine that the person is registered to possess a controlled substance.

(2) Suspicious orders. Each registrant shall design an operative system to disclose to the registrant any suspicious orders of controlled substances. Each registrant shall inform the board of suspicious orders when discovered. Suspicious orders shall include orders of unusual size, orders deviating from a normal pattern, and orders of unusual frequency.

(3) A controlled substance listed in schedules II through V shall not be distributed on a gratuitous basis by a manufacturer or distributor to a practitioner, mid-level practitioner, pharmacist, or any other person.

(d) Physical security controls for prescribers. Each prescriber shall provide effective controls and procedures to guard against theft and diversion of controlled substances in conformance with the security requirements of federal law, including the requirements of 21 CFR 1301.75 and 1301.76 as in effect on April 1, 1999, which are hereby adopted by reference.

(e) Other security controls for prescribers.

(1) In order to minimize the opportunities for diversion of controlled substances, each prescriber shall provide effective physical security, shall initiate additional procedures to reduce access by unauthorized personnel, and shall provide an alarm system if necessary.

(2) Minimum security standards for prescribers as set forth in this article shall be considered as guidelines to be used in evaluating security. Additional security controls and operating procedures may be required by the board to prevent diversion of controlled substances.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1998 Supp. 65-4102; implementing K.S.A. 65-4117; effective May 1, 1983; amended May 1, 1988; amended Sept. 9, 1991; amended March 20, 1995; amended Aug. 1, 1997; amended Feb. 5, 1999; amended Dec. 27, 1999.)

Kan. Admin. Regs. § 68-20-15b Notification to board; suspected diversion, theft, or loss of controlled substances

Either the pharmacist-in-charge or the pharmacy owner shall notify the board in writing within one day of any suspected diversion, theft, or loss of any controlled substance and, upon completion, shall provide the board with a copy of the completed DEA 106 form issued by the U.S. department of justice.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 2017 Supp. 65-4102; implementing K.S.A. 65-4117; effective Jan. 4, 2019.)

Kan. Admin. Regs. § 68-20-16 Records and inventories of registrants

(a) Except as provided in this regulation, each registrant shall keep records and maintain inventories in conformance with the recordkeeping and inventory requirements of 21 C.F.R. 1304.04(a)(2), (a)(3), (f), (g), (h)(1), (h)(2), (h)(3), and (h)(4), as in effect on February 1, 2022, which are hereby adopted by reference. Except as otherwise provided in this regulation, the registrant shall maintain executed order forms and controlled substance inventories at the registered facility and keep the records on file for at least five years.

(b) After the initial inventory is taken, the registrant shall take a subsequent inventory of all controlled substances and drugs of concern on hand at least every year but no later than 375 days after the date of the previous inventory. All controlled substances and drugs of concern shall be inventoried on the same calendar date.

(c) Each required inventory of schedule II controlled substances and nonliquid dosage forms of other controlled substances and drugs of concern shall be taken by exact count.

(d) Each registrant handling schedule V controlled substances and drugs of concern shall be subjected to the same inventory and recordkeeping requirements specified in subsections (a) and (b).

(e) Each inventory of controlled substances shall be maintained in legible, hard-copy format and shall include the following:

(1) The date the inventory was conducted;

(2) the name, license or registration number, and signature of each individual participating in the inventory; and

(3) documentation of whether the inventory was taken before the opening of business or after the close of business. If the pharmacy is open 24 hours per day and does not close, the time that the count was taken shall be documented.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102 and K.S.A. 65-4121; implementing K.S.A. 65-4121; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1989; amended July 31, 1998; amended Dec. 27, 1999; amended Nov. 13, 2009; amended June 2, 2023.)

Kan. Admin. Regs. § 68-20-17 Order forms

Each transfer of any schedule I or II controlled substance shall require the use of a drug enforcement agency (DEA) 222 form issued by the United States attorney general in accordance with 21 CFR part 1305 or an electronic order placed in accordance with 21 CFR part 1311.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; implementing K.S.A. 65-4102 and K.S.A. 65-4122; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1987; amended Feb. 5, 1999; amended Dec. 27, 1999; amended April 27, 2007.)

Kan. Admin. Regs. § 68-20-18 Information concerning prescriptions

(a) Any prescription for a controlled substance may be filled by a pharmacist if the prescription has been issued by a prescriber who meets the following requirements:

(1) Is legally authorized to prescribe controlled substances in Kansas or is authorized by the laws of another state; and

(2) is either registered or exempted from registration under K.S.A. 65-4116 or K.S.A. 65-4117 and amendments thereto.

(b)(1) To be valid, a prescription for a controlled substance shall be issued for a legitimate medical purpose by a prescriber acting in the usual course of professional practice. The responsibility for the proper prescribing and dispensing of controlled substances shall rest with the prescriber, but a corresponding responsibility shall rest with the pharmacist who fills the prescription. The individual filling an unlawful prescription, as well as the individual issuing it, shall be subject to the penalties provided for violations of the provisions of the act.

(2) A pharmacist shall not fill a prescription for a controlled substance or drug of concern for office use. However, any pharmacist may document on an invoice any distribution of controlled substances or drugs of concern made to a registrant.

(3) A prescription shall not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug-dependent individual for the purpose of continuing dependence upon these drugs, except as allowed by 21 C.F.R. 1306.07(d), as in effect on November 2, 2020, or in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program.

(c)(1) To be valid, a prescription for a controlled substance shall not be issued on a prescription blank that is preprinted or rubber-stamped with the name of a propriety preparation or with the strength, quantity, or directions.

(2) Each prescription for a controlled substance shall meet the following requirements:

(A) Be dated and signed on the date issued;

(B) bear the following information:

(i) The full name, address, and DEA registration number of the prescriber;

(ii) the name and address of the patient;

(iii) the drug name, strength, dosage form, quantity prescribed, and directions for use; and

(iv) if applicable, the identification number issued by the DEA or a written notice of action under the good faith exception pursuant to 21 C.F.R. 1301.28(e), as in effect on November 2, 2020, for a prescription for a schedule III, IV, or V narcotic drug approved by the FDA specifically for detoxification or maintenance treatment; and

(3) A prescriber shall manually sign a paper prescription in the same manner as that individual would sign a check or legal document. Each electronic prescription shall be issued and signed in accordance with 21 C.F.R. 1311.120(b)(9) and (b)(11), 21 C.F.R. 1311.135(a) and (c), 21 C.F.R. 1311.140, and 21 C.F.R. 1311.145, as in effect on February 1, 2022, which are hereby adopted by reference.

(4) Any prescription may be prepared by an agent for the signature of a prescriber, but the prescriber shall be responsible if the prescription does not conform in all essential respects to the state and federal law and regulations. A corresponding liability shall rest upon the pharmacist who fills a prescription that is not prepared in the form prescribed by this regulation.

(5) Each intern, resident, foreign physician, or foreign medical graduate exempted from registration under K.S.A. 65-4116, and amendments thereto, shall include on all prescriptions issued the registration number of the hospital or other institution and the special internal code number assigned to the intern, resident, foreign physician, or foreign medical graduate by the hospital or other institution as provided in K.A.R. 68-20-10. This requirement shall be in lieu of the registration number of the prescriber required by this subsection. Each prescription shall have the name of the intern, resident, foreign physician, or foreign medical graduate stamped or printed on it, as well as the signature of the prescriber.

(6) Each official exempted from registration under K.A.R. 68-20-10 shall include on all prescriptions issued the official's branch of service or agency and the service identification number. This requirement shall be in lieu of the registration number of the prescriber otherwise required by this subsection. The service identification number for a public health service employee shall be that individual's social security identification number. Each prescription shall have the name of the officer stamped or printed on it, as well as the signature of the officer.

(7) Any controlled substance prescription in schedules III through V may be issued as a paper or electronic prescription or transmitted by a prescriber or the prescriber's designated agent to a pharmacy by oral or facsimile transmission. Except as authorized by K.A.R. 68-2-22, each nonpaper prescription order shall be reduced to hard copy as soon as the order is reviewed by the pharmacist. The hard copy reduction shall include all information required by this regulation, except for the signature of the prescriber in the case of an oral transmission, and, if transmitted by other than the prescriber, shall bear the first name and last name of the person so transmitting the prescription. Each prescription sent by facsimile transmission shall be transmitted directly from the prescriber or the prescriber's designated agent to the pharmacy and shall contain a header identifying the sender of the prescription.

(8) Any controlled substance prescription in schedule II may be issued as a paper or electronic prescription. Each prescription for a schedule II controlled substance transmitted to a pharmacy by oral or facsimile transmission shall be dispensed in accordance with 21 C.F.R. 1306.11 and K.A.R. 68-20-19. Each prescription sent by facsimile transmission shall be transmitted directly from the prescriber or the prescriber's designated agent to the pharmacy and shall contain a header identifying the sender of the prescription.

(9) Any pharmacist may fill multiple prescriptions issued by a prescriber authorizing the patient to receive up to a 90-day supply of a schedule II controlled substance if all of the following conditions are met:

(A) Each separate prescription is issued for a legitimate medical purpose by a prescriber acting in the usual course of professional practice.

(B) The prescriber provides written instructions on each prescription other than the first prescription, if the prescriber intends for the first prescription to be filled immediately, indicating the earliest date on which the prescription may be filled.

(C) The prescriber concludes that providing the patient with multiple prescriptions does not create an undue risk of diversion or abuse.

(D) Each separate prescription meets all requirements for a schedule II controlled substances prescription, including being dated and signed on the date issued.

(d) A prescription for controlled substances shall be filled only by the following individuals:

(1) A pharmacist acting in the usual course of professional practice in a registered pharmacy, hospital drug room, or other registered place of employment; or

(2) a pharmacist intern acting under the direct supervision of a pharmacist.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; implementing K.S.A. 65-4123; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1988; amended Sept. 9, 1991; amended March 29, 1993; amended March 20, 1995; amended Dec. 27, 1999; amended June 2, 2023.)

Kan. Admin. Regs. § 68-20-18a Information concerning prescriptions; recordkeeping; pharmacy prescription application

(a) Each controlled substance shall be supplied or dispensed directly to a patient only pursuant to a prescription issued in accordance with K.A.R. 68-20-18. Each controlled substance shall be supplied at a registered facility for immediate facility administration to the ultimate user only pursuant to a medication order.

(b) Each dispensing, partial filling, or refilling of a prescription for a controlled substance shall be entered on the back of the prescription with the date, quantity, and name or initials of the pharmacist providing the final verification.

(c) As an alternative to the procedures provided by subsection (b), a pharmacy prescription application may be used for the storage and retrieval of dispensing, refill, and partial filling information for prescription orders for controlled substances if all of the following requirements are met:

(1) Each computerized system shall provide on-line retrieval, by computer monitor display or hard-copy printout, of original prescription order, refill, and partial fill information for those prescription orders that are authorized for filling. Each display or printout of information shall include the following:

(A) The original prescription number;

(B) the date of issuance of the original prescription order by the prescriber;

(D) the full name and address of the patient;

(E) the name, address, and DEA registration number of the prescriber;

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

(G) the identification code, or name or initials of the dispensing pharmacist;

(H) the total number of refills authorized by the prescriber, if applicable and allowable; and

(I) the total number of doses dispensed to date for that prescription order.

(2) Each pharmacist who makes use of a pharmacy prescription application shall document that the information in the pharmacy prescription application is correct each time the pharmacist fills, refills, or partially fills a controlled substance.

(A) If the pharmacy prescription application produces a hard-copy printout of each day's controlled substance prescription order data, the printout shall meet the following requirements:

(i) The printout shall be verified, dated, and signed by the pharmacist who filled or partially filled the prescription order. The pharmacist shall verify that the date indicated is correct and then sign this document in the same manner as the pharmacist would sign a check or legal document.

(ii) The printout shall be provided to each pharmacy using the computerized system within 72 hours of the date on which the controlled substance was dispensed.

(iii) The printout shall be verified and signed by each pharmacist who is involved in the dispensing.

(B) In lieu of signing a hard-copy printout of each day's controlled substance prescription order data, the pharmacy owner shall maintain a bound logbook or separate file in which each pharmacist involved in the dispensing shall sign a statement, in the manner described in paragraph (c)(2)(A), each day, attesting to the fact that the information entered into the pharmacy prescription application that day has been reviewed by the pharmacist and is correct as shown.

(3) Each pharmacy prescription application shall have the capability of producing a printout of any fill data that the facility is responsible for maintaining. Each printout shall include an audit trail for any specified strength and dosage form of any controlled substance, by brand, generic name, or both, in addition to the following:

(A) The name of the prescriber;

(B) the name and address of the patient;

(D) the date of dispensing of each fill;

(E) the name or identification code of the dispensing pharmacist; and

(F) the number of the original prescription order.

(4) If a pharmacy experiences a computer system outage of the pharmacy prescription application, the pharmacy shall have an auxiliary procedure that will be used for documentation of partial fills and refills of controlled substance prescriptions. This auxiliary procedure shall ensure that partial fills or refills are authorized by the original prescription, the maximum number of dosage units or refills has not been exceeded, the prescription is still valid for partial filling or refilling, and all appropriate data is retained for on-line data entry as soon as the computer system is available for use again.

(d) All prescriptions, records, and documents required by this article of the board's regulations shall be kept readily retrievable at the registered location for five years from the date of the last filling, refilling, partial filling, or entry into the record, except that financial and shipping records may be kept at other than the registered location with approval of the DEA.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4102, K.S.A. 65-4121, and K.S.A. 65-4123; effective June 2, 2023.)

Kan. Admin. Regs. § 68-20-19 Controlled substances listed in schedule II

(a)(1) A pharmacist shall dispense a controlled substance listed in schedule II that is a prescription-only drug only pursuant to a signed prescription issued in accordance with K.A.R. 68-20-18, except as provided in paragraph (a)(4).

(2) A prescription under the provisions of paragraph (a)(1) shall not be filled in either of the following circumstances:

(A) More than 90 days after the original date of issue appearing on the prescription; or

(B) before or after any date specified on the prescription by the prescriber.

(3)(A) For an emergency, as defined by paragraph (a)(4), a pharmacist may dispense a controlled substance listed in schedule II upon receiving the oral authorization of a prescriber, if all of the following requirements are met:

(i) The quantity prescribed and dispensed shall be limited to the amount adequate to treat the patient during the emergency period. Dispensing beyond the emergency period shall be pursuant to a signed prescription issued in accordance with K.A.R. 68-20-18.

(ii) The prescription shall be immediately reduced to a hard copy by the pharmacist and shall contain all information required under K.A.R. 68-20-18 except for the signature of the prescriber.

(iii) If the prescriber is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the authorization came from the prescriber, which may include a call back to the prescriber, using the prescriber's phone number as listed in the telephone directory or other good faith efforts to ensure the prescriber's identity, or both.

(iv) Within seven days after authorizing an emergency prescription drug order, the prescriber shall cause a written or electronic prescription drug order for the emergency quantity prescribed to be delivered to the dispensing pharmacist.

(B) In addition to meeting the requirements of K.A.R. 68-20-18, the prescription drug order shall have written on its face "Authorization for Emergency Dispensing" and the date of the prescription drug order.

(C) The written or electronic prescription drug order shall be delivered to the pharmacist in person within seven days of authorization or, if the written prescription is delivered by mail, it shall be postmarked within the seven-day period.

(D) Upon receipt, the dispensing pharmacist shall attach this written prescription drug order to the pharmacist's record of the emergency prescription drug order. For each electronic prescription, the dispensing pharmacist shall annotate the record of the electronic prescription with the original authorization and date of the oral order.

(E) The pharmacist shall notify the nearest office of the U.S. drug enforcement administration (DEA) if the prescribing practitioner fails to deliver a written or electronic prescription drug order to the pharmacist. Failure of the pharmacist to notify the DEA shall void the authority conferred by this regulation to dispense without a written or electronic prescription of a prescriber.

(4) For the purposes of authorizing a prescription of any controlled substance listed in schedule II of the federal or state uniform controlled substances act, the term "emergency situation" shall mean any situation in which the prescriber determines the following:

(A) That immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user;

(B) that no appropriate alternative treatment is available, including administration of a drug that is not a controlled substance under schedule II of the act; and

(C) that it is not reasonably possible for the prescriber to provide a written prescription to be presented, before dispensing, to the pharmacist dispensing the substance.

(b) The partial filling of a prescription for any controlled substance listed in schedule II shall be permissible, only as provided in this subsection.

(1) Whenever the pharmacist is unable to supply the full quantity called for in a written, electronic, or emergency prescription and the pharmacist makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency prescription, or electronic prescription record, the pharmacist shall perform the following:

(A) Fill the remaining portion of the prescription within 72 hours of the first partial filling or, if the remaining portion cannot be filled within the 72-hour period, the pharmacist shall notify the prescriber of the situation; and

(B) supply no further quantity beyond 72 hours without a new prescription.

(2) Prescriptions for schedule II controlled substances for patients in a long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities, including individual dosage units, as provided in this subsection. The pharmacist shall record on the prescription whether the patient is "terminally ill" or an "LTCF patient."

(A) The total quantity of schedule II controlled substances dispensed in all partial fillings shall not exceed the total quantity prescribed.

(B) These schedule II prescriptions shall be valid for partial filling for a period not to exceed 60 days from the issue date of the prescription unless terminated sooner by the discontinuance of medication.

(3) Any prescription for a schedule II controlled substance may be partially filled at the request of the patient or the prescriber who wrote the prescription. The pharmacist shall not fill or partially fill any remaining portions of the prescription more than 30 days after the date the prescription was written, except as provided by paragraphs (b)(1) and (2). The total quantity of schedule II controlled substances dispensed in all partial fillings shall not exceed the total quantity prescribed.

(c) Each pharmacist filling a written or emergency prescription for a controlled substance listed in schedule II shall ensure that a label that meets the requirements of K.A.R. 68-7-14 and 21 C.F.R. 290.5 is affixed to the package.

(d) All written prescriptions, electronic prescriptions, and written records of emergency prescriptions shall be kept in accordance with K.A.R. 68-20-16.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102; implementing K.S.A. 2022 Supp. 65-4107, K.S.A. 65-4121, and K.S.A. 65-4123; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended Sept. 9, 1991; amended March 29, 1993; amended March 20, 1995; amended Feb. 5, 1999; amended Dec. 27, 1999; amended June 2, 2023.)

Kan. Admin. Regs. § 68-20-20 Controlled substances listed in schedules III, IV, and V

(a) A pharmacist may dispense any controlled substance listed in schedule III, IV, or V that is a prescription-only drug pursuant only to a prescription issued in accordance with K.A.R. 68-20-18.

(b) Additional quantities of controlled substances listed in schedule III, IV, or V may be authorized by a prescriber through an oral refill authorization transmitted to the pharmacist if all of the following conditions are met:

(1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond six months from the date of issue of the original prescription.

(2) The pharmacist obtaining the oral authorization records on the reverse of the original prescription the following:

(A) The date;

(B) the quantity of refill;

(D) the initials of the pharmacist who received the authorization from the prescriber.

(3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

(4) The prescriber executes a new prescription as provided in K.A.R. 68-20-18 for any additional quantities beyond the five-refill, six-month limitation.

(5) The authorization of additional quantities is documented by either of the methods specified in K.A.R. 68-20-18a.

(c) A prescription for a controlled substance listed in schedule III, IV, or V may be partially filled if all of the following conditions are met:

(1) Each partial filling is recorded in the same manner as that for a refilling.

(2) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.

(3) No dispensing occurs after six months after the date on which the prescription was issued.

(d) Each pharmacist filling a prescription for a controlled substance listed in schedule III, IV, or V shall ensure that a label meeting the requirements of K.A.R. 68-7-14 is affixed to the package.

(e) All prescriptions for controlled substances listed in schedules III, IV, and V shall be kept in accordance with K.A.R. 68-20-16.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-4102 and K.S.A. 65-4121; implementing K.S.A. 65-4102, K.S.A. 65-4121, and K.S.A. 65-4123; effective, E-73-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1983; amended April 30, 1990; amended Aug. 4, 2000; amended June 2, 2023.)

Kan. Admin. Regs. § 68-20-21 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 1998 Supp. 65-4113; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended Dec. 27, 1999; revoked June 2, 2023.)

Kan. Admin. Regs. § 68-20-22 Selling without a prescription

Any controlled substance listed in schedule II, III, IV, or V that is not a prescription-only drug may be sold by a pharmacist without a prescription to a purchaser at retail if all of the following conditions are met:

(a) The sale of any substance that is a methamphetamine precursor is made in accordance with K.S.A. 65-16,102, and amendments thereto, and with 21 C.F.R. 1314.20, 21 C.F.R. 1314.25, 21 C.F.R. 1314.30, 21 C.F.R. 1314.100, and 21 C.F.R. 1314.105 as in effect on August 31, 2022.

(b) The sale of any substance that is not a methamphetamine precursor meets all of the following conditions:

(1) Approval of the sale is made only by a pharmacist and not by a nonpharmacist employee, even if under the supervision of a pharmacist.

(2) The pharmacist does not sell at retail more than 240 cc (8 ounces) of any controlled substance containing opium or more than 120 cc (4 ounces) of any other controlled substance to the same purchaser in any 48-hour period.

(3) The pharmacist does not sell at retail more than 48 dosage units of any controlled substance containing opium or more than 24 dosage units of any other controlled substance to the same purchaser in any 48-hour period.

(4) The purchaser is at least 18 years of age.

(5) The pharmacist requires every purchaser of a controlled substance to furnish suitable identification that includes proof of age.

(6) The pharmacist maintains a bound record book for the dispensing of controlled substances. The record 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 approved the sale of the substance to the purchaser. The record book shall be kept readily retrievable at the registered location for five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-16,106; implementing K.S.A. 65-16,102 and 65-16,104; effective May 1, 1978; amended June 2, 2023.)

Kan. Admin. Regs. § 68-20-23 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4102; effective, T-68-11-6-08, Nov. 6, 2008; effective March 6, 2009; revoked Oct. 27, 2023.)

Kan. Admin. Regs. § 68-20-31 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 2014 Supp. 65-4102; effective, T-68-1-23-15, Jan. 23, 2015; effective June 5, 2015; revoked Oct. 27, 2023.)

Kan. Admin. Regs. § 68-20-32 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4102; effective, T-68-7-17-23, July 17, 2023; effective Oct. 27, 2023; revoked Aug. 29, 2025.)

Kan. Admin. Regs. § 68-20-33 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by and implementing K.S.A. 65-4102; effective, T-68-10-10-23, Oct. 10, 2023; effective Jan. 12, 2024; revoked Aug. 29, 2025.)

Article 21 Prescription Monitoring Program

Kan. Admin. Regs. § 68-21-1 Definitions

As used in this article of the board's regulations, each of the following terms shall have the meaning specified in this regulation:

(a) "Authentication" means the provision of information, an electronic device, or a certificate by the board or its designee to a requester that allows the requester to electronically access prescription monitoring information. The authentication may include the provision of a user name, a password, or an electronic identification device or certificate.

(b) "DEA" means the drug enforcement administration of the United States department of justice.

(c) "Dispenser identification number" means the DEA number. If a DEA number is not issued to the dispenser, the dispenser identification number means the NPI number or the Kansas license number.

(d) "Drug enforcement administration number" means a unique registration number issued to a practitioner authorized by the DEA to prescribe controlled substances.

(e) "National provider identifier" and "NPI" mean a unique 10-digit number issued by the national provider identifier registry and used to identify each practitioner whose services are authorized by medicaid or medicare.

(f) "Patient identification number" means that patient's unexpired temporary or permanent driver's license number, state-issued identification card number, or pharmacy system-generated identification number. If the patient does not have one of those numbers, the dispenser shall use the patient's first, middle, and last initials, followed by the patient's eight-digit birth date. The patient identification number shall not include a social security number.

(g) "Report" means a compilation of data concerning a dispenser, patient, drug of concern, or scheduled substance as defined in K.S.A. 65-1682, and amendments thereto.

(h) "Valid photographic identification" means any of the following:

(1) An unexpired driver's license, state identification card, or instruction permit;

(2) an unexpired official passport issued by any nation;

(3) a United States military identification card; or

(4) an unexpired identification card issued by a United States Indian tribe.

(i) "Zero report" means an electronic data submission reflecting no dispensing activity for a given period.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1692; implementing K.S.A. 2022 Supp. 65-1682; effective Oct. 15, 2010; amended Aug. 13, 2014; amended June 2, 2023.)

Kan. Admin. Regs. § 68-21-2 Electronic reports

(a) Except as specified in subsections (d), (e), and (f) each dispenser shall file a report with the board for each scheduled substance and drug of concern sold in Kansas or to an address in Kansas. This report shall be submitted by the end of the next business day from the day that the drug is sold.

(b) Except as specified in subsections (c), (d), (e), and (f), each dispenser that does not dispense scheduled substances or drugs of concern in Kansas or to an address in Kansas during the reporting period specified in subsection (a) shall file a zero report with the board. Each zero report shall be filed by the end of the next business day.

(c) Any dispenser that meets the following conditions may submit a written request to the board for an exemption from subsection (b):

(1) The dispenser does not monthly dispense more than 10 prescriptions for scheduled substances and drugs of concern in Kansas or to an address in Kansas.

(2) The dispenser is unable to automate submission of a zero report.

(d) Any medical care facility, as defined by K.S.A. 65-1626, and amendments thereto, may submit a written request to the board for an exemption from subsections (a) and (b) if the medical care facility provides an interim supply of a scheduled substance or drug of concern to an outpatient on an emergency basis and the interim quantity does not exceed a 48-hour supply and, as described in K.A.R. 68-7-11(d)(2)(B), is limited to an amount sufficient to supply the outpatient's needs until a prescription can be filled in accordance with K.A.R. 68-7-11. This exemption shall apply only to the outpatient emergency interim supply of drugs and not to other outpatient dispensing or supply activities of the medical care facility.

(e) Any dispenser that does not dispense scheduled substances or drugs of concern in Kansas or to an address in Kansas may submit a written request to the board for an exemption from subsections (a) and (b) if both of the following conditions are met:

(1) The dispenser has submitted the required reports for at least three months or has provided three months of dispensing records to the board.

(2) The request is accompanied by the following:

(A) If the dispenser is a nonresident pharmacy, a list of states in which the pharmacy is registered;

(B) the current prescription monitoring program reporting status in each state in which the dispenser is registered; and

(C) a copy of any written reprimand, censure, or other disciplinary action related to prescription monitoring program reporting that the dispenser has had in any state, district, or territory.

(f) Any dispenser may submit a written request to the board for an exemption from subsections (a) and (b) of this regulation for each scheduled substance or drug of concern that is only dispensed to inmates at a correctional institution as defined by K.S.A. 75-5202, and amendments thereto, which do not exceed a 24-hour supply and are solely intended for administration to the inmates.

(g) Each dispenser or pharmacy that no longer meets the criteria for exemption specified in subsection (c), (d), (e) or (f) shall notify the board and begin submitting reports within seven days.

(h) Each exemption issued by the board shall expire annually on August 31.

(i) Each report required to be submitted pursuant to subsection (a) shall be submitted by secure file transfer protocol in the electronic format established by the American society for automation in pharmacy, dated no earlier than 2020, version 4, release 2b.

(j) Each dispenser shall correct any reporting error within seven days of discovering the error or being notified of the error by the board or the board's designee.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1692; implementing K.S.A. 2024 Supp. 65-1683; effective Oct. 15, 2010; amended April 15, 2011; amended Aug. 13, 2014; amended June 2, 2023; amended Aug. 29, 2025.)

Kan. Admin. Regs. § 68-21-3 Revoked

Publisher status: INEFFECTIVE (not currently effective).

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 2009 Supp. 65-1692; implementing K.S.A. 2009 Supp. 65-1683; effective Oct. 15, 2010; revoked June 2, 2023.)

Kan. Admin. Regs. § 68-21-4 Notice of requests for information

Each dispenser who may access information maintained by the board on each drug of concern and scheduled substance dispensed to one of the dispenser's patients for the purpose of providing medical or pharmaceutical care shall notify the patient of this access to program information by performing either of the following:

(a) Posting an easily viewable sign at the place where prescription orders are issued or accepted for dispensing; or

(b) providing written material about the dispenser's access to program information.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1692; implementing K.S.A. 65-1685, as amended by L. 2022, ch. 74, sec. 5; effective Oct. 15, 2010; amended June 2, 2023.)

Kan. Admin. Regs. § 68-21-5 Access to program information

(a) Any patient or patient's designee may obtain a report listing all program information that pertains to the patient by submitting a written request to the board on a form provided by the board, which shall include the following:

(1) The patient's name and, if applicable, the name of the patient's designee;

(2) the patient's residential address and, if applicable, the residential address of the patient's designee;

(3) the patient's telephone number and, if applicable, the telephone number of the patient's designee;

(4) the time period for which information is being requested;

(5) a copy of a valid photographic identification of the patient or the patient's designee; and

(6) if the requester is not the patient, a copy of official documents establishing either legal guardianship or power of attorney.

(b)(1) Any practitioner, dispenser, or delegate may obtain program information relating to a patient in accordance with K.S.A. 65-1685, and amendments thereto, by submitting an electronic request to the board in a manner established by the board, using authentication. Information regarding more than one patient may be submitted in a single request.

Each request shall be submitted in a format established by the board and shall include the following elements for each patient:

(A) The patient's first name and last name;

(B) the patient's date of birth; and

(2) The authentication and identity of the practitioner, dispenser, or delegate shall be verified by the board before allowing access to any program information. If the authentication is lost or missing or if the security of the authentication is compromised, the practitioner, dispenser, or delegate shall notify the board in writing as soon as possible.

(c) In conjunction with an active investigation, any designated representative of a professional licensing, certification, or regulatory agency charged with administrative oversight of practitioners or dispensers may obtain program information for a practitioner licensed or regulated by the agency or for a patient by submitting a written request to the board on a form provided by the board.

(1) If the request is for program information related to a practitioner, the request shall include the following:

(A) The requestor's name and agency;

(B) the practitioner's name;

(D) the practitioner's NPI number, if issued to the practitioner; and

(E) the time period for which information is being requested.

(2) If the request is for program information related to a patient, the request shall include the following:

(A) The requestor's name and agency;

(B) the patient's first name and last name;

(D) the time period for which information is being requested.

(d) Any designated representative from the department of health and environment, an overdose fatality review board established by the state, or an impaired provider program for practitioners may obtain program information related to a patient in accordance with K.S.A. 65-1685, and amendments thereto, by submitting an electronic written request to the board in a manner established by the board, using authentication. The request shall include the following:

(1) The patient's first name and last name;

(2) the patient's date of birth; and

(3) the time period for which information is being requested.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1692; implementing K.S.A. 65-1685, as amended by L. 2022, ch. 74, sec. 5; effective Oct. 15, 2010; amended June 2, 2023.)

Kan. Admin. Regs. § 68-21-6 Reciprocal agreements with other states or government entities to share information

(a) Reciprocal agreements with one or more of the following entities within the United States may be entered into by the board to share program data if the entity's prescription monitoring program is compatible with the program:

(1) A state, commonwealth, district, or territory;

(2) a military or veteran health system;

(3) an Indian health system or service; or

(4) a city, county, municipality, or township.

(b) In determining the compatibility of the entity's prescription monitoring program, the following may be considered by the board:

(1) The safeguards for privacy of patient records and the entity's success in protecting patient privacy;

(2) the persons authorized by the entity to view the data collected by the program;

(3) the schedules of controlled substances monitored by the entity;

(4) the data required by the entity to be submitted on each prescription; and

(5) the costs and benefits to the board of mutually sharing data with the entity.

(c) Any reciprocal agreement may be reviewed annually by the board to determine its continued compatibility with the program.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1692; implementing K.S.A. 65-1685; effective Oct. 15, 2010; amended Nov. 29, 2019.)

Kan. Admin. Regs. § 68-21-7 Drugs of concern

(a) Each of the following shall be classified as a drug of concern:

(1) Any product containing all three of these drugs: butalbital, acetaminophen, and caffeine;

(2) any compound, mixture, or preparation that contains any detectable quantity of ephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;

(3) any compound, mixture, or preparation that contains any detectable quantity of pseudoephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;

(4) promethazine with codeine; and

(5) any product, compound, mixture, or preparation that contains gabapentin.

(b) Each request to have a drug added to the program for monitoring shall be submitted in writing to the board.

This regulation shall take effect 90 days after publication in the Kansas register.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 2016 Supp. 65-1692; implementing K.S.A. 2016 Supp. 65-1682; effective Oct. 15, 2010; amended Feb. 4, 2015; amended July 25, 2018.)

Article 22 Electronic Supervision of Medical Care Facility's Pharmacy Personnel

Kan. Admin. Regs. § 68-22-1 Definitions

(a) "Medical care facility" shall have the meaning provided in K.S.A. 65-1626(w), and amendments thereto.

(b) "Pharmacy student" shall have the meaning provided in K.S.A. 65-1626(ee), and amendments thereto, and shall include a pharmacy intern registered with the board.

(d) "Real-time," when used to describe the transmission of information through data, video, and audio links, shall mean that the transmission is sufficiently rapid that the information is available simultaneously to the electronically supervising pharmacist and the pharmacy student or pharmacy technician being electronically supervised in the medical care facility's pharmacy.

(e) "Electronic supervision" shall mean the oversight provided by a pharmacist licensed in Kansas and supervising, by means of real-time communication equipment that meets the operating requirements listed in K.A.R. 68-22-5, a registered pharmacy student or pharmacy technician who is working in a Kansas medical care facility's pharmacy.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2009 Supp. 65-1626, K.S.A. 2009 Supp. 65-1642, K.S.A. 65-1648, and K.S.A. 2009 Supp. 65-1663; effective Nov. 18, 2011.)

Kan. Admin. Regs. § 68-22-2 Application for approval to utilize electronic supervision

The pharmacist in charge of any medical care facility's pharmacy located in Kansas and registered by the board who wants to seek approval for electronic supervision of a pharmacy student or pharmacy technician in that medical care facility pharmacy shall submit an application to the board. Each application shall be submitted on a form provided by the board and shall include the following:

(a) Identifying information concerning the applying medical care facility's pharmacy;

(b) the type and operational capabilities of the computer, video, and communication systems to be used for the electronic supervision; and

(c) a copy of the electronic supervision procedures manual and training manual approved by the pharmacist in charge of the medical care facility's pharmacy.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2009 Supp. 65-1626, K.S.A. 2009 Supp. 65-1642, K.S.A. 65-1648, and K.S.A. 2009 Supp. 65-1663; effective Nov. 18, 2011.)

Kan. Admin. Regs. § 68-22-3 Prior approval and training required

(a) The pharmacist in charge of a medical care facility's pharmacy shall not permit a pharmacy student or pharmacy technician to be in the pharmacy working under electronic supervision unless the pharmacy has a current approval for electronic supervision from the board.

(b) The pharmacist in charge of a medical care facility's pharmacy shall not permit a pharmacy student or pharmacy technician to be in the pharmacy working under electronic supervision before completing the pharmacy's electronic supervision training course.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2009 Supp. 65-1626, K.S.A. 2009 Supp. 65-1642, K.S.A. 65-1648, and K.S.A. 2009 Supp. 65-1663; effective Nov. 18, 2011.)

Kan. Admin. Regs. § 68-22-4 Electronic supervision

(a) Only a pharmacist licensed by the board may electronically supervise a pharmacy student or pharmacy technician working in a medical care facility's pharmacy.

(b) A pharmacist licensed by the board may be electronically connected to multiple medical care facility pharmacies at one time for the purpose of electronically supervising.

(c) A pharmacist licensed by the board may electronically supervise no more than one pharmacy technician working in any medical care facility's pharmacy at one time.

(d) No more than one pharmacy student or pharmacy technician that is being electronically supervised may work in a medical care facility's pharmacy at one time.

(e) Electronic supervision conducted in conformance with these regulations shall constitute direct supervision.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2009 Supp. 65-1626, K.S.A. 2009 Supp. 65-1642, K.S.A. 65-1648, and K.S.A. 2009 Supp. 65-1663; effective Nov. 18, 2011.)

Kan. Admin. Regs. § 68-22-5 Minimum operating requirements

(a) A pharmacy student or pharmacy technician may enter the pharmacy without a pharmacist present for purposes of turning on the data, video, or audio links and determining if a pharmacist is available for electronic supervision.

(b) Electronic supervision shall not be permitted if an interruption occurs in any of the data, video, or audio links. Whenever an interruption in any of the data, video, or audio links occurs, no medication order shall be filled or dispensed using electronic supervision.

(c) Data entry may be performed by the electronically supervising pharmacist or the pharmacy student or pharmacy technician being electronically supervised. Each entry performed by an electronically supervised pharmacy student or pharmacy technician shall be verified by the electronically supervising pharmacist before the drug leaves the pharmacy.

(d) All medication orders processed by a pharmacy student or a pharmacy technician being electronically supervised shall be capable of being displayed on a computer terminal at both the location of the electronically supervising pharmacist and the medical care facility's pharmacy. The quality of the image viewed by the pharmacist shall be sufficient for the pharmacist to be able to determine the accuracy of the work of the pharmacy student or pharmacy technician.

(e) All patient demographic information shall be viewable in real time at both the location of the electronically supervising pharmacist and the medical care facility's pharmacy.

(f) Before a drug leaves the medical care facility's pharmacy, all of the following requirements shall be met:

(1) The electronically supervising pharmacist shall utilize the data, audio, and video links and review the patient profile, the original scanned medication order, and the drug to be dispensed to ensure accuracy.

(2) The supervising pharmacist, pharmacy student, or pharmacy technician shall cause an electronic or paper image of the medication order and the drug, as seen by the electronically supervising pharmacist, to be captured and retained in the electronic or paper records of the medical care facility's pharmacy for the same time period as that required for the written medication order.

(3) The supervising pharmacist, pharmacy student, or pharmacy technician shall cause a paper or electronic record that includes the patient's name, the medication order number, the name of the pharmacy student or pharmacy technician, and the name of the electronically supervising pharmacist to be made.

(4) The pharmacist in charge of the medical care facility's pharmacy shall ensure that controls exist to protect the privacy and security of confidential records.

(5) The supervising pharmacist, pharmacy student, or pharmacy technician shall cause a permanent digital record of all duties electronically supervised and all data transmissions associated with the electronic supervision to be made. Each record shall be maintained for at least five years.

***** Authenticated Kansas Administrative Regulation *****

History

History: (Authorized by K.S.A. 65-1630; implementing K.S.A. 2009 Supp. 65-1626, K.S.A. 2009 Supp. 65-1642, K.S.A. 65-1648, and K.S.A. 2009 Supp. 65-1663; effective Nov. 18, 2011.)