Issue 20 - 05-18-2023 | Kansas State Board of Pharmacy | Permanent Administrative Regulations

Volume 42 - Issue 20 - May 18, 2023

State of Kansas

Board of Pharmacy

Permanent Administrative Regulations

Article 1.—REGISTRATION AND EXAMINATION OF PHARMACISTS

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. (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.)

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. (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.)

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. (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

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. (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.)

Article 7.—MISCELLANEOUS PROVISIONS

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. (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.)

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. (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.)

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. (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.)

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. (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.)

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. (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.)

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

Article 20.—CONTROLLED SUBSTANCES

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. (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.)

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. (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.)

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. (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.)

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. (Authorized by and implementing K.S.A. 65-4102, K.S.A. 65-4121, and K.S.A. 65-4123; effective June 2, 2023.)

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. (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.)

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. (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.)

68-20-21. (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.)

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.

(c) A prescription is not required for dispensing the substance pursuant to any other federal, state, or local law. (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.)

Article 21.—PRESCRIPTION MONITORING PROGRAM

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. (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.)

68-21-2. Electronic reports. (a) Except as specified in subsections (d) and (e), 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), and (e), 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) Each dispenser or pharmacy that no longer meets the criteria for exemption specified in subsection (c), (d), or (e) shall notify the board and begin submitting reports within seven days.

(g) Each exemption issued by the board shall expire annually on August 31.

(h) Except as specified in K.A.R. 68-21-3, 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.

(i) 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. (Authorized by K.S.A. 65-1692; implementing K.S.A. 2022 Supp. 65-1683; effective Oct. 15, 2010; amended April 15, 2011; amended Aug. 13, 2014; amended June 2, 2023.)

68-21-3. (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.)

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. (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.)

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. (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.)

Alexandra Blasi
Executive Secretary
Board of Pharmacy

Doc. No. 051149

Scott Schwab
Kansas Secretary of State

Kansas Register