Kan. Admin. Regs. § 68-20-19

Current through Register Vol. 43, No. 46, November 14, 2024

Section 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.

Kan. Admin. Regs. § 68-20-19

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 by Kansas Register Volume 42, No. 20; effective 6/2/2023.