Kan. Admin. Regs. § 68-20-20 - Controlled substances listed in schedules III and IV

Current through Register Vol. 40, No. 39, September 30, 2021

(a) Requirements of prescription.
(1) A pharmacist may dispense any controlled substance listed in schedule III, IV, or V that is a prescription drug as determined under the federal food, drug, and cosmetic act, pursuant only to a written prescription signed by a prescriber, or an oral prescription made by a prescriber, and promptly reduced to writing by the pharmacist containing all information required under K.A.R. 68-20-18(c), except for the signature of the prescriber.
(2) A prescriber may administer any controlled substance listed in schedule III, IV, or V in the course of the practitioner's professional practice without a prescription, subject to K.A.R. 68-20-18.
(3) A medical care facility registered with the board may administer or dispense directly, but shall not prescribe, any controlled substance listed in schedule III, IV, or V only pursuant to a written prescription signed by the prescriber, or to an order for medication made by a prescriber for immediate administration to the ultimate user.
(b) Filling of prescriptions.
(1) Each refilling of a prescription shall be entered on the back of a prescription, with the following additional information:
(A) The date of refilling or dispensing;
(B) the amount dispensed; and
(C) the name or initials of the dispensing pharmacist or pharmacist intern.
(2) Additional quantities of controlled substances listed in schedules III or IV may be authorized by a prescriber through an oral refill authorization transmitted to the pharmacist if all of the following conditions are met:
(A) 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.
(B) The pharmacist obtaining the oral authorization records on the reverse of the original prescription the following:
(i) The date;
(ii) the quantity of refill;
(iii) the number of additional refills authorized; and
(iv) the initials of the pharmacist who received the authorization from the prescriber.
(C) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.
(D) 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.
(3) As an alternative to the procedures provided by paragraph (b)(2), an automated data-processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in schedule III and IV, if all of the following requirements are met:
(A) Any such proposed computerized system shall provide on-line retrieval, via CRT display or hard-copy printout, of original prescription order information for those prescription orders that are currently authorized for refilling. This shall include the following:
(i) The original prescription number;
(ii) the date of issuance of the original prescription order by the prescriber;
(iii) the full name and address of the patient;
(iv) the name, address, and DEA registration number of the prescriber;
(v) the name, strength, dosage form, quantity of the controlled substance prescribed, and the quantity dispensed, if different from the quantity prescribed; and
(vi) the total number of refills authorized by the prescriber.
(B) Any such proposed computerized system shall also provide on-line retrieval, via CRT display or hard-copy printout, of the current refill history for schedule III or IV controlled substance prescription orders that have been authorized for refill during the past six months. This refill history shall include the following information:
(i) The name of the controlled substance;
(ii) the date of refill;
(iii) the quantity dispensed;
(iv) the identification code, or name or initials of the dispensing pharmacist for each refill; and
(v) the total number of refills dispensed to date for that prescription order.
(C) Documentation that the refill information entered into the computer each time a pharmacist refills an original prescription order for a schedule III or IV controlled substance is correct shall be provided by the individual pharmacist who makes use of such a system. If this system provides a hard-copy printout of each day's controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled the prescription order. The individual 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. This document shall be maintained in a separate file at the pharmacy for five years from the dispensing date. This printout of the day's controlled substance prescription order refill data shall be provided to each pharmacy using the computerized system within 72 hours of the date on which the refill was dispensed. This document shall be verified and signed by each pharmacist who is involved with the dispensing. In lieu of such a printout, the pharmacy shall maintain a bound logbook, or separate file, in which each individual pharmacist involved in the dispensing shall sign a statement, in the manner previously described, each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by the pharmacist and is correct as shown. This book or file shall be maintained at the pharmacy employing the system for five years after the date of dispensing the appropriately authorized refill.
(D) Any such computerized system shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining. This shall include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance, by brand, generic name, or both. This printout shall include the following:
(i) The name of the prescriber;
(ii) the name and address of the patient;
(iii) the quantity dispensed on each refill;
(iv) the date of dispensing for each refill;
(v) the name or identification code of the dispensing pharmacist; and
(vi) the number of the original prescription order.
(E) In any central computerized system employed by a user pharmacy, the central recordkeeping location shall be capable of sending the printout to the pharmacy within 48 hours, and if an authorized agent of the board requests a copy of this printout from the user pharmacy, it shall, if requested to do so by the agent, verify the printout transmittal capability of its system by documentation.
(F) If a pharmacy that employs such a computerized system experiences system downtime, the pharmacy shall have an auxiliary procedure that will be used for documentation of refills of schedule III and IV controlled substance prescription orders. This auxiliary procedure shall insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again.
(4) When filing refill information for original prescription orders for schedule III or IV controlled substances, a pharmacy may use one of the two systems described in paragraphs (2) or (3) of this subsection.
(5) In the case of medical care facilities registered with the board, all requirements specified in paragraphs (b) (1), (2), and (3) above shall be maintained in the medication records or other readily retrievable records regularly maintained by the medical care facility.
(c) Partial filling of prescriptions. 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 a refilling.
(2) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
(3) Except for a controlled substance listed in schedule V, no dispensing occurs after six months after the date on which the prescription was issued.
(d) Labeling of substances. The pharmacist filling a prescription for a controlled substance listed in schedule III or IV shall affix to the package a label showing the following:
(1) The pharmacy name and address;
(2) the serial number of the prescription;
(3) the date of initial filling;
(4) the name of the patient;
(5) the name of the prescriber issuing the prescription;
(6) the directions for use; and
(7) cautionary statements, if any, contained in the prescription as required by law, except as provided in 21 CFR 1306.24 as in effect on April 1, 1999, which is hereby adopted by reference.
(e) Filing prescriptions. All prescriptions for controlled substances listed in schedules III, IV, and V shall be kept in accordance with K.A.R. 68-20-16.

Notes

Kan. Admin. Regs. § 68-20-20
Authorized by and implementing K.S.A. 1998 Supp. 65-4102, K.S.A. 65-4121, 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.

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