856 IAC 2-6-13 - Schedules III, IV, and V controlled substances; refilling prescriptions; retrievable information

Authority: IC 35-48-3-1

Affected: IC 35-48-2; IC 35-48-3-9

Sec. 13.

(a) No prescription for a controlled substance listed in schedule III ( IC 35-48-2-8), schedule IV ( IC 35-48-2-10), or schedule V ( IC 35-48-2-12) shall be filled or refilled more than six (6) months after the date on which such prescription was issued, and no such prescription shall be authorized to be refilled more than five (5) times.

(b) Each refill of a prescription shall be recorded by one (1) of the following methods:

(1) On the back of the original prescription, an electronically transmitted record in accordance with applicable federal regulations, or a uniformly maintained, readily retrievable record.

(2) In the storage memory of an electronic data processing system if such board approved system is used in the pharmacy.

(c) The following prescription information shall be retrievable by using or entering the serial number of the prescription:

(1) The name (and strength, if applicable) and dosage form of the controlled substance.

(2) The date on which the prescription was written, electronically transmitted, or orally transmitted and reduced to writing by the pharmacist.

(3) The date of original filling and the date or dates of all refills.

(4) A notation or notations for the original filling and each and every subsequent refilling sufficient to identify the dispensing pharmacist.

(5) The total number of refills originally authorized and remaining for each individual prescription.

If the pharmacist does nothing more than date and initial the prescription to indicate a refill has been dispensed, the pharmacist shall be deemed to have dispensed a refill for the full face amount (that is the originally prescribed amount) of the prescription.

(d) Additional refills for prescriptions for controlled substances listed in schedule III ( IC 35-48-2-8), schedule IV ( IC 35-48-2-10), or schedule V ( IC 35-48-2-12) may be added to the original prescription pursuant to an authorization transmitted to the pharmacist by the original prescribing practitioner providing the following conditions are met:

(1) The total quantity authorized does not exceed the original face amount of the prescription and five (5) total refills, and none of the refills is for more dose units or a larger quantity than the original face amount of the prescription.

(2) No dispensing takes place pursuant to the original prescription more than six (6) months after the date of the original issue of the prescription.

(3) The pharmacist receiving the authorization records that authorization on the reverse of the original prescription, or in a readily retrievable record, and the following information:

(A) The date of the authorization.

(B) The number of the dose units or quantity authorized.

(C) The number of additional refills authorized.

(D) The initials of the pharmacist receiving the authorization.

(e) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five (5) refill, six (6) month limitation.

Notes

856 IAC 2-6-13

Indiana Board of Pharmacy; Reg 28, Ch VI, Sec 6.22; filed Jul 9, 1974, 9:29 a.m.: Unpublished; filed May 20, 1988, 9:30 a.m.: 11 IR 3564; filed Jul 5, 1995, 10:00 a.m.: 18 IR 2783; readopted filed Nov 14, 2001, 2:45 p.m.: 25 IR 1341; readopted filed Oct 4, 2007, 3:33 p.m.: 20071031-IR-856070060RFA; filed Jun 19, 2013, 10:06 a.m.: 20130717-IR-856120619FRA; readopted filed November 25, 2013, 9:24 a.m.: 20131225-IR-856130308RFA Readopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA