Okla. Admin. Code § 535:15-3-21

Current through Vol. 42, No. 4, November 1, 2024
Section 535:15-3-21 - Prescription fill, refill and partial fill records and reports
(a)Dangerous drugs.
(1) Refills may be entered on the back of each original prescription.
(2) Refill records may be kept by using an automated data processing system to maintain the refill information.
(b)Controlled dangerous Substances (CDS) - Schedule II. No refills are allowed on Schedule II CDS.
(c)Controlled dangerous Substances (CDS) - Schedule III, IV and V Hard copy method. The refills are entered on the back of the original (hard copy) prescription according to Oklahoma Bureau of Narcotics and Dangerous Drugs' rules in OAC 475:30-1-11 et seq.
(d)CDS automated data processing method. A pharmacy may elect to use an automated data processing system to maintain the prescription files including the original information and the refill information. Caution: The pharmacy must maintain complete and retrievable prescription records for five years whether logbooks, nightly reports, or a manual system are used. If the pharmacy elects the automated system certain compliance reports are required.
(1)Nightly reports. Nightly reports are required for Schedule II and for Schedule III, IV and V. These reports will include but are not limited to:
(A) Schedule II reports will include the information in ASAP/NABP Committee on Standardization's Computerized Compliance Reports (e.g. run date, run by, Rx #, drug name, dose form, quantity, date written, date dispensed; pharmacist, patient and prescriber names, DEA number, and patient and prescriber addresses.)
(B) Schedule III, IV and V reports will include the same information as in (A) above, except patient and prescriber addresses are not required. These reports may be mixed or be Schedule III, IV or V specific.
(C) These nightly reports shall be verified, signed and dated by the pharmacist as required. (See CFR 1306.22 , et seq.)
(D) These reports must be kept for five years.
(2)Logbook or file alternate procedure. In lieu of the nightly reports procedure for Schedule II, III, IV & V provided in 535:15-3-21, the pharmacy may choose to use the following method:
(A) The pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such refill dispensing shall sign a statement (in the manner described in CFR 1306.22) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by them and is correct as shown.
(B) Such a book or file must be maintained at the pharmacy employing such a system for a period of five years after the date of dispensing the appropriately authorized refill.
(3)Refill reports. Any pharmacy using an automated data processing system to track refills shall be able to print such reports as required in CFR 1306.22 et seq.
(4)Audit reports. If an automated data processing system is used to maintain refill information, the ability to print upon request the following Controlled Dangerous Substance (CDS) audit reports is required. The following required audit reports must include the information in ASAP/NABP Committee on Standardization's Computerized Compliance Reports:
(A) CDS Audit Report by Drug
(B) CDS Audit Report by Prescriber
(C) CDS Audit Report by Pharmacist
(D) Patient Profile Report

Okla. Admin. Code § 535:15-3-21

Added at 14 Ok Reg 3024, eff 7-1-97; Amended at 17 Ok Reg 2626, eff 7-1-00; Amended at 20 Ok Reg 2476, eff 7-11-03; Amended at 21 Ok Reg 2452, eff 7-1-04; Amended at 24 Ok Reg 2257, eff 7-1-07
Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015.
Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/11/2020