Okla. Admin. Code § 535:15-19-5

Current through Vol. 42, No. 4, November 1, 2024

Section 535:15-19-5 - Policies and procedures

(a) Written policies and procedures shall be established by and reviewed annually by the pharmacist-in-charge, be maintained in the pharmacy, and be available for review upon inspection.

(b) At a minimum, the pharmacy and pharmacy personnel shall establish and follow policies and procedures for the following:

(1) accurate filling, loading, and stocking of the system;

(2) sanitary operations of the system and preventing cross-contamination of cells, cartridges, containers, cassettes, or packages;

(3) investigating and addressing dispensing errors and system malfunctions;

(4) tracking and documenting prescription errors related to the system that are not corrected prior to dispensing to the patient;

(5) testing the proper function of the system and any accompanying electronic verification system; at a minimum, the system and electronic verification system shall be tested before the first use of the system or restarting the system and upon any modification to the system or electronic verification system that changes or alters the dispensing or electronic verification process;

(6) written documentation of training persons authorized to access, stock, or load the system in equipment use and operations which shall be maintained in the pharmacy and be available for inspection;

(7) preventing unauthorized access to the system, including, assigning, discontinuing, or changing security access;

(8) identifying and recording persons responsible for stocking, loading, and filling the system

(9) conducting routine and preventive maintenance and, if applicable, calibration;

(10) removing expired, adulterated, misbranded, or recalled drugs;

(11) ensuring proper drug storage within the system, consistent with the manufacturer's specifications and the USP;

(12) maintaining an ongoing quality assurance program that monitors performance of the system and any electronic verification system to ensure proper and accurate functioning; and

(13) ensuring compliance with state and federal law, including, all applicable labeling, storage, and security requirements.

Okla. Admin. Code § 535:15-19-5

Adopted by Oklahoma Register, Volume 35, Issue 24, September 4, 2018, eff. 9/14/2018