Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 15 - Pharmacies
Subchapter 19 - Automation Rules
Section 535:15-19-5 - Policies and procedures
Universal Citation: OK Admin Code 535:15-19-5
Current through Vol. 42, No. 1, September 16, 2024
(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.
Disclaimer: These regulations may not be the most recent version. Oklahoma may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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