(h) The community pharmacy maintains written policies and procedures to ensure the proper, safe, and secure functioning of the automated pharmacy system. The community pharmacy shall annually review the policies and procedures and maintain a record of such policies and procedures for a minimum of 4 years. The annual review must be documented in the community pharmacy’s records and must be made available to the board upon request. The policies and procedures must, at a minimum, address all of the following:1. Maintaining the automated pharmacy system and any accompanying electronic verification process in good working order.
2. Ensuring the integrity of the automated pharmacy system’s drug identifier database and its ability to identify the person responsible for making database entries.
3. Ensuring the accurate filling, stocking, restocking, and verification of the automated pharmacy system.
4. Ensuring the sanitary operation of the automated pharmacy system and the prevention of cross-contamination of cells, cartridges, containers, cassettes, or packages.
5. Testing the accuracy of the automated pharmacy system and any accompanying electronic verification process. The automated pharmacy system and accompanying electronic verification process must, at a minimum, be tested before the first use of the system, upon restarting the system, and after a modification of the system or electronic verification process which alters the filling, stocking, or restocking of the system or the electronic verification process.
6. Training of persons authorized to access, stock, restock, or use the system.
7. Conducting routine and preventative maintenance of the automated pharmacy system, including calibration of the system, if applicable.
8. Removing expired, adulterated, misbranded, or recalled medicinal drugs from the automated pharmacy system.
9. Preventing unauthorized persons from accessing the automated pharmacy system, including assigning, discontinuing, or modifying security access.
10. Identifying and recording persons responsible for filling, stocking, and restocking the automated pharmacy system.
11. Ensuring compliance with state and federal law, including, but not limited to, all applicable labeling, storage, and security requirements.
12. Maintaining an ongoing quality assurance program that monitors and records performance of the automated pharmacy system and any accompanying electronic verification process to ensure proper and accurate functioning, including tracking and documenting system errors. A community pharmacy must maintain such records for a minimum of 4 years and must make such records available to the board upon request.
