02-392-4 Me. Code R. § 20-2-13

Current through 2024-51, December 18, 2024

Section 392-4-20-2-13 - Development of Procedures

The pharmacist in charge shall develop, implement, maintain and follow procedures for the safe and effective use of drugs dispensed from an automated pharmacy system. At a minimum, the procedures shall ensure that:

1. An automated pharmacy system requires a person to enter a user name and password, or other unique identifier, in order to access the system. User names, passwords and other unique identifiers are assigned or authorized only by the pharmacist in charge;

2. Audit records of access to the system, including records of the delivery, receipt, loading, unloading, and returning of canisters, and records of the dispensing of drugs, are electronically tracked and recorded by the system and are maintained by the pharmacist in charge, and that such records are available to the board upon request;

3. Before an automated pharmacy system is deployed at a new point of care location, the pharmacist in charge has tested and validated the system to ensure that the system is releasing drugs properly;

4. The pharmacist in charge monitors an automated pharmacy system for proper use and tests the accuracy of the system at least every 6 months, and whenever any change or upgrade is made to the system;

5. Timely and documented maintenance is performed on the dispensing machine and all other components of an automated pharmacy system in accordance with the manufacturer's recommendations;

6. The purity, potency, and integrity of the drugs contained in the automated pharmacy system is preserved;

7. The automated pharmacy system provides all records required by the Maine Pharmacy Act, the rules of the board, and the federal laws and rules specified in Chapter 29 of the board's rules;

8. In the event of a consumer-level recall, the pharmacist in charge can access records of all drugs that have been secured in the automated pharmacy system;

9. The pharmacist in charge develops and maintains a comprehensive backup strategy and disaster recovery plan for use in the event of a technical malfunction resulting from loss of power or internet connectivity or a system malfunction; and

10. Requirements for controlled substances security are met.

02-392 C.M.R. ch. 4, § 20-2-13