Code of Maine Rules
02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
392 - MAINE BOARD OF PHARMACY
Part 4 - DISPENSING PRESCRIPTION DRUGS
Chapter 20 - AUTOMATED PHARMACY SYSTEMS
Subchapter 1 - Retail Pharmacies
Section 392-4-20-1-8 - Development of Procedures

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 and unloading of drugs, and records of the dispensing of drugs, are electronically tracked and recorded by the system and maintained by the pharmacist in charge, and that such records are available to the board upon request;

3. The automated pharmacy system has a documented and ongoing quality assurance program that monitors total system performance;

4. Timely and documented maintenance is performed on the automated pharmacy system in accordance with the manufacturer's recommendations;

5. The purity, potency, and integrity of the drugs contained in the automated pharmacy system shall be preserved;

6. 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; and

7. 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;

8. 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

9. Requirements for controlled substances security are met.