Code of Maine Rules
02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
392 - MAINE BOARD OF PHARMACY
Part 4 - DISPENSING PRESCRIPTION DRUGS
Chapter 19 - RECEIPT AND HANDLING OF PRESCRIPTION DRUG ORDERS
Section 392-4-19-7 - Automated Data Processing System

Universal Citation: 02 ME Code Rules ยง 392-4-19-7

Current through 2024-38, September 18, 2024

A pharmacy may employ an automated data processing system, subject to the following requirements:

1. Sight-Readable Documents vs. Printouts

The system shall be capable of producing sight-readable documents of all dispensing records required by Section 6 of this chapter. In the case of administrative proceedings before the board, records must be provided in paper printout form;

2. Completeness and Accuracy

A pharmacist is responsible for the completeness and accuracy of all entries into the system. The system shall be capable of providing a daily printout of the day's prescription drug information. The system or the retail pharmacy shall also be capable of identifying the individual pharmacists who-

A. Performed the drug utilization review; and

B. Performed the final check to ensure that the prescription was correct in all respects and ready for dispensing.

3. Handwritten Records During Period of Downtime

If the automated data processing system becomes inoperative and the pharmacy remains open, the pharmacy may temporarily revert to handwritten records or other auxiliary recordkeeping system in accordance with the terms of this subsection. The pharmacy shall ensure that all refills are authorized by the original prescription drug order and that the maximum number of refills is not exceeded. The pharmacy shall enter into the automatic data processing system all information regarding prescription drug orders that were filled or refilled during the period of downtime within 96 hours after the automatic data processing system is restored to service. However, nothing in this subsection shall preclude the pharmacist from exercising professional judgment for the benefit of a patient's health or safety.

4. Data Recovery

The pharmacy shall implement reasonable data backup, protection and recovery protocols to retrieve dispensing records created by or stored in the system in the event of human error, power failure, computer malfunction, accident or catastrophe resulting in the loss, destruction or corruption of data. The measures implemented shall be sufficient to provide reasonable continuity of service to the public.

5. Continuity of Supply

A pharmacy shall make arrangements with the supplier of data processing services or materials to assure that the pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with such supplier terminates for any reason. A pharmacy shall assure continuity in the maintenance of records;

6. Controlled Drugs

An automated data processing system used for controlled drugs must conform to the requirements of 21 CFR Parts 1311, 1300, 1304 and 1306 as listed in Section 3(4)(B) of this chapter, as well as all other requirements of this chapter and the board's rules.

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