02-392-3 Me. Code R. § 13-6

Current through 2024-51, December 18, 2024
Section 392-3-13-6 - Security of Prescription Filling Area
1. Absence of Pharmacist From Prescription Filling Area

A retail pharmacy and pharmacist on duty shall ensure that no person remains in the prescription filling area during the absence of a pharmacist from the prescription filling area other than a pharmacy technician, pharmacy intern or an authorized person.

2. Dispensing of Prescriptions in the Absence of a Pharmacist

A retail pharmacy may not dispense prescription drugs pursuant to an original prescription drug order in the absence of a pharmacist from the prescription filling area. A retail pharmacy may not dispense prescription drugs pursuant to a renewal prescription drug order in the absence of a pharmacist from the store premises.

3. Acceptance of Walk-In Prescription Drug Orders in the Absence of a Pharmacist

A pharmacy technician may accept prescription drug orders from walk-in patients in the absence of a pharmacist from the prescription filling area only when the pharmacist-

A. Is taking a customary and reasonable work break;
B. Is in the vicinity of the store in which the retail pharmacy is located or is in a closed-shop pharmacy at the same location as the retail pharmacy;
C. Is not engaged in any activity that would interfere with his/her immediate availability; and
D. Is reachable by the pharmacy technician during the absence.
4. Deployment of Barrier

During the absence of a pharmacist or pharmacy technician from the prescription filling area, the prescription filling area shall be secured with a barrier that extends from the floor or counter to the ceiling. The barrier must be constructed of a material of sufficient strength so that the barrier cannot be readily removed, penetrated or bent. If the barrier is constructed of non-solid material, any openings or interstices must be small enough to prevent the removal, by any means, of items from the prescription filling area. If, in addition, there is no authorized person in the prescription filling area, the barrier shall also be locked. The retail pharmacy and pharmacist in charge shall ensure that only a pharmacist or authorized person possesses or has access to the key, combination or activation code to the lock.

5. Alarm

The prescription filling area, drug storage areas and compounding area (if applicable) must be protected by an electronic security system. The electronic security system must be separate from any other electronic security system that may be installed at the retail pharmacy, and must be capable of activation/deactivation separately from any other electronic security system that may be installed at the retail pharmacy. The pharmacy shall activate the electronic security system during the absence of a pharmacist, pharmacy technician or authorized person from the prescription filling area. The retail pharmacy and pharmacist in charge shall ensure that only a pharmacist or authorized person possesses or has access to the key, combination or activation code to the electronic security system.

6. Security Cameras

A retail pharmacy shall deploy security cameras sufficient in number to monitor the critical areas of the pharmacy department, including, at a minimum, the prescription filling area, self-service customer kiosks, dispensing machines that are part of an automated pharmacy system, controlled drug storage areas, the checkout area and compounding area (if applicable). The cameras shall operate continuously, without interruption, 24 hours per day each day of the year. The cameras shall continuously record and store images of the monitored area at a frequency of no less than 15 frames per second. A retail pharmacy shall retain stored images for no less than 30 days after recordation and shall produce the stored images to the board upon request.

The requirement of security camera coverage of the compounding area (if applicable) and controlled drug storage areas goes into effect on July 1, 2014.

7.[deleted]
8. Designation of Authorized Persons and Authorized Pharmacy Technicians

A pharmacist in charge shall report on a form supplied by the board the name and other identifying information of all authorized persons designated by the pharmacist in charge.

9. Deliveries and Delivery Logs
A. All shipments containing only prescription drugs must be delivered in unopened containers to a pharmacist, pharmacy technician or authorized person. Only a pharmacist, pharmacy technician or authorized person may sign for the delivery.
B. A retail pharmacy shall maintain a log of all prescription drugs delivered to rural health centers and free clinics; and to dispensaries, hospital pharmacies, extended care facilities, boarding homes, nursing homes, drug abuse treatment centers, penal institutions, family planning centers, medical clinics and all other facilities that are not registered or licensed by the board. The log shall show the date and time of delivery, the name of the person making delivery on behalf of the retail pharmacy, the drugs delivered, the name and address of the institution receiving the drugs, and the name of the person accepting delivery on behalf of the institution.
C. A rural health center or free clinic; or a dispensary, hospital pharmacy, extended care facility, boarding home, nursing home, drug abuse treatment center, penal institution, family planning center, medical clinic or any other facility that is not registered or licensed by the board; shall maintain a log of all prescription drugs delivered to it by a retail pharmacy. The log shall show the date and time of delivery, the name of the retail pharmacy making delivery, the name of the person making delivery on behalf of the retail pharmacy, the drugs received, and the name of the person accepting delivery on behalf of the institution.

02-392 C.M.R. ch. 3, § 13-6