Md. Code Regs. 10.34.05.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.05.02 - Prescription Area

A. The pharmacy permit holder shall:

(1) Ensure that the prescription area:

(a) Maintains temperature and ventilation at levels that do not affect the prescription drugs or devices stored in the area; and

(b) Permits reasonable communication between the pharmacist and the public when the pharmacy is open;

(2) Provide a means of securing the prescription area;

(3) Prevent an individual from being in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services;

(4) Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and

(5) Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open.

B. The pharmacist shall:

(1) Secure the prescription area and its contents in order that the pharmacy permit holder or the pharmacy permit holder's agent may:

(a) Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and

(b) Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open;

(2) Have sole possession of a means of access to the pharmacy, except in emergencies; and

(3) Establish a means of access for use in an emergency when the pharmacist is not available to access the prescription area.

C. Security.

(1) A pharmacy shall be secure from unauthorized entry as follows:

(a) Access from outside the premises shall be:

(i) Kept to a minimum; and

(ii) Well controlled;

(b) The outside perimeter of the premises shall be well lit; and

(c) Entry into areas where prescription drugs or devices and patient records are stored shall be limited to authorized personnel.

(2) A pharmacy shall be equipped with:

(a) An alarm system to detect entry after hours;

(b) A security system that provides protection against theft and diversion;

(c) Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records;

(d) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting;

(e) A security system to protect the integrity and confidentiality of data and documents limited to authorized personnel; and

(f) A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, the Division of Drug Control, or federal and other State law enforcement officials.

Md. Code Regs. 10.34.05.02

Regulation .02C adopted effective February 19, 1990 (17:3 Md. R. 298)
Regulation .02C adopted effective July 1, 2010 (37:10 Md. R. 722)