Md. Code Regs. 10.34.03.06

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

Section 10.34.03.06 - Security

A. If a pharmacist is not present within the pharmacy, the pharmacist shall lock and secure the pharmacy and any of its decentralized areas that contain pharmaceuticals before leaving the pharmacy or the decentralized area.

B. Thedirector of pharmacy shall establish policies and procedures for emergency access to the pharmacy or any of its decentralized areas.

C. Security Requirements. Entry into an institutional pharmacy area where prescription drugs or devices are held shall be limited to authorized personnel under a pharmacist.s direct supervision.

D. An institutional pharmacy shall be equipped with:

(1) A security system to detect entry after hours, if applicable;

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

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

(4) An inventory management and control system designed to protect against, detect, and document instances of theft, diversion, or counterfeiting;

(5) A security system designed to protect the integrity and confidentiality of data and documents;

(6) Video monitoring of entrances and exits, or alternate acceptable security; and

(7) A means to make the data and documentation required under this chapter readily available to:

(a) The Board;

(b) An agent of the Board; or

(c) Federal and State regulatory and law enforcement officials.

Md. Code Regs. 10.34.03.06