Md. Code Regs. 10.19.03.12 - Physical Security Controls for Registrants

A. General.

(1) All applicants and registrants shall provide effective controls and procedures to guard against theft and unlawful diversion of controlled substances. In order to determine whether a registrant or applicant has provided protective controls against theft and unlawful diversion, the Department shall use the security requirements set forth in §B of this regulation and 21 CFR §§ 1307.71 - 1301.77 as standards for physical security controls and operating procedures necessary to prevent theft and unlawful diversion.

(2) Substantial Compliance. Substantial compliance with the standards set forth in §B of this regulation and 21 CFR §§ 1301.71- 1301.77 may be deemed sufficient by the Department after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall systems of a registrant or applicant, the Department may consider any or all of the following factors as relevant to the need for strict compliance with security requirements of §B of this regulation and 21 CFR §§ 1301.71- 1301.77:

(a) The type of activity conducted (e.g. packaging, labeling, cooperative buying);

(b) The type and form of controlled drug substances handled (e.g. bulk liquids, powders);

(c) The quantity of controlled drug substances handled;

(d) The location of the prescription department as it may be affected by security problems;

(e) The type of vault, safe, and secure enclosures or other storage system used for controlled dangerous substances;

(f) The type of locking mechanisms on areas to be secured;

(g) The adequacy of control over access to locked enclosures containing controlled dangerous substances;

(h) The extent of unsupervised public access to the prescription department;

(i) The adequacy of supervision over employees having access to the prescription department;

(j) The procedures for handling business agents, visitors, maintenance personnel, and nonemployee maintenance personnel, who may have need to enter the prescription department area at a pharmacy;

(k) The adequacy of the registrant's system for monitoring the receipt, distribution, dispensing, and disposition of controlled drug substances in its operations; or

(l) The adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources.

(3) Any registrant desiring to determine whether a proposed security system substantially complies with the requirements set forth in §B of this regulation may submit any plans, blueprints, sketches, or other materials regarding the proposed security system to the Department of Health and Mental Hygiene, Division of Drug Control.

B. Security Controls for Registrants.

(1) Controlled drug substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

(2) Controlled dangerous substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners (as defined in Regulation .07B(2) may disperse these substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled dangerous substances.

(3) The registrant may not knowingly employ as an agent or employee any person who has had an application for registration currently denied or has had a registration revoked, at any time, if this agent or employee will have access to controlled substances.

(4) The registrant shall notify the regional office of the Drug Enforcement Administration, and the Department of Health and Mental Hygiene, Division of Drug Control, of the theft or significant loss of any controlled drug substances upon discovery of a loss or theft. The registrant shall also complete DEA form 106 regarding a loss or theft.

(5) Only practitioners, duly registered pharmacists, pharmacy students, or other duly authorized personnel are allowed to participate in the handling or dispensing of controlled dangerous substances.

(6) Each pharmacy handling controlled dangerous substances shall have a specific area with clearly designated boundaries as the prescription department area. Only duly registered pharmacists, pharmacy students, or other personnel specifically authorized by the registrant shall be allowed to enter the area designated as the prescription department area.

C. This regulation shall also apply to nonpractitioners authorized to conduct research or chemical analysis under other registration.

Notes

Md. Code Regs. 10.19.03.12