Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 19 - DANGEROUS DEVICES AND SUBSTANCES › Chapter 10.19.03 - Controlled Dangerous Substances › Section 10.19.03.12 - Physical Security Controls for Registrants

Current through Register Vol. 51, No. 14, July 12, 2024
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.