Issue Date: December 21, 2018
Volume 45 • Issue 26 • Page 1267
MARYLAND DEPARTMENT OF HEALTH
Subtitle 34 BOARD OF
Health-Occupations Article, §12-205, Annotated Code of Maryland
Notice of Proposed
The Secretary of Health proposes to amend
Regulation .05 under COMAR 10.34.05 Pharmacy Security.
This action was considered by the Board of Pharmacy at an open meeting held on
September 19, 2018, notice of which was given by publication on the Board of
Pharmacy website, http://health.maryland.gov/pharmacy/Pages/index.aspx, from
September 13 — 19, 2018.
Statement of Purpose
The purpose of this action is to require pharmacy permit holders
to report a significant loss of controlled dangerous substances in addition to
the requirement to report thefts.
Comparison to Federal
There is a corresponding federal standard to this proposed action,
but the proposed action is not more restrictive or stringent.
Estimate of Economic
The proposed action has no economic impact.
Economic Impact on Small
The proposed action has minimal or no economic impact on small
Impact on Individuals
The proposed action has no impact on individuals with
Opportunity for Public
Comments may be sent to Jake Whitaker, Acting Director, Office of
Regulation and Policy Coordination, Maryland Department of Health, 201 W.
Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY
800-735-2258), or email to email@example.com, or fax to 410-767-6483.
Comments will be accepted through January 22, 2019. A public hearing has not
A. The pharmacy permit holder
is responsible for [assuring] ensuring that
pharmacists, employees, and others who enter the pharmacy:
[A.] (1) (text
[B.] (2) Maintain
those measures necessary to ensure this [chapters’] chapter’s enforcement; [and]
[C.] (3) Report [thefts] theft
or significant loss of [prescription drugs or devices] controlled
dangerous substances to the:
[(1)] (a)—[(2)] (b) (text
[(3)] (c) [Division
of Drug Control] Office of Controlled Substances Administration;
[(4)] (d) U.S.
Drug Enforcement Administration.]; and
(4) Report theft of non-controlled prescription
drugs or devices to the Board.
B. In determining whether a loss is significant pursuant to §A(3)
of this regulation, the pharmacy permit holder shall consider at least the following
(1) The actual quantity of controlled dangerous
substances lost in relation to the type of business;
(2) The specific controlled dangerous
(3) Whether the loss of the controlled dangerous substances can be
associated with access to those controlled dangerous substances by specific
individuals, or whether the loss can be attributed to unique activities that
may take place involving controlled dangerous substances;
(4) A pattern of losses over a specific time period, whether the
losses appear to be random, and the results of efforts taken to resolve the
(5) Whether the specific controlled dangerous
substances are likely candidates for diversion, if known; and
(6) Local trends and other indicators of the diversion potential
of the missing controlled dangerous substances, if known.
ROBERT R. NEALL
Secretary of Health
201 W. Preston Street, Baltimore, MD 21201-2399
(410) 767-6500 or 1-877-463-3464