Issue Date: December 21, 2018
Volume 45 • Issue 26 • Page 1267
MARYLAND DEPARTMENT OF HEALTH
Subtitle 34 BOARD OF PHARMACY
10.34.05 Pharmacy Security
Authority: Health-Occupations Article, §12-205, Annotated Code of Maryland
Notice of Proposed Action
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 Standards
There is a corresponding federal standard to this proposed action, but the proposed action is not more restrictive or stringent.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
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 firstname.lastname@example.org, or fax to 410-767-6483. Comments will be accepted through January 22, 2019. A public hearing has not been scheduled.
.05 Security Responsibility.
A. The pharmacy permit holder is responsible for [assuring] ensuring that pharmacists, employees, and others who enter the pharmacy:
[A.] (1) (text unchanged)
[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 unchanged)
[(3)] (c) [Division of Drug Control] Office of Controlled Substances Administration; and
[(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 factors:
(1) The actual quantity of controlled dangerous substances lost in relation to the type of business;
(2) The specific controlled dangerous substances lost;
(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 losses;
(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