• English
    X

    Google Translate Disclaimer

    The Maryland Department of Information Technology (“DoIT”) offers translations of the content through Google Translate. Because Google Translate is an external website, DoIT does not control the quality or accuracy of translated content. All DoIT content is filtered through Google Translate which may result in unexpected and unpredictable degradation of portions of text, images and the general appearance on translated pages. Google Translate may maintain unique privacy and use policies. These policies are not controlled by DoIT and are not associated with DoIT’s privacy and use policies. After selecting a translation option, users will be notified that they are leaving DoIT’s website. Users should consult the original English content on DoIT’s website if there are any questions about the translated content.

    DoIT uses Google Translate to provide language translations of its content. Google Translate is a free, automated service that relies on data and technology to provide its translations. The Google Translate feature is provided for informational purposes only. Translations cannot be guaranteed as exact or without the inclusion of incorrect or inappropriate language. Google Translate is a third-party service and site users will be leaving DoIT to utilize translated content. As such, DoIT does not guarantee and does not accept responsibility for, the accuracy, reliability, or performance of this service nor the limitations provided by this service, such as the inability to translate specific files like PDFs and graphics (e.g. .jpgs, .gifs, etc.).

    DoIT provides Google Translate as an online tool for its users, but DoIT does not directly endorse the website or imply that it is the only solution available to users. All site visitors may choose to use alternate tools for their translation needs. Any individuals or parties that use DoIT content in translated form, whether by Google Translate or by any other translation services, do so at their own risk. DoIT is not liable for any loss or damages arising out of, or issues related to, the use of or reliance on translated content. DoIT assumes no liability for any site visitor’s activities in connection with use of the Google Translate functionality or content.

    The Google Translate service is a means by which DoIT offers translations of content and is meant solely for the convenience of non-English speaking users of the website. The translated content is provided directly and dynamically by Google; DoIT has no direct control over the translated content as it appears using this tool. Therefore, in all contexts, the English content, as directly provided by DoIT is to be held authoritative.

    Maryland Department of Health
    Regulations

    ​PROPOSAL

    Maryland Register

    Issue Date:  December 21, 2018

    Volume 45 • Issue 26 • Page 1267

    Title 10 
    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

    [18-345-P]

    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 mdh.regs@maryland.gov, 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

     

     ​