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    Maryland Register

    Issue Date:  January 18, 2019

    Volume 46 • Issue 2 • Page 68-69

    Title 10 

    Subtitle 34 BOARD OF PHARMACY

    10.34.30 Change to Permit—Pharmacy or Wholesale Distribution Permit Holder

    Authority: Health Occupations Article, §§12-205 and 12-206, Annotated Code of Maryland

    Notice of Proposed Action


    The Secretary of Health proposes to amend Regulations .01 and .02, repeal Regulation .01-1, and adopt new Regulations .03—.06 under COMAR 10.34.30 Change to Permit—Pharmacy or Wholesale Distribution Permit Holder. This action was considered by the Board of Pharmacy at a public meeting held on April 18, 2018, notice of which was provided by posting on the Board’s website, http://health.maryland.gov/pharmacy/Pages/index.aspx, from April 13, 2018, through April 18, 2018, pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland.

    Statement of Purpose

    The purpose of this action is to codify existing Board of Pharmacy practices and policies regarding name change, ownership change, location change, and other changes to information contained in a previously submitted application. Additionally, the Board’s practice of closing incomplete applications after 1 year enhances administrative efficiency by allowing the Board to direct its resources to handling timely and complete applications as well as ensuring that the Board’s decisions on applications are based on up-to-date information.

    Comparison to Federal Standards

    There is no corresponding federal standard to this proposed action.

    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 West 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 February 19, 2019. A public hearing has not been scheduled.

    .01 Application for Name Change [Requirements].

    The name of an individual or entity required to possess a pharmacy or wholesale distribution permit may be changed on a permit if:

    A. The permit holder submits a notice of name change to the Board within 30 days [before orafter the name change, on a form that the Board requires; [and]

    B. The permit holder submits to the Board documentation verifying the name change; and

    [B.C. (text unchanged)

    [.01-1 Hours of Operation Change Requirements.

    A pharmacy or wholesale distribution permit holder shall notify the Board, on a form that the Board requires, within 30 days before a change in hours of operation.]

    .02 Application for Name Change—Fee.

    [A.There is no fee for a name change under this chapter[, if the permit holder complies with Regulation .01 of this chapter].

    [B. If a permit holder fails to comply with Regulation .01 of this chapter, the permit holder shall pay to the Board the name change late fee established in COMAR 10.34.09.]

    .03 Applications for Pharmacy or Wholesale Distributor Establishment Change of Ownership.

    If the controlling interest in ownership of a pharmacy or wholesale distributor changes, the new owner shall:

    A. Submit an initial application and fee for a pharmacy or wholesale distributor permit, as applicable; and

    B. Submit and comply with the requirements of closing and opening operations as set forth in:

    (1) COMAR 10.34.14, for pharmacies; and

    (2) Health Occupations Article, §12-6C-05(d), Annotated Code of Maryland, and COMAR, for wholesale distributors.

    .04 Applications for Pharmacy or Wholesale Distributor Establishment Change of Location.

    A. Permits issued to operate a pharmacy or engage in wholesale distribution, whether located in the State or outside the State, are:

    (1) Not transferable; and

    (2) Specific to the establishment location that has undergone an opening inspection by the Board.

    B. A pharmacy or wholesale distributor that intends to change its establishment location shall:

    (1) Submit an application to the Board on a form required by the Board;

    (2) If located in the State, comply with opening and closing inspection requirements in order to:

    (a) Commence operations at the new establishment location; and

    (b) Cease operations at the existing establishment location; and

    (3) If located outside the State, submit an inspection report for the new location conducted by the authorized entity in the state in which the establishment is located, or provide documentation of supplemental accreditation, if applicable.

    .05 Change of Information Provided in Applications.

    Notwithstanding any other reporting requirements, a permit holder shall provide written notification to the Board at least 30 days prior to any change in information in its application provided to the Board, to include:

    A. Change in hours of operation; or

    B. Change in the physical structure of the establishment, to include any:

    (1) Deviation from the floorplan submitted by the permit holder as part of the application; or

    (2) Other change that may affect the security or storage conditions of prescription drugs or devices.

    .06 Incomplete Applications.

    A. The Board may hold an incomplete initial or reinstatement application for a license, registration, or permit for up to one year from the date of receipt.

    B. After 1 year from the date of receipt, the Board shall close a pending application that is incomplete.

    C. If an application has been closed under §B of this regulation, the applicant shall submit a new application fee and otherwise comply with all applicable license, registration, or permit requirements.

    D. If an applicant presents extenuating circumstances to the Board, the Board may, in its sole discretion, extend the 1-year application completion period.

    Secretary of Health