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<chapter num="30" heading="Change to Permit — Pharmacy or Wholesale Distribution Permit Holder" title_num="10" subtitle_num="34">
  <regulation prefix="Regulation" num=".01" heading="Application for Name Change.">
    <text>The name of an individual or entity required to possess a pharmacy or wholesale distribution permit may be changed on a permit if:</text>
    <paragraph num="A.">
      <text>The permit holder submits a notice of name change to the Board within 30 days after the name change, on a form that the Board requires;</text>
    </paragraph>
    <paragraph num="B.">
      <text>The permit holder submits to the Board documentation verifying the name change; and</text>
    </paragraph>
    <paragraph num="C.">
      <text>There is no other change in the individual or entity required to possess a pharmacy or wholesale distribution permit including no change in controlling ownership interest, type of business entity, or location.</text>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".02" heading="Application for Name Change — Fee.">
    <text>There is no fee for a name change under this chapter.</text>
  </regulation>
  <regulation prefix="Regulation" num=".03" heading="Applications for Pharmacy or Wholesale Distributor Establishment Change of Ownership.">
    <text>If the controlling interest in ownership of a pharmacy or wholesale distributor changes, the new owner shall:</text>
    <paragraph num="A.">
      <text>Submit an initial application and fee for a pharmacy or wholesale distributor permit, as applicable; and</text>
    </paragraph>
    <paragraph num="B.">
      <text>Submit and comply with the requirements of closing and opening operations as set forth in:</text>
      <paragraph num="(1)">
        <text>COMAR 10.34.14, for pharmacies; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Health Occupations Article, §12-6C-05(d), Annotated Code of Maryland, and COMAR 10.34.22.10, for wholesale distributors.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".04" heading="Applications for Pharmacy or Wholesale Distributor Establishment Change of Location.">
    <paragraph num="A.">
      <text>Permits issued to operate a pharmacy or engage in wholesale distribution, whether located in the State or outside the State, are:</text>
      <paragraph num="(1)">
        <text>Not transferable; and</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Specific to the establishment location that has undergone an opening inspection by the Board.</text>
      </paragraph>
    </paragraph>
    <paragraph num="B.">
      <text>A pharmacy or wholesale distributor that intends to change its establishment location shall:</text>
      <paragraph num="(1)">
        <text>Submit an application to the Board on a form required by the Board;</text>
      </paragraph>
      <paragraph num="(2)">
        <text>If located in the State, comply with opening and closing inspection requirements in order to:</text>
        <paragraph num="(a)">
          <text>Commence operations at the new establishment location; and</text>
        </paragraph>
        <paragraph num="(b)">
          <text>Cease operations at the existing establishment location; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(3)">
        <text>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.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".05" heading="Change of Information Provided in Applications.">
    <text>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:</text>
    <paragraph num="A.">
      <text>Change in hours of operation; or</text>
    </paragraph>
    <paragraph num="B.">
      <text>Change in the physical structure of the establishment, to include any:</text>
      <paragraph num="(1)">
        <text>Deviation from the floorplan submitted by the permit holder as part of the application; or</text>
      </paragraph>
      <paragraph num="(2)">
        <text>Other change that may affect the security or storage conditions of prescription drugs or devices.</text>
      </paragraph>
    </paragraph>
  </regulation>
  <regulation prefix="Regulation" num=".06" heading="Incomplete Applications.">
    <paragraph num="A.">
      <text>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.</text>
    </paragraph>
    <paragraph num="B.">
      <text>After 1 year from the date of receipt, the Board shall close a pending application that is incomplete.</text>
    </paragraph>
    <paragraph num="C.">
      <text>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.</text>
    </paragraph>
    <paragraph num="D.">
      <text>If an applicant presents extenuating circumstances to the Board, the Board may, in its sole discretion, extend the 1-year application completion period.</text>
    </paragraph>
  </regulation>
  <annotations>
    <annotation type="Authority">Health Occupations Article, §§12-205 and 12-206, Annotated Code of Maryland</annotation>
    <annotation type="History" subtype="Administrative History">Effective date: November 10, 2003 (30:22 Md. R. 1582)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 8, 2013 (40:13 Md. R. 1076)</annotation>
    <annotation type="History" subtype="Administrative History">Regulation .01-1 adopted effective July 8, 2013 (40:13 Md. R. 1076)</annotation>
    <annotation type="History" subtype="Administrative History">Chapter revised effective May 20, 2019 (46:10 Md. R. 489)</annotation>
  </annotations>
</chapter>