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<section article="gho" article_name="Health Occupations" number="12-401.1" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="4" subtitle_name="Pharmacy Permits">
  <level label="a">
    <text>A person shall hold a clinical research pharmacy permit issued by the Board before the person may establish or operate a clinical research pharmacy in the State.</text>
  </level>
  <level label="b">
    <text>A separate clinical research pharmacy permit is required for each clinical research pharmacy that a person establishes or operates.</text>
  </level>
  <level label="c">
    <text>The Board may issue a clinical research pharmacy permit to a pharmacy that:</text>
    <level label="1">
      <text>Exclusively compounds, dispenses, or distributes prescription or nonprescription drugs as part of scientific research conducted under protocols established by an institutional review board that meet U.S. Food and Drug Administration guidelines;</text>
    </level>
    <level label="2">
      <text>Compounds, dispenses, or distributes pharmaceuticals solely incident to the research being conducted and consistent with related protocols;</text>
    </level>
    <level label="3">
      <text>Is not open to the general public for retail pharmaceutical services and is strictly limited to dispensing to participants in a clinical trial;</text>
    </level>
    <level label="4">
      <text>Complies with security and storage protocols established by United States Pharmacopeia and the Board; and</text>
    </level>
    <level label="5">
      <text>Satisfies any other requirement established by the Board in regulation.</text>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>The Board shall adopt regulations to carry out this section.</text>
    </level>
    <level label="2">
      <text>The regulations adopted by the Board shall include:</text>
      <level label="i">
        <text>Required standards for the operation of a clinical research pharmacy;</text>
      </level>
      <level label="ii">
        <text>Application procedures;</text>
      </level>
      <level label="iii">
        <text>Standards for the suspension and revocation of a clinical research pharmacy permit; and</text>
      </level>
      <level label="iv">
        <text>Requirements related to the entry and inspection of clinical research pharmacies.</text>
      </level>
    </level>
  </level>
  <level label="e">
    <text>Except as otherwise provided in this title, an individual may not be required to obtain a license, certification, or other authorization to practice under this article to own or have an ownership interest in a clinical research pharmacy.</text>
  </level>
  <level label="f">
    <level label="1">
      <text>The ownership or possession of an ownership interest in a clinical research pharmacy by an individual who is not licensed, certified, or otherwise authorized to practice under this article may not be the sole basis for the Board to initiate a disciplinary action against the individual.</text>
    </level>
    <level label="2">
      <text>The applicable health occupations board may investigate an allegation that an individual employed by a clinical research pharmacy:</text>
      <level label="i">
        <text>Is practicing a profession regulated by the health occupations board under this article without a license, certificate, or other authorization or with an unauthorized person; or</text>
      </level>
      <level label="ii">
        <text>Has violated a provision of this article under the jurisdiction of the health occupations board.</text>
      </level>
    </level>
  </level>
  <level label="g">
    <text>A health care provider with a substantial ownership interest in a clinical research pharmacy may not:</text>
    <level label="1">
      <text>Serve as a clinical investigator for a scientific research protocol conducted by the clinical research pharmacy; or</text>
    </level>
    <level label="2">
      <text>Impede or impair a pharmacist’s ability to fully exercise the pharmacist’s professional judgment.</text>
    </level>
  </level>
  <level label="h">
    <text>This section does not limit:</text>
    <level label="1">
      <text>The right of an individual to practice a health occupation that the individual is authorized to practice under this article; or</text>
    </level>
    <level label="2">
      <text>The right of a person to establish or operate a pharmacy under other provisions of this title.</text>
    </level>
  </level>
</section>
