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<section article="gho" article_name="Health Occupations" number="12-510" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="5" subtitle_name="Practice of Pharmacy and Operation of Pharmacies">
  <level label="a">
    <text>Except as provided in subsection (b) of this section, a pharmacist may provide compounded nonsterile preparations or compounded sterile preparations without a patient–specific prescription to a licensed veterinarian who intends to dispense the compounded nonsterile preparations or compounded sterile preparations in accordance with § 2–313(c) of the Agriculture Article if the pharmacist:</text>
    <level label="1">
      <text>Complies with USP 795 or USP 797, as applicable;</text>
    </level>
    <level label="2">
      <text>Labels the compounded nonsterile preparations or compounded sterile preparations with:</text>
      <level label="i">
        <text>The name and strength of the compounded nonsterile preparations or compounded sterile preparations or a list of the active ingredients and the strength of the active ingredients in the compounded nonsterile preparations or compounded sterile preparations;</text>
      </level>
      <level label="ii">
        <text>An appropriate beyond–use date as determined by the pharmacist in accordance with USP–NF standards for pharmacy compounding;</text>
      </level>
      <level label="iii">
        <text>The quantity of compounded nonsterile preparations or compounded sterile preparations; and</text>
      </level>
      <level label="iv">
        <text>The name, address, and license number of the pharmacy; and</text>
      </level>
    </level>
    <level label="3">
      <text>Complies with applicable federal law and regulations.</text>
    </level>
  </level>
  <level label="b">
    <level label="1">
      <text>This subsection does not apply to dispensing compounded nonsterile preparations or compounded sterile preparations dispensed for a patient–specific prescription.</text>
    </level>
    <level label="2">
      <text>A pharmacy may not provide compounded nonsterile preparations or compounded sterile preparations compounded using bulk drug substances to a licensed veterinarian:</text>
      <level label="i">
        <text>In an amount greater than 10% of the total amount of drug products sold or dispensed from the pharmacy; or</text>
      </level>
      <level label="ii">
        <text>If the compounded nonsterile preparations or compounded sterile preparations are copies or close approximations to products approved by the federal Food and Drug Administration.</text>
      </level>
    </level>
    <level label="3">
      <text>For purposes of the limitation established in paragraph (2)(i) of this subsection:</text>
      <level label="i">
        <text>The calculation shall be made on an annual basis and use the number of dosage units sold or dispensed; and</text>
      </level>
      <level label="ii">
        <text>For nonresident pharmacies, the total amount of drug products sold or dispensed shall be the pharmacy’s total business within the State.</text>
      </level>
    </level>
  </level>
</section>
