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<section article="gho" article_name="Health Occupations" number="12-6C-09" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act">
  <level label="a">
    <level label="1">
      <text>A wholesale distributor shall receive prescription  drug returns or exchanges from a pharmacy or pharmacy warehouse  according to the terms and conditions of the agreement between  the wholesale distributor and the pharmacy or pharmacy  warehouse.</text>
    </level>
    <level label="2">
      <text>Returns of expired, damaged, recalled, or otherwise  nonsaleable prescription drugs shall be distributed by the  receiving wholesale distributor only to either the original  manufacturer or a third party returns processor.</text>
    </level>
    <level label="3">
      <text>Returns or exchanges of prescription drugs,  saleable or otherwise, including any redistribution by a receiving  wholesaler, are not subject to the pedigree requirements of § 12–6C–10 of this subtitle if they are exempt from the pedigree  requirement of the U.S. Food and Drug Administration’s currently  applicable Prescription Drug Marketing Act guidelines.</text>
    </level>
    <level label="4">
      <text>Wholesale distributors and pharmacies shall be  accountable for:</text>
      <level label="i">
        <text>Administering their returns process; and</text>
      </level>
      <level label="ii">
        <text>Ensuring that the returns process is secure  and does not permit the entry of adulterated and counterfeit  product.</text>
      </level>
    </level>
  </level>
  <level label="b">
    <text>A wholesale distributor may supply prescription drugs  only to a person authorized by law to dispense or receive  prescription drugs.</text>
  </level>
  <level label="c">
    <level label="1">
      <text>Except as provided in paragraph (2) of this  subsection, a wholesale distributor may deliver prescription drugs  only to:</text>
      <level label="i">
        <text>The premises listed on the recipient’s license  or permit; or</text>
      </level>
      <level label="ii">
        <text>An authorized person or an agent of an  authorized person at the premises of the wholesale distributor if:</text>
        <level label="1">
          <text>The identity and authorization of the  person or agent is properly established; and</text>
        </level>
        <level label="2">
          <text>This method of delivery is employed only  to meet the immediate needs of a particular patient of the  authorized person.</text>
        </level>
      </level>
    </level>
    <level label="2">
      <level label="i">
        <text>Prescription drugs may be supplied to a  hospital pharmacy receiving area if a pharmacist or authorized  receiving personnel of the hospital pharmacy signs, at the time of  delivery, a receipt showing the type and quantity of the  prescription drug received.</text>
      </level>
      <level label="ii">
        <text>Any discrepancy between the type and quantity  of the prescription drug indicated on the receipt and the type and  quantity of the prescription drug received:</text>
        <level label="1">
          <text>Shall be reported to the delivering  wholesale distributor by the next business day after the delivery  to the hospital pharmacy receiving area; and</text>
        </level>
        <level label="2">
          <text>May be reported to the Board for  investigation.</text>
        </level>
      </level>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>A wholesale distributor may not accept payment or  allow the use of a person’s credit to establish an account for the  purchase of prescription drugs from any person other than the  owner of record, the chief executive officer, or the chief financial  officer listed on the license or permit of a person legally  authorized to receive prescription drugs.</text>
    </level>
    <level label="2">
      <text>Any account established for the purchase of  prescription drugs shall bear the name of the license or permit  holder.</text>
    </level>
  </level>
  <level label="e">
    <text>A wholesale distributor may not operate out of a  residence.</text>
  </level>
</section>
