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<section article="gho" article_name="Health Occupations" number="12-6C-10" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act">
  <level label="a">
    <text>A person who is engaged in the wholesale distribution of  a prescription drug that leaves, or has ever left, the normal  distribution channel shall provide, before each wholesale  distribution of the prescription drug, a pedigree to the person who  receives the prescription drug.</text>
  </level>
  <level label="b">
    <text>A retail pharmacy or pharmacy warehouse shall comply  with the requirements of this section only if the pharmacy or  pharmacy warehouse engages in the wholesale distribution of a  prescription drug in the State.</text>
  </level>
  <level label="c">
    <level label="1">
      <text>To be considered part of the normal distribution  channel, a wholesale distributor, a manufacturer’s exclusive  distributor, and a manufacturer’s third party logistics provider  also must be an authorized distributor of record.</text>
    </level>
    <level label="2">
      <text>Notwithstanding paragraph (1) of this subsection, a  pharmacy warehouse that is not an authorized distributor of  record shall be considered part of the normal distribution  channel.</text>
    </level>
  </level>
  <level label="d">
    <text>Each person who engages in the wholesale distribution of  a prescription drug, including repackagers but excluding the  original manufacturer of the finished form of the prescription  drug, who is provided a pedigree for the prescription drug and  attempts to further distribute the prescription drug, shall  authenticate, before any distribution of the prescription drug  occurs, that each transaction listed on the pedigree has occurred.</text>
  </level>
  <level label="e">
    <text>The pedigree shall include:</text>
    <level label="1">
      <text>All necessary identifying information relating to  each sale in the chain of distribution of the prescription drug from  the manufacturer or the manufacturer’s third party logistics  provider, co–licensed partner, or manufacturer’s exclusive  distributor, through acquisition and sale by any wholesale  distributor or repackager, until final sale to a pharmacy or other  person dispensing or administering the prescription drug,  including:</text>
      <level label="i">
        <text>The name, address, telephone number, and if  available, electronic mail address, of each owner and each  wholesale distributor of the prescription drug;</text>
      </level>
      <level label="ii">
        <text>The name and address of each location from  which the prescription drug was shipped, if different from the  owner’s;</text>
      </level>
      <level label="iii">
        <text>Transaction dates; and</text>
      </level>
      <level label="iv">
        <text>Certification that each recipient has  authenticated the pedigree;</text>
      </level>
    </level>
    <level label="2">
      <text>The name of the prescription drug;</text>
    </level>
    <level label="3">
      <text>The dosage form and strength of the prescription  drug;</text>
    </level>
    <level label="4">
      <text>The size of the container;</text>
    </level>
    <level label="5">
      <text>The number of containers;</text>
    </level>
    <level label="6">
      <text>The lot number and National Drug Code of the  prescription drug; and</text>
    </level>
    <level label="7">
      <text>The name of the manufacturer of the finished  dosage form.</text>
    </level>
  </level>
  <level label="f">
    <text>Each pedigree for a prescription drug shall be:</text>
    <level label="1">
      <text>Maintained by the purchaser and the wholesale  distributor for 3 years from the date of sale or transfer; and</text>
    </level>
    <level label="2">
      <text>Available for inspection or use within 5 business  days on request of the Board, the Board’s designee, or an  authorized law enforcement officer.</text>
    </level>
  </level>
</section>
