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<section article="gho" article_name="Health Occupations" number="12-6C-09.1" 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>In this section the following words have the meanings indicated.</text>
    </level>
    <level label="2">
      <text>“Covered entity” has the meaning stated in 42 U.S.C. § 256b(a)(4).</text>
    </level>
    <level label="3">
      <text>“Package” has the meaning stated in 21 U.S.C. § 360eee(11).</text>
    </level>
    <level label="4">
      <level label="i">
        <text>“340B drug” means a drug that:</text>
        <level label="1">
          <text>Is a covered outpatient drug under 42 U.S.C. § 256b;</text>
        </level>
        <level label="2">
          <text>Has been subject to an offer for reduced prices by a 340B manufacturer under 42 U.S.C. § 256b(a)(1); and</text>
        </level>
        <level label="3">
          <text>Is purchased by a covered entity.</text>
        </level>
      </level>
      <level label="ii">
        <text>“340B drug” includes a drug that would have been purchased but for the limitation under subsection (c) of this section.</text>
      </level>
    </level>
    <level label="5">
      <text>“340B manufacturer” means a manufacturer, as defined in 42 U.S.C. § 1396r–8(k)(5), of covered outpatient drugs that has signed a pharmaceutical pricing agreement under 42 U.S.C. § 256b(a)(1).</text>
    </level>
  </level>
  <level label="b">
    <text>This section may not be construed to be:</text>
    <level label="1">
      <text>Less restrictive than any federal law that is applicable to a person regulated by this section; or</text>
    </level>
    <level label="2">
      <text>In conflict with applicable federal and State laws and regulations.</text>
    </level>
  </level>
  <level label="c">
    <level label="1">
      <text>Except as provided in paragraph (2) of this subsection, a 340B manufacturer may not directly or indirectly deny, restrict, prohibit, discriminate against, or otherwise limit the acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract with or otherwise authorized by a covered entity to receive 340B drugs on behalf of the covered entity unless the receipt of 340B drugs is prohibited by the U.S. Department of Health and Human Services.</text>
    </level>
    <level label="2">
      <text>A 340B manufacturer may limit the distribution of a 340B drug if the limitation is required under 21 U.S.C. § 355–1.</text>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <level label="i">
        <text>A violation of subsection (c) of this section:</text>
        <level label="1">
          <text>Subject to paragraph (2) of this subsection, is an unfair, abusive, or deceptive trade practice within the meaning of Title 13 of the Commercial Law Article and is subject to the enforcement and penalty provisions contained in Title 13 of the Commercial Law Article; and</text>
        </level>
        <level label="2">
          <level label="A">
            <text>If the alleged violation was committed by a person that is licensed or permitted by the Board, shall be investigated by the Board or the Consumer Protection Division of the Office of the Attorney General; or</text>
          </level>
        </level>
        <level label="B">
          <text>If the alleged violation was committed by a person that is not licensed or permitted by the Board, shall be investigated by the Consumer Protection Division of the Office of the Attorney General.</text>
        </level>
      </level>
      <level label="ii">
        <text>As part of an investigation conducted under subparagraph (1)(i)2 of this paragraph, the Board or the Consumer Protection Division of the Office of the Attorney General may investigate an affiliate or a contractor of the 340B manufacturer, including a wholesaler or third–party logistics provider.</text>
      </level>
    </level>
    <level label="2">
      <level label="i">
        <text>In addition to the penalties under Title 13 of the Commercial Law Article, a civil fine may be assessed in the amount of $5,000 per violation of subsection (c) of this section.</text>
      </level>
      <level label="ii">
        <text>A violation of this section does not create a private right of action under § 13–408 of the Commercial Law Article.</text>
      </level>
    </level>
    <level label="3">
      <text>If a violation of subsection (c) of this section is committed by a person licensed or permitted by the Board, the Board may impose discipline, suspension, or revocation of the person’s license or permit.</text>
    </level>
    <level label="4">
      <text>Each package of 340B drugs subject to a violation of subsection (c) of this section shall constitute a separate violation.</text>
    </level>
  </level>
</section>
