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<section article="ghg" article_name="Health - General" number="21-2C-01" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2C" subtitle_name="Prescription Drug Affordability Board">
  <level label="a">
    <text>In this subtitle the following words have the meanings indicated.</text>
  </level>
  <level label="b">
    <text>“Biologic” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 C.F.R. § 447.502.</text>
  </level>
  <level label="c">
    <text>“Biosimilar” means a drug that is produced or distributed in accordance with a biologics license application approved under 42 U.S.C. § 262(k)(3).</text>
  </level>
  <level label="d">
    <text>“Board” means the Prescription Drug Affordability Board.</text>
  </level>
  <level label="e">
    <level label="1">
      <text>“Brand name drug” means a drug that is produced or distributed in accordance with an original new drug application approved under 21 U.S.C. § 355(c).</text>
    </level>
    <level label="2">
      <text>“Brand name drug” does not include an authorized generic as defined by 42 C.F.R. § 447.502.</text>
    </level>
  </level>
  <level label="f">
    <text>“Current shortage” means a drug:</text>
    <level label="1">
      <text>Listed as current on the federal Food and Drug Administration’s Drug Shortage Database; or</text>
    </level>
    <level label="2">
      <text>Otherwise determined by the Board to be in short supply in the State.</text>
    </level>
  </level>
  <level label="g">
    <text>“Generic drug” means:</text>
    <level label="1">
      <text>A retail drug that is marketed or distributed in accordance with an abbreviated new drug application, approved under 21 U.S.C. § 355(j);</text>
    </level>
    <level label="2">
      <text>An authorized generic as defined by 42 C.F.R. § 447.502; or</text>
    </level>
    <level label="3">
      <text>A drug that entered the market before 1962 that was not originally marketed under a new drug application.</text>
    </level>
  </level>
  <level label="h">
    <text>“Manufacturer” means an entity that:</text>
    <level label="1">
      <level label="i">
        <text>Engages in the manufacture of a prescription drug product; or</text>
      </level>
      <level label="ii">
        <text>Enters into a lease with another manufacturer to market and distribute a prescription drug product under the entity’s own name; and</text>
      </level>
    </level>
    <level label="2">
      <text>Sets or changes the wholesale acquisition cost of the prescription drug product it manufactures or markets.</text>
    </level>
  </level>
  <level label="i">
    <text>“Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.</text>
  </level>
  <level label="j">
    <text>“Stakeholder Council” means the Prescription Drug Affordability Stakeholder Council.</text>
  </level>
</section>
