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<section article="ghg" article_name="Health - General" number="2-801" title_number="2" title_name="Maryland Department of Health" subtitle_number="8" subtitle_name="Prohibition Against Price Gouging for Essential Off-Patent or Generic Drugs">
  <level label="a">
    <text>In this subtitle the following words have the meanings indicated.</text>
  </level>
  <level label="b">
    <level label="1">
      <text>“Essential off–patent or generic drug” means any prescription drug:</text>
      <level label="i">
        <text>For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired;</text>
      </level>
      <level label="ii">
        <level label="1">
          <text>That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or</text>
        </level>
        <level label="2">
          <text>That has been designated by the Secretary as an essential medicine due to its efficacy in treating a life–threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living;</text>
        </level>
      </level>
      <level label="iii">
        <text>That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and</text>
      </level>
      <level label="iv">
        <text>That is made available for sale in the State.</text>
      </level>
    </level>
    <level label="2">
      <text>“Essential off–patent or generic drug” includes any drug–device combination product used for the delivery of a drug for which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired.</text>
    </level>
  </level>
  <level label="c">
    <text>“Price gouging” means an unconscionable increase in the price of a prescription drug.</text>
  </level>
  <level label="d">
    <text>“State health plan” has the meaning stated in § 2–601 of this title.</text>
  </level>
  <level label="e">
    <text>“State health program” has the meaning stated in § 2–601 of this title.</text>
  </level>
  <level label="f">
    <text>“Unconscionable increase” means an increase in the price of a prescription drug that:</text>
    <level label="1">
      <text>Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health; and</text>
    </level>
    <level label="2">
      <text>Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of:</text>
      <level label="i">
        <text>The importance of the drug to their health; and</text>
      </level>
      <level label="ii">
        <text>Insufficient competition in the market for the drug.</text>
      </level>
    </level>
  </level>
  <level label="g">
    <text>“Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.</text>
  </level>
</section>
