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<section article="ghg" article_name="Health - General" number="21-216" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2" subtitle_name="Maryland Food, Drug, and Cosmetic Act">
  <level label="a">
    <text>For purposes of this subtitle, a drug or device is adulterated if the standards in this section apply.</text>
  </level>
  <level label="b">
    <text>A drug or device is adulterated if:</text>
    <level label="1">
      <text>Any part of it is a filthy, putrid, or decomposed substance; or</text>
    </level>
    <level label="2">
      <text>It was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:</text>
      <level label="i">
        <text>Contaminated it with filth; or</text>
      </level>
      <level label="ii">
        <text>Caused it to be injurious to health.</text>
      </level>
    </level>
  </level>
  <level label="c">
    <text>In addition to the grounds specified in subsection (b) of this section, a drug is adulterated if:</text>
    <level label="1">
      <text>Any part of its container is composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the drug to be injurious to health;</text>
    </level>
    <level label="2">
      <text>For purposes of coloring only, it is or it contains a color additive, the particular use of which has not been found safe as provided under § 21–239 of this subtitle;</text>
    </level>
    <level label="3">
      <text>The mixing or packing of any substance with the drug has reduced the quality or strength of the drug;</text>
    </level>
    <level label="4">
      <text>Any substance has been substituted for any part of the drug;</text>
    </level>
    <level label="5">
      <text>The methods, facilities, or controls used in the manufacture, processing, packing, or holding of the drug do not conform to, or are not administered in conformity to, good practice to assure that the drug:</text>
      <level label="i">
        <text>Meets the requirements of this subtitle as to safety; and</text>
      </level>
      <level label="ii">
        <text>Has the identity, strength, quality, and purity that it purports to have;</text>
      </level>
    </level>
    <level label="6">
      <text>It is purported to be a drug the name of which is recognized in an official compendium and:</text>
      <level label="i">
        <text>The strength of the drug differs from, or the quality or purity of the drug falls below, the standard set in the official compendium; and</text>
      </level>
      <level label="ii">
        <text>The difference in strength, quality, or purity is not stated plainly on its label; or</text>
      </level>
    </level>
    <level label="7">
      <text>Although not purported to be a drug recognized in an official compendium, the strength of the drug differs from, or the quality or purity of the drug falls below that which the drug purports to possess.</text>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>For purposes of administering subsection (c)(6) of this section, any determination as to whether the strength of a drug differs from or as to whether its quality or purity falls below the standard set in an official compendium shall be made in accordance with the tests or methods of assay set forth in the official compendium, or, in the absence of or inadequacy of those tests or methods of assay, those provided under the federal act.</text>
    </level>
    <level label="2">
      <level label="i">
        <text>Except as provided in subparagraph (ii) of this paragraph, if a drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States, it is subject to the requirements of the United States Pharmacopoeia and National Formulary.</text>
      </level>
      <level label="ii">
        <text>If the drug is labeled and offered for sale as a homeopathic drug, it is subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia and National Formulary.</text>
      </level>
    </level>
  </level>
</section>
