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<section article="ghg" article_name="Health - General" number="21-217" 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 misbranded if the standards in this section or in § 21-218 or § 21-220(d) or (e) of this subtitle apply.</text>
  </level>
  <level label="b">
    <text>A drug or device is misbranded if:</text>
    <level label="1">
      <text>Its labeling is false or misleading in any way;</text>
    </level>
    <level label="2">
      <text>Its labeling or packaging does not conform with any provision of § 21-248 of this subtitle;</text>
    </level>
    <level label="3">
      <text>It is in package form and it does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;</text>
    </level>
    <level label="4">
      <text>Any word, statement, or other information required under this subtitle to appear on its labeling is not placed prominently on the labeling in a manner that is:</text>
      <level label="i">
        <text>Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and</text>
      </level>
      <level label="ii">
        <text>In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use;</text>
      </level>
    </level>
    <level label="5">
      <text>Its labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device:</text>
      <level label="i">
        <text>Adequate directions for the use of the drug or device; and</text>
      </level>
      <level label="ii">
        <text>Adequate warnings against:</text>
        <level label="1">
          <text>The use of the drug or device by anyone suffering from a pathological condition that may cause its use to be dangerous to health;</text>
        </level>
        <level label="2">
          <text>The use of the drug or device by a child if its use by a child may be dangerous; and</text>
        </level>
        <level label="3">
          <text>Unsafe dosages, methods of administration, or duration of administration of the drug or device;</text>
        </level>
      </level>
    </level>
    <level label="6">
      <text>It is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or</text>
    </level>
    <level label="7">
      <text>The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud.</text>
    </level>
  </level>
  <level label="c">
    <level label="1">
      <text>Subsection (b)(5)(i) of this section, which concerns the provision of directions for the use of a drug or device, does not apply to a drug or device that is exempted by:</text>
      <level label="i">
        <text>A rule or regulation adopted under the federal act; or</text>
      </level>
      <level label="ii">
        <text>A rule or regulation adopted by the Secretary under this subsection.</text>
      </level>
    </level>
    <level label="2">
      <text>If the Secretary finds that, as applied to a particular drug or device, any requirement of subsection (b)(5)(i) of this section is not necessary for the protection of the public health, the Secretary shall adopt a rule or regulation to exempt the drug or device from that requirement.</text>
    </level>
  </level>
</section>
