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<regulation prefix="Regulation" num=".02" citation="COMAR 10.13.02.02" title_num="10" subtitle_num="13" chapter_num="02" heading="Definitions.">
  <paragraph num="A.">
    <text>In this chapter, the following terms have the meanings indicated.</text>
  </paragraph>
  <paragraph num="B.">
    <text>Terms Defined.</text>
    <paragraph num="(1)">
      <text>“Adulterated” means a drug or device where:</text>
      <paragraph num="(a)">
        <text>Any part of the drug or device is filthy, putrid, or a decomposed substance; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have:</text>
        <paragraph num="(i)">
          <text>Contaminated the drug or device with filth; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Caused the drug or device to be injurious to health.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>“Board” means the State Board of Pharmacy.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Department” means the Maryland Department of Health.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Misbranded” means a drug or device where:</text>
      <paragraph num="(a)">
        <text>The drug’s or device’s:</text>
        <paragraph num="(i)">
          <text>Labeling is false or misleading in any way; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Labeling or packaging does not conform with Health-General Article, §21-248, Annotated Code of Maryland;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>The drug or device is in package form and does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Any word, statement, or other information required under Health-General Article, Title 21, Subtitle 2, Annotated Code of Maryland, to appear on the drug’s or device’s labeling is not placed prominently on the labeling in a manner that is:</text>
        <paragraph num="(i)">
          <text>Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(d)">
        <text>The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate directions for the use of the drug or device;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate warnings against:</text>
        <paragraph num="(i)">
          <text>The use of the drug or device by anyone suffering from a pathological condition that may cause the drug’s or device’s use to be dangerous to health;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The use of the drug or device by a child if the use by a child may be dangerous; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Unsafe dosages, methods of administration, or duration of administration of the drug or device;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(f)">
        <text>The drug or device 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>
      </paragraph>
      <paragraph num="(g)">
        <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>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>“Pedigree” means a record of the tracking of a drug or device through the supply chain, with each trading partner authenticating the drug or device upon receipt and transfer.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Prescription device” means a device required by federal law or regulation to be dispensed only by a prescription.</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Prescription Drug.</text>
      <paragraph num="(a)">
        <text>“Prescription drug” means a drug required by federal law or regulation to be dispensed only by a prescription.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Prescription drug” includes:</text>
        <paragraph num="(i)">
          <text>A biological product; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug, and Cosmetic Act.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>“Prescription drug” does not include:</text>
        <paragraph num="(i)">
          <text>Blood and blood components intended for transfusion; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Biological products that are also medical devices.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(8)">
      <text>“Public health purposes” includes the purpose of controlling communicable diseases or environmental health hazards.</text>
    </paragraph>
    <paragraph num="(9)">
      <text>“Secretary” means the Secretary of Health.</text>
    </paragraph>
  </paragraph>
</regulation>