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<regulation prefix="Regulation" num=".02" citation="COMAR 15.01.15.02" title_num="15" subtitle_num="01" chapter_num="15" 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>“Administered in a regular pattern” means used:</text>
      <paragraph num="(a)">
        <text>For multiple courses of therapy in the same animal or group of animals; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>As a standard operating procedure, including:</text>
        <paragraph num="(i)">
          <text>In correspondence with a particular life stage of an animal, such as in ovo, at birth or hatch, or at weaning;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>As an ongoing management strategy or tool, such as in correspondence with a particular age or weight of an animal, time of the week, month, or year, or season; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>When moving animals from one location to another.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>“Animal” means cattle, swine or poultry.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Dry cycle” means a period of time when a cow is not lactating.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Elevated Risk.</text>
      <paragraph num="(a)">
        <text>“Elevated risk” means a risk that is significantly higher than that present under normal or standard operating conditions.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Elevated risk” does not include a risk typically or frequently present under normal or standard operating conditions.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>“Prophylaxis” or “Prophylactic” means the prevention of disease or infection in the absence of documented clinical signs of disease or infection.</text>
    </paragraph>
    <paragraph num="(6)">
      <text>“Medically important antimicrobial drug” means any drug from a class of drug or a derivative of a class of drug that is either:</text>
      <paragraph num="(a)">
        <text>Made from a mold or bacterium that kills or slows the growth of other microbes, specifically bacteria, and used in human beings or intended for use in human beings to treat or prevent disease or infection; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Listed in:</text>
        <paragraph num="(i)">
          <text>Appendix A of the federal Food and Drug Administration’s Guidance for Industry #152, including critically important, highly important, or important antimicrobial drugs; or</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>A subsequent guidance document created by the federal Food and Drug Administration that ranks the medical importance of antimicrobial drugs.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>