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<subtitle article="gag" title_number="3" subtitle_number="10" title_name="Regulation of Livestock and Poultry" subtitle_name="Use of Antimicrobial Drugs">
  <section article="gag" article_name="Agriculture" number="3-1001" title_number="3" title_name="Regulation of Livestock and Poultry" subtitle_number="10" subtitle_name="Use of Antimicrobial Drugs">
    <level label="a">
      <text>In this subtitle the following words have the meanings indicated.</text>
    </level>
    <level label="b">
      <text>“Administered in a regular pattern” means used:</text>
      <level label="1">
        <text>For multiple courses of therapy in the same animal or group of animals; or</text>
      </level>
      <level label="2">
        <text>As standard operating procedure, including:</text>
        <level label="i">
          <text>In correspondence with a particular life stage of an animal, such as in ovo, at birth or hatch, or at weaning;</text>
        </level>
        <level label="ii">
          <text>As an ongoing management strategy or tool, such as in correspondence with a particular:</text>
          <level label="1">
            <text>Age or weight of an animal;</text>
          </level>
          <level label="2">
            <text>Time of the week, month, or year; or</text>
          </level>
          <level label="3">
            <text>Season; or</text>
          </level>
        </level>
        <level label="iii">
          <text>When moving animals from one location to another.</text>
        </level>
      </level>
    </level>
    <level label="c">
      <text>“Control the spread of disease or infection” means to contain the transmission of a documented disease or infection present in:</text>
      <level label="1">
        <text>A group of animals in contact with each other; or</text>
      </level>
      <level label="2">
        <text>A barn or equivalent animal housing unit.</text>
      </level>
    </level>
    <level label="d">
      <text>“Documented” means acknowledged and recorded.</text>
    </level>
    <level label="e">
      <level label="1">
        <text>“Elevated risk” means a risk that is significantly higher than that present under normal or standard operating conditions.</text>
      </level>
      <level label="2">
        <text>“Elevated risk” does not include a risk typically or frequently present under normal or standard operating conditions.</text>
      </level>
    </level>
    <level label="f">
      <text>“Medically important antimicrobial drug” means any drug from a class of drug or derivative of a class of drug that is:</text>
      <level label="1">
        <level label="i">
          <text>Made from a mold or bacterium that kills or slows the growth of other microbes, specifically bacteria; and</text>
        </level>
        <level label="ii">
          <text>Used in human beings or intended for use in human beings to treat or prevent disease or infection; or</text>
        </level>
      </level>
      <level label="2">
        <text>Listed in:</text>
        <level label="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>
        </level>
        <level label="ii">
          <text>A subsequent guidance document created by the federal Food and Drug Administration that ranks the medical importance of antimicrobial drugs.</text>
        </level>
      </level>
    </level>
    <level label="g">
      <text>“Medically important antimicrobial drug prescription” means an order issued by a veterinarian licensed in the State in the course of the veterinarian’s professional practice:</text>
      <level label="1">
        <text>For a medically important antimicrobial drug that is:</text>
        <level label="i">
          <text>In a water–soluble powder form; and</text>
        </level>
        <level label="ii">
          <text>To be added to the drinking water of cattle, swine, or poultry; and</text>
        </level>
      </level>
      <level label="2">
        <text>That provides the same or substantially similar information as the information that is required for a veterinary feed directive under Title 21, § 558.6(b)(3) and (4) of the Code of Federal Regulations.</text>
      </level>
    </level>
    <level label="h">
      <text>“Owner” means a person that:</text>
      <level label="1">
        <text>Has an ownership interest in cattle, swine, or poultry, including a right or an option to purchase the cattle, swine, or poultry; or</text>
      </level>
      <level label="2">
        <text>Is otherwise engaged in the business of obtaining live cattle, swine, or poultry under a growing agreement for the purpose of either slaughtering the cattle, swine, or poultry or selling the cattle, swine, or poultry for slaughter.</text>
      </level>
    </level>
    <level label="i">
      <text>“Prophylaxis” means the prevention of disease or infection in the absence of documented clinical signs of disease or infection.</text>
    </level>
    <level label="j">
      <text>“Treat a disease or infection” means to resolve clinical signs of infection or disease in an infected animal.</text>
    </level>
    <level label="k">
      <text>“Veterinary feed directive” means a written statement issued by a veterinarian licensed in the State in the course of the veterinarian’s professional practice that:</text>
      <level label="1">
        <text>Orders the use of an animal drug in or on animal feed;</text>
      </level>
      <level label="2">
        <text>Authorizes an owner or a caretaker of an animal to obtain and use animal feed bearing or containing an animal drug to treat the animal; and</text>
      </level>
      <level label="3">
        <text>Meets the conditions and requirements specified under Title 21, § 558.6 of the Code of Federal Regulations.</text>
      </level>
    </level>
  </section>
  <section article="gag" article_name="Agriculture" number="3-1002" title_number="3" title_name="Regulation of Livestock and Poultry" subtitle_number="10" subtitle_name="Use of Antimicrobial Drugs">
    <text>Except as otherwise provided in federal law or regulation, this subtitle does not apply to antimicrobial use in:</text>
    <level label="1">
      <text>Cattle on a farm operation that sells fewer than 200 cattle per year;</text>
    </level>
    <level label="2">
      <text>Dairy cattle on a farm operation with a herd size of fewer than 300 dairy cattle;</text>
    </level>
    <level label="3">
      <text>Swine on a farm operation that sells fewer than 200 swine per year; or</text>
    </level>
    <level label="4">
      <text>Poultry on a farm operation that sells fewer than 60,000 birds per year.</text>
    </level>
  </section>
  <section article="gag" article_name="Agriculture" number="3-1003" title_number="3" title_name="Regulation of Livestock and Poultry" subtitle_number="10" subtitle_name="Use of Antimicrobial Drugs">
    <level label="a">
      <text>A medically important antimicrobial drug may not be administered in feed or water to cattle, swine, or poultry unless ordered by a licensed veterinarian through:</text>
      <level label="1">
        <text>A medically important antimicrobial drug prescription; or</text>
      </level>
      <level label="2">
        <text>A veterinary feed directive.</text>
      </level>
    </level>
    <level label="b">
      <level label="1">
        <text>On or after January 1, 2018, and subject to subsection (c) of this section, a medically important antimicrobial drug may be administered to cattle, swine, or poultry if, in the professional judgment of a licensed veterinarian, the medically important antimicrobial drug is necessary:</text>
        <level label="i">
          <text>To treat a disease or infection;</text>
        </level>
        <level label="ii">
          <text>To control the spread of a disease or infection; or</text>
        </level>
        <level label="iii">
          <text>For a surgery or medical procedure.</text>
        </level>
      </level>
      <level label="2">
        <level label="i">
          <text>On or after January 1, 2018, a medically important antimicrobial drug may be administered to cattle, swine, or poultry if, in the professional judgment of a licensed veterinarian, the medically important antimicrobial drug is necessary for prophylaxis to address an elevated risk of contraction of a particular disease or infection.</text>
        </level>
        <level label="ii">
          <text>Notwithstanding subsection (e) of this section, administration of a medically important antimicrobial drug for the purpose of prophylaxis may not exceed 21 days unless federal label directions require a longer period of use.</text>
        </level>
      </level>
    </level>
    <level label="c">
      <text>Unless administration of a medically important antimicrobial drug is consistent with subsection (b)(1) of this section, a medically important antimicrobial drug may not be administered in a regular pattern to cattle, swine, or poultry.</text>
    </level>
    <level label="d">
      <text>A medically important antimicrobial drug may not be administered to cattle, swine, or poultry solely for the purpose of:</text>
      <level label="1">
        <text>Promoting weight gain; or</text>
      </level>
      <level label="2">
        <text>Improving feed efficiency.</text>
      </level>
    </level>
    <level label="e">
      <level label="1">
        <text>Except as provided in paragraphs (2) and (3) of this subsection, a medically important antimicrobial drug may not be administered to cattle, swine, or poultry for a period longer than 21 days.</text>
      </level>
      <level label="2">
        <text>A medically important antimicrobial drug may be administered to cattle, swine, or poultry for a period longer than 21 days if the federal label directions for the drug require a longer period of use.</text>
      </level>
      <level label="3">
        <level label="i">
          <text>A licensed veterinarian may extend administration of a medically important antimicrobial drug for not more than 21 days if, after conducting an on–site visit, the veterinarian determines that the extension is necessary to treat or control the spread of disease or infection.</text>
        </level>
        <level label="ii">
          <text>A licensed veterinarian may grant additional extensions of not more than 21 days, provided that the veterinarian conducts an on–site visit before each extension.</text>
        </level>
      </level>
    </level>
    <level label="f">
      <text>On or before January 1, 2021, the Department shall adopt regulations prohibiting the routine administration of a medically important antimicrobial drug to dairy cattle entering a dry cycle except when necessary based on an assessment of the presence of an intramammary infection.</text>
    </level>
  </section>
  <section article="gag" article_name="Agriculture" number="3-1004" title_number="3" title_name="Regulation of Livestock and Poultry" subtitle_number="10" subtitle_name="Use of Antimicrobial Drugs">
    <level label="a">
      <text>Each year the Department shall collect publicly available data on the use in the State of medically important antimicrobial drugs in cattle, swine, and poultry from:</text>
      <level label="1">
        <text>The U.S. Department of Agriculture;</text>
      </level>
      <level label="2">
        <text>The Centers for Disease Control and Prevention;</text>
      </level>
      <level label="3">
        <text>The U.S. Food and Drug Administration; and</text>
      </level>
      <level label="4">
        <text>Appropriate national and State trade associations, organizations, and councils.</text>
      </level>
    </level>
    <level label="b">
      <text>On or before February 1 each year, a licensed veterinarian shall submit to the Department, in a manner determined by the Department:</text>
      <level label="1">
        <text>A copy of the record prescribing the medically important antimicrobial drug or a copy of the veterinary feed directive for each medically important antimicrobial drug, as listed in Appendix A of the federal Food and Drug Administration’s Guidance for Industry #152, administered in feed or water to cattle, swine, or poultry during the previous calendar year; and</text>
      </level>
      <level label="2">
        <text>An accounting, as provided by the owner, of the total number of animals raised during the previous calendar year, categorized by species and production class.</text>
      </level>
    </level>
    <level label="c">
      <level label="1">
        <text>On or before July 1 each year, the Department shall report to the General Assembly, in accordance with § 2–1257 of the State Government Article, on the data collected under subsections (a) and (b) of this section.</text>
      </level>
      <level label="2">
        <text>The report shall include the following information for the previous calendar year:</text>
        <level label="i">
          <text>The total number of animals raised on farm operations covered by this subtitle, categorized by species and production class;</text>
        </level>
        <level label="ii">
          <text>The specific antimicrobial active ingredients and classes of antimicrobial active ingredients used;</text>
        </level>
        <level label="iii">
          <text>The total weight of antimicrobial active ingredients used;</text>
        </level>
        <level label="iv">
          <text>Indications for which veterinarians prescribed medically important antimicrobial drugs; and</text>
        </level>
        <level label="v">
          <text>Patterns of use for medically important antimicrobial drugs, including duration and seasonal variation.</text>
        </level>
      </level>
      <level label="3">
        <level label="i">
          <text>Subject to subparagraph (ii) of this paragraph, the information required under paragraph (2) of this subsection shall be disaggregated by county.</text>
        </level>
        <level label="ii">
          <text>If there are two or fewer reporting farm operations in a particular county for any of the categories described in paragraph (2) of this subsection, the Department may report the information for that category on a regional or statewide basis.</text>
        </level>
      </level>
    </level>
    <level label="d">
      <text>The Department shall maintain all records and information relating to the administration of medically important antimicrobial drugs submitted to the Department under this section:</text>
      <level label="1">
        <text>In a manner that protects the identity of the owner, operator, and veterinarian for whom the information was submitted; and</text>
      </level>
      <level label="2">
        <text>For at least 5 years.</text>
      </level>
    </level>
  </section>
  <section article="gag" article_name="Agriculture" number="3-1005" title_number="3" title_name="Regulation of Livestock and Poultry" subtitle_number="10" subtitle_name="Use of Antimicrobial Drugs">
    <text>The Secretary may impose an administrative penalty, not exceeding $2,000 per violation, on a person that violates this subtitle.</text>
  </section>
  <section article="gag" article_name="Agriculture" number="3-1006" title_number="3" title_name="Regulation of Livestock and Poultry" subtitle_number="10" subtitle_name="Use of Antimicrobial Drugs">
    <text>The Department may adopt regulations to carry out this subtitle.</text>
  </section>
</subtitle>