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<regulation prefix="Regulation" num=".02" citation="COMAR 10.32.23.02" title_num="10" subtitle_num="32" chapter_num="23" 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>“Board” means the State Board of Physicians.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>“Controlled dangerous substance (CDS)” has the meaning stated in Criminal Law Article, §5-101(g), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>“Dispense” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>“Drug sample” has the meaning stated in 21 CFR §203.3(i).</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Final Check.</text>
      <paragraph num="(a)">
        <text>“Final check” means the verification of the accuracy and completeness of a filled prescription order by the permit holder before the drug is dispensed to the patient.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Final check” includes the assumption of responsibility for the filled prescription, including verifying the:</text>
        <paragraph num="(i)">
          <text>Appropriateness of the dose;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Accurate expiration date;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Accuracy of the drug dispensed;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Strength of the drug dispensed;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Labeling that complies with Health Occupations Article, §12-505, Annotated Code of Maryland; and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(6)">
      <text>“In good standing” means that an individual:</text>
      <paragraph num="(a)">
        <text>Holds a license to practice medicine in this State;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Is not currently suspended by any order imposed by any medical licensing board;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Is not currently on probation by any order imposed by any medical licensing board;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Is not currently subject to any restrictions on practice related to the abuse, misuse, or improper prescribing of drugs;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Has not been within the past 5 years sanctioned by any medical licensing board for the commission of a crime of moral turpitude or for a violation of Health Occupations Article, §14-404(a)(7), (8), (9), (10), or (28), Annotated Code of Maryland, or a similar statute of another state; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Has not within the past 5 years had the CDS registration issued by the OCSA or its predecessor, the registration issued by the federal Drug Enforcement Agency, or the Board dispensing permit:</text>
        <paragraph num="(i)">
          <text>Revoked;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Suspended; or</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Voluntarily relinquished or surrendered while under investigation or after being informed that an investigation will be commenced.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(7)">
      <text>“In the public interest” means that a pharmacy is not conveniently available to the patient.</text>
    </paragraph>
    <paragraph num="(8)">
      <text>Mechanical Act.</text>
      <paragraph num="(a)">
        <text>“Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>“Mechanical act” does not include:</text>
        <paragraph num="(i)">
          <text>Selecting a drug;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Labeling;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Measuring or calculating dosages;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Substituting one dosage form of a drug for another;</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>Altering the route of administration; or</text>
        </paragraph>
        <paragraph num="(vii)">
          <text>Counseling patients.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(9)">
      <text>“OCSA” means the Office of Controlled Substances Administration of the Maryland Department of Health.</text>
    </paragraph>
    <paragraph num="(10)">
      <text>“Permit holder” means a physician licensed in this State who holds a valid dispensing permit under this chapter.</text>
    </paragraph>
    <paragraph num="(11)">
      <text>“Readily retrievable” means maintained by any method by which the permit holder can retrieve and produce the record to OCSA during the course of an unscheduled on-site inspection.</text>
    </paragraph>
    <paragraph num="(12)">
      <text>“Sample unit” has the meaning stated in 21 CFR §203.3 (aa).</text>
    </paragraph>
    <paragraph num="(13)">
      <text>“Supplier” means:</text>
      <paragraph num="(a)">
        <text>A wholesale distributor as defined in Health Occupations Article, §12-6C-01(v), Annotated Code of Maryland; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>A pharmacy, to the extent permitted by Health Occupations Article, §12-406(b), Annotated Code of Maryland.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>