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<section article="ghg" article_name="Health - General" number="21-2A-01" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2A" subtitle_name="Prescription Drug Monitoring Program">
  <level label="a">
    <text>In this subtitle the following words have the meanings indicated.</text>
  </level>
  <level label="b">
    <text>“Board” means the Advisory Board on Prescription Drug Monitoring.</text>
  </level>
  <level label="c">
    <level label="1">
      <text>“Dispense” has the meaning stated in § 12–101 of the Health Occupations Article.</text>
    </level>
    <level label="2">
      <text>“Dispense” does not include:</text>
      <level label="i">
        <text>Directly administering a monitored prescription drug to a patient; or</text>
      </level>
      <level label="ii">
        <text>Giving out prescription drug samples.</text>
      </level>
    </level>
  </level>
  <level label="d">
    <level label="1">
      <text>“Dispenser” means a person authorized by law to dispense a monitored prescription drug to a patient or the patient’s agent in the State.</text>
    </level>
    <level label="2">
      <text>“Dispenser” includes a nonresident pharmacy.</text>
    </level>
    <level label="3">
      <text>“Dispenser” does not include:</text>
      <level label="i">
        <text>A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;</text>
      </level>
      <level label="ii">
        <text>An opioid treatment services program;</text>
      </level>
      <level label="iii">
        <text>A veterinarian licensed under Title 2, Subtitle 3 of the Agriculture Article when prescribing controlled substances for animals in the usual course of providing professional services;</text>
      </level>
      <level label="iv">
        <text>A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and</text>
      </level>
      <level label="v">
        <text>A pharmacy that:</text>
        <level label="1">
          <text>Dispenses medications to an inpatient hospice; and</text>
        </level>
        <level label="2">
          <text>Has been granted a waiver under § 21–2A–03(f) of this subtitle.</text>
        </level>
      </level>
    </level>
  </level>
  <level label="e">
    <text>“Licensing entity” means an entity authorized under the Health Occupations Article to license, regulate, or discipline a prescriber or dispenser.</text>
  </level>
  <level label="f">
    <level label="1">
      <text>“Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Title 5, Subtitle 4 of the Criminal Law Article.</text>
    </level>
    <level label="2">
      <text>“Monitored prescription drug” does not include naloxone medication.</text>
    </level>
  </level>
  <level label="g">
    <text>“Naloxone medication” means an opioid antagonist approved by the federal Food and Drug Administration for the reversal of an opioid overdose.</text>
  </level>
  <level label="h">
    <text>“Naloxone medication data” means the information submitted to the Program for naloxone medication.</text>
  </level>
  <level label="i">
    <text>“Office” means the Office of Controlled Substances Administration in the Department.</text>
  </level>
  <level label="j">
    <text>“Opioid treatment services program” means a program that:</text>
    <level label="1">
      <text>Is certified in accordance with § 8–401 of this article or licensed by the State under § 7.5–401 of this article;</text>
    </level>
    <level label="2">
      <text>Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence;</text>
    </level>
    <level label="3">
      <text>Complies with:</text>
      <level label="i">
        <text>The Code of Federal Regulations 42, Part 8;</text>
      </level>
      <level label="ii">
        <text>COMAR 10.47.02.11; and</text>
      </level>
      <level label="iii">
        <text>Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the Office; and</text>
      </level>
    </level>
    <level label="4">
      <text>Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the federal Center for Substance Abuse Treatment.</text>
    </level>
  </level>
  <level label="k">
    <text>“Pharmacist” means an individual who is licensed under Title 12 of the Health Occupations Article, or by another state, to dispense a monitored prescription drug.</text>
  </level>
  <level label="l">
    <text>“Pharmacist delegate” means an individual who is:</text>
    <level label="1">
      <text>Authorized by a registered pharmacist to request or access prescription monitoring data; and</text>
    </level>
    <level label="2">
      <text>Employed by or under contract with the same professional practice as the registered pharmacist.</text>
    </level>
  </level>
  <level label="m">
    <text>“Prescriber” means a licensed health care professional authorized by law to prescribe a monitored prescription drug.</text>
  </level>
  <level label="n">
    <text>“Prescriber delegate” means an individual who is:</text>
    <level label="1">
      <text>Authorized by a registered prescriber to request or access prescription monitoring data; and</text>
    </level>
    <level label="2">
      <text>Employed by or under contract with the same professional practice as the prescriber.</text>
    </level>
  </level>
  <level label="o">
    <text>“Prescription drug” has the meaning stated in § 21–201 of this title.</text>
  </level>
  <level label="p">
    <text>“Prescription monitoring data” means the information submitted to the Program for a monitored prescription drug.</text>
  </level>
  <level label="q">
    <text>“Program” means the Prescription Drug Monitoring Program established under this subtitle.</text>
  </level>
  <level label="r">
    <text>“Registered” means registered with the Program to request or access prescription monitoring data for clinical use.</text>
  </level>
  <level label="s">
    <text>“Terminal illness” means a medical condition that, within reasonable medical judgment, involves a prognosis for a patient that likely will result in the patient’s death within 6 months.</text>
  </level>
</section>
