<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".04" citation="COMAR 10.19.03.04" title_num="10" subtitle_num="19" chapter_num="03" heading="Registration: Requirements and Qualifications.">
  <paragraph num="A.">
    <text>Except for military and federal employees working within the scope of federal employment, a person shall register with the Department and obtain a registration certificate before the person:</text>
    <paragraph num="(1)">
      <text>Manufactures, distributes, dispenses, stores, and orders controlled substances;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Conducts research or instructional activities with controlled substances listed in Schedules II through V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Conducts research or instructional activities with a controlled substance listed in Schedule I of Criminal Law Article, §5-402, Annotated Code of Maryland, with prior registration from the DEA;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Conducts a chemical analysis with controlled substances listed in any schedule;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Installs and maintains an automated dispensing machine containing controlled substances; or</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Manufactures peyote for, or distributes peyote to, the Native American Church for bona fide religious ceremonies of the Native American Church.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>An authorized provider shall:</text>
    <paragraph num="(1)">
      <text>Apply for a registration certificate on a form made available by the Department to:</text>
      <paragraph num="(a)">
        <text>Obtain one registration for all locations that a provider prescribes only and no controlled substances are stored; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Obtain a single registration for each separate location where the provider prescribes, dispenses, orders, and stores controlled substances;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Have a professional license in good standing;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be of good moral character;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Have no convictions for crimes of moral turpitude;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Be 18 years of age or older;</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Be registered with the Prescription Drug Monitoring Program if the authorized provider is also a prescriber as defined under Health-General Article, §21-2A-04.1, Annotated Code of Maryland; and</text>
    </paragraph>
    <paragraph num="(7)">
      <text>Except for researchers, have completed 2 continuing education credit hours:</text>
      <paragraph num="(a)">
        <text>Prior to applying for an initial controlled substance registration occurring on or after October 1, 2018; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Prior to the first renewal of a controlled substance registration occurring on or after October 1, 2018.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Continuing Education.</text>
    <paragraph num="(1)">
      <text>The continuing education shall:</text>
      <paragraph num="(a)">
        <text>Be accredited by the Accreditation Council for Continuing Medical Education; or</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Meet the requirements for approval by the authorized providers professional board.</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>The continuing education shall pertain to the prescribing or dispensing of controlled substances.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Authorized providers shall meet the requirements of §§B and C of this regulation upon the completion of the 2 credit hours of continuing education.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Recent graduates meet the requirements of §§B and C of this regulation upon initial application if two academic course credits were issued relating to controlled substances.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>An establishment shall:</text>
    <paragraph num="(1)">
      <text>Apply for a registration certificate on a form made available by the Department;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Obtain one registration for each separate place of business, professional practice, or location where controlled substances are:</text>
      <paragraph num="(a)">
        <text>Ordered;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Purchased;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Administered;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Delivered to the ultimate user;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Stored;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Manufactured; or</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Distributed; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Have a professional or occupational license in good standing to perform any of the following functions related to controlled substances:</text>
      <paragraph num="(a)">
        <text>Manufacture;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Distribute;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Deliver to the ultimate user;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Administer;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Store;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Order;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Prescribe;</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Package;</text>
      </paragraph>
      <paragraph num="(i)">
        <text>Label; or</text>
      </paragraph>
      <paragraph num="(j)">
        <text>Compound.</text>
      </paragraph>
    </paragraph>
  </paragraph>
</regulation>