<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".09" citation="COMAR 10.47.08.09" title_num="10" subtitle_num="47" chapter_num="08" heading="Record Maintenance and Reporting.">
  <paragraph num="A.">
    <text>The Department shall maintain the following records:</text>
    <paragraph num="(1)">
      <text>Information on private or public entities authorized by the Department, including:</text>
      <paragraph num="(a)">
        <text>Names of entities and directors;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Addresses of entities;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Serial numbers of the initial authorizations;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Initial authorization dates; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Dates of authorization renewals; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Information on private or public entities whose authorization has been suspended or revoked, including:</text>
      <paragraph num="(a)">
        <text>Names of entities and directors;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Addresses of entities;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Serial numbers of the initial authorizations;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Effective dates of suspensions or revocations;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Reasons for suspensions or revocations; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>If applicable, dates on which the approvals for authorization were reinstated.</text>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>If providing naloxone, a private or public entity authorized by the Department shall maintain records for each individual who has been provided naloxone, including:</text>
    <paragraph num="(1)">
      <text>Full name of individual;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Name of prescriber;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Name and address of dispenser;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Date of dispensing; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Type and dosage of naloxone dispensed.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Reporting Information to the Department. A private or public entity authorized by the Department shall report to the Department:</text>
    <paragraph num="(1)">
      <text>Information on program operations, including:</text>
      <paragraph num="(a)">
        <text>Number of individuals who have completed education and training programs;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>For private or public entities authorized by the Department that provide naloxone directly or by means of a voucher for redemption at a pharmacy:</text>
        <paragraph num="(i)">
          <text>Form of naloxone dispensed;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Number of initial doses of naloxone dispensed; and</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Number of naloxone refills dispensed; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>Number and location of naloxone administrations and overdose reversals to the extent this information is reported to the private or public entity authorized by the Department;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>Demographic information on individuals who participated in an education and training program, including aggregate number of individuals by:</text>
      <paragraph num="(a)">
        <text>Sex;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Ethnicity;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Race;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Age; and</text>
      </paragraph>
      <paragraph num="(e)">
        <text>The specific reason to receive education and training; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Any other information required by the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>Information under §C of this regulation shall be reported by the private or public entity authorized by the Department on a monthly basis in a format specified by the Department.</text>
  </paragraph>
</regulation>