<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".03" citation="COMAR 10.47.08.03" title_num="10" subtitle_num="47" chapter_num="08" heading="Authorization of a Private or Public Entity.">
  <paragraph num="A.">
    <text>Application for Authorization. A private or public entity that seeks to conduct education and training programs under Health-General Article, Title 13, Subtitle 31, Annotated Code of Maryland, shall submit to the Department:</text>
    <paragraph num="(1)">
      <text>A completed application form containing all identifying information for the private or public entity that is required by the Department, including:</text>
      <paragraph num="(a)">
        <text>Entity name;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Type of entity based on categories supplied by the Department;</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Entity address;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Entity telephone number;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Entity email address;</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Name of Entity Director;</text>
      </paragraph>
      <paragraph num="(g)">
        <text>Name of Training Program Director; and</text>
      </paragraph>
      <paragraph num="(h)">
        <text>Any additional information as requested by the Department;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(2)">
      <text>For a public or private entity intending to provide naloxone:</text>
      <paragraph num="(a)">
        <text>A copy of a written agreement between a health care provider with prescribing authority and the private or public entity for the prescribing and dispensing of naloxone;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Identifying information for the health care provider with prescribing authority including:</text>
        <paragraph num="(i)">
          <text>Name;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Title;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Address;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Phone number;</text>
        </paragraph>
        <paragraph num="(v)">
          <text>Email address; and</text>
        </paragraph>
        <paragraph num="(vi)">
          <text>State license number; and</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>If applicable, a copy of the entity’s dispensing protocols for naloxone;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>A description of ancillary topics to be covered in addition to the core educational training curriculum provided by the Department pursuant to Regulation .04A(2) of this chapter, and copies of any training materials to be used during instruction;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Any other information required by the Department; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Any fee required by the Department.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Approval of Applications. Upon approval of an application for authorization, the Department shall issue to the private or public entity a form that includes:</text>
    <paragraph num="(1)">
      <text>The name of the private or public entity and its director;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>A statement that the private or public entity is authorized by the Department to conduct education and training programs;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>A serial number;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>The date of the approval of the authorization; and</text>
    </paragraph>
    <paragraph num="(5)">
      <text>The date of the expiration of the authorization.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Term of Authorization. An authorization under this chapter shall be valid for 2 years.</text>
  </paragraph>
  <paragraph num="D.">
    <text>Notification of Significant Change of Information. An authorized private or public entity shall notify the Department in writing of any significant change in the information that was submitted in the application for authorization under §A(1)—(5) of this chapter within 30 days of such change.</text>
  </paragraph>
  <paragraph num="E.">
    <text>Authorization Renewal.</text>
    <paragraph num="(1)">
      <text>An authorized private or public entity may apply to the Department for renewal of its authorization to conduct education and training programs.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>An authorized private or public entity shall submit to the Department a completed renewal application form, along with any fee required by the Department, on a schedule set by the Department.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>The Department may request additional information from the private or public entity as necessary to render a decision on the renewal application.</text>
    </paragraph>
    <paragraph num="(4)">
      <text>If the Department finds, after review of the application for authorization renewal, that the private or public entity is in compliance with the requirements for initial authorization set forth in this chapter, the Department shall issue a renewal authorization form to the private or public entity that includes the information set forth in §B of this regulation.</text>
    </paragraph>
    <paragraph num="(5)">
      <text>An authorization renewal under this chapter shall be valid for 2 years.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>Expiration without Renewal. The Department may require a private or public entity whose authorization has expired without renewal to reapply for initial authorization as required under §A of this regulation.</text>
  </paragraph>
  <paragraph num="G.">
    <text>Maintenance of Records. The Department shall maintain a record of each authorized private or public entity, including all information submitted by the private or public entity in the initial application for authorization and any additional information provided in an application for authorization renewal.</text>
  </paragraph>
</regulation>