<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".18" citation="COMAR 10.19.03.18" title_num="10" subtitle_num="19" chapter_num="03" heading="Administrative Inspections and Warrants.">
  <paragraph num="A.">
    <text>Administrative Inspections.</text>
    <paragraph num="(1)">
      <text>Procedures regarding administrative inspections and warrants pursuant to Criminal Law Article, §§5-305, 5-804, and 5-805, Annotated Code of Maryland, are governed generally by those sections of the Annotated Code and specifically by this regulation.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Authority to make inspections is authorized in accordance with Criminal Law Article, §§5-804 and 5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of the following:</text>
      <paragraph num="(a)">
        <text>Documents required to be kept or made pursuant to 21 CFR §1304, under the Act, or regulations promulgated under the Act may be:</text>
        <paragraph num="(i)">
          <text>Inspected;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Copied;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>Verified for correctness; and</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>Inventoried;</text>
        </paragraph>
      </paragraph>
      <paragraph num="(b)">
        <text>Collecting samples of controlled substances or precursors (if samples are collected during an inspection, the inspector shall issue a receipt for these samples to the owner, operator, or agent in charge of the premises);</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Review of records and information on the distribution of controlled substances by the authorized provider;</text>
      </paragraph>
      <paragraph num="(d)">
        <text>Reviewing the authorized providers processes;</text>
      </paragraph>
      <paragraph num="(e)">
        <text>Reviewing the authorized providers controls; and</text>
      </paragraph>
      <paragraph num="(f)">
        <text>Inspecting the authorized providers facility operations;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(3)">
      <text>Entry.</text>
      <paragraph num="(a)">
        <text>An inspection shall be carried out by an inspector.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>An inspector shall have the right to enter the premises and conduct inspections at reasonable times and in a reasonable manner, upon the following conditions:</text>
        <paragraph num="(i)">
          <text>Stating the inspector’s purpose; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>Presenting to the owner, operator, or agent in charge of the premises to be inspected, appropriate credentials and written notice of the inspector’s inspection authority under Criminal Law Article, §5-305, 5-804, or 5-805, Annotated Code of Maryland.</text>
        </paragraph>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Consent to Inspection of Financial Data, Sales Data Other than Shipment Data, or Pricing Data.</text>
      <paragraph num="(a)">
        <text>If inspection is desired of financing, sales, or pricing data, written consent shall first be obtained from the owner, operator, or agent in charge of the premises to be inspected.</text>
      </paragraph>
      <paragraph num="(b)">
        <text>This written consent shall contain the following information:</text>
        <paragraph num="(i)">
          <text>That the owner, operator, or agent in charge has the right to refuse to consent to an inspection of these items;</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>That anything of an incriminating nature which may be found may be seized and used against the owner, operator, or agent in charge in a criminal prosecution;</text>
        </paragraph>
        <paragraph num="(iii)">
          <text>That the owner, operator, or agent in charge has been presented with a notice of inspection;</text>
        </paragraph>
        <paragraph num="(iv)">
          <text>That the consent is given by the owner, operator, or agent in charge voluntarily and without threats of any kind; and</text>
        </paragraph>
        <paragraph num="(v)">
          <text>That the owner, operator, or agent in charge may withdraw the owner’s, operator’s, or agent in charge’s consent at any time during the course of inspection.</text>
        </paragraph>
      </paragraph>
      <paragraph num="(c)">
        <text>The written consent shall be produced in duplicate and be distributed as follows:</text>
        <paragraph num="(i)">
          <text>The original will be retained by the inspector; and</text>
        </paragraph>
        <paragraph num="(ii)">
          <text>The duplicate will be given to the authorized provider inspected.</text>
        </paragraph>
      </paragraph>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Administrative Warrants.</text>
    <paragraph num="(1)">
      <text>Probable Cause. If the Department is satisfied that administrative probable cause exists, the Department shall issue an administrative warrant.</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Execution of Warrants. An administrative inspection warrant shall be executed as required by Criminal Law Article, §5-804(d), Annotated Code of Maryland.</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Refusal to Allow Inspection with an Administrative Warrant. If an authorized provider or any person subject to the Act refuses to permit execution of an administrative warrant, or impedes the inspector in the execution of that warrant, the authorized provider or person shall be advised that this refusal or action constitutes a violation of Criminal Law Article, §5-902(a)(3), Annotated Code of Maryland.</text>
    </paragraph>
  </paragraph>
</regulation>