<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".17" citation="COMAR 10.34.19.17" title_num="10" subtitle_num="34" chapter_num="19" heading="Minimum Requirements for Inspections.">
  <paragraph num="A.">
    <text>The Board shall inspect pharmacies located in Maryland at least annually.</text>
  </paragraph>
  <paragraph num="B.">
    <text>The pharmacy shall provide as part of the inspection process:</text>
    <paragraph num="(1)">
      <text>Quality assurance testing reports;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Documentation of reporting adverse events as required in Regulation .18 of this chapter;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Microbial testing of a sampling of the sterile compounded preparations of the pharmacy if applicable according to USP 797 Standards; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Any other information requested to ensure compliance with USP 797 Standards.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Within 90 days before the date of application, inspections of nonresident pharmacies may be conducted by:</text>
    <paragraph num="(1)">
      <text>A designee of the Board;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The U.S. Food and Drug Administration; or</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Another appropriate state entity which indicates compliance with USP 797 Standards.</text>
    </paragraph>
  </paragraph>
  <paragraph num="D.">
    <text>The Board or designee shall inspect nonresident pharmacies upon initial application and upon renewal.</text>
  </paragraph>
  <paragraph num="E.">
    <text>The Board may inspect a pharmacy at any time to:</text>
    <paragraph num="(1)">
      <text>Verify compliance with permit requirements; or</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Investigate a complaint.</text>
    </paragraph>
  </paragraph>
</regulation>