<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".18" citation="COMAR 10.34.19.18" title_num="10" subtitle_num="34" chapter_num="19" heading="Reporting Requirements Pharmacies.">
  <text>A pharmacy shall:</text>
  <paragraph num="A.">
    <text>Document and perform routine testing as required by USP 797 Standards for the appropriate risk levels of sterile compounded preparations; and</text>
  </paragraph>
  <paragraph num="B.">
    <text>Report to the Board within 5 calendar days:</text>
    <paragraph num="(1)">
      <text>Adverse events that have been discovered including corrective actions taken or proposed;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Deficiencies related to the sterile compounding process;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Disciplinary actions in other states or by other state agencies;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Changes in accreditation status;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Disciplinary actions taken against a pharmacist who is an owner, operator, or employee of the pharmacy; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Disciplinary actions taken against any other known permit, or any other authorization, held by the pharmacy permit holder.</text>
    </paragraph>
  </paragraph>
</regulation>