<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".02" citation="COMAR 10.34.37.02" title_num="10" subtitle_num="34" chapter_num="37" heading="Pharmacies Issued a Waiver Permit.">
  <paragraph num="A.">
    <text>A pharmacy that is issued a waiver permit by the Board under Health Occupations Article, §12–403(c), Annotated Code of Maryland, may engage in wholesale distribution, provided that:</text>
    <paragraph num="(1)">
      <text>The waiver pharmacy only engages in wholesale distribution with another pharmacy; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>The wholesale distribution business does not exceed 5 percent of the waiver pharmacy’s annual sales.</text>
    </paragraph>
  </paragraph>
  <paragraph num="B.">
    <text>Record Keeping Requirements. A waiver pharmacy that conducts wholesale distribution as set forth in §A of this regulation shall:</text>
    <paragraph num="(1)">
      <text>Maintain records of the waiver pharmacy’s wholesale distribution separately from its other records; and</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Make records of wholesale distribution available for inspection by the Board.</text>
    </paragraph>
  </paragraph>
</regulation>