<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".19" citation="COMAR 10.34.19.19" title_num="10" subtitle_num="34" chapter_num="19" heading="Office Use.">
  <text>Unless otherwise authorized, a person that prepares and distributes sterile compounded medications for office use into, out of, or within the State shall hold:</text>
  <paragraph num="A.">
    <text>A manufacturer’s permit or other permit designated by the U.S. Food and Drug Administration to ensure the safety of sterile compounded medications for office use; and</text>
  </paragraph>
  <paragraph num="B.">
    <text>If applicable, a wholesale distributor’s permit, issued by the Board under Health Occupations Article, Title 12, Subtitle 6C, Annotated Code of Maryland.</text>
  </paragraph>
</regulation>