<?xml version='1.0' encoding='utf-8'?>
<section article="gho" article_name="Health Occupations" number="12-6C-03.2" title_number="12" title_name="Pharmacists and Pharmacies" subtitle_number="6C" subtitle_name="Wholesale Distributor Permitting and Prescription Drug Integrity Act">
  <level label="a">
    <text>Notwithstanding any other provision of this subtitle, a wholesale distributor applicant or permit holder that prepares sterile drug products shall submit to the Board a report of an inspection conducted by the U.S. Food and Drug Administration or a Board designee:</text>
    <level label="1">
      <text>At the time of application; and</text>
    </level>
    <level label="2">
      <text>On renewal.</text>
    </level>
  </level>
  <level label="b">
    <text>The inspection report required under subsection (a) of this section shall:</text>
    <level label="1">
      <text>Be conducted within 1 year before the date of application or renewal; and</text>
    </level>
    <level label="2">
      <text>Demonstrate compliance with applicable federal good manufacturing practice standards.</text>
    </level>
  </level>
  <level label="c">
    <text>An applicant or permit holder is responsible for obtaining an inspection to meet the requirements of this section.</text>
  </level>
</section>
