(a) 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:
(1) At the time of application; and
(2) On renewal.
(b) The inspection report required under subsection (a) of this section shall:
(1) Be conducted within 1 year before the date of application or renewal; and
(2) Demonstrate compliance with applicable federal good manufacturing practice standards.
(c) An applicant or permit holder is responsible for obtaining an inspection to meet the requirements of this section.
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