(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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