§ 12-6C-03.2
108 words·~1 min read·
/md/health-occupations/12-6c-03-2·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
§12–6C–03.2.
(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.