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Maryland Code, Health Occupations § 12-6C-03.2

Current as of January 01, 2025 | Updated by Findlaw Staff

(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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Cite this article: FindLaw.com - Maryland Code, Health Occupations § 12-6C-03.2 - last updated January 01, 2025 | https://codes.findlaw.com/md/health-occupations/md-code-health-occup-sect-12-6c-03-2/

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