Md. Code, Health Occupations § 12-6C-03.2
This is the official text of Md. Code, Health Occupations § 12-6C-03.2, part of Maryland’s Code, Health Occupations — governs the licensing of healthcare professionals.
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§12–6C–03.
Official statutory text
§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.
(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.
Status: in_force · Read it on the official government site
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