Md. Code Ann., Health Occ. § 12-6C-03.2
Reporting requirements relating to inspections
Effective Apr 14, 2015Added by Acts 2013, c. 397, § 1, eff. July 1, 2013. Amended by Acts 2014, c. 45, § 1, eff. April 8, 2014; Acts 2015, c. 5, § 3, eff. April 14, 2015.State of Maryland
(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.
Added by Acts 2013, c. 397, § 1, eff. July 1, 2013. Amended by Acts 2014, c. 45, § 1, eff. April 8, 2014; Acts 2015, c. 5, § 3, eff. April 14, 2015.