Md. Code, Health Occ. § 12-6C-03.2

Current with changes from the 2024 Legislative Session

Section 12-6C-03.2 - Inspection of sterile drug products; report

(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.

Md. Code, HO § 12-6C-03.2

Amended by 2015 Md. Laws, Ch. 5,Sec. 3, eff. 4/14/2015.

Amended by 2014 Md. Laws, Ch. 45,Sec. 1, eff. 4/8/2014.

Added by 2013 Md. Laws, Ch. 397,Sec. 1, eff. 7/1/2013.