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

   (a) Report of inspection required. -- 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) Requirements for inspection reports. -- The inspection report required under subsection (a) of this section shall be:

   (1) Conducted within 1 year before the date of application or renewal; and

   (2) Demonstrate compliance with applicable federal good manufacturing practice standards or USP 797, as defined in § 12-4A-01 of this title.

(c) Applicant or permit holder responsible for obtaining inspection. -- An applicant or permit holder is responsible for obtaining an inspection to meet the requirements of this section.

HISTORY: 2013, ch. 397.