§ 12–6C-03.2
Statutes in effect as of October 1, 2026.
Md. Code Ann., Health Occ. § 12-6C-03.2 (2026)
Title 12. Pharmacists and Pharmacies
Subtitle 6C. Wholesale Distributor Permitting and Prescription Drug Integrity Act
§ 12–6C-03.2LinkCopy Citation
(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.