# Health Occupations (GHO)

## Title 12. Pharmacists and Pharmacies

### Subtitle 6C. Wholesale Distributor Permitting and Prescription Drug Integrity Act

#### Section 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.

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Md. Code Ann., Health Occ. (as displayed at mgaleg.maryland.gov, October 16, 2026)