(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.
Structure Maryland Statutes
Title 12 - Pharmacists and Pharmacies
Subtitle 6C - Wholesale Distributor Permitting and Prescription Drug Integrity Act
Section 12-6C-01 - Definitions
Section 12-6C-03 - Permit Required
Section 12-6C-03.1 - Purchase and Distribution of Prescription Drugs and Devices by Department
Section 12-6C-03.2 - Inspection of Sterile Drug Products; Report
Section 12-6C-04 - Accreditation and Reciprocity
Section 12-6C-05 - Application Requirements
Section 12-6C-06 - Expiration and Renewal
Section 12-6C-07 - Regulations -- Inspections; Requirements
Section 12-6C-08 - Disclosure of Information
Section 12-6C-09 - Distribution of Prescription Drugs; Returns or Exchanges
Section 12-6C-11 - Violations; Penalties