FL H1037

Requires outsourcing facilities located in Florida to obtain a permit from the Department of Health before compounding, dispensing, or distributing compounded drug products, with applications reviewed by the Board of Pharmacy

Initial permit applications must include FDA inspection documentation demonstrating compliance with federal good manufacturing practices; permits cannot be issued to facilities that have not been inspected by the FDA

Establishes the Board of Pharmacy as the sole state regulatory authority for permitting, oversight, and discipline of outsourcing facilities, exempting them from separate licensure under the Florida Drug and Cosmetic Act

Requires the state to recognize FDA inspection reports as satisfying state inspection requirements for both initial permitting and renewals, though the department may conduct inspections upon credible evidence of noncompliance

Facilities holding valid outsourcing permits issued before July 1, 2026 are deemed compliant and may continue operating until permit expiration, renewal, suspension, or revocation