FL S0966

Creates a new permit requirement for outsourcing facilities (compounding pharmacies registered under federal law) located in Florida, requiring them to apply to the Department of Health through the Board of Pharmacy before compounding, dispensing, or distributing drug products

Requires initial permit applicants to submit FDA inspection documentation demonstrating compliance with federal good manufacturing practices; the department cannot issue permits to facilities not yet inspected by the FDA

Establishes that FDA inspection reports satisfy state inspection requirements for both initial permits and renewals, eliminating duplicative state inspections, though the department may still conduct inspections upon credible evidence of noncompliance

Designates the Board of Pharmacy as the sole state regulatory authority for outsourcing facilities and exempts permitted facilities from separate licensure requirements under the Florida Drug and Cosmetic Act for activities within their federal scope

Grandfathers outsourcing facilities holding valid permits issued before July 1, 2026, allowing them to continue operating under existing permits until expiration, renewal, suspension, or revocation