No. SB 966
Filed under Healthcare.
Outsourcing Facilities; Requiring outsourcing facilities to apply to the Department of Health, using a form prescribed by the Board of Pharmacy, to obtain a permit before engaging in specified activities; requiring the board to review such documentation and consider certain actions of the applicant outsourcing facility; providing that outsourcing facilities holding a valid outsourcing permit issued before a specified date are deemed to be in compliance with certain permitting requirements; providing that the board is the sole state regulatory authority responsible for the permitting, oversight, and discipline of outsourcing facilities, etc.
Plain English Summary
AI-GENERATEDOutsourcing facilities operating in Florida must get a state permit before compounding, dispensing, or distributing compounded drugs, whether the drugs stay in Florida or ship elsewhere, and the state cannot issue that permit until the FDA has inspected the facility.
Rather than inspecting these facilities itself, the state must treat the facility's most recent FDA inspection report as meeting any state inspection requirement, both for a new permit and at renewal, keeping its own inspection power to cases with credible evidence of a problem.
The Board of Pharmacy becomes the only state body that can permit, oversee, or discipline outsourcing facilities, and a permitted facility no longer needs the separate manufacturer or distributor license that chapter 499 would otherwise require for the same activity.
Facilities that already hold a valid outsourcing permit issued before July 1, 2026 are automatically deemed compliant and can keep operating under their current permit until it expires, is renewed, suspended, or revoked, so the stricter FDA-inspection rule only binds new applicants.
AIAn outsourcing facility located in Florida must apply to the Department of Health, using a Board of Pharmacy form, and obtain a permit before it may compound, dispense, distribute, or otherwise furnish compounded drug products anywhere.
AIThe department is barred from issuing an initial permit to any outsourcing facility that has not already been inspected by the FDA, and the initial application must document that inspection's finding of compliance with federal manufacturing standards.
AIFor both initial permitting and renewal, the board and department must rely on and recognize the facility's most recent FDA inspection report as satisfying any state inspection requirement, rather than the state conducting its own routine inspection.
AIThe Board of Pharmacy is designated the sole state regulatory authority responsible for permitting, overseeing, and disciplining outsourcing facilities, displacing any other state agency's independent authority over that activity.
AIAn outsourcing facility that holds this new permit no longer needs separate licensure or permitting under part I of chapter 499, the Florida Drug and Cosmetic Act, for the activities that fall within its federally defined outsourcing-facility scope.
AIThe new application requirements apply only to facilities that submit an initial application on or after July 1, 2026; a facility already holding a valid permit issued before that date is deemed compliant and may keep operating under it until it lapses.