No. HB 1037
Filed under Healthcare.
Outsourcing Facilities; Requires outsourcing facilities apply to DOH, using form prescribed by Board of Pharmacy, to obtain permit before engaging in specified activities; requires department to issue outsourcing facility permits to applicants board certifies as meeting certain criteria; requires that initial application for permit include specified documentation; requires board to review such documentation & consider certain actions of applicant outsourcing facility; prohibits department from issuing permit to outsourcing facility; provides that certain outsourcing facilities are only required to obtain outsourcing facility permit; requires outsourcing facilities to obtain additional applicable permits if they engage in certain activities; provides applicability; provides that outsourcing facilities holding valid outsourcing permit issued before specified date are deemed to be in compliance with certain permitting requirements; authorizes such facilities to continue operating under such permit until certain condition occurs; requires board & department to rely on & recognize certain federal inspection reports as satisfying state inspection requirements for purposes of initial permitting & subsequent renewals; authorizes department to conduct inspections; provides that board is sole state regulatory authority responsible for permitting, oversight, & discipline of outsourcing facilities; exempts permitted outsourcing facilities from separate licensure or permitting requirements under Florida Drug & Cosmetic Act for engaging in specified activities; requires board to adopt rules; exempts permitted outsourcing facilities from applicability of Florida Drug & Cosmetic Act.
Plain English Summary
AI-GENERATEDOutsourcing facilities -- large-scale drug compounders registered with the FDA under federal law -- must now get a Florida permit from the Board of Pharmacy before compounding, dispensing, distributing, or shipping compounded drugs anywhere, in or out of state.
A facility cannot get its first permit unless it has already passed an FDA inspection showing it meets current federal manufacturing standards. Florida will not permit a facility the FDA has never inspected.
For both new permits and renewals, the state must accept the facility's most recent FDA inspection report instead of doing its own routine inspection, though it can still inspect for cause if there's evidence of a problem.
A facility that only compounds for other providers needs just this one permit. One that also fills patient-specific prescriptions must additionally hold a pharmacy permit, and the whole category is pulled out of separate Florida Drug and Cosmetic Act licensing.
AIAn outsourcing facility located in Florida must apply to the Department of Health and get an outsourcing facility permit before compounding, dispensing, distributing, or furnishing compounded drugs anywhere, in state or out.
AIThe department may not issue an outsourcing facility its first Florida permit unless the FDA has already inspected the facility and found it meets current federal manufacturing standards.
AIFor both initial permits and renewals, the board and department must rely on and treat the facility's most recent FDA inspection report as satisfying Florida's own inspection requirement.
AIThe Board of Pharmacy is the sole state authority over permitting, oversight, and discipline of outsourcing facilities, which are exempted from separate licensure under the Florida Drug and Cosmetic Act for in-scope activities.
AIA facility that does patient-specific sterile compounding under a prescription must obtain a community or institutional pharmacy permit in addition to the outsourcing facility permit; other facilities need only the one permit.
AIA facility that already holds a valid outsourcing facility permit issued before July 1, 2026 is deemed compliant with the new rules and can keep operating under that permit until it expires, is renewed, suspended, or revoked.