summary
Introduced
12/18/2025
12/18/2025
In Committee
01/07/2026
01/07/2026
Crossed Over
Passed
Dead
Introduced Session
2026 Regular Session
Bill Summary
An act relating to outsourcing facilities; creating s. 465.0199, F.S.; providing legislative findings and intent; 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 department to issue outsourcing facility permits to applicants the board certifies as meeting certain criteria; requiring that the initial application for the permit include specified documentation; requiring the board to review such documentation and consider certain actions of the applicant outsourcing facility; prohibiting the department from issuing a permit to an outsourcing facility under certain circumstances; providing that certain outsourcing facilities are only required to obtain an outsourcing facility permit; requiring outsourcing facilities to obtain additional applicable permits if they engage in certain activities; providing applicability; providing that outsourcing facilities holding a valid outsourcing permit issued before a specified date are deemed to be in compliance with certain permitting requirements; authorizing such facilities to continue operating under such permit until a certain condition occurs; requiring the board and the department to rely on and recognize certain federal inspection reports as satisfying state inspection requirements for purposes of initial permitting and subsequent renewals; authorizing the department to conduct inspections under certain circumstances; providing that the board is the sole state regulatory authority responsible for the permitting, oversight, and discipline of outsourcing facilities; exempting permitted outsourcing facilities from separate licensure or permitting requirements under the Florida Drug and Cosmetic Act for engaging in specified activities; requiring the board to adopt rules; amending s. 499.002, F.S.; exempting permitted outsourcing facilities from the applicability of the Florida Drug and Cosmetic Act under certain circumstances; providing an effective date.
AI Summary
This bill establishes a comprehensive regulatory framework for outsourcing facilities (specialized pharmacies that compound and distribute drug products) in Florida, focusing on streamlining state and federal oversight. The bill requires such facilities to apply to the Department of Health for a permit, using a form prescribed by the Board of Pharmacy, before engaging in compounding, dispensing, distributing, or furnishing compounded drug products. Facilities must provide documentation of a federal Food and Drug Administration (FDA) inspection demonstrating compliance with good manufacturing practices, and the department will only issue permits to facilities that have been federally inspected. The bill recognizes that duplicative state and federal inspections create unnecessary administrative burdens and aims to prioritize federal oversight while maintaining public health protections. Outsourcing facilities will need different permits depending on their specific activities, such as patient-specific sterile compounding, and will be exempt from certain separate state licensure requirements. The Board of Pharmacy will be the sole state regulatory authority for these facilities, responsible for permitting, oversight, and discipline. The new regulations will take effect on July 1, 2026, with existing permit holders deemed compliant until their current permits expire.
Sponsors (1)
Last Action
Introduced (on 01/13/2026)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.flsenate.gov/Session/Bill/2026/966 |
| BillText | https://www.flsenate.gov/Session/Bill/2026/966/BillText/Filed/HTML |
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