summary
Introduced
01/06/2026
01/06/2026
In Committee
01/12/2026
01/12/2026
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 new permitting process for outsourcing facilities, which are entities that compound drugs for patient use under federal regulation (21 U.S.C. s. 353b). The bill aims to streamline regulation by recognizing the primary oversight role of the U.S. Food and Drug Administration (FDA). Outsourcing facilities located in Florida must obtain a permit from the Department of Health, based on certification by the Board of Pharmacy, before compounding or dispensing drugs. Initial applications will require documentation of a recent FDA inspection demonstrating compliance with federal good manufacturing practices, and the Board of Pharmacy will consider any corrective actions taken by the facility. The bill prohibits issuing a permit to facilities that haven't been inspected by the FDA. While outsourcing facilities generally only need this specific permit, they may require additional pharmacy permits if they engage in patient-specific sterile compounding. Facilities already holding a valid outsourcing permit before July 1, 2026, will be considered compliant until their permit expires or is renewed. For both initial permits and renewals, state authorities will rely on FDA inspection reports, though the Department of Health can still conduct inspections if there's evidence of non-compliance or to verify corrective actions. The Board of Pharmacy is designated as the sole state authority for permitting, oversight, and discipline of these facilities, and permitted outsourcing facilities will be exempt from separate licensing under the Florida Drug and Cosmetic Act for activities within their scope. The bill also amends the Florida Drug and Cosmetic Act to reflect these exemptions and takes effect on July 1, 2026.
Committee Categories
Health and Social Services
Sponsors (1)
Last Action
1st Reading (Original Filed Version) (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/2026/1037 |
| BillText | https://www.flsenate.gov/Session/Bill/2026/1037/BillText/Filed/PDF |
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