Florida SB 966: Safe Storage of Firearms

Bill Text

966 
Outsourcing Facilities 
2025-12-18T09:56:23Z 
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. 
Original Filed Version 
2026 
S 
2026-07-01T00:00:00Z 
GB 
General Bill 
__ 

 Florida Senate - 2026 SB 966 

 By Senator McClain 

 9-01277A-26 2026966__ 
 1 A bill to be entitled 
 2 An act relating to outsourcing facilities; creating s. 
 3 465.0199, F.S.; providing legislative findings and 
 4 intent; requiring outsourcing facilities to apply to 
 5 the Department of Health, using a form prescribed by 
 6 the Board of Pharmacy, to obtain a permit before 
 7 engaging in specified activities; requiring the 
 8 department to issue outsourcing facility permits to 
 9 applicants the board certifies as meeting certain 
 10 criteria; requiring that the initial application for 
 11 the permit include specified documentation; requiring 
 12 the board to review such documentation and consider 
 13 certain actions of the applicant outsourcing facility; 
 14 prohibiting the department from issuing a permit to an 
 15 outsourcing facility under certain circumstances; 
 16 providing that certain outsourcing facilities are only 
 17 required to obtain an outsourcing facility permit; 
 18 requiring outsourcing facilities to obtain additional 
 19 applicable permits if they engage in certain 
 20 activities; providing applicability; providing that 
 21 outsourcing facilities holding a valid outsourcing 
 22 permit issued before a specified date are deemed to be 
 23 in compliance with certain permitting requirements; 
 24 authorizing such facilities to continue operating 
 25 under such permit until a certain condition occurs; 
 26 requiring the board and the department to rely on and 
 27 recognize certain federal inspection reports as 
 28 satisfying state inspection requirements for purposes 
 29 of initial permitting and subsequent renewals; 
 30 authorizing the department to conduct inspections 
 31 under certain circumstances; providing that the board 
 32 is the sole state regulatory authority responsible for 
 33 the permitting, oversight, and discipline of 
 34 outsourcing facilities; exempting permitted 
 35 outsourcing facilities from separate licensure or 
 36 permitting requirements under the Florida Drug and 
 37 Cosmetic Act for engaging in specified activities; 
 38 requiring the board to adopt rules; amending s. 
 39 499.002, F.S.; exempting permitted outsourcing 
 40 facilities from the applicability of the Florida Drug 
 41 and Cosmetic Act under certain circumstances; 
 42 providing an effective date. 
 43 
 44 Be It Enacted by the Legislature of the State of Florida: 
 45 
 46 Section 1. Section 465.0199, Florida Statutes, is created 
 47 to read: 
 48 465.0199 Outsourcing facility permit; inspection; board 
 49 authority.— 
 50 (1) LEGISLATIVE INTENT.—The Legislature finds that 
 51 outsourcing facilities registered under 21 U.S.C. s. 353b are 
 52 subject to comprehensive federal inspection and oversight by the 
 53 United States Food and Drug Administration to ensure the 
 54 quality, safety, and integrity of compounded drug products. The 
 55 Legislature further finds that duplicative state and federal 
 56 inspection regimes, overlapping regulatory requirements, and 
 57 inconsistent standards among jurisdictions create unnecessary 
 58 administrative burdens and confusion, thereby diminishing the 
 59 effectiveness of regulatory oversight. It is the intent of the 
 60 Legislature to recognize the primacy of federal oversight under 
 61 21 U.S.C. s. 353b, ensure coordination between federal and state 
 62 regulatory authorities, and promote efficient regulation of 
 63 outsourcing facilities while maintaining the protection of the 
 64 public’s health, welfare, and safety. 
 65 (2) PERMIT REQUIRED.— 
 66 (a) An outsourcing facility as defined in s. 465.003 which 
 67 is located within this state must apply to the department, using 
 68 a form prescribed by the board, and obtain an outsourcing 
 69 facility permit before engaging in the compounding, dispensing, 
 70 distributing, or other furnishing of compounded drug products 
 71 within this state or in any jurisdiction outside this state. 
 72 (b) The department shall issue an outsourcing facility 
 73 permit to an outsourcing facility that the board certifies as 
 74 meeting the requirements of this chapter and applicable federal 
 75 law. 
 76 (c) An initial application for an