Florida SB 860: Compounded Drugs

Bill Text

860 
Compounded Drugs 
2025-12-10T09:15:54Z 
Defining the term “compounded medication”; prohibiting any person or entity from engaging in the sale, transfer, or distribution of compounded medications for weight loss unless they provide specified documentation to the Department of Business and Professional Regulation; providing administrative penalties, etc. 
Original Filed Version 
2026 
S 
GB 
General Bill 
__ 

 Florida Senate - 2026 SB 860 

 By Senator Bradley 

 6-00621A-26 2026860__ 
 1 A bill to be entitled 
 2 An act relating to compounded drugs; creating s. 
 3 499.038, F.S.; defining the term “compounded 
 4 medication”; prohibiting any person or entity from 
 5 engaging in the sale, transfer, or distribution of 
 6 compounded medications for weight loss unless they 
 7 provide specified documentation to the Department of 
 8 Business and Professional Regulation; providing 
 9 administrative penalties; authorizing the department 
 10 to adopt rules and conduct inspections as necessary to 
 11 implement specified provisions; providing an effective 
 12 date. 
 13 
 14 WHEREAS, the Legislature finds that the safety and 
 15 integrity of compounded medications are paramount for the health 
 16 and well-being of the residents of this state, and 
 17 WHEREAS, the Legislature recognizes that while the United 
 18 States Food and Drug Administration (FDA) sets internationally 
 19 recognized standards for drug approval and regulatory oversight, 
 20 there have been increasing attempts by bad actors to circumvent 
 21 these regulations, undermining public trust and patient safety, 
 22 and 
 23 WHEREAS, the Legislature further finds that foreign 
 24 entities, including those from countries such as China, have 
 25 exploited regulatory gaps to introduce inferior or contaminated 
 26 active pharmaceutical ingredients into the supply chain for 
 27 medications intended for compounding, and 
 28 WHEREAS, recent cases, including those involving 
 29 medications for weight loss, have demonstrated that high demand 
 30 can lead to the proliferation of the use of illicit, 
 31 substandard, and potentially harmful active pharmaceutical 
 32 ingredients that jeopardize patient health and safety, and 
 33 WHEREAS, while the FDA bears responsibility for enforcing 
 34 federal laws to protect citizens from misbranded and adulterated 
 35 pharmaceutical ingredients, its enforcement has proven 
 36 insufficient to curtail the influx of these substances into this 
 37 state, and despite FDA action to curb imports of active 
 38 pharmaceutical ingredients for weight loss medications from 
 39 entities that are not compliant with current good manufacturing 
 40 practices, patients in our state remain at risk of receiving 
 41 compounded medications containing such active pharmaceutical 
 42 ingredients, and 
 43 WHEREAS, the Legislature therefore finds it necessary for 
 44 the state to take action to protect its residents by ensuring 
 45 that all active pharmaceutical ingredients used in compounding 
 46 are sourced from reputable, registered, and inspected 
 47 establishments, and that only pharmaceutical-grade, safe, and 
 48 unadulterated ingredients are used in medications for weight 
 49 loss, NOW, THEREFORE, 
 50 
 51 Be It Enacted by the Legislature of the State of Florida: 
 52 
 53 Section 1. Section 499.038, Florida Statutes, is created to 
 54 read: 
 55 499.038 Regulation of medications containing certain active 
 56 pharmaceutical ingredients.— 
 57 (1) DEFINITION.—As used in this section, the term 
 58 “compounded medication” means a customized drug prepared by a 
 59 licensed pharmacist or licensed physician by combining, mixing, 
 60 or altering the ingredients of one or more drugs or products, 
 61 which drug is commonly prescribed if a commercially available 
 62 medication does not meet a patient’s specific health need. 
 63 (2) PROHIBITION.—A person or an entity may not engage in 
 64 the sale, transfer, or distribution of a compounded medication 
 65 for weight loss unless the person or entity provides 
 66 documentation to the department certifying all of the following: 
 67 (a) If a licensed pharmacist or licensed physician 
 68 compounds the medication pursuant to 21 U.S.C. s. 
 69 353a(b)(1)(A)(i)(II), that the active pharmaceutical ingredient 
 70 used is: 
 71 1. Identical to that used in the manufacture of a drug 
 72 approved by the United States Food and Drug Administration 
 73 (FDA); and 
 74 2. Manufactured according to the manufacturing process for 
 75 that ingredient as specified on the label of a drug approved by 
 76 the FDA. 
 77 (b) That the active pharmaceutical ingredient is a 
 78 pharmaceutical-grade product. 
 79 (c) That the active pharmaceutical ingredient is 
 80 accompanied by a valid certificate of analysis that provides 
 81 informational material as to the safety and effectiveness of the 
 82 drugs compounded using the active pharmaceutical ingredient, 
 83 including t