Florida Senate - 2026 SB 860 By Senator Bradley 6-00621A-26 2026860__ Page 1 of 5 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1

An act relating to compounded drugs; creating s. 2 499.038, F.S.; defining the term “compounded 3 medication”; prohibiting any person or entity from 4 engaging in the sale, transfer, or distribution of 5 compounded medications for weight loss unless they 6 provide specified documentation to the Department of 7 Business and Professional Regulation; providing 8 administrative penalties; authorizing the department 9 to adopt rules and conduct inspections as necessary to 10 implement specified provisions; providing an effective 11 date. 12 13 WHEREAS, the Legislature finds that the safety and 14 integrity of compounded medications are paramount for the health 15 and well-being of the residents of this state, and 16 WHEREAS, the Legislature recognizes that while the United 17 States Food and Drug Administration (FDA) sets internationally 18 recognized standards for drug approval and regulatory oversight, 19 there have been increasing attempts by bad actors to circumvent 20 these regulations, undermining public trust and patient safety, 21 and 22 WHEREAS, the Legislature further finds that foreign 23 entities, including those from countries such as China, have 24 exploited regulatory gaps to introduce inferior or contaminated 25 active pharmaceutical ingredients into the supply chain for 26 medications intended for compounding, and 27 WHEREAS, recent cases, including those involving 28 medications for weight loss, have demonstrated that high demand 29

Florida Senate - 2026 SB 860 6-00621A-26 2026860__ Page 2 of 5 CODING: Words stricken are deletions; words underlined are additions. can lead to the proliferation of the use of illicit, 30 substandard, and potentially harmful active pharmaceutical 31 ingredients that jeopardize patient health and safety, and 32 WHEREAS, while the FDA bears responsibility for enforcing 33 federal laws to protect citizens from misbranded and adulterated 34 pharmaceutical ingredients, its enforcement has proven 35 insufficient to curtail the influx of these substances into this 36 state, and despite FDA action to curb imports of active 37 pharmaceutical ingredients for weight loss medications from 38 entities that are not compliant with current good manufacturing 39 practices, patients in our state remain at risk of receiving 40 compounded medications containing such active pharmaceutical 41 ingredients, and 42 WHEREAS, the Legislature therefore finds it necessary for 43 the state to take action to protect its residents by ensuring 44 that all active pharmaceutical ingredients used in compounding 45 are sourced from reputable, registered, and inspected 46 establishments, and that only pharmaceutical-grade, safe, and 47 unadulterated ingredients are used in medications for weight 48 loss, NOW, THEREFORE, 49 50 Be It Enacted by the Legislature of the State of Florida: 51 52

Section

Section 499.038, Florida Statutes, is created to 53 read: 54 499.038 Regulation of medications containing certain active 55 pharmaceutical ingredients.— 56

(1) DEFINITION.—As used in this section, the term 57 “compounded medication” means a customized drug prepared by a 58

Florida Senate - 2026 SB 860 6-00621A-26 2026860__ Page 3 of 5 CODING: Words stricken are deletions; words underlined are additions. licensed pharmacist or licensed physician by combining, mixing, 59 or altering the ingredients of one or more drugs or products, 60 which drug is commonly prescribed if a commercially available 61 medication does not meet a patient’s specific health need. 62

(2) PROHIBITION.—A person or an entity may not engage in 63 the sale, transfer, or distribution of a compounded medication 64 for weight loss unless the person or entity provides 65 documentation to the department certifying all of the following: 66 (

a) If a licensed pharmacist or licensed physician 67 compounds the medication pursuant to 21 U.S.C. s. 68 353a(b)(1)(A)(i)(II), that the active pharmaceutical ingredient 69 used is: 70 1. Identical to that used in the manufacture of a drug 71 approved by the United States Food and Drug Administration 72 (FDA); and 73 2. Manufactured according to the manufacturing process for 74 that ingredient as specified on the label of a drug approved by 75 the FDA. 76 (

b) That the active pharmaceutical ingredient is a 77 pharmaceutical-grade product. 78 (

c) That the active pharmaceutical ingredient is 79 accompanied by a valid certificate of analysis that provides 80 informational material as to the safety and effectiveness of the 81 drugs compounded using the active pharmaceutical ingredient, 82 including the identity and content of the active pharmaceutical 83 ingredient and the identity of each impurity by chemical name 84 and amount present. A certificate of analysis is not valid 85 unless it is accompanied by testing data from the original 86 manufacturing establishment demonstrating that the information 87

Florida Senate - 2026 SB 860 6-00621A-26 2026860__ Page 4 of 5 CODING: Words stricken are deletions; words underlined are additions. on the certificate of analysis is accurate. 88 (

d) That the active pharmaceutical ingredient was 89 manufactured in a facility that: 90 1. Is registered with the FDA pursuant to 21 U.S.C. s. 360; 91 and 92 2. Has been inspected by the FDA as a human drug 93 establishment within the preceding 2 years, and such inspection: 94 a. Included monitoring compliance with current good 95 manufacturing practices for the relevant active pharmaceutical 96 ingredient; and 97 b. Resulted in a “Voluntary Action Indicated” or “No Action 98 Indicated” classification under the FDA’s inspection 99 classification system. 100 (

e) That the person or entity conducted quality control 101 testing of the active pharmaceutical ingredient before its use 102 in a compounded drug to confirm: 103 1. The identity and content of the active pharmaceutical 104 ingredient; and 105 2. That any impurity present in the active pharmaceutical 106 ingredient has been identified, characterized, quantified, and 107 justified given the product or the product’s intended use. 108

(3) ENFORCEMENT AND PENALTIES.—A person or an entity that 109 violates this

section is subject to the following penalties: 110 (

a) A fine of $1,000 per dose of the illegally compounded 111 drug sold, dispensed, transferred, or distributed by the person 112 or entity; and 113 (

b) Revocation of the person’s or entity’s license or 114 permit by the Board of Pharmacy or the department, as 115 applicable. 116

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(4) RULEMAKING.—The department may adopt rules and conduct 117 inspections as necessary to implement this section. 118

Section 2. This act shall take effect upon becoming a law. 119