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THE BILL ITSELF

SB 860

Compounded Drugs

VERSION S 860 Filed · BACK TO THE SUMMARY · OFFICIAL RECORD

underlined language is being added; struck language is being deleted. Line numbers are the Legislature's own — the same ones amendments cite.

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.
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,
51 Be It Enacted by the Legislature of the State of Florida:
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 the identity and content of the active pharmaceutical
84 ingredient and the identity of each impurity by chemical name
85 and amount present. A certificate of analysis is not valid
86 unless it is accompanied by testing data from the original
87 manufacturing establishment demonstrating that the information
88 on the certificate of analysis is accurate.
89 (d) That the active pharmaceutical ingredient was
90 manufactured in a facility that:
91 1. Is registered with the FDA pursuant to 21 U.S.C. s. 360;
92 and
93 2. Has been inspected by the FDA as a human drug
94 establishment within the preceding 2 years, and such inspection:
95 a. Included monitoring compliance with current good
96 manufacturing practices for the relevant active pharmaceutical
97 ingredient; and
98 b. Resulted in a “Voluntary Action Indicated” or “No Action
99 Indicated” classification under the FDA’s inspection
100 classification system.
101 (e) That the person or entity conducted quality control
102 testing of the active pharmaceutical ingredient before its use
103 in a compounded drug to confirm:
104 1. The identity and content of the active pharmaceutical
105 ingredient; and
106 2. That any impurity present in the active pharmaceutical
107 ingredient has been identified, characterized, quantified, and
108 justified given the product or the product’s intended use.
109 (3) ENFORCEMENT AND PENALTIES.—A person or an entity that
110 violates this section is subject to the following penalties:
111 (a) A fine of $1,000 per dose of the illegally compounded
112 drug sold, dispensed, transferred, or distributed by the person
113 or entity; and
114 (b) Revocation of the person’s or entity’s license or
115 permit by the Board of Pharmacy or the department, as
116 applicable.
117 (4) RULEMAKING.—The department may adopt rules and conduct
118 inspections as necessary to implement this section.
119 Section 2. This act shall take effect upon becoming a law.