Read the full stored bill text
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 co
mmonly 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
p
rovides
66
documentation to the
department
certifying
all of the following
:
67
(a)
If a
licensed pharmacist or licensed physician
68
compound
s
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
.
I
dentical to
that used in the manufacture of a drug
72
approved by the United States Food and Drug Administration
73
(FDA); and
74
2
.
M
anufactured 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 t
he active pharmaceutical ingredient is a
78
pharmaceutical
-
grade product.
79
(c)
That t
he 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
drug
s
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 t
he 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.
I
ncluded
monitoring compliance with
current good
96
manufacturing practice
s
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.
T
he
identity and content o
f t
he active pharmaceutical
105
ingredient
; and
106
2.
That a
ny 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.