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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
A bill to be entitled 1
An act relating to foods containing vaccines or 2
vaccine materials; amending s. 499.003, F.S.; revising 3
the definition of the term "drug"; defining the term 4
"vaccine or vaccine material"; amending s. 499.007, 5
F.S.; deeming a drug misbranded if it is a food 6
containing a vaccine or vaccine material, but its 7
label does not include specified information; amending 8
s. 500.11, F.S.; deeming a food misbranded if it 9
contains a vaccine or vaccine material, but its label 10
does not include specified information; amending ss. 11
499.01 and 499.05, F.S.; conforming cross -references; 12
providing an effective date. 13
14
Be It Enacted by the Legislature of the State of Florida: 15
16
Section 1. Present subsections (47), (48), and (49) of 17
section 499.003, Florida Statutes, are redesignated as 18
subsections (48), (49), and (50), respectively, a new subsection 19
(47) is added to that section, and subsections (17) and (40) of 20
that section are amended, to read: 21
499.003 Definitions of terms used in this part. —As used in 22
this part, the term: 23
(17) "Drug" means an article that is: 24
(a) Recognized in the current edition of the United States 25
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
Pharmacopoeia and National Formulary, official Homeop athic 26
Pharmacopoeia of the United States, or any supplement to any of 27
those publications; 28
(b) Intended for use in the diagnosis, cure, mitigation, 29
treatment, therapy, or prevention of disease in humans or other 30
animals; 31
(c) Intended to affect the struc ture or any function of 32
the body of humans or other animals; or 33
(d) Intended for use as a component of any article 34
specified in paragraph (a), paragraph (b), or paragraph (c), and 35
includes active pharmaceutical ingredients, but does not include 36
devices or their nondrug components, parts, or accessories ; or 37
(e) Food as defined in s. 500.03 which contains a vaccine 38
or vaccine material. 39
(40) "Prescription drug" means a prescription, medicinal, 40
or legend drug, including, but not limited to, finished dosag e 41
forms or active pharmaceutical ingredients subject to, defined 42
by, or described by s. 503(b) of the federal act or s. 465.003, 43
s. 499.007(13), subsection (31), or subsection (48) (47), except 44
that an active pharmaceutical ingredient is a prescription dru g 45
only if substantially all finished dosage forms in which it may 46
be lawfully dispensed or administered in this state are also 47
prescription drugs. 48
(47) "Vaccine or vaccine material" means a substance 49
authorized or approved by the United States Food and D rug 50
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
Administration which is intended for use in humans to stimulate 51
the production of antibodies and provide immunity against 52
disease and which is prepared from the causative agent of a 53
disease, its products, or a synthetic substitute and is treated 54
to act as an antigen without inducing the disease. 55
Section 2. Present subsection (17) of section 499.007, 56
Florida Statutes, is redesignated as subsection (18), and a new 57
subsection (17) is added to that section, to read: 58
499.007 Misbranded drug or device. —A drug or device is 59
misbranded: 60
(17) If it is a food as defined in s. 500.03 and contains 61
a vaccine or vaccine material, but its label does not bear, in 62
type of uniform size and prominence, the words "contains vaccine 63
or vaccine material" and does not specify that the food is 64
classified as a drug under the Florida Drug and Cosmetic Act. 65
Section 3. Paragraph (q) is added to subsection (1) of 66
section 500.11, Florida Statutes, to read: 67
500.11 Food deemed misbranded. — 68
(1) A food is deemed to be misb randed: 69
(q) If it contains a vaccine or vaccine material as 70
defined in s. 499.003, unless its label bears, in type of 71
uniform size and prominence, the words "contains vaccine or 72
vaccine material" and specifies that the food is classified as a 73
drug under the Florida Drug and Cosmetic Act. 74
Section 4. Paragraphs (a), (b), and (h) of subsection (2) 75
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of section 499.01, Florida Statutes, are amended to read: 76
499.01 Permits.— 77
(2) The following permits are established: 78
(a) Prescription drug manufacturer permit.—A prescription 79
drug manufacturer permit is required for any person that is a 80
manufacturer of a prescription drug and that manufactures or 81
distributes such prescription drugs in this state. 82
1. A person that operates an establishment permitted as a 83
prescription drug manufacturer may engage in distribution of 84
prescription drugs for which the person is the manufacturer and 85
must comply with s. 499.0121 and all other provisions of this 86
part and rules adopted under this part. The department shall 87
adopt rules for issuing a virtual prescription drug manufacturer 88
permit to a person who engages in the manufacture of 89
prescription drugs but does not make or take physical possession 90
of any prescription drugs. The rules adopted by the department 91
under this section may exempt virtual manufacturers from certain 92
establishment, security, and storage requirements set forth in 93
s. 499.0121. 94
2. A prescription drug manufacturer must comply with all 95
appropriate state and federal good manufacturing practices. 96
3. A blood establishment, as defined in s. 381.06014, 97
operating in a manner consistent with the provisions of 21 98
C.F.R. parts 211 and 600 -640, and manufacturing only the 99
prescription drugs described in s. 499.003(49)(j) s. 100
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499.003(48)(j) is not required to be permitt ed as a prescription 101
drug manufacturer under this paragraph or to register products 102
under s. 499.015. 103
(b) Prescription drug repackager permit. —A prescription 104
drug repackager permit is required for any person that 105
repackages a prescription drug in this st ate. 106
1. A person that operates an establishment permitted as a 107
prescription drug repackager may engage in distribution of 108
prescription drugs repackaged at that establishment and must 109
comply with all of the provisions of this part and the rules 110
adopted under this part that apply to a prescription drug 111
manufacturer. 112
2. A prescription drug repackager must comply with all 113
appropriate state and federal good manufacturing practices. 114
3. A prescription drug repackager permit is not required 115
for distributing medicinal drugs or prepackaged drug products 116
between entities under common control which each hold either an 117
active Class III institutional pharmacy permit under chapter 465 118
or an active health care clinic establishment permit under 119
paragraph (r). For purpo ses of this subparagraph, the term 120
"common control" has the same meaning as in s. 499.003(49)(a)3. 121
s. 499.003(48)(a)3. 122
(h) Restricted prescription drug distributor permit. — 123
1. A restricted prescription drug distributor permit is 124
required for: 125
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
a. Any person located in this state who engages in the 126
distribution of a prescription drug, which distribution is not 127
considered "wholesale distribution" under s. 499.003(49)(a) s. 128
499.003(48)(a). 129
b. Any person located in this state who engages in the 130
receipt or distribution of a prescription drug in this state for 131
the purpose of processing its return or its destruction if such 132
person is not the person initiating the return, the prescription 133
drug wholesale supplier of the person initiating the return, or 134
the manufacturer of the drug. 135
c. A blood establishment located in this state which 136
collects blood and blood components only from volunteer donors 137
as defined in s. 381.06014 or pursuant to an authorized 138
practitioner's order for medical treatment or therapy and 139
engages in the wholesale distribution of a prescription drug not 140
described in s. 499.003(49)(j) s. 499.003(48)(j) to a health 141
care entity. A mobile blood unit operated by a blood 142
establishment permitted under this sub -subparagraph is not 143
required to be separately permitted. The health care entity 144
receiving a prescription drug distributed under this sub -145
subparagraph must be licensed as a closed pharmacy or provide 146
health care services at that establishment. The blood 147
establishment must operate in accordance w ith s. 381.06014 and 148
may distribute only: 149
(I) Prescription drugs indicated for a bleeding or 150
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clotting disorder or anemia; 151
(II) Blood-collection containers approved under s. 505 of 152
the federal act; 153
(III) Drugs that are blood derivatives, or a recombin ant 154
or synthetic form of a blood derivative; 155
(IV) Prescription drugs that are identified in rules 156
adopted by the department and that are essential to services 157
performed or provided by blood establishments and authorized for 158
distribution by blood establis hments under federal law; or 159
(V) To the extent authorized by federal law, drugs 160
necessary to collect blood or blood components from volunteer 161
blood donors; for blood establishment personnel to perform 162
therapeutic procedures under the direction and superv ision of a 163
licensed physician; and to diagnose, treat, manage, and prevent 164
any reaction of a volunteer blood donor or a patient undergoing 165
a therapeutic procedure performed under the direction and 166
supervision of a licensed physician, 167
168
as long as all of the health care services provided by the blood 169
establishment are related to its activities as a registered 170
blood establishment or the health care services consist of 171
collecting, processing, storing, or administering human 172
hematopoietic stem cells or progenito r cells or performing 173
diagnostic testing of specimens if such specimens are tested 174
together with specimens undergoing routine donor testing. The 175
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
blood establishment may purchase and possess the drugs described 176
in this sub-subparagraph without a health care clinic 177
establishment permit. 178
2. Storage, handling, and recordkeeping of these 179
distributions by a person required to be permitted as a 180
restricted prescription drug distributor must be in accordance 181
with the requirements for wholesale distributors under s . 182
499.0121. 183
3. A person who applies for a permit as a restricted 184
prescription drug distributor, or for the renewal of such a 185
permit, must provide to the department the information required 186
under s. 499.012. 187
4. The department may adopt rules regarding the 188
distribution of prescription drugs by hospitals, health care 189
entities, charitable organizations, other persons not involved 190
in wholesale distribution, and blood establishments, which rules 191
are necessary for the protection of the public health, safety, 192
and welfare. 193
5. A restricted prescription drug distributor permit is 194
not required for distributions between pharmacies that each hold 195
an active permit under chapter 465, have a common ownership, and 196
are operating in a freestanding end -stage renal dialysis clinic, 197
if such distributions are made to meet the immediate emergency 198
medical needs of specifically identified patients and do not 199
occur with such frequency as to amount to the regular and 200
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F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
systematic supplying of that drug between the pharmacies. The 201
department shall adopt rules establishing when the distribution 202
of a prescription drug under this subparagraph amounts to the 203
regular and systematic supplying of that drug. 204
6. A restricted prescription drug distributor permit is 205
not required for distributi ng medicinal drugs or prepackaged 206
drug products between entities under common control that each 207
hold either an active Class III institutional pharmacy permit 208
under chapter 465 or an active health care clinic establishment 209
permit under paragraph (r). For pu rposes of this subparagraph, 210
the term "common control" has the same meaning as in s. 211
499.003(49)(a)3. s. 499.003(48)(a)3. 212
Section 5. Paragraphs (i) and (l) of subsection (1) of 213
section 499.05, Florida Statutes, are amended to read: 214
499.05 Rules.— 215
(1) The department shall adopt rules to implement and 216
enforce this chapter with respect to: 217
(i) Additional conditions that qualify as an emergency 218
medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or 219
s. 499.82. 220
(l) The recordkeeping, storage, and handling with respect 221
to each of the distributions of prescription drugs specified in 222
s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14). 223
Section 6. This act shall take effect July 1, 2025. 224