Bill Text: FL S0196 | 2025 | Regular Session | Introduced
Bill Title: Foods Containing Vaccines or Vaccine Materials
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced) 2025-01-24 - Referred to Regulated Industries; Appropriations Committee on Agriculture, Environment, and General Government; Rules [S0196 Detail]
Download: Florida-2025-S0196-Introduced.html
Florida Senate - 2025 SB 196
By Senator Gruters
22-00130-25 2025196__
1 A bill to be entitled
2 An act relating to foods containing vaccines or
3 vaccine materials; amending s. 499.003, F.S.; revising
4 the definition of the term “drug”; defining the term
5 “vaccine or vaccine material”; amending s. 499.007,
6 F.S.; deeming a drug misbranded if it is a food
7 containing a vaccine or vaccine material, but its
8 label does not include specified information; amending
9 s. 500.11, F.S.; deeming a food misbranded if it
10 contains a vaccine or vaccine material, but its label
11 does not include specified information; amending ss.
12 499.01 and 499.05, F.S.; conforming cross-references;
13 providing an effective date.
14
15 Be It Enacted by the Legislature of the State of Florida:
16
17 Section 1. Present subsections (47), (48), and (49) of
18 section 499.003, Florida Statutes, are redesignated as
19 subsections (48), (49), and (50), respectively, a new subsection
20 (47) is added to that section, and subsections (17) and (40) of
21 that section are amended, to read:
22 499.003 Definitions of terms used in this part.—As used in
23 this part, the term:
24 (17) “Drug” means an article that is:
25 (a) Recognized in the current edition of the United States
26 Pharmacopoeia and National Formulary, official Homeopathic
27 Pharmacopoeia of the United States, or any supplement to any of
28 those publications;
29 (b) Intended for use in the diagnosis, cure, mitigation,
30 treatment, therapy, or prevention of disease in humans or other
31 animals;
32 (c) Intended to affect the structure or any function of the
33 body of humans or other animals; or
34 (d) Intended for use as a component of any article
35 specified in paragraph (a), paragraph (b), or paragraph (c), and
36 includes active pharmaceutical ingredients, but does not include
37 devices or their nondrug components, parts, or accessories; or
38 (e) Food as defined in s. 500.03 which contains a vaccine
39 or vaccine material.
40 (40) “Prescription drug” means a prescription, medicinal,
41 or legend drug, including, but not limited to, finished dosage
42 forms or active pharmaceutical ingredients subject to, defined
43 by, or described by s. 503(b) of the federal act or s. 465.003,
44 s. 499.007(13), subsection (31), or subsection (48) (47), except
45 that an active pharmaceutical ingredient is a prescription drug
46 only if substantially all finished dosage forms in which it may
47 be lawfully dispensed or administered in this state are also
48 prescription drugs.
49 (47) “Vaccine or vaccine material” means a substance
50 authorized or approved by the United States Food and Drug
51 Administration which is intended for use in humans to stimulate
52 the production of antibodies and provide immunity against
53 disease and which is prepared from the causative agent of a
54 disease, its products, or a synthetic substitute and is treated
55 to act as an antigen without inducing the disease.
56 Section 2. Present subsection (17) of section 499.007,
57 Florida Statutes, is redesignated as subsection (18), and a new
58 subsection (17) is added to that section, to read:
59 499.007 Misbranded drug or device.—A drug or device is
60 misbranded:
61 (17) If it is a food as defined in s. 500.03 and contains a
62 vaccine or vaccine material, but its label does not bear, in
63 type of uniform size and prominence, the words “contains vaccine
64 or vaccine material” and does not specify that the food is
65 classified as a drug under the Florida Drug and Cosmetic Act.
66 Section 3. Paragraph (q) is added to subsection (1) of
67 section 500.11, Florida Statutes, to read:
68 500.11 Food deemed misbranded.—
69 (1) A food is deemed to be misbranded:
70 (q) If it contains a vaccine or vaccine material as defined
71 in s. 499.003, unless its label bears, in type of uniform size
72 and prominence, the words “contains vaccine or vaccine material”
73 and specifies that the food is classified as a drug under the
74 Florida Drug and Cosmetic Act.
75 Section 4. Paragraphs (a), (b), and (h) of subsection (2)
76 of section 499.01, Florida Statutes, are amended to read:
77 499.01 Permits.—
78 (2) The following permits are established:
79 (a) Prescription drug manufacturer permit.—A prescription
80 drug manufacturer permit is required for any person that is a
81 manufacturer of a prescription drug and that manufactures or
82 distributes such prescription drugs in this state.
83 1. A person that operates an establishment permitted as a
84 prescription drug manufacturer may engage in distribution of
85 prescription drugs for which the person is the manufacturer and
86 must comply with s. 499.0121 and all other provisions of this
87 part and rules adopted under this part. The department shall
88 adopt rules for issuing a virtual prescription drug manufacturer
89 permit to a person who engages in the manufacture of
90 prescription drugs but does not make or take physical possession
91 of any prescription drugs. The rules adopted by the department
92 under this section may exempt virtual manufacturers from certain
93 establishment, security, and storage requirements set forth in
94 s. 499.0121.
95 2. A prescription drug manufacturer must comply with all
96 appropriate state and federal good manufacturing practices.
97 3. A blood establishment, as defined in s. 381.06014,
98 operating in a manner consistent with the provisions of 21
99 C.F.R. parts 211 and 600-640, and manufacturing only the
100 prescription drugs described in s. 499.003(49)(j) s.
101 499.003(48)(j) is not required to be permitted as a prescription
102 drug manufacturer under this paragraph or to register products
103 under s. 499.015.
104 (b) Prescription drug repackager permit.—A prescription
105 drug repackager permit is required for any person that
106 repackages a prescription drug in this state.
107 1. A person that operates an establishment permitted as a
108 prescription drug repackager may engage in distribution of
109 prescription drugs repackaged at that establishment and must
110 comply with all of the provisions of this part and the rules
111 adopted under this part that apply to a prescription drug
112 manufacturer.
113 2. A prescription drug repackager must comply with all
114 appropriate state and federal good manufacturing practices.
115 3. A prescription drug repackager permit is not required
116 for distributing medicinal drugs or prepackaged drug products
117 between entities under common control which each hold either an
118 active Class III institutional pharmacy permit under chapter 465
119 or an active health care clinic establishment permit under
120 paragraph (r). For purposes of this subparagraph, the term
121 “common control” has the same meaning as in s. 499.003(49)(a)3.
122 s. 499.003(48)(a)3.
123 (h) Restricted prescription drug distributor permit.—
124 1. A restricted prescription drug distributor permit is
125 required for:
126 a. Any person located in this state who engages in the
127 distribution of a prescription drug, which distribution is not
128 considered “wholesale distribution” under s. 499.003(49)(a) s.
129 499.003(48)(a).
130 b. Any person located in this state who engages in the
131 receipt or distribution of a prescription drug in this state for
132 the purpose of processing its return or its destruction if such
133 person is not the person initiating the return, the prescription
134 drug wholesale supplier of the person initiating the return, or
135 the manufacturer of the drug.
136 c. A blood establishment located in this state which
137 collects blood and blood components only from volunteer donors
138 as defined in s. 381.06014 or pursuant to an authorized
139 practitioner’s order for medical treatment or therapy and
140 engages in the wholesale distribution of a prescription drug not
141 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health
142 care entity. A mobile blood unit operated by a blood
143 establishment permitted under this sub-subparagraph is not
144 required to be separately permitted. The health care entity
145 receiving a prescription drug distributed under this sub
146 subparagraph must be licensed as a closed pharmacy or provide
147 health care services at that establishment. The blood
148 establishment must operate in accordance with s. 381.06014 and
149 may distribute only:
150 (I) Prescription drugs indicated for a bleeding or clotting
151 disorder or anemia;
152 (II) Blood-collection containers approved under s. 505 of
153 the federal act;
154 (III) Drugs that are blood derivatives, or a recombinant or
155 synthetic form of a blood derivative;
156 (IV) Prescription drugs that are identified in rules
157 adopted by the department and that are essential to services
158 performed or provided by blood establishments and authorized for
159 distribution by blood establishments under federal law; or
160 (V) To the extent authorized by federal law, drugs
161 necessary to collect blood or blood components from volunteer
162 blood donors; for blood establishment personnel to perform
163 therapeutic procedures under the direction and supervision of a
164 licensed physician; and to diagnose, treat, manage, and prevent
165 any reaction of a volunteer blood donor or a patient undergoing
166 a therapeutic procedure performed under the direction and
167 supervision of a licensed physician,
168
169 as long as all of the health care services provided by the blood
170 establishment are related to its activities as a registered
171 blood establishment or the health care services consist of
172 collecting, processing, storing, or administering human
173 hematopoietic stem cells or progenitor cells or performing
174 diagnostic testing of specimens if such specimens are tested
175 together with specimens undergoing routine donor testing. The
176 blood establishment may purchase and possess the drugs described
177 in this sub-subparagraph without a health care clinic
178 establishment permit.
179 2. Storage, handling, and recordkeeping of these
180 distributions by a person required to be permitted as a
181 restricted prescription drug distributor must be in accordance
182 with the requirements for wholesale distributors under s.
183 499.0121.
184 3. A person who applies for a permit as a restricted
185 prescription drug distributor, or for the renewal of such a
186 permit, must provide to the department the information required
187 under s. 499.012.
188 4. The department may adopt rules regarding the
189 distribution of prescription drugs by hospitals, health care
190 entities, charitable organizations, other persons not involved
191 in wholesale distribution, and blood establishments, which rules
192 are necessary for the protection of the public health, safety,
193 and welfare.
194 5. A restricted prescription drug distributor permit is not
195 required for distributions between pharmacies that each hold an
196 active permit under chapter 465, have a common ownership, and
197 are operating in a freestanding end-stage renal dialysis clinic,
198 if such distributions are made to meet the immediate emergency
199 medical needs of specifically identified patients and do not
200 occur with such frequency as to amount to the regular and
201 systematic supplying of that drug between the pharmacies. The
202 department shall adopt rules establishing when the distribution
203 of a prescription drug under this subparagraph amounts to the
204 regular and systematic supplying of that drug.
205 6. A restricted prescription drug distributor permit is not
206 required for distributing medicinal drugs or prepackaged drug
207 products between entities under common control that each hold
208 either an active Class III institutional pharmacy permit under
209 chapter 465 or an active health care clinic establishment permit
210 under paragraph (r). For purposes of this subparagraph, the term
211 “common control” has the same meaning as in s. 499.003(49)(a)3.
212 s. 499.003(48)(a)3.
213 Section 5. Paragraphs (i) and (l) of subsection (1) of
214 section 499.05, Florida Statutes, are amended to read:
215 499.05 Rules.—
216 (1) The department shall adopt rules to implement and
217 enforce this chapter with respect to:
218 (i) Additional conditions that qualify as an emergency
219 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or
220 s. 499.82.
221 (l) The recordkeeping, storage, and handling with respect
222 to each of the distributions of prescription drugs specified in
223 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14).
224 Section 6. This act shall take effect July 1, 2025.
