CS for CS for CS for SB 196 First Engrossed
2025196e1
1 A bill to be entitled
2 An act relating to chemicals in consumer products;
3 amending s. 499.003, F.S.; revising the definition of
4 the term “drug”; defining the term “vaccine or vaccine
5 material”; amending s. 499.007, F.S.; deeming a drug
6 misbranded if it is a food containing a vaccine or
7 vaccine material, but its label does not include
8 specified information; creating s. 499.0095, F.S.;
9 defining terms; requiring that, beginning on a
10 specified date, cosmetics manufactured, sold, offered
11 or distributed for sale, or distributed for use in
12 this state provide notice of specified added
13 ingredients on a website that is created and
14 maintained by the cosmetics manufacturer and made
15 available to the public regarding such added
16 ingredients; prohibiting, by a specified date,
17 cosmetics that release formaldehyde from being
18 manufactured, sold, offered or distributed for sale,
19 or distributed for use in this state, unless it is a
20 natural byproduct with no functional or technical
21 purpose; providing an exception; providing
22 construction; providing penalties and remedies;
23 providing applicability; authorizing the Department of
24 Business and Professional Regulation to adopt rules;
25 amending s. 500.03, F.S.; defining the term “messenger
26 ribonucleic acid vaccine” or “mRNA vaccine”; amending
27 s. 500.04, F.S.; prohibiting the use of fruits and
28 vegetables to deliver an mRNA vaccine; amending s.
29 500.11, F.S.; deeming a food misbranded if it contains
30 a vaccine or vaccine material, but its label does not
31 include specified information; amending ss. 499.01 and
32 499.05, F.S.; conforming cross-references; providing
33 an effective date.
34
35 Be It Enacted by the Legislature of the State of Florida:
36
37 Section 1. Present subsections (47), (48), and (49) of
38 section 499.003, Florida Statutes, are redesignated as
39 subsections (48), (49), and (50), respectively, a new subsection
40 (47) is added to that section, and subsections (17) and (40) of
41 that section are amended, to read:
42 499.003 Definitions of terms used in this part.—As used in
43 this part, the term:
44 (17) “Drug” means an article that is:
45 (a) Recognized in the current edition of the United States
46 Pharmacopoeia and National Formulary, official Homeopathic
47 Pharmacopoeia of the United States, or any supplement to any of
48 those publications;
49 (b) Intended for use in the diagnosis, cure, mitigation,
50 treatment, therapy, or prevention of disease in humans or other
51 animals;
52 (c) Intended to affect the structure or any function of the
53 body of humans or other animals; or
54 (d) Intended for use as a component of any article
55 specified in paragraph (a), paragraph (b), or paragraph (c), and
56 includes active pharmaceutical ingredients, but does not include
57 devices or their nondrug components, parts, or accessories; or
58 (e) Food as defined in s. 500.03 which contains a vaccine
59 or vaccine material.
60 (40) “Prescription drug” means a prescription, medicinal,
61 or legend drug, including, but not limited to, finished dosage
62 forms or active pharmaceutical ingredients subject to, defined
63 by, or described by s. 503(b) of the federal act or s. 465.003,
64 s. 499.007(13), subsection (31), or subsection (48) (47), except
65 that an active pharmaceutical ingredient is a prescription drug
66 only if substantially all finished dosage forms in which it may
67 be lawfully dispensed or administered in this state are also
68 prescription drugs.
69 (47) “Vaccine or vaccine material” means a substance
70 authorized or approved by the United States Food and Drug
71 Administration which is intended for use in humans to stimulate
72 the production of antibodies and provide immunity against
73 disease and which is prepared from the causative agent of a
74 disease, its products, or a synthetic substitute and is treated
75 to act as an antigen without inducing the disease.
76 Section 2. Present subsection (17) of section 499.007,
77 Florida Statutes, is redesignated as subsection (18), and a new
78 subsection (17) is added to that section, to read:
79 499.007 Misbranded drug or device.—A drug or device is
80 misbranded:
81 (17) If it is a food as defined in s. 500.03 and contains a
82 vaccine or vaccine material, but its label does not bear, in
83 type of uniform size and prominence, the words “contains vaccine
84 or vaccine material” and does not specify that the food is
85 classified as a drug under the Florida Drug and Cosmetic Act.
86 Section 3. Section 499.0095, Florida Statutes, is created
87 to read:
88 499.0095 Presence of certain ingredients in cosmetics;
89 notice required.—
90 (1) As used in this section, the term:
91 (a) “Incidental ingredient” means a substance that has no
92 technical or functional effect in the cosmetics but is present
93 by reason of having been incorporated into the cosmetics as an
94 ingredient of another cosmetic ingredient.
95 (b) “Ingredient” means:
96 1. Any chemical or mixture of chemicals intentionally used
97 in the manufacturing of cosmetics. The term does not include any
98 incidental ingredient that is present in cosmetics at
99 insignificant levels or that has no technical or functional
100 effect; or
101 2. A processing aid, including any of the following:
102 a. A substance that is used in the processing of cosmetics
103 but is removed from the cosmetics in accordance with good
104 manufacturing practices before the cosmetics are packaged in
105 their finished form.
106 b. A substance that is used in the processing of cosmetics
107 for its technical or functional effect to produce the cosmetics
108 and is then converted to a substance the same as constituents of
109 a declared ingredient, in accordance with good manufacturing
110 practices, and does not significantly increase the concentration
111 of such constituents before the cosmetics are packaged in their
112 finished form.
113 c. A substance that is used in the processing of cosmetics
114 for its technical or functional effect to produce the cosmetics
115 in accordance with good manufacturing practices, that is present
116 in the cosmetics’ finished form at insignificant concentrations,
117 and that does not have any technical or functional effect in
118 such cosmetics.
119 (c) “Ortho-phthalates” means esters of ortho-phthalic acid.
120 (d) “Perfluoroalkyl and polyfluoroalkyl substances” or
121 “PFAS” means a class of fluorinated organic chemicals containing
122 at least one fully fluorinated carbon atom.
123 (2) Except as provided in subsection (5), beginning July 1,
124 2026, cosmetics manufactured, sold, offered or distributed for
125 sale, or distributed for use in this state must provide notice
126 on a website that is created and maintained by the cosmetics
127 manufacturer and made available to the public regarding the
128 following intentionally added chemicals or chemical classes:
129 (a) Ortho-phthalates.
130 (b) PFAS.
131 (c) Formaldehyde as identified in CAS 50-00-0.
132 (d) Methylene glycol as identified in CAS 463-57-0.
133 (e) Mercury as identified in CAS 7439-97-6.
134 (f) Triclosan as identified in CAS 3380-34-5.
135 (g) M-phenylenediamine or its salt derivatives as
136 identified in CAS 108-45-2.
137 (h) O-phenylenediamine or its salt derivatives as
138 identified in CAS 95-54-5.
139 (3) Except as provided in subsection (5), beginning July 1,
140 2026, cosmetics manufactured, sold, offered or distributed for
141 sale, or distributed for use in this state must provide notice
142 on a website that is created and maintained by the cosmetics
143 manufacturer and made available to the public regarding any lead
144 or lead compounds as identified by CAS 7439-92-1, whether
145 intentionally added or naturally occurring, at 10 parts per
146 million or more, or as otherwise determined by department rule.
147 (4) Except as provided in subsection (5), beginning July 1,
148 2026, cosmetics manufactured, sold, offered or distributed for
149 sale, or distributed for use in this state may not release
150 formaldehyde as identified in paragraph (2)(c) unless it is a
151 natural byproduct with no functional or technical purpose.
152 (5) A retailer in possession of cosmetics that do not
153 comply with the requirements of this section as of July 1, 2026,
154 may exhaust its existing stock through sales to the public until
155 July 1, 2027.
156 (6) A violation of this section is subject to the penalties
157 and remedies provided in s. 499.066.
158 (7) This section does not apply to cosmetic products
159 regulated as drugs by the United States Food and Drug
160 Administration.
161 (8) The department may adopt rules necessary to implement
162 this section.
163 Section 4. Present paragraphs (t) through (z) of subsection
164 (1) of section 500.03, Florida Statutes, are redesignated as
165 paragraphs (u) through (aa), respectively, and a new paragraph
166 (t) is added to that subsection, to read:
167 500.03 Definitions; construction; applicability.—
168 (1) For the purpose of this chapter, the term:
169 (t) “Messenger ribonucleic acid vaccine” or “mRNA vaccine”
170 means a vaccine that uses laboratory-produced messenger
171 ribonucleic acid to trigger the human body’s immune system to
172 generate an immune response.
173 Section 5. Subsection (12) is added to section 500.04,
174 Florida Statutes, to read:
175 500.04 Prohibited acts.—The following acts and the causing
176 thereof within the state are prohibited:
177 (12) The use of a fruit or vegetable as a delivery
178 mechanism for an mRNA vaccine as defined in s. 500.03.
179 Section 6. Paragraph (q) is added to subsection (1) of
180 section 500.11, Florida Statutes, to read:
181 500.11 Food deemed misbranded.—
182 (1) A food is deemed to be misbranded:
183 (q) If it contains a vaccine or vaccine material as defined
184 in s. 499.003, unless its label bears, in type of uniform size
185 and prominence, the words “contains vaccine or vaccine material”
186 and specifies that the food is classified as a drug under the
187 Florida Drug and Cosmetic Act.
188 Section 7. Paragraphs (a), (b), and (h) of subsection (2)
189 of section 499.01, Florida Statutes, are amended to read:
190 499.01 Permits.—
191 (2) The following permits are established:
192 (a) Prescription drug manufacturer permit.—A prescription
193 drug manufacturer permit is required for any person that is a
194 manufacturer of a prescription drug and that manufactures or
195 distributes such prescription drugs in this state.
196 1. A person that operates an establishment permitted as a
197 prescription drug manufacturer may engage in distribution of
198 prescription drugs for which the person is the manufacturer and
199 must comply with s. 499.0121 and all other provisions of this
200 part and rules adopted under this part. The department shall
201 adopt rules for issuing a virtual prescription drug manufacturer
202 permit to a person who engages in the manufacture of
203 prescription drugs but does not make or take physical possession
204 of any prescription drugs. The rules adopted by the department
205 under this section may exempt virtual manufacturers from certain
206 establishment, security, and storage requirements set forth in
207 s. 499.0121.
208 2. A prescription drug manufacturer must comply with all
209 appropriate state and federal good manufacturing practices.
210 3. A blood establishment, as defined in s. 381.06014,
211 operating in a manner consistent with the provisions of 21
212 C.F.R. parts 211 and 600-640, and manufacturing only the
213 prescription drugs described in s. 499.003(49)(j) s.
214 499.003(48)(j) is not required to be permitted as a prescription
215 drug manufacturer under this paragraph or to register products
216 under s. 499.015.
217 (b) Prescription drug repackager permit.—A prescription
218 drug repackager permit is required for any person that
219 repackages a prescription drug in this state.
220 1. A person that operates an establishment permitted as a
221 prescription drug repackager may engage in distribution of
222 prescription drugs repackaged at that establishment and must
223 comply with all of the provisions of this part and the rules
224 adopted under this part that apply to a prescription drug
225 manufacturer.
226 2. A prescription drug repackager must comply with all
227 appropriate state and federal good manufacturing practices.
228 3. A prescription drug repackager permit is not required
229 for distributing medicinal drugs or prepackaged drug products
230 between entities under common control which each hold either an
231 active Class III institutional pharmacy permit under chapter 465
232 or an active health care clinic establishment permit under
233 paragraph (r). For purposes of this subparagraph, the term
234 “common control” has the same meaning as in s. 499.003(49)(a)3.
235 s. 499.003(48)(a)3.
236 (h) Restricted prescription drug distributor permit.—
237 1. A restricted prescription drug distributor permit is
238 required for:
239 a. Any person located in this state who engages in the
240 distribution of a prescription drug, which distribution is not
241 considered “wholesale distribution” under s. 499.003(49)(a) s.
242 499.003(48)(a).
243 b. Any person located in this state who engages in the
244 receipt or distribution of a prescription drug in this state for
245 the purpose of processing its return or its destruction if such
246 person is not the person initiating the return, the prescription
247 drug wholesale supplier of the person initiating the return, or
248 the manufacturer of the drug.
249 c. A blood establishment located in this state which
250 collects blood and blood components only from volunteer donors
251 as defined in s. 381.06014 or pursuant to an authorized
252 practitioner’s order for medical treatment or therapy and
253 engages in the wholesale distribution of a prescription drug not
254 described in s. 499.003(49)(j) s. 499.003(48)(j) to a health
255 care entity. A mobile blood unit operated by a blood
256 establishment permitted under this sub-subparagraph is not
257 required to be separately permitted. The health care entity
258 receiving a prescription drug distributed under this sub
259 subparagraph must be licensed as a closed pharmacy or provide
260 health care services at that establishment. The blood
261 establishment must operate in accordance with s. 381.06014 and
262 may distribute only:
263 (I) Prescription drugs indicated for a bleeding or clotting
264 disorder or anemia;
265 (II) Blood-collection containers approved under s. 505 of
266 the federal act;
267 (III) Drugs that are blood derivatives, or a recombinant or
268 synthetic form of a blood derivative;
269 (IV) Prescription drugs that are identified in rules
270 adopted by the department and that are essential to services
271 performed or provided by blood establishments and authorized for
272 distribution by blood establishments under federal law; or
273 (V) To the extent authorized by federal law, drugs
274 necessary to collect blood or blood components from volunteer
275 blood donors; for blood establishment personnel to perform
276 therapeutic procedures under the direction and supervision of a
277 licensed physician; and to diagnose, treat, manage, and prevent
278 any reaction of a volunteer blood donor or a patient undergoing
279 a therapeutic procedure performed under the direction and
280 supervision of a licensed physician, as long as all of the
281 health care services provided by the blood establishment are
282 related to its activities as a registered blood establishment or
283 the health care services consist of collecting, processing,
284 storing, or administering human hematopoietic stem cells or
285 progenitor cells or performing diagnostic testing of specimens
286 if such specimens are tested together with specimens undergoing
287 routine donor testing. The blood establishment may purchase and
288 possess the drugs described in this sub-subparagraph without a
289 health care clinic establishment permit.
290 2. Storage, handling, and recordkeeping of these
291 distributions by a person required to be permitted as a
292 restricted prescription drug distributor must be in accordance
293 with the requirements for wholesale distributors under s.
294 499.0121.
295 3. A person who applies for a permit as a restricted
296 prescription drug distributor, or for the renewal of such a
297 permit, must provide to the department the information required
298 under s. 499.012.
299 4. The department may adopt rules regarding the
300 distribution of prescription drugs by hospitals, health care
301 entities, charitable organizations, other persons not involved
302 in wholesale distribution, and blood establishments, which rules
303 are necessary for the protection of the public health, safety,
304 and welfare.
305 5. A restricted prescription drug distributor permit is not
306 required for distributions between pharmacies that each hold an
307 active permit under chapter 465, have a common ownership, and
308 are operating in a freestanding end-stage renal dialysis clinic,
309 if such distributions are made to meet the immediate emergency
310 medical needs of specifically identified patients and do not
311 occur with such frequency as to amount to the regular and
312 systematic supplying of that drug between the pharmacies. The
313 department shall adopt rules establishing when the distribution
314 of a prescription drug under this subparagraph amounts to the
315 regular and systematic supplying of that drug.
316 6. A restricted prescription drug distributor permit is not
317 required for distributing medicinal drugs or prepackaged drug
318 products between entities under common control that each hold
319 either an active Class III institutional pharmacy permit under
320 chapter 465 or an active health care clinic establishment permit
321 under paragraph (r). For purposes of this subparagraph, the term
322 “common control” has the same meaning as in s. 499.003(49)(a)3.
323 s. 499.003(48)(a)3.
324 Section 8. Paragraphs (i) and (l) of subsection (1) of
325 section 499.05, Florida Statutes, are amended to read:
326 499.05 Rules.—
327 (1) The department shall adopt rules to implement and
328 enforce this chapter with respect to:
329 (i) Additional conditions that qualify as an emergency
330 medical reason under s. 499.003(49)(b)2. s. 499.003(48)(b)2. or
331 s. 499.82.
332 (l) The recordkeeping, storage, and handling with respect
333 to each of the distributions of prescription drugs specified in
334 s. 499.003(49)(a)-(v) s. 499.003(48)(a)-(v) or s. 499.82(14).
335 Section 9. This act shall take effect July 1, 2025.