S 1418

Florida Senate - 2026  SB 1418
By Senator Polsky
30-01314-26  20261418__
1A bill to be entitled
2An act relating to the testing of cosmetics on
3animals; providing a short title; amending s. 499.005,
4F.S.; providing that it is unlawful for a person to
5manufacture, repackage, sell, hold, or offer for sale
6cosmetics that have been tested on animals as part of
7the manufacturing process; creating s. 499.0095, F.S.;
8prohibiting manufacturers from using animal testing as
9part of the cosmetics manufacturing process;
10prohibiting manufacturers from repackaging, selling,
11holding, or offering for sale cosmetics that have been
12tested on animals; providing exceptions; providing
13that manufacturers, upon issuance of a cosmetic
14manufacturer permit, consent to specified inspections
15by the Department of Business and Professional
16Regulation; providing a penalty for refusal to allow
17such inspections; requiring holders of such permits to
18submit to the department certain written documentation
19by a specified date each year; providing for criminal
20penalties; providing an administrative penalty;
21providing for a cause of action by the department;
22authorizing the department to adopt rules; amending
23ss. 499.01, 499.003, and 499.0051, F.S.; conforming a
24provision and cross-references to changes made by the
25act; providing an effective date.
26
27Be It Enacted by the Legislature of the State of Florida:
28
29Section 1. This act may be cited as the “Sickles High
30School Ought to be a Law Cosmetic Animal Testing Act of 2026.”
31Section 2. Present subsections (5) through (29) of section
32499.005, Florida Statutes, are redesignated as subsections (6)
33through (30), respectively, and a new subsection (5) is added to
34that section, to read:
35499.005 Prohibited acts.—It is unlawful for a person to
36perform or cause the performance of any of the following acts in
37this state:
38(5)The manufacture, repackaging, sale, holding, or
39offering for sale of cosmetics that have been tested on animals
40as part of the manufacturing process.
41Section 3. Section 499.0095, Florida Statutes, is created
42to read:
43499.0095Cosmetics tested on animals prohibited.—
44(1)(a)A manufacturer may not use animal testing as part of
45the process to manufacture cosmetics.
46(b)A manufacturer may not repackage, sell, hold, or offer
47for sale cosmetics that have been tested on animals.
48(2)This section does not apply to the manufacturing of
49cosmetics, or the repackaging, selling, holding, or offering for
50sale of cosmetics, if animal testing of such products is:
51(a)Required by federal law.
52(b)Conducted to comply with the requirements of a foreign
53regulatory authority or the laws of any foreign country.
54(c)Conducted for purposes other than cosmetic purposes,
55and the data collected from such testing is not used to evaluate
56the safety or effectiveness of cosmetics sold in this state.
57(3)(a)A manufacturer, upon issuance of a cosmetic
58manufacturer permit pursuant to s. 499.01(2)(p), consents to the
59department’s authorized officer or employee entering and
60inspecting the premises on an annual basis to determine
61compliance with this section and department rules, as
62applicable. A refusal to allow an authorized officer or employee
63of the department to enter the premises or to conduct an
64inspection is a violation of s. 499.005(7) and is grounds for
65disciplinary action pursuant to s. 499.066.
66(b)By January 31 of each year, each holder of a cosmetic
67manufacturer permit issued pursuant to s. 499.01 shall submit to
68the department written documentation to verify his or her
69compliance with this section.
70(4)(a)A person who violates this section or s. 499.005
71commits a misdemeanor of the second degree, punishable as
72provided in s. 775.082 or s. 775.083.
73(b)In addition to the criminal penalties imposed in
74paragraph (a), a person who violates this section is subject to
75an administrative penalty of $5,000 for each violation. Each day
76the violation continues constitutes a separate violation.
77Penalties collected pursuant to this paragraph are payable to
78the department to be deposited into the Professional Regulation
79Trust Fund for the sole purpose of carrying out this section.
80(c)In addition to other penalties, the department may
81institute such suits or other legal proceedings as are required
82to enforce this section pursuant to s. 499.066.
83(5)The department may adopt rules to implement this
84section.
85Section 4. Paragraph (p) of subsection (2), subsection (3),
86and paragraph (g) of subsection (4) of section 499.01, Florida
87Statutes, are amended to read:
88499.01 Permits.—
89(2) The following permits are established:
90(p) Cosmetic manufacturer permit.—A cosmetic manufacturer
91permit is required for any person that manufactures or
92repackages cosmetics in this state. A person that only labels or
93changes the labeling of a cosmetic but does not open the
94container sealed by the manufacturer of the product is exempt
95from obtaining a permit under this paragraph. A person who
96manufactures cosmetics and has annual gross sales of $25,000 or
97less is exempt from the permit requirements of this paragraph,
98unless such person manufacturers cosmetics using animal testing
99as part of the manufacturing process. Upon request, an exempt
100cosmetic manufacturer must provide to the department written
101documentation to verify his or her annual gross sales, including
102all sales of cosmetic products at any location, regardless of
103the types of products sold or the number of persons involved in
104the operation.
1051. An exempt cosmetic manufacturer may only:
106a. Sell prepackaged cosmetics affixed with a label
107containing information required by the United States Food and
108Drug Administration.
109b. Manufacture and sell cosmetics that are soaps, not
110otherwise exempt from the definition of cosmetics, lotions,
111moisturizers, and creams.
112c. Sell cosmetics that are not adulterated or misbranded in
113accordance with 21 U.S.C. ss. 361 and 362.
114d. Sell cosmetic products that are stored on the premises
115of the cosmetic manufacturing operation.
1162. Each unit of cosmetics manufactured under this paragraph
117must contain, in contrasting color and not less than 10-point
118type, the following statement: “Made by a manufacturer exempt
119from Florida’s cosmetic manufacturing permit requirements.”
1203. The department may investigate any complaint which
121alleges that an exempt cosmetic manufacturer has violated an
122applicable provision of this chapter or a rule adopted under
123this chapter. The department’s authorized officer or employee
124may enter and inspect the premises of an exempt cosmetic
125manufacturer to determine compliance with this chapter and
126department rules, as applicable. A refusal to permit an
127authorized officer or employee of the department to enter the
128premises or to conduct an inspection is a violation of s.
129499.005(7) [s. 499.005(6)] and is grounds for disciplinary action
130pursuant to s. 499.066.
1314. This paragraph does not exempt any person from any state
132or federal tax law, rule, regulation, or certificate or from any
133county or municipal law or ordinance that applies to cosmetic
134manufacturing.
135(3) A nonresident prescription drug manufacturer permit is
136not required for a manufacturer to distribute a prescription
137drug active pharmaceutical ingredient that it manufactures to a
138prescription drug manufacturer permitted in this state intended
139for research and development and not for resale or human use
140other than lawful clinical trials and biostudies authorized and
141regulated by federal law. A manufacturer claiming to be exempt
142from the permit requirements of this subsection and the
143prescription drug manufacturer purchasing and receiving the
144active pharmaceutical ingredient shall comply with the
145recordkeeping requirements of s. 499.0121(6). The prescription
146drug manufacturer purchasing and receiving the active
147pharmaceutical ingredient shall maintain on file a record of the
148FDA registration number; if available, the out-of-state license,
149permit, or registration number; and, if available, a copy of the
150most current FDA inspection report, for all manufacturers from
151whom they purchase active pharmaceutical ingredients under this
152section. The failure to comply with the requirements of this
153subsection, or rules adopted by the department to administer
154this subsection, for the purchase of prescription drug active
155pharmaceutical ingredients is a violation of s. 499.005(15) [s.]
156[499.005(14)], and a knowing failure is a violation of s.
157499.0051(3).
158(a) The immediate package or container of a prescription
159drug active pharmaceutical ingredient distributed into the state
160that is intended for research and development under this
161subsection shall bear a label prominently displaying the
162statement: “Caution: Research and Development Only—Not for
163Manufacturing, Compounding, or Resale.”
164(b) A prescription drug manufacturer that obtains a
165prescription drug active pharmaceutical ingredient under this
166subsection for use in clinical trials and or biostudies
167authorized and regulated by federal law must create and maintain
168records detailing the specific clinical trials or biostudies for
169which the prescription drug active pharmaceutical ingredient was
170obtained.
171(4)
172(g) The department may adopt rules to administer this
173subsection which are necessary for the protection of the public
174health, safety, and welfare. Failure to comply with the
175requirements of this subsection, or rules adopted by the
176department to administer this subsection, is a violation of s.
177499.005(15) [s. 499.005(14)], and a knowing failure is a violation
178of s. 499.0051(3).
179Section 5. Paragraphs (a) and (b) of subsection (48) of
180section 499.003, Florida Statutes, are amended to read:
181499.003 Definitions of terms used in this part.—As used in
182this part, the term:
183(48) “Wholesale distribution” means the distribution of a
184prescription drug to a person other than a consumer or patient,
185or the receipt of a prescription drug by a person other than the
186consumer or patient, but does not include:
187(a) Any of the following activities, which is not a
188violation of s. 499.005(22) [s. 499.005(21)] if such activity is
189conducted in accordance with s. 499.01(2)(h):
1901. The purchase or other acquisition by a hospital or other
191health care entity that is a member of a group purchasing
192organization of a prescription drug for its own use from the
193group purchasing organization or from other hospitals or health
194care entities that are members of that organization.
1952. The distribution of a prescription drug or an offer to
196distribute a prescription drug by a charitable organization
197described in s. 501(c)(3) of the Internal Revenue Code of 1986,
198as amended and revised, to a nonprofit affiliate of the
199organization to the extent otherwise permitted by law.
2003. The distribution of a prescription drug among hospitals
201or other health care entities that are under common control. For
202purposes of this subparagraph, “common control” means the power
203to direct or cause the direction of the management and policies
204of a person or an organization, whether by ownership of stock,
205by voting rights, by contract, or otherwise.
2064. The distribution of a prescription drug from or for any
207federal, state, or local government agency or any entity
208eligible to purchase prescription drugs at public health
209services prices pursuant to Pub. L. No. 102-585, s. 602 to a
210contract provider or its subcontractor for eligible patients of
211the agency or entity under the following conditions:
212a. The agency or entity must obtain written authorization
213for the distribution of a prescription drug under this
214subparagraph from the Secretary of Business and Professional
215Regulation or his or her designee.
216b. The contract provider or subcontractor must be
217authorized by law to administer or dispense prescription drugs.
218c. In the case of a subcontractor, the agency or entity
219must be a party to and execute the subcontract.
220d. The contract provider and subcontractor must maintain
221and produce immediately for inspection all records of movement
222or transfer of all the prescription drugs belonging to the
223agency or entity, including, but not limited to, the records of
224receipt and disposition of prescription drugs. Each contractor
225and subcontractor dispensing or administering these drugs must
226maintain and produce records documenting the dispensing or
227administration. Records that are required to be maintained
228include, but are not limited to, a perpetual inventory itemizing
229drugs received and drugs dispensed by prescription number or
230administered by patient identifier, which must be submitted to
231the agency or entity quarterly.
232e. The contract provider or subcontractor may administer or
233dispense the prescription drugs only to the eligible patients of
234the agency or entity or must return the prescription drugs for
235or to the agency or entity. The contract provider or
236subcontractor must require proof from each person seeking to
237fill a prescription or obtain treatment that the person is an
238eligible patient of the agency or entity and must, at a minimum,
239maintain a copy of this proof as part of the records of the
240contractor or subcontractor required under sub-subparagraph d.
241f. In addition to the departmental inspection authority set
242forth in s. 499.051, the establishment of the contract provider
243and subcontractor and all records pertaining to prescription
244drugs subject to this subparagraph shall be subject to
245inspection by the agency or entity. All records relating to
246prescription drugs of a manufacturer under this subparagraph
247shall be subject to audit by the manufacturer of those drugs,
248without identifying individual patient information.
249(b) Any of the following activities, which is not a
250violation of s. 499.005(22) [s. 499.005(21)] if such activity is
251conducted in accordance with rules established by the
252department:
2531. The distribution of a prescription drug among federal,
254state, or local government health care entities that are under
255common control and are authorized to purchase such prescription
256drug.
2572. The distribution of a prescription drug or offer to
258distribute a prescription drug for emergency medical reasons,
259which may include transfers of prescription drugs by a retail
260pharmacy to another retail pharmacy to alleviate a temporary
261shortage. For purposes of this subparagraph, a drug shortage not
262caused by a public health emergency does not constitute an
263emergency medical reason.
2643. The distribution of a prescription drug acquired by a
265medical director on behalf of a licensed emergency medical
266services provider to that emergency medical services provider
267and its transport vehicles for use in accordance with the
268provider’s license under chapter 401.
2694. The donation of a prescription drug by a health care
270entity to a charitable organization that has been granted an
271exemption under s. 501(c)(3) of the Internal Revenue Code of
2721986, as amended, and that is authorized to possess prescription
273drugs.
2745. The distribution of a prescription drug by a person
275authorized to purchase or receive prescription drugs to a person
276licensed or permitted to handle reverse distributions or
277destruction under the laws of the jurisdiction in which the
278person handling the reverse distribution or destruction receives
279the drug.
2806. The distribution of a prescription drug by a hospital or
281other health care entity to a person licensed under this part to
282repackage prescription drugs for the purpose of repackaging the
283prescription drug for use by that hospital, or other health care
284entity and other health care entities that are under common
285control, if ownership of the prescription drugs remains with the
286hospital or other health care entity at all times. In addition
287to the recordkeeping requirements of s. 499.0121(6), the
288hospital or health care entity that distributes prescription
289drugs pursuant to this subparagraph must reconcile all drugs
290distributed and returned and resolve any discrepancies in a
291timely manner.
292Section 6. Paragraph (a) of subsection (10) of section
293499.0051, Florida Statutes, is amended to read:
294499.0051 Criminal acts.—
295(10) VIOLATIONS OF S. 499.005 RELATED TO DEVICES AND
296COSMETICS; DISSEMINATION OF FALSE ADVERTISEMENT.—
297(a) Any person who violates any of the provisions of s.
298499.005 with respect to a device or cosmetic commits a
299misdemeanor of the second degree, punishable as provided in s.
300775.082 or s. 775.083; but, if the violation is committed after
301a conviction of such person under this subsection has become
302final, such person is guilty of a misdemeanor of the first
303degree, punishable as provided in s. 775.082 or s. 775.083 or as
304otherwise provided in this part, except that any person who
305violates s. 499.005(9) or (11) [s. 499.005(8) or (10)] with
306respect to a device or cosmetic commits a felony of the third
307degree, punishable as provided in s. 775.082, s. 775.083, or s.
308775.084, or as otherwise provided in this part.
309Section 7. This act shall take effect January 1, 2027.