H 1333

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    HB 1333  2026
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.
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26
27    Be It Enacted by the Legislature of the State of Florida:
28
29Section 1.        This act may be cited as the "Sickles High
30    School Ought to be a Law Cosmetic Animal Testing Act of 2026."
31Section 2.       Present subsections (5) through (29) of section
32    499.005, Florida Statutes, are redesignated as subsections (6)
33    through (30), respectively, and a new subsection (5) is added to
34    that section, to read:
35499.005      Prohibited acts.—It is unlawful for a person to
36    perform or cause the performance of any of the following acts in
37    this state:
38(5)     The manufacture, repackaging, sale, holding, or
39    offering for sale of cosmetics that have been tested on animals
40    as part of the manufacturing process.
41Section 3.       Section 499.0095, Florida Statutes, is created
42    to read:
43499.0095        Cosmetics tested on animals prohibited.—
44(1)(a)      A manufacturer may not use animal testing as part
45    of the process to manufacture cosmetics.
46(b)     A manufacturer may not repackage, sell, hold, or offer
47    for sale cosmetics that have been tested on animals.
48(2)     This section does not apply to the manufacturing of
49    cosmetics, or the repackaging, selling, holding, or offering for
50    sale of cosmetics, if animal testing of such products is:
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51(a)     Required by federal law.
52(b)     Conducted to comply with the requirements of a foreign
53    regulatory authority or the laws of any foreign country.
54(c)     Conducted for purposes other than cosmetic purposes,
55    and the data collected from such testing is not used to evaluate
56    the safety or effectiveness of cosmetics sold in this state.
57(3)(a)      A manufacturer, upon issuance of a cosmetic
58    manufacturer permit pursuant to s. 499.01(2)(p), consents to the
59    department's authorized officer or employee entering and
60    inspecting the premises on an annual basis to determine
61    compliance with this section and department rules, as
62    applicable. A refusal to allow an authorized officer or employee
63    of the department to enter the premises or to conduct an
64    inspection is a violation of s. 499.005(7) and is grounds for
65    disciplinary action pursuant to s. 499.066.
66(b)     By January 31 of each year, each holder of a cosmetic
67    manufacturer permit issued pursuant to s. 499.01 shall submit to
68    the department written documentation to verify his or her
69    compliance with this section.
70(4)(a)      A person who violates this section or s. 499.005
71    commits a misdemeanor of the second degree, punishable as
72    provided in s. 775.082 or s. 775.083.
73(b)     In addition to the criminal penalties imposed in
74    paragraph (a), a person who violates this section is subject to
75    an administrative penalty of $5,000 for each violation. Each day
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76     the violation continues constitutes a separate violation.
77     Penalties collected pursuant to this paragraph are payable to
78     the department to be deposited into the Professional Regulation
79     Trust Fund for the sole purpose of carrying out this section.
80(c)     In addition to other penalties, the department may
81     institute such suits or other legal proceedings as are required
82     to enforce this section pursuant to s. 499.066.
83(5)     The department may adopt rules to implement this
84     section.
85Section 4.       Paragraph (p) of subsection (2) of section
86     499.01, Florida Statutes, is amended to read:
87499.01      Permits.—
88(2)     The following permits are established:
89(p)     Cosmetic manufacturer permit.—A cosmetic manufacturer
90     permit is required for any person that manufactures or
91     repackages cosmetics in this state. A person that only labels or
92     changes the labeling of a cosmetic but does not open the
93     container sealed by the manufacturer of the product is exempt
94     from obtaining a permit under this paragraph. A person who
95     manufactures cosmetics and has annual gross sales of $25,000 or
96     less is exempt from the permit requirements of this paragraph,
97     unless such person manufacturers cosmetics using animal testing
98     as part of the manufacturing process. Upon request, an exempt
99     cosmetic manufacturer must provide to the department written
100    documentation to verify his or her annual gross sales, including
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101    all sales of cosmetic products at any location, regardless of
102    the types of products sold or the number of persons involved in
103    the operation.
1041.      An exempt cosmetic manufacturer may only:
105a.      Sell prepackaged cosmetics affixed with a label
106    containing information required by the United States Food and
107    Drug Administration.
108b.      Manufacture and sell cosmetics that are soaps, not
109    otherwise exempt from the definition of cosmetics, lotions,
110    moisturizers, and creams.
111c.      Sell cosmetics that are not adulterated or misbranded
112    in accordance with 21 U.S.C. ss. 361 and 362.
113d.      Sell cosmetic products that are stored on the premises
114    of the cosmetic manufacturing operation.
1152.      Each unit of cosmetics manufactured under this
116    paragraph must contain, in contrasting color and not less than
117    10-point type, the following statement: "Made by a manufacturer
118    exempt from Florida's cosmetic manufacturing permit
119    requirements."
1203.      The department may investigate any complaint which
121    alleges that an exempt cosmetic manufacturer has violated an
122    applicable provision of this chapter or a rule adopted under
123    this chapter. The department's authorized officer or employee
124    may enter and inspect the premises of an exempt cosmetic
125    manufacturer to determine compliance with this chapter and
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126    department rules, as applicable. A refusal to permit an
127    authorized officer or employee of the department to enter the
128    premises or to conduct an inspection is a violation of s.
129    499.005(7) s. 499.005(6) and is grounds for disciplinary action
130    pursuant to s. 499.066.
1314.      This paragraph does not exempt any person from any
132    state or federal tax law, rule, regulation, or certificate or
133    from any county or municipal law or ordinance that applies to
134    cosmetic manufacturing.
135(3)     A nonresident prescription drug manufacturer permit is
136    not required for a manufacturer to distribute a prescription
137    drug active pharmaceutical ingredient that it manufactures to a
138    prescription drug manufacturer permitted in this state intended
139    for research and development and not for resale or human use
140    other than lawful clinical trials and biostudies authorized and
141    regulated by federal law. A manufacturer claiming to be exempt
142    from the permit requirements of this subsection and the
143    prescription drug manufacturer purchasing and receiving the
144    active pharmaceutical ingredient shall comply with the
145    recordkeeping requirements of s. 499.0121(6). The prescription
146    drug manufacturer purchasing and receiving the active
147    pharmaceutical ingredient shall maintain on file a record of the
148    FDA registration number; if available, the out-of-state license,
149    permit, or registration number; and, if available, a copy of the
150    most current FDA inspection report, for all manufacturers from
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151    whom they purchase active pharmaceutical ingredients under this
152    section. The failure to comply with the requirements of this
153    subsection, or rules adopted by the department to administer
154    this subsection, for the purchase of prescription drug active
155    pharmaceutical ingredients is a violation of s. 499.005(15) s.
156    499.005(14), and a knowing failure is a violation of s.
157    499.0051(3).
158(a)     The immediate package or container of a prescription
159    drug active pharmaceutical ingredient distributed into the state
160    that is intended for research and development under this
161    subsection shall bear a label prominently displaying the
162    statement: "Caution: Research and Development Only—Not for
163    Manufacturing, Compounding, or Resale."
164(b)     A prescription drug manufacturer that obtains a
165    prescription drug active pharmaceutical ingredient under this
166    subsection for use in clinical trials and or biostudies
167    authorized and regulated by federal law must create and maintain
168    records detailing the specific clinical trials or biostudies for
169    which the prescription drug active pharmaceutical ingredient was
170    obtained.
171(4)
172(g)     The department may adopt rules to administer this
173    subsection which are necessary for the protection of the public
174    health, safety, and welfare. Failure to comply with the
175    requirements of this subsection, or rules adopted by the
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176    department to administer this subsection, is a violation of s.
177    499.005(15) s. 499.005(14), and a knowing failure is a violation
178    of s. 499.0051(3).
179Section 5.        Paragraphs (a) and (b) of subsection (48) of
180    section 499.003, Florida Statutes, are amended to read:
181499.003        Definitions of terms used in this part.—As used in
182    this part, the term:
183(48)        "Wholesale distribution" means the distribution of a
184    prescription drug to a person other than a consumer or patient,
185    or the receipt of a prescription drug by a person other than the
186    consumer or patient, but does not include:
187(a)      Any of the following activities, which is not a
188    violation of s. 499.005(22) s. 499.005(21) if such activity is
189    conducted in accordance with s. 499.01(2)(h):
1901.      The purchase or other acquisition by a hospital or
191    other health care entity that is a member of a group purchasing
192    organization of a prescription drug for its own use from the
193    group purchasing organization or from other hospitals or health
194    care entities that are members of that organization.
1952.      The distribution of a prescription drug or an offer to
196    distribute a prescription drug by a charitable organization
197    described in s. 501(c)(3) of the Internal Revenue Code of 1986,
198    as amended and revised, to a nonprofit affiliate of the
199    organization to the extent otherwise permitted by law.
2003.      The distribution of a prescription drug among hospitals
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201    or other health care entities that are under common control. For
202    purposes of this subparagraph, "common control" means the power
203    to direct or cause the direction of the management and policies
204    of a person or an organization, whether by ownership of stock,
205    by voting rights, by contract, or otherwise.
2064.      The distribution of a prescription drug from or for any
207    federal, state, or local government agency or any entity
208    eligible to purchase prescription drugs at public health
209    services prices pursuant to Pub. L. No. 102-585, s. 602 to a
210    contract provider or its subcontractor for eligible patients of
211    the agency or entity under the following conditions:
212a.      The agency or entity must obtain written authorization
213    for the distribution of a prescription drug under this
214    subparagraph from the Secretary of Business and Professional
215    Regulation or his or her designee.
216b.      The contract provider or subcontractor must be
217    authorized by law to administer or dispense prescription drugs.
218c.      In the case of a subcontractor, the agency or entity
219    must be a party to and execute the subcontract.
220d.      The contract provider and subcontractor must maintain
221    and produce immediately for inspection all records of movement
222    or transfer of all the prescription drugs belonging to the
223    agency or entity, including, but not limited to, the records of
224    receipt and disposition of prescription drugs. Each contractor
225    and subcontractor dispensing or administering these drugs must
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226    maintain and produce records documenting the dispensing or
227    administration. Records that are required to be maintained
228    include, but are not limited to, a perpetual inventory itemizing
229    drugs received and drugs dispensed by prescription number or
230    administered by patient identifier, which must be submitted to
231    the agency or entity quarterly.
232e.      The contract provider or subcontractor may administer
233    or dispense the prescription drugs only to the eligible patients
234    of the agency or entity or must return the prescription drugs
235    for or to the agency or entity. The contract provider or
236    subcontractor must require proof from each person seeking to
237    fill a prescription or obtain treatment that the person is an
238    eligible patient of the agency or entity and must, at a minimum,
239    maintain a copy of this proof as part of the records of the
240    contractor or subcontractor required under sub-subparagraph d.
241f.      In addition to the departmental inspection authority
242    set forth in s. 499.051, the establishment of the contract
243    provider and subcontractor and all records pertaining to
244    prescription drugs subject to this subparagraph shall be subject
245    to inspection by the agency or entity. All records relating to
246    prescription drugs of a manufacturer under this subparagraph
247    shall be subject to audit by the manufacturer of those drugs,
248    without identifying individual patient information.
249(b)      Any of the following activities, which is not a
250    violation of s. 499.005(22) s. 499.005(21) if such activity is
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251    conducted in accordance with rules established by the
252    department:
2531.      The distribution of a prescription drug among federal,
254    state, or local government health care entities that are under
255    common control and are authorized to purchase such prescription
256    drug.
2572.      The distribution of a prescription drug or offer to
258    distribute a prescription drug for emergency medical reasons,
259    which may include transfers of prescription drugs by a retail
260    pharmacy to another retail pharmacy to alleviate a temporary
261    shortage. For purposes of this subparagraph, a drug shortage not
262    caused by a public health emergency does not constitute an
263    emergency medical reason.
2643.      The distribution of a prescription drug acquired by a
265    medical director on behalf of a licensed emergency medical
266    services provider to that emergency medical services provider
267    and its transport vehicles for use in accordance with the
268    provider's license under chapter 401.
2694.      The donation of a prescription drug by a health care
270    entity to a charitable organization that has been granted an
271    exemption under s. 501(c)(3) of the Internal Revenue Code of
272    1986, as amended, and that is authorized to possess prescription
273    drugs.
2745.      The distribution of a prescription drug by a person
275    authorized to purchase or receive prescription drugs to a person
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276    licensed or permitted to handle reverse distributions or
277    destruction under the laws of the jurisdiction in which the
278    person handling the reverse distribution or destruction receives
279    the drug.
2806.      The distribution of a prescription drug by a hospital
281    or other health care entity to a person licensed under this part
282    to repackage prescription drugs for the purpose of repackaging
283    the prescription drug for use by that hospital, or other health
284    care entity and other health care entities that are under common
285    control, if ownership of the prescription drugs remains with the
286    hospital or other health care entity at all times. In addition
287    to the recordkeeping requirements of s. 499.0121(6), the
288    hospital or health care entity that distributes prescription
289    drugs pursuant to this subparagraph must reconcile all drugs
290    distributed and returned and resolve any discrepancies in a
291    timely manner.
292Section 6.  Paragraph (a) of subsection (10) of section
293    499.0051, Florida Statutes, is amended to read:
294499.0051  Criminal acts.—
295(10)        VIOLATIONS OF S. 499.005 RELATED TO DEVICES AND
296    COSMETICS; DISSEMINATION OF FALSE ADVERTISEMENT.—
297(a)      Any person who violates any of the provisions of s.
298    499.005 with respect to a device or cosmetic commits a
299    misdemeanor of the second degree, punishable as provided in s.
300    775.082 or s. 775.083; but, if the violation is committed after
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301    a conviction of such person under this subsection has become
302    final, such person is guilty of a misdemeanor of the first
303    degree, punishable as provided in s. 775.082 or s. 775.083 or as
304    otherwise provided in this part, except that any person who
305    violates s. 499.005(9) or (11) s. 499.005(8) or (10) with
306    respect to a device or cosmetic commits a felony of the third
307    degree, punishable as provided in s. 775.082, s. 775.083, or s.
308    775.084, or as otherwise provided in this part.
309Section 7.       This act shall take effect January 1, 2027.
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