Florida Senate - 2025 CS for CS for SB 1768
By the Committees on Rules; and Health Policy; and Senator
Trumbull
595-03688-25 20251768c2
1 A bill to be entitled
2 An act relating to stem cell therapy; creating ss.
3 458.3245 and 459.0127, F.S.; providing legislative
4 findings and intent; defining terms; authorizing
5 physicians to perform stem cell therapy not approved
6 by the United States Food and Drug Administration
7 under certain circumstances; specifying requirements
8 for the stem cells that may be used by such
9 physicians; requiring such physicians to adhere to
10 applicable current good manufacturing practices in the
11 performance of such therapies; requiring physicians to
12 include a specified notice in any form of
13 advertisement; providing requirements for such notice;
14 requiring physicians to obtain a signed consent form
15 from the patient or his or her representative before
16 performing the therapy; specifying requirements for
17 the consent form; providing applicability; providing
18 for disciplinary action; requiring the Board of
19 Medicine and the Board of Osteopathic Medicine,
20 respectively, to adopt rules in consultation with one
21 another; providing an effective date.
22
23 Be It Enacted by the Legislature of the State of Florida:
24
25 Section 1. Section 458.3245, Florida Statutes, is created
26 to read:
27 458.3245 Stem cell therapy.—
28 (1) The Legislature recognizes the significant potential of
29 stem cell therapies in advancing medical treatments and
30 improving patient outcomes and further recognizes the need to
31 ensure that such therapies are provided using stem cells
32 obtained in an ethical manner that does not involve stem cells
33 derived from aborted fetuses. It is the intent of the
34 Legislature to foster medical innovation while upholding ethical
35 standards that respect the sanctity of life. By encouraging the
36 use of stem cell sources such as adult stem cells, umbilical
37 cord blood, and other ethically obtained human cells, tissues,
38 or cellular or tissue-based products, the state will advance
39 regenerative medicine in a manner consistent with the values of
40 this state.
41 (2) As used in this section, the term:
42 (a) “Human cells, tissues, or cellular or tissue-based
43 products” means articles containing or consisting of human cells
44 or tissues collected from cord blood donors who are residents of
45 the United States which are intended for implantation,
46 transplantation, infusion, or transfer into a human recipient,
47 including, but not limited to, bones, ligaments, skin, dura
48 mater, heart valves, corneas, hematopoietic stem or progenitor
49 cells derived from peripheral and cord blood, manipulated
50 autologous chondrocytes, epithelial cells on a synthetic matrix,
51 and semen or other reproductive tissue. The term does not
52 include any of the following:
53 1. Vascularized human organs for transplantation.
54 2. Whole blood or blood components or blood derivative
55 products subject to regulation under part I of chapter 499.
56 3. Secreted or extracted human products, such as milk,
57 collagen, and cell factors; except that semen is considered a
58 human cell, tissue, or cellular or tissue-based product for
59 purposes of this paragraph.
60 4. Minimally manipulated bone marrow for homologous use and
61 not combined with another article, except for with water,
62 crystalloids, or a sterilizing, preserving, or storage agent, if
63 the addition of the agent does not raise new clinical safety
64 concerns with respect to the bone marrow.
65 5. Ancillary products used in the manufacture of human
66 cells, tissues, or cellular or tissue-based products.
67 6. Cells, tissues, and organs derived from animals other
68 than humans.
69 7. In vitro diagnostic products.
70 8. Blood vessels recovered with an organ, as defined in 42
71 C.F.R. s. 121.2, which are intended for use in organ
72 transplantation and labeled, “For use in organ transplantation
73 only.”
74 9. Fetal-derived stem cells.
75 10. Adipose-derived mesenchymal stem cells for
76 transplantation.
77 (b) “Minimally manipulated” means:
78 1. For structural tissue, processing that does not alter
79 the original relevant characteristics of the tissue relating to
80 the tissue’s utility for reconstruction, repair, or replacement.
81 2. For cells or nonstructural tissues, processing that does
82 not alter the relevant biological characteristics of cells or
83 tissues.
84 (c) “Physician” means a physician licensed under this
85 chapter or under chapter 459 acting in the course and scope of
86 his or her employment.
87 (d) “Stem cell therapy” means a treatment involving the use
88 of human cells, tissues, or cellular or tissue-based products
89 which complies with the regulatory and reporting requirements
90 provided in this section. The term does not include treatment or
91 research using human cells or tissues that were derived from a
92 fetus or an embryo after an abortion.
93 (3)(a) A physician may perform stem cell therapy that is
94 not approved by the United States Food and Drug Administration
95 if such therapy is used for treatment or procedures that are
96 within the scope of practice for such physician and the
97 therapies are related to orthopedics, wound care, or pain
98 management.
99 (b) To ensure that the retrieval, manufacture, storage, and
100 use of stem cells used for therapies conducted under this
101 section meet the highest standards, any stem cells used by a
102 physician for therapy provided under this section must:
103 1. Be manufactured in a clean room space that has been
104 certified by the United States Food and Drug Administration for
105 using high-efficiency particulate air filtration or ultra-low
106 penetration air filtration to minimize nonviable and viable
107 particulate contamination;
108 2. Be retrieved, manufactured, and stored in a facility
109 that is registered and regulated by the United States Food and
110 Drug Administration and licensed or registered with one of the
111 following entities:
112 a. National Marrow Donor Program.
113 b. World Marrow Donor Association.
114 c. Association for the Advancement of Blood and
115 Biotherapies.
116 d. American Association of Tissue Banks; and
117 3. Contain viable or live cells upon post-thaw analysis and
118 be included in a post-thaw viability analysis report for the
119 product lot which will be sent to the physician before use with
120 the physician’s patient.
121 (4) In the performance of any procedure using or purporting
122 to use stem cells or products containing stem cells, the
123 physician shall adhere to the applicable current good
124 manufacturing practices for the collection, removal, processing,
125 implantation, and transfer of stem cells, or products containing
126 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
127 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
128 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
129 Based Products.
130 (5)(a) A physician who conducts stem cell therapy pursuant
131 to this section shall include the following notice in any form
132 of advertisement:
133
134 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
135 This physician performs one or more stem cell
136 therapies that have not yet been approved by the
137 United States Food and Drug Administration. You are
138 encouraged to consult with your primary care provider
139 before undergoing any stem cell therapy.
140
141 (b) The notice required by paragraph (a) must be clearly
142 legible and in a type size no smaller than the largest type size
143 used in the advertisement.
144 (6)(a) A physician who conducts stem cell therapy pursuant
145 to this section shall obtain a signed consent form from the
146 patient before performing the stem cell therapy.
147 (b) The consent form must be signed by the patient or, if
148 the patient is not legally competent, the patient’s
149 representative and must state all of the following in language
150 the patient or his or her representative could reasonably be
151 expected to understand:
152 1. The nature and character of the proposed treatment.
153 2. That the proposed stem cell therapy has not yet been
154 approved by the United States Food and Drug Administration.
155 3. The anticipated results of the proposed treatment.
156 4. The recognized serious possible risks, complications,
157 and anticipated benefits involved in the treatment and in the
158 recognized possible alternative forms of treatment, including
159 nontreatment.
160 5. That the patient is encouraged to consult with his or
161 her primary care provider before undergoing any stem cell
162 therapy.
163 (7) This section does not apply to either of the following:
164 (a) A physician who has obtained approval for an
165 investigational new drug or device from the United States Food
166 and Drug Administration for the use of human cells, tissues, or
167 cellular or tissue-based products.
168 (b) A physician who performs stem cell therapy under an
169 employment or other contract on behalf of an institution
170 certified by any of the following:
171 1. The Foundation for the Accreditation of Cellular
172 Therapy.
173 2. The Blood and Marrow Transplant Clinical Trials Network.
174 3. The Association for the Advancement of Blood and
175 Biotherapies.
176 4. An entity with expertise in stem cell therapy as
177 determined by the department.
178 (8) A violation of this section may subject the physician
179 to disciplinary action by the board or the department.
180 (9) The Board of Medicine shall adopt rules in consultation
181 with the Board of Osteopathic Medicine to implement this
182 section.
183 Section 2. Section 459.0127, Florida Statutes, is created
184 to read:
185 459.0127 Stem cell therapy.—
186 (1) The Legislature recognizes the significant potential of
187 stem cell therapies in advancing medical treatments and
188 improving patient outcomes and further recognizes the need to
189 ensure that such therapies are provided using stem cells
190 obtained in an ethical manner that does not involve stem cells
191 derived from aborted fetuses. It is the intent of the
192 Legislature to foster medical innovation while upholding ethical
193 standards that respect the sanctity of life. By encouraging the
194 use of stem cell sources such as adult stem cells, umbilical
195 cord blood, and other ethically obtained human cells, tissues,
196 or cellular or tissue-based products, the state will advance
197 regenerative medicine in a manner consistent with the values of
198 this state.
199 (2) As used in this section, the term:
200 (a) “Human cells, tissues, or cellular or tissue-based
201 products” means articles containing or consisting of human cells
202 or tissues collected from cord blood donors who are residents of
203 the United States which are intended for implantation,
204 transplantation, infusion, or transfer into a human recipient,
205 including, but not limited to, bones, ligaments, skin, dura
206 mater, heart valves, corneas, hematopoietic stem or progenitor
207 cells derived from peripheral and cord blood, manipulated
208 autologous chondrocytes, epithelial cells on a synthetic matrix,
209 and semen or other reproductive tissue. The term does not
210 include any of the following:
211 1. Vascularized human organs for transplantation.
212 2. Whole blood or blood components or blood derivative
213 products subject to regulation under part I of chapter 499.
214 3. Secreted or extracted human products, such as milk,
215 collagen, and cell factors; except that semen is considered a
216 human cell, tissue, or cellular or tissue-based product for
217 purposes of this paragraph.
218 4. Minimally manipulated bone marrow for homologous use and
219 not combined with another article, except for with water,
220 crystalloids, or a sterilizing, preserving, or storage agent, if
221 the addition of the agent does not raise new clinical safety
222 concerns with respect to the bone marrow.
223 5. Ancillary products used in the manufacture of human
224 cells, tissues, or cellular or tissue-based products.
225 6. Cells, tissues, and organs derived from animals other
226 than humans.
227 7. In vitro diagnostic products.
228 8. Blood vessels recovered with an organ, as defined in 42
229 C.F.R. s. 121.2, which are intended for use in organ
230 transplantation and labeled, “For use in organ transplantation
231 only.”
232 9. Fetal-derived stem cells.
233 10. Adipose-derived mesenchymal stem cells for
234 transplantation.
235 (b) “Minimally manipulated” means:
236 1. For structural tissue, processing that does not alter
237 the original relevant characteristics of the tissue relating to
238 the tissue’s utility for reconstruction, repair, or replacement.
239 2. For cells or nonstructural tissues, processing that does
240 not alter the relevant biological characteristics of cells or
241 tissues.
242 (c) “Physician” means a physician licensed under this
243 chapter or under chapter 458 acting in the course and scope of
244 his or her employment.
245 (d) “Stem cell therapy” means a treatment involving the use
246 of human cells, tissues, or cellular or tissue-based products
247 which complies with the regulatory and reporting requirements
248 provided in this section. The term does not include treatment or
249 research using human cells or tissues that were derived from a
250 fetus or an embryo after an abortion.
251 (3)(a) A physician may perform stem cell therapy that is
252 not approved by the United States Food and Drug Administration
253 if such therapy is used for treatment or procedures that are
254 within the scope of practice for such physician and the
255 therapies are related to orthopedics, wound care, or pain
256 management.
257 (b) To ensure that the retrieval, manufacture, storage, and
258 use of stem cells used for therapies conducted under this
259 section meet the highest standards, any stem cells used by a
260 physician for therapy provided under this section must:
261 1. Be manufactured in a clean room space that has been
262 certified by the United States Food and Drug Administration for
263 using high-efficiency particulate air filtration or ultra-low
264 penetration air filtration to minimize nonviable and viable
265 particulate contamination;
266 2. Be retrieved, manufactured, and stored in a facility
267 that is registered and regulated by the United States Food and
268 Drug Administration and licensed or registered with one of the
269 following entities:
270 a. National Marrow Donor Program.
271 b. World Marrow Donor Association.
272 c. Association for the Advancement of Blood and
273 Biotherapies.
274 d. American Association of Tissue Banks; and
275 3. Contain viable or live cells upon post-thaw analysis and
276 be included in a post-thaw viability analysis report for the
277 product lot which will be sent to the physician before use with
278 the physician’s patient.
279 (4) In the performance of any procedure using or purporting
280 to use stem cells or products containing stem cells, the
281 physician shall adhere to the applicable current good
282 manufacturing practices for the collection, removal, processing,
283 implantation, and transfer of stem cells, or products containing
284 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
285 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
286 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
287 Based Products.
288 (5)(a) A physician who conducts stem cell therapy pursuant
289 to this section shall include the following notice in any form
290 of advertisement:
291
292 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
293 This physician performs one or more stem cell
294 therapies that have not yet been approved by the
295 United States Food and Drug Administration. You are
296 encouraged to consult with your primary care provider
297 before undergoing any stem cell therapy.
298
299 (b) The notice required by paragraph (a) must be clearly
300 legible and in a type size no smaller than the largest type size
301 used in the advertisement.
302 (6)(a) A physician who conducts stem cell therapy pursuant
303 to this section shall obtain a signed consent form from the
304 patient before performing the stem cell therapy.
305 (b) The consent form must be signed by the patient or, if
306 the patient is not legally competent, the patient’s
307 representative and must state all of the following in language
308 the patient or his or her representative could reasonably be
309 expected to understand:
310 1. The nature and character of the proposed treatment.
311 2. That the proposed stem cell therapy has not yet been
312 approved by the United States Food and Drug Administration.
313 3. The anticipated results of the proposed treatment.
314 4. The recognized serious possible risks, complications,
315 and anticipated benefits involved in the treatment and in the
316 recognized possible alternative forms of treatment, including
317 nontreatment.
318 (7) This section does not apply to either of the following:
319 (a) A physician who has obtained approval for an
320 investigational new drug or device from the United States Food
321 and Drug Administration for the use of human cells, tissues, or
322 cellular or tissue-based products.
323 (b) A physician who performs a stem cell therapy under an
324 employment or other contract on behalf of an institution
325 certified by any of the following:
326 1. The Foundation for the Accreditation of Cellular
327 Therapy.
328 2. The Blood and Marrow Transplant Clinical Trials Network.
329 3. The Association for the Advancement of Blood and
330 Biotherapies.
331 4. An entity with expertise in stem cell therapy as
332 determined by the department.
333 (8) A violation of this section may subject the physician
334 to disciplinary action under the rules that have been developed
335 by the board or the department as applicable.
336 (9) The Board of Osteopathic Medicine shall adopt rules in
337 consultation with the Board of Medicine to implement this
338 section.
339 Section 3. This act shall take effect July 1, 2025.