Florida Senate - 2025 CS for SB 1768
By the Committee on Health Policy; and Senator Trumbull
588-03144-25 20251768c1
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 provide a specified written notice to patients before
13 performing any stem cell therapy; specifying
14 requirements for the written notice; providing
15 advertisement requirements; requiring physicians to
16 obtain written consent from the patient or his or her
17 representative before performing the therapy;
18 specifying requirements for the consent form;
19 providing applicability; providing for disciplinary
20 action; requiring the Board of Medicine and the Board
21 of Osteopathic Medicine, respectively, to adopt rules
22 in consultation with one another; providing an
23 effective date.
24
25 Be It Enacted by the Legislature of the State of Florida:
26
27 Section 1. Section 458.3245, Florida Statutes, is created
28 to read:
29 458.3245 Stem cell therapy.—
30 (1) The Legislature recognizes the significant potential of
31 stem cell therapies in advancing medical treatments and
32 improving patient outcomes and further recognizes the need to
33 ensure that such therapies are provided using stem cells
34 obtained in an ethical manner that does not involve stem cells
35 derived from aborted fetuses. It is the intent of the
36 Legislature to foster medical innovation while upholding ethical
37 standards that respect the sanctity of life. By encouraging the
38 use of stem cell sources such as adult stem cells, umbilical
39 cord blood, and other ethically obtained human cells, tissues,
40 or cellular or tissue-based products, the state will advance
41 regenerative medicine in a manner consistent with the values of
42 this state.
43 (2) As used in this section, the term:
44 (a) “Human cells, tissues, or cellular or tissue-based
45 products” means articles containing or consisting of human cells
46 or tissues collected from cord blood donors who are residents of
47 the United States which are intended for implantation,
48 transplantation, infusion, or transfer into a human recipient,
49 including, but not limited to, bones, ligaments, skin, dura
50 mater, heart valves, corneas, hematopoietic stem or progenitor
51 cells derived from peripheral and cord blood, manipulated
52 autologous chondrocytes, epithelial cells on a synthetic matrix,
53 and semen or other reproductive tissue. The term does not
54 include any of the following:
55 1. Vascularized human organs for transplantation.
56 2. Whole blood or blood components or blood derivative
57 products subject to regulation under part I of chapter 499.
58 3. Secreted or extracted human products, such as milk,
59 collagen, and cell factors; except that semen is considered a
60 human cell, tissue, or cellular or tissue-based product for
61 purposes of this paragraph.
62 4. Minimally manipulated bone marrow for homologous use and
63 not combined with another article, except for with water,
64 crystalloids, or a sterilizing, preserving, or storage agent, if
65 the addition of the agent does not raise new clinical safety
66 concerns with respect to the bone marrow.
67 5. Ancillary products used in the manufacture of human
68 cells, tissues, or cellular or tissue-based products.
69 6. Cells, tissues, and organs derived from animals other
70 than humans.
71 7. In vitro diagnostic products.
72 8. Blood vessels recovered with an organ, as defined in 42
73 C.F.R. s. 121.2, which are intended for use in organ
74 transplantation and labeled, “For use in organ transplantation
75 only.”
76 9. Fetal-derived stem cells.
77 10. Adipose-derived mesenchymal stem cells for
78 transplantation.
79 (b) “Minimally manipulated” means:
80 1. For structural tissue, processing that does not alter
81 the original relevant characteristics of the tissue relating to
82 the tissue’s utility for reconstruction, repair, or replacement.
83 2. For cells or nonstructural tissues, processing that does
84 not alter the relevant biological characteristics of cells or
85 tissues.
86 (c) “Physician” means a physician licensed under this
87 chapter or under chapter 459 acting in the course and scope of
88 his or her employment.
89 (d) “Stem cell therapy” means a treatment involving the use
90 of human cells, tissues, or cellular or tissue-based products.
91 The term does not include treatment or research using human
92 cells or tissues that were derived from a fetus or an embryo
93 after an abortion.
94 (3)(a) A physician may perform stem cell therapy that is
95 not approved by the United States Food and Drug Administration
96 if such therapy is used for treatment or procedures that are
97 within the scope of practice for such physician and the
98 therapies are related to orthopedics, wound care, or pain
99 management.
100 (b) To ensure that the retrieval, manufacture, storage, and
101 use of stem cells used for therapies conducted under this
102 section meet the highest standards, any stem cells used by a
103 physician for therapy provided under this section must be:
104 1. Manufactured in a clean room space that has been
105 certified by the United States Food and Drug Administration for
106 using high-efficiency particulate air filtration or ultra-low
107 penetration air filtration to minimize nonviable and viable
108 particulate contamination; and
109 2. Retrieved, manufactured, and stored in a facility that
110 is registered and regulated by the United States Food and Drug
111 Administration and licensed or registered with one of the
112 following entities:
113 a. National Marrow Donor Program.
114 b. World Marrow Donor Association.
115 c. Association for the Advancement of Blood and
116 Biotherapies.
117 d. American Association of Tissue Banks.
118 (4) In the performance of any procedure using or purporting
119 to use stem cells or products containing stem cells, the
120 physician shall adhere to the applicable current good
121 manufacturing practices for the collection, removal, processing,
122 implantation, and transfer of stem cells, or products containing
123 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
124 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
125 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
126 Based Products.
127 (5) A physician who conducts stem cell therapy pursuant to
128 this section shall provide a patient who is being treated with
129 stem cell therapy with the following written notice before
130 performing the therapy:
131
132 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
133 This physician performs one or more stem cell
134 therapies that have not yet been approved by the
135 United States Food and Drug Administration. You are
136 encouraged to consult with your primary care provider
137 before undergoing any stem cell therapy.
138
139 (6) A physician who is required to provide the written
140 notice under subsection (5) shall:
141 (a) Provide the written notice to a patient on paper that
142 is at least 8.5 inches by 11 inches and printed in no less than
143 40-point type.
144 (b) Prominently display the written notice at the entrance
145 to the physician’s office and in an area visible to patients
146 inside such office.
147 (c) Include the notice in any advertisement for the stem
148 cell therapy. In any form of advertisement, the notice must be
149 clearly legible and in a font size no smaller than the largest
150 font size used in the advertisement.
151 (7)(a) A physician required to provide the written notice
152 under subsection (5) must obtain a signed consent form from the
153 patient before performing the stem cell therapy.
154 (b) The consent form must be signed by the patient or, if
155 the patient is legally not competent, the patient’s
156 representative and must state all of the following in language
157 the patient or his or her representative could reasonably be
158 expected to understand:
159 1. The nature and character of the proposed treatment,
160 including the treatment’s United States Food and Drug
161 Administration approval status.
162 2. The anticipated results of the proposed treatment.
163 3. The recognized possible alternative forms of treatment.
164 4. The recognized serious possible risks, complications,
165 and anticipated benefits involved in the treatment and in the
166 recognized possible alternative forms of treatment, including
167 nontreatment.
168 (8) This section does not apply to either of the following:
169 (a) A physician who has obtained approval for an
170 investigational new drug or device from the United States Food
171 and Drug Administration for the use of human cells, tissues, or
172 cellular or tissue-based products.
173 (b) A physician who performs a stem cell therapy under an
174 employment or other contract on behalf of an institution
175 certified by any of the following:
176 1. The Foundation for the Accreditation of Cellular
177 Therapy.
178 2. The Blood and Marrow Transplant Clinical Trials Network.
179 3. The Association for the Advancement of Blood and
180 Biotherapies.
181 4. An entity with expertise in stem cell therapy as
182 determined by the department.
183 (9) A violation of this section may subject the physician
184 to disciplinary action by the board or the department.
185 (10) The Board of Medicine shall adopt rules in
186 consultation with the Board of Osteopathic Medicine to implement
187 this section.
188 Section 2. Section 459.0127, Florida Statutes, is created
189 to read:
190 459.0127 Stem cell therapy.—
191 (1) The Legislature recognizes the significant potential of
192 stem cell therapies in advancing medical treatments and
193 improving patient outcomes and further recognizes the need to
194 ensure that such therapies are provided using stem cells
195 obtained in an ethical manner that does not involve stem cells
196 derived from aborted fetuses. It is the intent of the
197 Legislature to foster medical innovation while upholding ethical
198 standards that respect the sanctity of life. By encouraging the
199 use of stem cell sources such as adult stem cells, umbilical
200 cord blood, and other ethically obtained human cells, tissues,
201 or cellular or tissue-based products, the state will advance
202 regenerative medicine in a manner consistent with the values of
203 this state.
204 (2) As used in this section, the term:
205 (a) “Human cells, tissues, or cellular or tissue-based
206 products” means articles containing or consisting of human cells
207 or tissues collected from cord blood donors who are residents of
208 the United States which are intended for implantation,
209 transplantation, infusion, or transfer into a human recipient,
210 including, but not limited to, bones, ligaments, skin, dura
211 mater, heart valves, corneas, hematopoietic stem or progenitor
212 cells derived from peripheral and cord blood, manipulated
213 autologous chondrocytes, epithelial cells on a synthetic matrix,
214 and semen or other reproductive tissue. The term does not
215 include any of the following:
216 1. Vascularized human organs for transplantation.
217 2. Whole blood or blood components or blood derivative
218 products subject to regulation under part I of chapter 499.
219 3. Secreted or extracted human products, such as milk,
220 collagen, and cell factors; except that semen is considered a
221 human cell, tissue, or cellular or tissue-based product for
222 purposes of this paragraph.
223 4. Minimally manipulated bone marrow for homologous use and
224 not combined with another article, except for with water,
225 crystalloids, or a sterilizing, preserving, or storage agent, if
226 the addition of the agent does not raise new clinical safety
227 concerns with respect to the bone marrow.
228 5. Ancillary products used in the manufacture of human
229 cells, tissues, or cellular or tissue-based products.
230 6. Cells, tissues, and organs derived from animals other
231 than humans.
232 7. In vitro diagnostic products.
233 8. Blood vessels recovered with an organ, as defined in 42
234 C.F.R. s. 121.2, which are intended for use in organ
235 transplantation and labeled, “For use in organ transplantation
236 only.”
237 9. Fetal-derived stem cells.
238 10. Adipose-derived mesenchymal stem cells for
239 transplantation.
240 (b) “Minimally manipulated” means:
241 1. For structural tissue, processing that does not alter
242 the original relevant characteristics of the tissue relating to
243 the tissue’s utility for reconstruction, repair, or replacement.
244 2. For cells or nonstructural tissues, processing that does
245 not alter the relevant biological characteristics of cells or
246 tissues.
247 (c) “Physician” means a physician licensed under this
248 chapter or under chapter 458 acting in the course and scope of
249 his or her employment.
250 (d) “Stem cell therapy” means a treatment involving the use
251 of human cells, tissues, or cellular or tissue-based products.
252 The term does not include treatment or research using human
253 cells or tissues that were derived from a fetus or an embryo
254 after an abortion.
255 (3)(a) A physician may perform stem cell therapy that is
256 not approved by the United States Food and Drug Administration
257 if such therapy is used for treatment or procedures that are
258 within the scope of practice for such physician and the
259 therapies are related to orthopedics, wound care, or pain
260 management.
261 (b) To ensure that the retrieval, manufacture, storage, and
262 use of stem cells used for therapies conducted under this
263 section meet the highest standards, any stem cells used by a
264 physician for therapy provided under this section must be:
265 1. Manufactured in a clean room space that has been
266 certified by the United States Food and Drug Administration for
267 using high-efficiency particulate air filtration or ultra-low
268 penetration air filtration to minimize nonviable and viable
269 particulate contamination; and
270 2. Retrieved, manufactured, and stored in a facility that
271 is registered and regulated by the United States Food and Drug
272 Administration and licensed or registered with one of the
273 following entities:
274 a. National Marrow Donor Program.
275 b. World Marrow Donor Association.
276 c. Association for the Advancement of Blood and
277 Biotherapies.
278 d. American Association of Tissue Banks.
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 physician who conducts stem cell therapy pursuant to
289 this section shall provide a patient who is being treated with
290 stem cell therapy with the following written notice before
291 performing the therapy:
292
293 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
294 This physician performs one or more stem cell
295 therapies that have not yet been approved by the
296 United States Food and Drug Administration. You are
297 encouraged to consult with your primary care provider
298 before undergoing any stem cell therapy.
299
300 (6) A physician who is required to provide the written
301 notice under subsection (5) shall:
302 (a) Provide the written notice to a patient on paper that
303 is at least 8.5 inches by 11 inches and printed in no less than
304 40-point type.
305 (b) Prominently display the written notice at the entrance
306 to the physician’s office and in an area visible to patients
307 inside such office.
308 (c) Include the notice in any advertisement for the stem
309 cell therapy. In any form of advertisement, the notice must be
310 clearly legible and in a font size no smaller than the largest
311 font size used in the advertisement.
312 (7)(a) A physician required to provide the written notice
313 under subsection (5) must obtain a signed consent form from the
314 patient before performing the stem cell therapy.
315 (b) The consent form must be signed by the patient or, if
316 the patient is legally not competent, the patient’s
317 representative and must state all of the following in language
318 the patient or his or her representative could reasonably be
319 expected to understand:
320 1. The nature and character of the proposed treatment,
321 including the treatment’s United States Food and Drug
322 Administration approval status.
323 2. The anticipated results of the proposed treatment.
324 3. The recognized possible alternative forms of treatment.
325 4. The recognized serious possible risks, complications,
326 and anticipated benefits involved in the treatment and in the
327 recognized possible alternative forms of treatment, including
328 nontreatment.
329 (8) This section does not apply to either of the following:
330 (a) A physician who has obtained approval for an
331 investigational new drug or device from the United States Food
332 and Drug Administration for the use of human cells, tissues, or
333 cellular or tissue-based products.
334 (b) A physician who performs a stem cell therapy under an
335 employment or other contract on behalf of an institution
336 certified by any of the following:
337 1. The Foundation for the Accreditation of Cellular
338 Therapy.
339 2. The Blood and Marrow Transplant Clinical Trials Network.
340 3. The Association for the Advancement of Blood and
341 Biotherapies.
342 4. An entity with expertise in stem cell therapy as
343 determined by the department.
344 (9) A violation of this section may subject the physician
345 to disciplinary action under the rules that have been developed
346 by the board or the department as applicable.
347 (10) The Board of Osteopathic Medicine shall adopt rules in
348 consultation with the Board of Medicine to implement this
349 section.
350 Section 3. This act shall take effect July 1, 2025.