Florida Senate - 2025 COMMITTEE AMENDMENT
Bill No. CS for SB 1768
Ì642556:Î642556
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
04/17/2025 .
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The Committee on Rules (Trumbull) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 90 - 328
4 and insert:
5 of human cells, tissues, or cellular or tissue-based products
6 which complies with the regulatory and reporting requirements
7 provided in this section. The term does not include treatment or
8 research using human cells or tissues that were derived from a
9 fetus or an embryo after an abortion.
10 (3)(a) A physician may perform stem cell therapy that is
11 not approved by the United States Food and Drug Administration
12 if such therapy is used for treatment or procedures that are
13 within the scope of practice for such physician and the
14 therapies are related to orthopedics, wound care, or pain
15 management.
16 (b) To ensure that the retrieval, manufacture, storage, and
17 use of stem cells used for therapies conducted under this
18 section meet the highest standards, any stem cells used by a
19 physician for therapy provided under this section must:
20 1. Be manufactured in a clean room space that has been
21 certified by the United States Food and Drug Administration for
22 using high-efficiency particulate air filtration or ultra-low
23 penetration air filtration to minimize nonviable and viable
24 particulate contamination;
25 2. Be retrieved, manufactured, and stored in a facility
26 that is registered and regulated by the United States Food and
27 Drug Administration and licensed or registered with one of the
28 following entities:
29 a. National Marrow Donor Program.
30 b. World Marrow Donor Association.
31 c. Association for the Advancement of Blood and
32 Biotherapies.
33 d. American Association of Tissue Banks; and
34 3. Contain viable or live cells upon post-thaw analysis and
35 be included in a post-thaw viability analysis report for the
36 product lot which will be sent to the health care provider
37 before use with the provider’s patient.
38 (4) In the performance of any procedure using or purporting
39 to use stem cells or products containing stem cells, the
40 physician shall adhere to the applicable current good
41 manufacturing practices for the collection, removal, processing,
42 implantation, and transfer of stem cells, or products containing
43 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
44 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
45 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
46 Based Products.
47 (5)(a) A physician who conducts stem cell therapy pursuant
48 to this section shall include the following notice in any form
49 of advertisement:
50
51 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
52 This physician performs one or more stem cell
53 therapies that have not yet been approved by the
54 United States Food and Drug Administration. You are
55 encouraged to consult with your primary care provider
56 before undergoing any stem cell therapy.
57
58 (b) The notice required by paragraph (a) must be clearly
59 legible and in a type size no smaller than the largest type size
60 used in the advertisement.
61 (6)(a) A physician who conducts stem cell therapy pursuant
62 to this section shall obtain a signed consent form from the
63 patient before performing the stem cell therapy.
64 (b) The consent form must be signed by the patient or, if
65 the patient is not legally competent, the patient’s
66 representative and must state all of the following in language
67 the patient or his or her representative could reasonably be
68 expected to understand:
69 1. The nature and character of the proposed treatment.
70 2. That the proposed stem cell therapy has not yet been
71 approved by the United States Food and Drug Administration.
72 3. The anticipated results of the proposed treatment.
73 4. The recognized serious possible risks, complications,
74 and anticipated benefits involved in the treatment and in the
75 recognized possible alternative forms of treatment, including
76 nontreatment.
77 5. That the patient is encouraged to consult with his or
78 her primary care provider before undergoing any stem cell
79 therapy.
80 (7) This section does not apply to either of the following:
81 (a) A physician who has obtained approval for an
82 investigational new drug or device from the United States Food
83 and Drug Administration for the use of human cells, tissues, or
84 cellular or tissue-based products.
85 (b) A physician who performs stem cell therapy under an
86 employment or other contract on behalf of an institution
87 certified by any of the following:
88 1. The Foundation for the Accreditation of Cellular
89 Therapy.
90 2. The Blood and Marrow Transplant Clinical Trials Network.
91 3. The Association for the Advancement of Blood and
92 Biotherapies.
93 4. An entity with expertise in stem cell therapy as
94 determined by the department.
95 (8) A violation of this section may subject the physician
96 to disciplinary action by the board or the department.
97 (9) The Board of Medicine shall adopt rules in consultation
98 with the Board of Osteopathic Medicine to implement this
99 section.
100 Section 2. Section 459.0127, Florida Statutes, is created
101 to read:
102 459.0127 Stem cell therapy.—
103 (1) The Legislature recognizes the significant potential of
104 stem cell therapies in advancing medical treatments and
105 improving patient outcomes and further recognizes the need to
106 ensure that such therapies are provided using stem cells
107 obtained in an ethical manner that does not involve stem cells
108 derived from aborted fetuses. It is the intent of the
109 Legislature to foster medical innovation while upholding ethical
110 standards that respect the sanctity of life. By encouraging the
111 use of stem cell sources such as adult stem cells, umbilical
112 cord blood, and other ethically obtained human cells, tissues,
113 or cellular or tissue-based products, the state will advance
114 regenerative medicine in a manner consistent with the values of
115 this state.
116 (2) As used in this section, the term:
117 (a) “Human cells, tissues, or cellular or tissue-based
118 products” means articles containing or consisting of human cells
119 or tissues collected from cord blood donors who are residents of
120 the United States which are intended for implantation,
121 transplantation, infusion, or transfer into a human recipient,
122 including, but not limited to, bones, ligaments, skin, dura
123 mater, heart valves, corneas, hematopoietic stem or progenitor
124 cells derived from peripheral and cord blood, manipulated
125 autologous chondrocytes, epithelial cells on a synthetic matrix,
126 and semen or other reproductive tissue. The term does not
127 include any of the following:
128 1. Vascularized human organs for transplantation.
129 2. Whole blood or blood components or blood derivative
130 products subject to regulation under part I of chapter 499.
131 3. Secreted or extracted human products, such as milk,
132 collagen, and cell factors; except that semen is considered a
133 human cell, tissue, or cellular or tissue-based product for
134 purposes of this paragraph.
135 4. Minimally manipulated bone marrow for homologous use and
136 not combined with another article, except for with water,
137 crystalloids, or a sterilizing, preserving, or storage agent, if
138 the addition of the agent does not raise new clinical safety
139 concerns with respect to the bone marrow.
140 5. Ancillary products used in the manufacture of human
141 cells, tissues, or cellular or tissue-based products.
142 6. Cells, tissues, and organs derived from animals other
143 than humans.
144 7. In vitro diagnostic products.
145 8. Blood vessels recovered with an organ, as defined in 42
146 C.F.R. s. 121.2, which are intended for use in organ
147 transplantation and labeled, “For use in organ transplantation
148 only.”
149 9. Fetal-derived stem cells.
150 10. Adipose-derived mesenchymal stem cells for
151 transplantation.
152 (b) “Minimally manipulated” means:
153 1. For structural tissue, processing that does not alter
154 the original relevant characteristics of the tissue relating to
155 the tissue’s utility for reconstruction, repair, or replacement.
156 2. For cells or nonstructural tissues, processing that does
157 not alter the relevant biological characteristics of cells or
158 tissues.
159 (c) “Physician” means a physician licensed under this
160 chapter or under chapter 458 acting in the course and scope of
161 his or her employment.
162 (d) “Stem cell therapy” means a treatment involving the use
163 of human cells, tissues, or cellular or tissue-based products
164 which complies with the regulatory and reporting requirements
165 provided in this section. The term does not include treatment or
166 research using human cells or tissues that were derived from a
167 fetus or an embryo after an abortion.
168 (3)(a) A physician may perform stem cell therapy that is
169 not approved by the United States Food and Drug Administration
170 if such therapy is used for treatment or procedures that are
171 within the scope of practice for such physician and the
172 therapies are related to orthopedics, wound care, or pain
173 management.
174 (b) To ensure that the retrieval, manufacture, storage, and
175 use of stem cells used for therapies conducted under this
176 section meet the highest standards, any stem cells used by a
177 physician for therapy provided under this section must:
178 1. Be manufactured in a clean room space that has been
179 certified by the United States Food and Drug Administration for
180 using high-efficiency particulate air filtration or ultra-low
181 penetration air filtration to minimize nonviable and viable
182 particulate contamination;
183 2. Be retrieved, manufactured, and stored in a facility
184 that is registered and regulated by the United States Food and
185 Drug Administration and licensed or registered with one of the
186 following entities:
187 a. National Marrow Donor Program.
188 b. World Marrow Donor Association.
189 c. Association for the Advancement of Blood and
190 Biotherapies.
191 d. American Association of Tissue Banks; and
192 3. Contain viable or live cells upon post-thaw analysis and
193 be included in a post-thaw viability analysis report for the
194 product lot which will be sent to the health care provider
195 before use with the provider’s patient.
196 (4) In the performance of any procedure using or purporting
197 to use stem cells or products containing stem cells, the
198 physician shall adhere to the applicable current good
199 manufacturing practices for the collection, removal, processing,
200 implantation, and transfer of stem cells, or products containing
201 stem cells, pursuant to the Federal Food, Drug, and Cosmetic
202 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
203 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
204 Based Products.
205 (5)(a) A physician who conducts stem cell therapy pursuant
206 to this section shall include the following notice in any form
207 of advertisement:
208
209 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
210 This physician performs one or more stem cell
211 therapies that have not yet been approved by the
212 United States Food and Drug Administration. You are
213 encouraged to consult with your primary care provider
214 before undergoing any stem cell therapy.
215
216 (b) The notice required by paragraph (a) must be clearly
217 legible and in a type size no smaller than the largest type size
218 used in the advertisement.
219 (6)(a) A physician who conducts stem cell therapy pursuant
220 to this section shall obtain a signed consent form from the
221 patient before performing the stem cell therapy.
222 (b) The consent form must be signed by the patient or, if
223 the patient is not legally competent, the patient’s
224 representative and must state all of the following in language
225 the patient or his or her representative could reasonably be
226 expected to understand:
227 1. The nature and character of the proposed treatment.
228 2. That the proposed stem cell therapy has not yet been
229 approved by the United States Food and Drug Administration.
230 3. The anticipated results of the proposed treatment.
231 4. The recognized serious possible risks, complications,
232 and anticipated benefits involved in the treatment and in the
233 recognized possible alternative forms of treatment, including
234 nontreatment.
235
236 ================= T I T L E A M E N D M E N T ================
237 And the title is amended as follows:
238 Delete lines 12 - 16
239 and insert:
240 include a specified notice in any form of
241 advertisement; providing requirements for such notice;
242 requiring physicians to obtain a signed consent form
243 from the patient or his or her