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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: 27 458.3245Stem 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 tissues 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 physicians 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 patients 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: 185 459.0127Stem 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 tissues 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 physicians 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 patients 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.
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