Florida Senate - 2025 COMMITTEE AMENDMENT Bill No. SB 1768 Ì947004zÎ947004 LEGISLATIVE ACTION Senate . House Comm: RCS . 04/02/2025 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Health Policy (Trumbull) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 458.3245, Florida Statutes, is created 6 to read: 7 458.3245 Stem cell therapy.— 8 (1) The Legislature recognizes the significant potential of 9 stem cell therapies in advancing medical treatments and 10 improving patient outcomes and further recognizes the need to 11 ensure that such therapies are provided using stem cells 12 obtained in an ethical manner that does not involve stem cells 13 derived from aborted fetuses. It is the intent of the 14 Legislature to foster medical innovation while upholding ethical 15 standards that respect the sanctity of life. By encouraging the 16 use of stem cell sources such as adult stem cells, umbilical 17 cord blood, and other ethically obtained human cells, tissues, 18 or cellular or tissue-based products, the state will advance 19 regenerative medicine in a manner consistent with the values of 20 this state. 21 (2) As used in this section, the term: 22 (a) “Human cells, tissues, or cellular or tissue-based 23 products” means articles containing or consisting of human cells 24 or tissues collected from cord blood donors who are residents of 25 the United States which are intended for implantation, 26 transplantation, infusion, or transfer into a human recipient, 27 including but not limited to, bones, ligaments, skin, dura 28 mater, heart valves, corneas, hematopoietic stem or progenitor 29 cells derived from peripheral and cord blood, manipulated 30 autologous chondrocytes, epithelial cells on a synthetic matrix, 31 and semen or other reproductive tissue. The term does not 32 include any of the following: 33 1. Vascularized human organs for transplantation. 34 2. Whole blood or blood components or blood derivative 35 products subject to regulation under part I of chapter 499. 36 3. Secreted or extracted human products, such as milk, 37 collagen, and cell factors; except that semen is considered a 38 human cell, tissue, or cellular or tissue-based product for 39 purposes of this paragraph. 40 4. Minimally manipulated bone marrow for homologous use and 41 not combined with another article, except for with water, 42 crystalloids, or a sterilizing, preserving, or storage agent, if 43 the addition of the agent does not raise new clinical safety 44 concerns with respect to the bone marrow. 45 5. Ancillary products used in the manufacture of human 46 cells, tissues, or cellular or tissue-based products. 47 6. Cells, tissues, and organs derived from animals other 48 than humans. 49 7. In vitro diagnostic products. 50 8. Blood vessels recovered with an organ, as defined in 42 51 C.F.R. s. 121.2, which are intended for use in organ 52 transplantation and labeled, “For use in organ transplantation 53 only.” 54 9. Fetal-derived stem cells. 55 10. Adipose-derived mesenchymal stem cells for 56 transplantation. 57 (b) “Minimally manipulated” means: 58 1. For structural tissue, processing that does not alter 59 the original relevant characteristics of the tissue relating to 60 the tissue’s utility for reconstruction, repair, or replacement. 61 2. For cells or nonstructural tissues, processing that does 62 not alter the relevant biological characteristics of cells or 63 tissues. 64 (c) “Physician” means a physician licensed under this 65 chapter or under chapter 459 acting in the course and scope of 66 his or her employment. 67 (d) “Stem cell therapy” means a treatment involving the use 68 of human cells, tissues, or cellular or tissue-based products. 69 The term does not include treatment or research using human 70 cells or tissues that were derived from a fetus or an embryo 71 after an abortion. 72 (3)(a) A physician may perform stem cell therapy that is 73 not approved by the United States Food and Drug Administration 74 if such therapy is used for treatment or procedures that are 75 within the scope of practice for such physician and the 76 therapies are related to orthopedics, wound care, or pain 77 management. 78 (b) To ensure that the retrieval, manufacture, storage, and 79 use of stem cells used for therapies conducted under this 80 section meet the highest standards, any stem cells used by a 81 physician for therapy provided under this section must be: 82 1. Manufactured in a clean room space that has been 83 certified by the United States Food and Drug Administration for 84 using high-efficiency particulate air filtration or ultra-low 85 penetration air filtration to minimize nonviable and viable 86 particulate contamination; and 87 2. Retrieved, manufactured, and stored in a facility that 88 is registered and regulated by the United States Food and Drug 89 Administration and licensed or registered with one of the 90 following entities: 91 a. National Marrow Donor Program. 92 b. World Marrow Donor Association. 93 c. Association for the Advancement of Blood and 94 Biotherapies. 95 d. American Association of Tissue Banks. 96 (4) In the performance of any procedure using or purporting 97 to use stem cells or products containing stem cells, the 98 physician shall adhere to the applicable current good 99 manufacturing practices for the collection, removal, processing, 100 implantation, and transfer of stem cells, or products containing 101 stem cells, pursuant to the Federal Food, Drug, and Cosmetic 102 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21 103 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue 104 Based Products. 105 (5) A physician who conducts stem cell therapy pursuant to 106 this section shall provide a patient who is being treated with 107 stem cell therapy with the following written notice before 108 performing the therapy: 109 110 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. 111 This physician performs one or more stem cell 112 therapies that have not yet been approved by the 113 United States Food and Drug Administration. You are 114 encouraged to consult with your primary care provider 115 before undergoing any stem cell therapy. 116 117 (6) A physician who is required to provide the written 118 notice under subsection (5) shall: 119 (a) Provide the written notice to a patient on paper that 120 is at least 8.5 inches by 11 inches and printed in no less than 121 40-point type. 122 (b) Prominently display the written notice at the entrance 123 to the physician’s office and in an area visible to patients 124 inside such office. 125 (c) Include the notice in any advertisement for the stem 126 cell therapy. In any form of advertisement, the notice must be 127 clearly legible and in a font size no smaller than the largest 128 font size used in the advertisement. 129 (7)(a) A physician required to provide the written notice 130 under subsection (5) must obtain a signed consent form from the 131 patient before performing the stem cell therapy. 132 (b) The consent form must be signed by the patient or, if 133 the patient is legally not competent, the patient’s 134 representative and must state all of the following in language 135 the patient or his or her representative could reasonably be 136 expected to understand: 137 1. The nature and character of the proposed treatment, 138 including the treatment’s United States Food and Drug 139 Administration approval status. 140 2. The anticipated results of the proposed treatment. 141 3. The recognized possible alternative forms of treatment. 142 4. The recognized serious possible risks, complications, 143 and anticipated benefits involved in the treatment and in the 144 recognized possible alternative forms of treatment, including 145 nontreatment. 146 (8) This section does not apply to either of the following: 147 (a) A physician who has obtained approval for an 148 investigational new drug or device from the United States Food 149 and Drug Administration for the use of human cells, tissues, or 150 cellular or tissue-based products. 151 (b) A physician who performs a stem cell therapy under an 152 employment or other contract on behalf of an institution 153 certified by any of the following: 154 1. The Foundation for the Accreditation of Cellular 155 Therapy. 156 2. The Blood and Marrow Transplant Clinical Trials Network. 157 3. The Association for the Advancement of Blood and 158 Biotherapies. 159 4. An entity with expertise in stem cell therapy as 160 determined by the department. 161 (9) A violation of this section may subject the physician 162 to disciplinary action by the board or the department. 163 (10) The Board of Medicine shall adopt rules in 164 consultation with the Board of Osteopathic Medicine to implement 165 this section. 166 Section 2. Section 459.0127, Florida Statutes, is created 167 to read: 168 459.0127 Stem cell therapy.— 169 (1) The Legislature recognizes the significant potential of 170 stem cell therapies in advancing medical treatments and 171 improving patient outcomes and further recognizes the need to 172 ensure that such therapies are provided using stem cells 173 obtained in an ethical manner that does not involve stem cells 174 derived from aborted fetuses. It is the intent of the 175 Legislature to foster medical innovation while upholding ethical 176 standards that respect the sanctity of life. By encouraging the 177 use of stem cell sources such as adult stem cells, umbilical 178 cord blood, and other ethically obtained human cells, tissues, 179 or cellular or tissue-based products, the state will advance 180 regenerative medicine in a manner consistent with the values of 181 this state. 182 (2) As used in this section, the term: 183 (a) “Human cells, tissues, or cellular or tissue-based 184 products” means articles containing or consisting of human cells 185 or tissues collected from cord blood donors who are residents of 186 the United States which are intended for implantation, 187 transplantation, infusion, or transfer into a human recipient, 188 including but not limited to, bones, ligaments, skin, dura 189 mater, heart valves, corneas, hematopoietic stem or progenitor 190 cells derived from peripheral and cord blood, manipulated 191 autologous chondrocytes, epithelial cells on a synthetic matrix, 192 and semen or other reproductive tissue. The term does not 193 include any of the following: 194 1. Vascularized human organs for transplantation. 195 2. Whole blood or blood components or blood derivative 196 products subject to regulation under part I of chapter 499. 197 3. Secreted or extracted human products, such as milk, 198 collagen, and cell factors; except that semen is considered a 199 human cell, tissue, or cellular or tissue-based product for 200 purposes of this paragraph. 201 4. Minimally manipulated bone marrow for homologous use and 202 not combined with another article, except for with water, 203 crystalloids, or a sterilizing, preserving, or storage agent, if 204 the addition of the agent does not raise new clinical safety 205 concerns with respect to the bone marrow. 206 5. Ancillary products used in the manufacture of human 207 cells, tissues, or cellular or tissue-based products. 208 6. Cells, tissues, and organs derived from animals other 209 than humans. 210 7. In vitro diagnostic products. 211 8. Blood vessels recovered with an organ, as defined in 42 212 C.F.R. s. 121.2, which are intended for use in organ 213 transplantation and labeled, “For use in organ transplantation 214 only.” 215 9. Fetal-derived stem cells. 216 10. Adipose-derived mesenchymal stem cells for 217 transplantation. 218 (b) “Minimally manipulated” means: 219 1. For structural tissue, processing that does not alter 220 the original relevant characteristics of the tissue relating to 221 the tissue’s utility for reconstruction, repair, or replacement. 222 2. For cells or nonstructural tissues, processing that does 223 not alter the relevant biological characteristics of cells or 224 tissues. 225 (c) “Physician” means a physician licensed under this 226 chapter or under chapter 458 acting in the course and scope of 227 his or her employment. 228 (d) “Stem cell therapy” means a treatment involving the use 229 of human cells, tissues, or cellular or tissue-based products. 230 The term does not include treatment or research using human 231 cells or tissues that were derived from a fetus or an embryo 232 after an abortion. 233 (3)(a) A physician may perform stem cell therapy that is 234 not approved by the United States Food and Drug Administration 235 if such therapy is used for treatment or procedures that are 236 within the scope of practice for such physician and the 237 therapies are related to orthopedics, wound care, or pain 238 management. 239 (b) To ensure that the retrieval, manufacture, storage, and 240 use of stem cells used for therapies conducted under this 241 section meet the highest standards, any stem cells used by a 242 physician for therapy provided under this section must be: 243 1. Manufactured in a clean room space that has been 244 certified by the United States Food and Drug Administration for 245 using high-efficiency particulate air filtration or ultra-low 246 penetration air filtration to minimize nonviable and viable 247 particulate contamination; and 248 2. Retrieved, manufactured, and stored in a facility that 249 is registered and regulated by the United States Food and Drug 250 Administration and licensed or registered with one of the 251 following entities: 252 a. National Marrow Donor Program. 253 b. World Marrow Donor Association. 254 c. Association for the Advancement of Blood and 255 Biotherapies. 256 d. American Association of Tissue Banks. 257 (4) In the performance of any procedure using or purporting 258 to use stem cells or products containing stem cells, the 259 physician shall adhere to the applicable current good 260 manufacturing practices for the collection, removal, processing, 261 implantation, and transfer of stem cells, or products containing 262 stem cells, pursuant to the Federal Food, Drug, and Cosmetic 263 Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21 264 C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue 265 Based Products. 266 (5) A physician who conducts stem cell therapy pursuant to 267 this section shall provide a patient who is being treated with 268 stem cell therapy with the following written notice before 269 performing the therapy: 270 271 THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. 272 This physician performs one or more stem cell 273 therapies that have not yet been approved by the 274 United States Food and Drug Administration. You are 275 encouraged to consult with your primary care provider 276 before undergoing any stem cell therapy. 277 278 (6) A physician who is required to provide the written 279 notice under subsection (5) shall: 280 (a) Provide the written notice to a patient on paper that 281 is at least 8.5 inches by 11 inches and printed in no less than 282 40-point type. 283 (b) Prominently display the written notice at the entrance 284 to the physician’s office and in an area visible to patients 285 inside such office. 286 (c) Include the notice in any advertisement for the stem 287 cell therapy. In any form of advertisement, the notice must be 288 clearly legible and in a font size no smaller than the largest 289 font size used in the advertisement. 290 (7)(a) A physician required to provide the written notice 291 under subsection (5) must obtain a signed consent form from the 292 patient before performing the stem cell therapy. 293 (b) The consent form must be signed by the patient or, if 294 the patient is legally not competent, the patient’s 295 representative and must state all of the following in language 296 the patient or his or her representative could reasonably be 297 expected to understand: 298 1. The nature and character of the proposed treatment, 299 including the treatment’s United States Food and Drug 300 Administration approval status. 301 2. The anticipated results of the proposed treatment. 302 3. The recognized possible alternative forms of treatment. 303 4. The recognized serious possible risks, complications, 304 and anticipated benefits involved in the treatment and in the 305 recognized possible alternative forms of treatment, including 306 nontreatment. 307 (8) This section does not apply to either of the following: 308 (a) A physician who has obtained approval for an 309 investigational new drug or device from the United States Food 310 and Drug Administration for the use of human cells, tissues, or 311 cellular or tissue-based products. 312 (b) A physician who performs a stem cell therapy under an 313 employment or other contract on behalf of an institution 314 certified by any of the following: 315 1. The Foundation for the Accreditation of Cellular 316 Therapy. 317 2. The Blood and Marrow Transplant Clinical Trials Network. 318 3. The Association for the Advancement of Blood and 319 Biotherapies. 320 4. An entity with expertise in stem cell therapy as 321 determined by the department. 322 (9) A violation of this section may subject the physician 323 to disciplinary action under the rules that have been developed 324 by the board or the department as applicable. 325 (10) The Board of Osteopathic Medicine shall adopt rules in 326 consultation with the Board of Medicine to implement this 327 section. 328 Section 3. This act shall take effect July 1, 2025. 329 330 ================= T I T L E A M E N D M E N T ================ 331 And the title is amended as follows: 332 Delete everything before the enacting clause 333 and insert: 334 A bill to be entitled 335 An act relating to stem cell therapy; creating ss. 336 458.3245 and 459.0127, F.S.; providing legislative 337 findings and intent; defining terms; authorizing 338 physicians to perform stem cell therapy not approved 339 by the United States Food and Drug Administration 340 under certain circumstances; specifying requirements 341 for the stem cells that may be used by such 342 physicians; requiring such physicians to adhere to 343 applicable current good manufacturing practices in the 344 performance of such therapies; requiring physicians to 345 provide a specified written notice to patients before 346 performing any stem cell therapy; specifying 347 requirements for the written notice; providing 348 advertisement requirements; requiring physicians to 349 obtain written consent from the patient or his or her 350 representative before performing the therapy; 351 specifying requirements for the consent form; 352 providing applicability; providing for disciplinary 353 action; requiring the Board of Medicine and the Board 354 of Osteopathic Medicine, respectively, to adopt rules 355 in consultation with one another; providing an 356 effective date.