ENROLLED
       2025 Legislature            CS for CS for SB 1768, 1st Engrossed
       
       
       
       
       
       
                                                             20251768er
    1  
    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; providing criminal penalties;
   19         authorizing the Board of Medicine to adopt rules;
   20         providing an effective date.
   21          
   22  Be It Enacted by the Legislature of the State of Florida:
   23  
   24         Section 1. Section 458.3245, Florida Statutes, is created
   25  to read:
   26         458.3245 Stem cell therapy.—
   27         (1) The Legislature recognizes the significant potential of
   28  stem cell therapies in advancing medical treatments and
   29  improving patient outcomes and further recognizes the need to
   30  ensure that such therapies are provided using stem cells
   31  obtained in an ethical manner that does not involve stem cells
   32  derived from aborted fetuses. It is the intent of the
   33  Legislature to foster medical innovation while upholding ethical
   34  standards that respect the sanctity of life. By encouraging the
   35  use of stem cell sources such as adult stem cells, umbilical
   36  cord blood, and other ethically obtained human cells, tissues,
   37  or cellular or tissue-based products, the state will advance
   38  regenerative medicine in a manner consistent with the values of
   39  this state.
   40         (2) As used in this section, the term:
   41         (a) “Human cells, tissues, or cellular or tissue-based
   42  products” means articles containing or consisting of human cells
   43  or tissues that are intended for implantation, transplantation,
   44  infusion, or transfer into a human recipient. The term does not
   45  include:
   46         1. Vascularized human organs for transplantation;
   47         2. Whole blood or blood components or blood derivative
   48  products;
   49         3. Secreted or extracted human products, such as milk,
   50  collagen, and cell factors, other than semen;
   51         4. Minimally manipulated bone marrow for homologous use and
   52  not combined with another article other than water,
   53  crystalloids, or a sterilizing, preserving, or storage agent, if
   54  the addition of the agent does not raise new clinical safety
   55  concerns with respect to the bone marrow;
   56         5. Ancillary products used in the manufacture of human
   57  cells, tissues, or cellular or tissue-based products;
   58         6. Cells, tissues, and organs derived from animals other
   59  than humans;
   60         7. In vitro diagnostic products; or
   61         8. Blood vessels recovered with an organ which are intended
   62  for use in organ transplantation and labeled “For use in organ
   63  transplantation only.”
   64         (b) “Minimally manipulated” means:
   65         1. For structural tissue, processing that does not alter
   66  the original relevant characteristics of the tissue relating to
   67  the tissue’s utility for reconstruction, repair, or replacement.
   68         2. For cells or nonstructural tissues, processing that does
   69  not alter the relevant biological characteristics of cells or
   70  tissues.
   71         (c) “Physician” means a physician licensed under this
   72  chapter acting in the course and scope of his or her employment.
   73         (d) “Stem cell therapy” means a treatment involving the use
   74  of afterbirth placental perinatal stem cells, or human cells,
   75  tissues, or cellular or tissue-based products, which complies
   76  with the regulatory requirements provided in this section. The
   77  term does not include treatment or research using human cells or
   78  tissues that were derived from a fetus or an embryo after an
   79  abortion.
   80         (3)(a) A physician may perform stem cell therapy that is
   81  not approved by the United States Food and Drug Administration
   82  if such therapy is used for treatment or procedures that are
   83  within the scope of practice for such physician and the
   84  therapies are related to orthopedics, wound care, or pain
   85  management.
   86         (b) To ensure that the retrieval, manufacture, storage, and
   87  use of stem cells used for therapies conducted under this
   88  section meet the highest standards, any stem cells used by a
   89  physician for therapy provided under this section must:
   90         1. Be retrieved, manufactured, and stored in a facility
   91  that is registered and regulated by the United States Food and
   92  Drug Administration;
   93         2. Be retrieved, manufactured, and stored in a facility
   94  that is certified or accredited by one of the following
   95  entities:
   96         a. National Marrow Donor Program.
   97         b. World Marrow Donor Association.
   98         c. Association for the Advancement of Blood and
   99  Biotherapies.
  100         d. American Association of Tissue Banks; and
  101         3. Contain viable or live cells upon post-thaw analysis and
  102  be included in a post-thaw viability analysis report for the
  103  product lot which will be sent to the physician before use with
  104  the physician’s patient.
  105         (c) A physician performing stem cell therapy may not obtain
  106  stem cells for therapies from a facility engaging in the
  107  retrieval, manufacture, or storage of stem cells intended for
  108  human use under this section unless the facility maintains valid
  109  certification or accreditation as required by this subsection.
  110  Any contract or other agreement by which a physician obtains
  111  stem cells for therapies from such a facility must include the
  112  following:
  113         1. A requirement that the facility provide all of the
  114  following information to the physician:
  115         a. The name and address of the facility.
  116         b. The certifying or accrediting organization.
  117         c. The type and scope of certification or accreditation.
  118         d. The effective and expiration dates of the certification
  119  or accreditation.
  120         e. Any limitations or conditions imposed by the certifying
  121  or accrediting organization.
  122         2. A requirement that the facility notify the physician
  123  within 30 days after any change in certification or
  124  accreditation status, including renewal, suspension, revocation,
  125  or expiration.
  126         (4) In the performance of any procedure using or purporting
  127  to use stem cells or products containing stem cells, the
  128  physician shall use stem cell therapy products obtained from
  129  facilities that adhere to the applicable current good
  130  manufacturing practices for the collection, removal, processing,
  131  implantation, and transfer of stem cells, or products containing
  132  stem cells, pursuant to the Federal Food, Drug, and Cosmetic
  133  Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
  134  C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
  135  Based Products.
  136         (5)(a) A physician who conducts stem cell therapy pursuant
  137  to this section shall include the following in any form of
  138  advertisement:
  139  
  140         THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
  141         This physician performs one or more stem cell
  142         therapies that have not yet been approved by the
  143         United States Food and Drug Administration. You are
  144         encouraged to consult with your primary care provider
  145         before undergoing any stem cell therapy.
  146  
  147         (b) The notice required under paragraph (a) must be clearly
  148  legible and in a type size no smaller than the largest type size
  149  used in the advertisement.
  150         (6)(a) A physician who conducts stem cell therapy pursuant
  151  to this section shall obtain a signed consent form from the
  152  patient before performing the stem cell therapy.
  153         (b) The consent form must be signed by the patient or, if
  154  the patient is not legally competent, the patient’s
  155  representative and must state all of the following in language
  156  the patient or his or her representative may reasonably be
  157  expected to understand:
  158         1. The nature and character of the proposed treatment.
  159         2. That the proposed stem cell therapy has not yet been
  160  approved by the United States Food and Drug Administration.
  161         3. The anticipated results of the proposed treatment.
  162         4. The recognized serious possible risks, complications,
  163  and anticipated benefits involved in the treatment and in the
  164  recognized possible alternative forms of treatment, including
  165  nontreatment.
  166         5. That the patient is encouraged to consult with his or
  167  her primary care provider before undergoing any stem cell
  168  therapy.
  169         (7) This section does not apply to the following:
  170         (a) A physician who has obtained approval for an
  171  investigational new drug or device from the United States Food
  172  and Drug Administration for the use of human cells, tissues, or
  173  cellular or tissue-based products; or
  174         (b) A physician who performs stem cell therapy under an
  175  employment or other contract on behalf of an institution
  176  certified or accredited by any of the following:
  177         1. The Foundation for the Accreditation of Cellular
  178  Therapy.
  179         2. The Blood and Marrow Transplant Clinical Trials Network.
  180         3. The Association for the Advancement of Blood and
  181  Biotherapies.
  182         4. An entity with expertise in stem cell therapy as
  183  determined by the department.
  184         (8) A violation of this section may subject the physician
  185  to disciplinary action by the board.
  186         (9) A physician who willfully performs, or actively
  187  participates in, the following commits a felony of the third
  188  degree, punishable as provided in s. 775.082, s. 775.083, or s.
  189  775.084, and is subject to disciplinary action under this
  190  chapter and s. 456.072:
  191         (a) Treatment or research using human cells or tissues
  192  derived from a fetus or an embryo after an abortion; or
  193         (b) The sale, manufacture, or distribution of computer
  194  products created using human cells, tissues, or cellular or
  195  tissue-based products.
  196         (10) The board may adopt rules necessary to implement this
  197  section.
  198         Section 2. Section 459.0127, Florida Statutes, is created
  199  to read:
  200         459.0127 Stem cell therapy.—
  201         (1) The Legislature recognizes the significant potential of
  202  stem cell therapies in advancing medical treatments and
  203  improving patient outcomes and further recognizes the need to
  204  ensure that such therapies are provided using stem cells
  205  obtained in an ethical manner that does not involve stem cells
  206  derived from aborted fetuses. It is the intent of the
  207  Legislature to foster medical innovation while upholding ethical
  208  standards that respect the sanctity of life. By encouraging the
  209  use of stem cell sources such as adult stem cells, umbilical
  210  cord blood, and other ethically obtained human cells, tissues,
  211  or cellular or tissue-based products, the state will advance
  212  regenerative medicine in a manner consistent with the values of
  213  this state.
  214         (2) As used in this section, the term:
  215         (a) “Human cells, tissues, or cellular or tissue-based
  216  products” means articles containing or consisting of human cells
  217  or tissues that are intended for implantation, transplantation,
  218  infusion, or transfer into a human recipient. The term does not
  219  include:
  220         1. Vascularized human organs for transplantation;
  221         2. Whole blood or blood components or blood derivative
  222  products;
  223         3. Secreted or extracted human products, such as milk,
  224  collagen, and cell factors, other than semen;
  225         4. Minimally manipulated bone marrow for homologous use and
  226  not combined with another article other than water,
  227  crystalloids, or a sterilizing, preserving, or storage agent, if
  228  the addition of the agent does not raise new clinical safety
  229  concerns with respect to the bone marrow;
  230         5. Ancillary products used in the manufacture of human
  231  cells, tissues, or cellular or tissue-based products;
  232         6. Cells, tissues, and organs derived from animals other
  233  than humans;
  234         7. In vitro diagnostic products; or
  235         8. Blood vessels recovered with an organ which are intended
  236  for use in organ transplantation and labeled “For use in organ
  237  transplantation only.”
  238         (b) “Minimally manipulated” means:
  239         1. For structural tissue, processing that does not alter
  240  the original relevant characteristics of the tissue relating to
  241  the tissue’s utility for reconstruction, repair, or replacement.
  242         2. For cells or nonstructural tissues, processing that does
  243  not alter the relevant biological characteristics of cells or
  244  tissues.
  245         (c) “Physician” means a physician licensed under this
  246  chapter acting in the course and scope of his or her employment.
  247         (d) “Stem cell therapy” means a treatment involving the use
  248  of afterbirth placental perinatal stem cells, or human cells,
  249  tissues, or cellular or tissue-based products, which complies
  250  with the regulatory requirements provided in this section. The
  251  term does not include treatment or research using human cells or
  252  tissues that were derived from a fetus or an embryo after an
  253  abortion.
  254         (3)(a) A physician may perform stem cell therapy that is
  255  not approved by the United States Food and Drug Administration
  256  if such therapy is used for treatment or procedures that are
  257  within the scope of practice for such physician and the
  258  therapies are related to orthopedics, wound care, or pain
  259  management.
  260         (b) To ensure that the retrieval, manufacture, storage, and
  261  use of stem cells used for therapies conducted under this
  262  section meet the highest standards, any stem cells used by a
  263  physician for therapy provided under this section must:
  264         1. Be retrieved, manufactured, and stored in a facility
  265  that is registered and regulated by the United States Food and
  266  Drug Administration;
  267         2. Be retrieved, manufactured, and stored in a facility
  268  that is certified or accredited by one of the following
  269  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         (c) A physician performing stem cell therapy may not obtain
  280  stem cells for therapies from a facility engaging in the
  281  retrieval, manufacture, or storage of stem cells intended for
  282  human use under this section unless the facility maintains valid
  283  certification or accreditation as required by this subsection.
  284  Any contract or other agreement by which a physician obtains
  285  stem cells for therapies from such a facility must include the
  286  following:
  287         1. A requirement that the facility provide all of the
  288  following information to the physician:
  289         a. The name and address of the facility.
  290         b. The certifying or accrediting organization.
  291         c. The type and scope of certification or accreditation.
  292         d. The effective and expiration dates of the certification
  293  or accreditation.
  294         e. Any limitations or conditions imposed by the certifying
  295  or accrediting organization.
  296         2. A requirement that the facility notify the physician
  297  within 30 days after any change in certification or
  298  accreditation status, including renewal, suspension, revocation,
  299  or expiration.
  300         (4) In the performance of any procedure using or purporting
  301  to use stem cells or products containing stem cells, the
  302  physician shall use stem cell therapy products obtained from
  303  facilities that adhere to the applicable current good
  304  manufacturing practices for the collection, removal, processing,
  305  implantation, and transfer of stem cells, or products containing
  306  stem cells, pursuant to the Federal Food, Drug, and Cosmetic
  307  Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.; and 21
  308  C.F.R. part 1271, Human Cells, Tissues, and Cellular and Tissue
  309  Based Products.
  310         (5)(a) A physician who conducts stem cell therapy pursuant
  311  to this section shall include the following in any form of
  312  advertisement:
  313  
  314         THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW.
  315         This physician performs one or more stem cell
  316         therapies that have not yet been approved by the
  317         United States Food and Drug Administration. You are
  318         encouraged to consult with your primary care provider
  319         before undergoing any stem cell therapy.
  320  
  321         (b) The notice required under paragraph (a) must be clearly
  322  legible and in a type size no smaller than the largest type size
  323  used in the advertisement.
  324         (6)(a) A physician who conducts stem cell therapy pursuant
  325  to this section shall obtain a signed consent form from the
  326  patient before performing the stem cell therapy.
  327         (b) The consent form must be signed by the patient or, if
  328  the patient is not legally competent, the patient’s
  329  representative and must state all of the following in language
  330  the patient or his or her representative may reasonably be
  331  expected to understand:
  332         1. The nature and character of the proposed treatment.
  333         2. That the proposed stem cell therapy has not yet been
  334  approved by the United States Food and Drug Administration.
  335         3. The anticipated results of the proposed treatment.
  336         4. The recognized serious possible risks, complications,
  337  and anticipated benefits involved in the treatment and in the
  338  recognized possible alternative forms of treatment, including
  339  nontreatment.
  340         5. That the patient is encouraged to consult with his or
  341  her primary care provider before undergoing any stem cell
  342  therapy.
  343         (7) This section does not apply to the following:
  344         (a) A physician who has obtained approval for an
  345  investigational new drug or device from the United States Food
  346  and Drug Administration for the use of human cells, tissues, or
  347  cellular or tissue-based products; or
  348         (b) A physician who performs stem cell therapy under an
  349  employment or other contract on behalf of an institution
  350  certified or accredited by any of the following:
  351         1. The Foundation for the Accreditation of Cellular
  352  Therapy.
  353         2. The Blood and Marrow Transplant Clinical Trials Network.
  354         3. The Association for the Advancement of Blood and
  355  Biotherapies.
  356         4. An entity with expertise in stem cell therapy as
  357  determined by the department.
  358         (8) A violation of this section may subject the physician
  359  to disciplinary action by the board.
  360         (9) A physician who willfully performs, or actively
  361  participates in, the following commits a felony of the third
  362  degree, punishable as provided in s. 775.082, s. 775.083, or s.
  363  775.084, and is subject to disciplinary action under this
  364  chapter and s. 456.072:
  365         (a) Treatment or research using human cells or tissues
  366  derived from a fetus or an embryo after an abortion; or
  367         (b) The sale, manufacture, or distribution of computer
  368  products created using human cells, tissues, or cellular or
  369  tissue-based products.
  370         (10) The board may adopt rules necessary to implement this
  371  section.
  372         Section 3. This act shall take effect July 1, 2025.