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FloridaSB 17682025Senate

Stem Cell Therapy

Sponsored By: Jay Trumbull (Republican)

Signed by Governor

AppropriationHealth PolicyAppropriations Committee on Health and Human ServicesRulesHouse Calendar

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Bill Overview

Analyzed Economic Effects

4 provisions identified: 2 benefits, 1 costs, 1 mixed.

Safety standards for patients’ stem cell treatments

Outside the exemptions, physicians must obtain stem cells from FDA-regulated facilities with certification or accreditation from a named organization. These organizations are the National Marrow Donor Program, World Marrow Donor Association, Association for the Advancement of Blood and Biotherapies, and American Association of Tissue Banks. Cells must remain alive after thawing, and physicians must receive a report for the product lot before use. Supply agreements must list the facility’s name and address, accrediting organization, approval type and scope, start and expiration dates, and restrictions. Facilities must notify physicians within 30 days after certification or accreditation changes, including renewal, suspension, revocation, or expiration. For procedures using or claiming to use stem cells, products must come from facilities following applicable federal manufacturing and handling standards.

Limited stem cell access with exemptions

Beginning July 1, 2025, Florida-licensed physicians can provide stem cell therapies not approved by the Food and Drug Administration (FDA). Treatment must fit the physician’s scope of practice and involve bone and joint care, wound care, or pain management. The framework excludes cells or tissues from a fetus or embryo after an abortion. Physicians with FDA approval for an investigational drug or device involving covered cells or tissues are exempt from these therapy requirements. Exemptions also cover physicians working under employment or contract for institutions certified or accredited by the Foundation for the Accreditation of Cellular Therapy, Blood and Marrow Transplant Clinical Trials Network, or Association for the Advancement of Blood and Biotherapies, or for entities the Florida Department of Health recognizes as having stem cell therapy expertise.

Clearer warnings for stem cell patients

Physicians covered by these requirements must disclose in every advertisement that their stem cell therapies lack FDA approval. The notice must encourage consulting a primary care provider and use text at least as large as the ad’s largest text. Before treatment, physicians must obtain signed consent in language the patient can reasonably understand. A legally authorized representative signs when the patient cannot legally consent. The form must explain the treatment, lack of FDA approval, expected results and benefits, serious known risks and complications, and alternatives—including no treatment—and recommend consulting a primary care provider.

Physicians face penalties for banned cell uses

Physicians commit a third-degree felony by willfully performing or actively participating in treatment or research using cells or tissues from a fetus or embryo after an abortion. The same penalty applies to willfully making, selling, or distributing computer products created using human cells, tissues, or cell- or tissue-based products. Physicians can also face licensing discipline for violating the stem cell therapy rules. The relevant licensing board can adopt rules, and the Florida Department of Health oversees recognition of additional qualified organizations.

Sponsors & Cosponsors

Sponsor

  • Jay Trumbull

    Republican • Senate

Cosponsors

  • Health Policy

    Affiliation unavailable

  • Rules

    Affiliation unavailable

Roll Call Votes

All Roll Calls

Yes: 225 • No: 2

Senate vote • 5/1/2025

Senate Floor Vote

Yes: 37 • No: 0

House vote • 4/30/2025

House Floor Vote

Yes: 112 • No: 0

Senate vote • 4/23/2025

Senate Floor Vote

Yes: 37 • No: 0

Senate vote • 4/16/2025

Rules Vote

Yes: 22 • No: 1

Senate vote • 4/10/2025

Appropriations Committee on Health and Human Services Vote

Yes: 7 • No: 1

Senate vote • 4/1/2025

Health Policy Vote

Yes: 10 • No: 0

Actions Timeline

  1. Chapter No. 2025-185

    6/26/2025

  2. Approved by Governor

    6/25/2025

  3. Signed by Officers and presented to Governor

    6/18/2025

  4. Ordered engrossed, then enrolled

    5/1/2025Senate

  5. CS passed as amended; YEAS 37 NAYS 0 -SJ 1064

    5/1/2025Senate

  6. Concurred in 1 amendment(s) (660139) -SJ 1064

    5/1/2025Senate

  7. In returning messages

    4/30/2025Senate

  8. CS passed as amended; YEAS 112, NAYS 0

    4/30/2025House

  9. Read 3rd time

    4/30/2025House

  10. Added to Third Reading Calendar

    4/30/2025House

  11. Placed on 3rd reading

    4/30/2025House

  12. Amendment 660139 adopted

    4/30/2025House

  13. Read 2nd time

    4/30/2025House

  14. Bill added to Special Order Calendar (4/30/2025)

    4/29/2025House

  15. Added to Second Reading Calendar

    4/29/2025House

  16. Temporarily postponed, on 2nd Reading

    4/29/2025House

  17. 1st Reading (Committee Substitute 2)

    4/28/2025House

  18. Bill added to Special Order Calendar (4/29/2025)

    4/28/2025House

  19. Bill referred to House Calendar

    4/28/2025House

  20. In Messages

    4/23/2025House

  21. CS passed; YEAS 37 NAYS 0 -SJ 491

    4/23/2025Senate

  22. Read 3rd time -SJ 491

    4/23/2025Senate

  23. Read 2nd time -SJ 491

    4/23/2025Senate

  24. CS/CS by Rules read 1st time

    4/22/2025Senate

  25. Placed on Special Order Calendar, 04/23/25

    4/21/2025Senate

Bill Text

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