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TennesseeHB 2246114th General Assembly (2025-2026)House

AN ACT to amend Tennessee Code Annotated, Title 63 and Title 68, relative to stem cell therapies.

Sponsored By: Sponsor information unavailable

Signed by Governor

Health Care

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 1 benefits, 0 costs, 1 mixed.

New Safeguards For Stem Cell Patients

Beginning July 1, 2026, doctors must get signed written consent before providing covered stem cell or regenerative therapy. The patient signs, or the patient's representative signs if the patient is not legally competent. Each therapy ad must say the doctor offers one or more treatments without Food and Drug Administration approval. It must encourage patients to consult their primary care provider. The notice must be clearly readable and at least as large as the ad's biggest text. Doctors must report adverse medical events to their licensing authority, even when the therapy may not have caused them. For donor-cell therapies, doctors must also notify the manufacturer and any applicable accrediting group within 30 days of learning about the event. Licensing authorities may discipline doctors for violations; participation in clinical outcome registries is encouraged, not required. The law authorizes licensing authorities to issue rules, with that authority effective upon enactment.

Stem Cell Access With Product Limits

Beginning July 1, 2026, Tennessee doctors may provide stem cell and regenerative therapies without Food and Drug Administration (FDA) approval. Treatments must fall within the doctor's scope of practice, and products must come only from facilities meeting the law's standards. Regenerative products require manufacturer validation, a lot-specific sterility report, and a certificate of analysis before patient use. Validation includes cell viability and surface markers, Wharton's jelly viscosity, or exosome particle counts, depending on the product. Their suppliers must be FDA-registered or hold an accreditation or certification listed in the law. Stem cell facilities need FDA registration for donor-cell products or a federal lab compliance certificate for patient-cell products. Stored stem cell products must stay at -80°C or colder, with exceptions for certain treatments using the patient's own cells. Reports must show more than 90% cell viability before thawing and at least 80% after thawing. Products also need documented manufacturing acceptance and regulatory compliance, except for same-day treatment using the patient's own cells. The framework excludes cells or tissues from a fetus or embryo after an abortion. It does not apply to FDA-authorized investigational uses, hospitals, affiliated hospital outpatient clinics, or Tennessee Right to Try therapies. The law does not require insurance coverage or set patient prices.

Sponsors & Cosponsors

Sponsors

There is no primary sponsor on record.

Cosponsors

  • Susan M. Lynn

    Republican • House

Roll Call Votes

All Roll Calls

Yes: 159 • No: 0

Senate vote • 4/16/2026

FLOOR VOTE: Third Consideration 4/16/2026

Yes: 31 • No: 0

House vote • 4/13/2026

FLOOR VOTE: REGULAR CALENDAR AS AMENDED PASSAGE ON THIRD CONSIDERATION 4/13/2026

Yes: 92 • No: 0

House vote • 4/13/2026

HOUSE CALENDAR & RULES COMMITTEE

Yes: 0 • No: 0

House vote • 4/6/2026

HOUSE GOVERNMENT OPERATIONS COMMITTEE

Yes: 10 • No: 0

House vote • 3/31/2026

HOUSE HEALTH COMMITTEE

Yes: 19 • No: 0

House vote • 3/18/2026

HOUSE HEALTH SUBCOMMITTEE

Yes: 7 • No: 0

Actions Timeline

  1. Effective date(s) 05/19/2026, 07/01/2026

    5/26/2026

  2. Pub. Ch. 1016

    5/26/2026

  3. Signed by Governor.

    5/19/2026

  4. Transmitted to Governor for his action.

    5/7/2026House

  5. Signed by Senate Speaker

    5/5/2026Senate

  6. Signed by H. Speaker

    4/30/2026House

  7. Enrolled; ready for sig. of H. Speaker.

    4/29/2026House

  8. Passed Senate, Ayes 31, Nays 0

    4/16/2026Senate

  9. Amendment withdrawn. (Amendment 1 - SA0975)

    4/16/2026Senate

  10. Senate substituted House Bill for companion Senate Bill.

    4/16/2026Senate

  11. Received from House, Passed on First Consideration

    4/14/2026Senate

  12. Engrossed; ready for transmission to Sen.

    4/13/2026House

  13. Passed H., as am., Ayes 92, Nays 0, PNV 2

    4/13/2026House

  14. H. adopted am. (Amendment 1 - HA0940)

    4/13/2026House

  15. H. Placed on Regular Calendar for 4/13/2026

    4/9/2026House

  16. Placed on cal. Calendar & Rules Committee for 4/9/2026

    4/8/2026House

  17. Rec. for pass; ref to Calendar & Rules Committee

    4/6/2026House

  18. Placed on cal. Government Operations Committee for 4/6/2026

    4/1/2026House

  19. Rec. for pass. if am., ref. to Government Operations Committee

    3/31/2026House

  20. Placed on cal. Health Committee for 3/31/2026

    3/25/2026House

  21. Action def. in Health Committee to 3/31/2026

    3/24/2026House

  22. Sponsor(s) Added.

    3/20/2026House

  23. Placed on cal. Health Committee for 3/24/2026

    3/18/2026House

  24. Rec for pass if am by s/c ref. to Health Committee

    3/18/2026House

  25. Placed on s/c cal Health Subcommittee for 3/18/2026

    3/11/2026House

Bill Text

  • HA0940 (Substitute)

    4/13/2026

    PDF

  • Enrolled / Public Chapter

    PDF

  • Fiscal Note

    PDF

  • Introduced

    PDF

  • SA0975

    PDF

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