TennesseeHB 2246114th General Assembly (2025-2026)HouseWALLET

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

Sponsored By: Chris Hurt, Chris (Republican)

Became Law

Health Care

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Bill Overview

Analyzed Economic Effects

5 provisions identified: 3 benefits, 0 costs, 2 mixed.

Stronger safety rules for stem cell products

Starting July 1, 2026, makers and suppliers must meet strict lab and sterility testing for each lot and use FDA-registered or accredited facilities. For donor products, storage must be at or below -80° C, with more than 90% live cells before freezing and at least 80% after thaw. Same-day use of your own cells can waive some paperwork. Doctors must buy products only from facilities that meet these rules.

Doctors can offer unapproved stem cell care

Starting July 1, 2026, licensed Tennessee doctors can provide stem cell or regenerative treatments that are not FDA-approved, if the care is within their normal scope of practice. This expands patient access to these treatments. These therapies are not FDA-approved, so they may carry safety risks and higher out-of-pocket costs.

Clear ads and written consent required

Starting July 1, 2026, doctors who advertise non-FDA-approved stem cell treatments must include a clear notice in each ad, in a type size as large as any other text, and suggest talking with your primary care provider. Before treatment, doctors must get a written consent form signed by you or your authorized representative. This improves transparency and patient choice.

Adverse event reporting and oversight

Starting July 1, 2026, doctors using donor cells must report infections, allergic reactions, disease transmission, or other unexpected outcomes to the manufacturer and, if applicable, an accrediting group within 30 days of learning about them. All doctors who give these therapies must report such events to their licensing board. Doctors are encouraged to join accredited outcome registries. State medical boards can write rules and can discipline doctors who break these requirements.

What is outside these stem cell rules

Starting July 1, 2026, these rules do not apply to FDA-approved investigational use (IND/IDE), hospitals and their outpatient clinics, or treatments under Tennessee’s Right to Try law. The law also does not cover fetal or embryo-derived cells after an abortion, whole blood and its parts, or secreted human products like milk or collagen (not including semen). This clarifies who and what is not covered by the section.

Sponsors & Cosponsors

Sponsor

  • Chris Hurt, Chris

    Republican • House

Cosponsors

  • Susan M. Lynn, Susan M.

    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. Pub. Ch. 1016

    5/26/2026
  2. Effective date(s) 05/19/2026, 07/01/2026

    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. Senate substituted House Bill for companion Senate Bill.

    4/16/2026Senate
  9. Amendment withdrawn. (Amendment 1 - SA0975)

    4/16/2026Senate
  10. Passed Senate, Ayes 31, Nays 0

    4/16/2026Senate
  11. Received from House, Passed on First Consideration

    4/14/2026Senate
  12. H. adopted am. (Amendment 1 - HA0940)

    4/13/2026House
  13. Passed H., as am., Ayes 92, Nays 0, PNV 2

    4/13/2026House
  14. Engrossed; ready for transmission to Sen.

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

    3/18/2026House
  24. Placed on cal. Health Committee for 3/24/2026

    3/18/2026House
  25. Action Def. in s/c Health Subcommittee to 3/18/2026

    3/11/2026House

Bill Text

  • HA0940 (Substitute)

    4/13/2026

  • Enrolled / Public Chapter

  • Fiscal Note

  • Introduced

  • SA0975

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