TennesseeTennessee physicians may use certain unapproved cell therapies under safeguards
Tennessee law lets physicians perform certain cell therapies without federal approval if the treatment fits their practice and the products meet quality rules.
What it does
Physicians may perform certain cell therapies without federal approval when the treatment is within their professional scope and the products meet required quality and facility rules.
Physicians must get written consent before treatment and place a clear notice in every ad saying the therapy lacks federal approval and encouraging patients to consult their primary care provider.
Physicians must report medical events associated with covered therapy to their licensing authority. For therapy using another person’s cells, they must also report to the manufacturer and, when applicable, an accrediting group within 30 days of learning of the event.
Argument forPatients could get more safety oversight because covered products must meet quality checks and physicians must report medical events linked to treatment.
Argument againstPatients could still choose a therapy without federal approval after receiving a notice and signing consent, though some may prefer treatments with federal approval.
More detail
Physicians may perform certain stem cell or regenerative medicine therapies without federal approval. The rules cover physicians using qualifying human cell or tissue products for stem cell or regenerative medicine therapy. The treatment or procedure must be within the physician’s professional scope. The products must meet the law’s testing, handling, and facility requirements, and the physician must obtain them from a compliant facility. This section does not apply to FDA-approved investigational therapies, hospitals and affiliated outpatient clinics, or treatments under the Right to Try law. It also excludes certain products and treatments, including those using cells or tissues derived from a fetus or embryo after an abortion. These provisions took effect July 1, 2026.
Physicians must include an approval notice in each ad for covered therapy and obtain written consent before treatment. These duties apply to physicians performing the therapies covered by this section. The notice must say the therapy has not received federal approval and encourage patients to consult their primary care provider. The notice must be clearly readable and at least as large as the largest type in the ad. The patient signs the consent form, or the patient’s representative signs if the patient is not legally competent. Consent is required before the physician performs the therapy.
Physicians must report associated medical events to their licensing authority; physicians performing allogeneic therapy must also report them to the manufacturer and, when applicable, an accrediting organization. These reporting rules apply to physicians performing therapy under this section. The extra report to the manufacturer and accrediting organization applies to allogeneic therapy, which uses cells from another person. A report to the manufacturer and, when applicable, an accrediting organization is due within 30 days after the physician learns of the event. An adverse event means any untoward medical occurrence associated with the therapy, whether or not it is considered related to the therapy. Physicians are encouraged, but not required, to take part in clinical outcomes registries. The 30-day deadline begins when the physician becomes aware of the event.
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Where it stands
- Introduced
- Passed House
- Passed Senate
- To Governor
- Became Law
Looking ahead
No hearings or votes scheduled.
History
- 2026
- May 26Pub. Ch. 1016Latest
- May 26Effective date(s) 05/19/2026, 07/01/2026
- May 19Signed by Governor Bill Lee.Became Law
- May 7Transmitted to Governor for his action.To Governor
- May 5Signed by Senate SpeakerMajor
- Apr 30Signed by H. SpeakerMajor
- Apr 29Enrolled; ready for sig. of H. Speaker.Minor
- Apr 16Senate substituted House Bill for companion Senate Bill.Major
- Vote recorded FLOOR VOTE: Third Consideration 4/16/2026 Passed. Result: pass.Upper
- Apr 16Amendment withdrawn. (Amendment 1 - SA0975)
- Apr 16Passed Senate, Ayes 31, Nays 0Passed Senate
- Apr 14Received from House, Passed on First ConsiderationMinor
- Apr 13H. adopted am. (Amendment 1 - HA0940)Major
- Vote recorded HOUSE CALENDAR & RULES COMMITTEE: H. Placed on Regular Calendar for 4/13/2026 4/9/2026. Result: fail.Lower
- Vote recorded FLOOR VOTE: REGULAR CALENDAR AS AMENDED PASSAGE ON THIRD CONSIDERATION 4/13/2026 Passed. Result: pass.Lower
- Apr 13Passed H., as am., Ayes 92, Nays 0, PNV 2Passed House
- Apr 13Engrossed; ready for transmission to Sen.Minor
- Apr 9H. Placed on Regular Calendar for 4/13/2026
- Apr 8Placed on cal. Calendar & Rules Committee for 4/9/2026
- Apr 6Rec. for pass; ref to Calendar & Rules CommitteeMinor
- Vote recorded HOUSE GOVERNMENT OPERATIONS COMMITTEE: Rec. for pass; ref to Calendar & Rules Committee 4/6/2026 Passed. Result: pass.Lower
- Apr 1Placed on cal. Government Operations Committee for 4/6/2026
- Mar 31Rec. for pass. if am., ref. to Government Operations CommitteeMinor
- Vote recorded HOUSE HEALTH COMMITTEE: Rec. for pass. if am., ref. to Government Operations Committee 3/31/2026 Passed. Result: pass.Lower
- Mar 25Placed on cal. Health Committee for 3/31/2026
- Mar 24Action def. in Health Committee to 3/31/2026
- Mar 20Sponsor(s) Added.Minor
- Mar 18Rec for pass if am by s/c ref. to Health CommitteeMinor
- Vote recorded HOUSE HEALTH SUBCOMMITTEE: Rec for pass if am by s/c ref. to Health Committee 3/18/2026 Passed. Result: pass.Lower
- Mar 18Placed on cal. Health Committee for 3/24/2026
- Mar 11Action Def. in s/c Health Subcommittee to 3/18/2026
- Mar 11Placed on s/c cal Health Subcommittee for 3/18/2026
- Mar 4Placed on s/c cal Health Subcommittee for 3/11/2026
- Feb 5P2C, ref. to Health Committee - Government Operations for ReviewMinor
- Feb 5Assigned to s/c Health SubcommitteeMinor
- Feb 4Intro., P1C.Minor
- Feb 2Filed for introductionIntroduced
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