Shown verbatim: the complete text as captured from the official PDF posted by the Tennessee General Assembly, fetched 2026-09-25. Page and line markers are part of the official record; nothing is edited or removed. This is the chaptered version. The official bill page.
....(•'\~·_·;..;..;.;..e...·..sJ·i·.·-.,.
~:.-11•.
U~\\ t:§~\
i: )) ·'"~-"""'='=--
$tate of ~ennessee
PUBLIC CHAPTER NO. 1016
HOUSE BILL NO. 2246
By Representatives Hurt, Lynn
Substituted for: Senate Bill No. 2586
By Senators Jackson, Pody, Bailey, Bowling, Reeves
AN ACT to amend Tennessee Code Annotated, Title 63 and Title 68, relative to stem
cell therapies.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF TENNESSEE:
SECTION 1. Tennessee Code Annotated, Title 63, Chapter 6, Part 2, is amended by
adding the following as a new section:
(a) As used in this section:
(1) "Human cells, tissues, or cellular or tissue-based products":
(A) Means articles containing or consisting of human cells or
tissues that are intended for implantation, transplantation, infusion, or
transfer into a human recipient; and
(B) Does not include:
(i) Vascularized human organs for transplantation;
(ii) Ancillary products used in the manufacture of human
cells, tissues, or cellular or tissue-based products;
(iii) Cells, tissues, media, serums, and organs derived from
an animal;
(iv) In vitro diagnostic products; and
(v) Blood vessels recovered with an organ that is intended
for use in organ transplantation and are clearly labeled "For use in
organ transplantation only";
(2) "Physician" means a person licensed pursuant to chapter 6 or 9 of this
title;
(3) "Regenerative medicine therapy11:
(A) Means the use of products that:
(i) Are supplied by a manufacturer that validates its
isolation techniques by including cell viability and surface marker
reports for cellular products, a viscosity report for Wharton's jelly,
and particle counts for exosome-based regenerative products;
(ii) Contain a lot-specific sterility report and certificate of
analysis for each product before the product is used on a patient;
and
(iii) Are supplied by a manufacturer that retrieves,
manufactures, and stores the product in a facility that is registered
with the United States food and drug administration or accredited
HB2246
or certified by a recognized third-party accrediting organization,
including:
(a) American Association of Tissue Banks;
(b) American Academy of Stem Cell Medicine;
(c) Association for the Advancement of Blood and
Biotherapies;
(d) Foundation for the Accreditation of Cellular
Therapy; and
(e) World Marrow Donor Program; and
(8) Does not include treatment or research using human
cells or tissues that were derived from a fetus or an embryo after
an abortion; and
(4) "Stem cell therapy":
(A) Means a treatment involving the use of cellular or tissue-based
products that:
(i) Are retrieved, manufactured, and stored in a facility that
provides the physician proof of registration from the United States
food and drug administration for allogeneic therapy or are
retrieved, manufactured, and stored in a facility with a Clinical
Laboratory Improvement Amendments of 1988 (CUA) certificate
of compliance for autologous therapy;
(ii) Are stored in a freezer that maintains a temperature no
higher than negative eighty degrees centigrade (-80° C), unless
the cellular or tissue-based products are for autologous therapy;
(iii) Contain viable or live cells greater than ninety percent
(90%), as indicated in a pre-thaw certificate of analysis report, and
contain no less than eighty percent (80%) viable or live cells, as
indicated in a post-thaw viability analysis report for the product lot
sent before use on the patient, unless the cellular or tissue-based
products are for autologous therapy; and
(iv) Contain documentation that the cellular or tissue-based
products meet acceptance criteria established by validated
manufacturing procedures, if used for allogeneic therapy, and
consistent with applicable regulatory standards before cell
administration, unless the cellular or tissue-based products are
used for same-day autologous therapy; and
(8) Does not include:
(i) Treatment or research using human cells or tissues that
were derived from a fetus or an embryo after an abortion;
(ii) Whole blood, blood components, or blood derivative
products; and
(iii) Secreted or extracted human products, such as milk,
collagen, and cell factors, other than semen.
(b) A physician may perform stem cell therapy or regenerative medicine therapy
that is not approved by the United States food and drug administration if the therapy is
used for a treatment or procedure that is within the scope of practice of the physician.
2
HB2246
(c) A physician who performs stem cell therapy or regenerative medicine therapy
shall obtain human cells, tissues, or cellular or tissue-based products for the therapy
only from a facility that complies with this section.
(d)
(1) A physician who conducts stem cell therapy or regenerative medicine
therapy under this section must include the following notice in each
advertisement for therapy:
THIS NOTICE MUST BE PROVIDED TO YOU UNDER
TENNESSEE LAW. This physician performs one (1) or more stem cell or
regenerative medicine therapies that have not yet been approved by the
United States food and drug administration. You are encouraged to
consult with your primary care provider before undergoing any stem cell
or regenerative medicine therapy.
(2) The notice required by subdivision (d)(1) must be clearly legible and in
a type size no smaller than the largest type size used in the advertisement.
(e) Before performing stem cell therapy or regenerative medicine therapy under
this section, a physician must obtain a written consent form signed by the patient or, if
the patient is not legally competent, the patient's representative.
(f) This section does not apply to:
(1) A physician who performs therapy approved for an investigational new
drug or device by the United States food and drug administration for the use of
human cells, tissues, or cellular or tissue-based products;
(2) A hospital as defined in § 68-11-201(31), or an affiliated hospital
outpatient clinic; or
(3) A therapy performed pursuant to the Phil Timp-Amanda Wilcox Right
to Try Act, compiled in chapter 6, part 3 of this title.
(g) A physician who violates this section may be subject to disciplinary action by
the physician's licensing authority.
(h)
(1) A physician who performs allogeneic stem cell therapy or regenerative
medicine therapy under this section shall report an adverse event associated
with such therapy to the manufacturer and, if applicable, to an accrediting
organization as described in subdivision (a)(3)(A)(iii) within thirty (30) days after
the physician becomes aware of such adverse event.
(2) A physician who performs stem cell therapy or regenerative medicine
therapy under this section is encouraged to participate in clinical outcomes
registries maintained by an accredited organization for purposes of ongoing
safety monitoring, quality improvement, and evidence-based practice
development.
(3) A physician who performs stem cell therapy or regenerative medicine
therapy under this section shall report an adverse event associated with such
therapy to the physician's licensing authority.
(4) As used in this subsection (h), "adverse event" means any untoward
medical occurrence associated with the use of stem cell therapy or regenerative
medicine therapy, regardless of whether such event is considered related to the
therapy, including infection, allergic reaction, disease transmission, or an
unanticipated clinical outcome.
(i)
3
HB2246
(1) The board of medical examiners may promulgate rules to effectuate
this section. _The rules must be promulgated in accordance with the Uniform
Administrative Procedures Act, compiled in title 4, chapter 5.
(2) The board of osteopathic examination may promulgate rules to
effectuate this section. The rules must be promulgated in accordance with the
Uniform Administrative Procedures Act, compiled in title 4, chapter 5.
SECTION 2. For purposes of promulgating rules, this act takes effect upon becoming a
law, the public welfare requiring it. For all other purposes, this act takes effect July 1, 2026, the
public welfare requiring it.
4
HOUSE BILL NO. 2246
PASSED: April 16, 2026
<::::~
CAMERONSEXTON,SPEAKER
HOUSE OF REPRESENTATIVES
n "'· ... ) -
-- - ~~ .rlt
' RANDY.
SPEAKER OF THE SENATE
APPROVED this \ ~ day of a ~ 2026
&«~<
BILL LEE, GOVERNOREvery fact on this page links to its source, starting with the official bill record.