(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 therapy”:(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 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(B) 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 (CLIA) 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(B) 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.
(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”;
(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”;
(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 therapy”:(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 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(B) Does not include treatment or research using human cells or tissues that were derived from a fetus or an embryo after an abortion; and
(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 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
(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 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
(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
(B) 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 (CLIA) 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(B) 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.
(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 (CLIA) 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
(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 (CLIA) 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
(B) 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.
(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.
(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.
(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.
(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.
(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) (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.
(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.