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REFERENCE TITLE: stem cells; birth tissue; therapy |
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State of Arizona Senate Fifty-seventh Legislature Second Regular Session 2026
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SB 1214 |
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Introduced by Senator Shamp
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AN ACT
Amending title 32, chapter 13, Arizona Revised Statutes, by adding article 7; amending title 32, chapter 17, Arizona Revised Statutes, by adding article 5; relating to the practice of medicine.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Title 32, chapter 13, Arizona Revised Statutes, is amended by adding article 7, to read:
ARTICLE 7. STEM CELL AND BIRTH TISSUE THERAPY
32-1492. Stem cell therapy; birth tissue therapy; ethical requirements; informed consent; advertising; violations; classification; rules; definitions
A. A physician may not perform or participate in any stem cell therapy or birth tissue therapy involving cells or tissues derived from an aborted fetus or embryo.
B. A physician may perform stem cell therapy or birth tissue therapy that is not approved by the United States food and drug administration if all of the following apply:
1. The stem cell therapy or birth tissue therapy is within the physician's lawful scope of practice.
2. The stem cell therapy or birth tissue therapy is related to orthopedics, wound care or pain management.
3. The stem cells or birth tissue being used meets the following requirements:
(a) Is retrieved, processed and stored in a facility that is either registered and regulated by the United States food and drug administration or certified or accredited by any of the following:
(i) The national marrow donor program.
(ii) The world marrow donor association.
(iii) The association for the advancement of blood and biotherapies.
(iv) The American association of tissue banks.
(b) If stem cells, contain viable or live cells on post-thaw analysis and are accompanied by a post-thaw viability analysis report provided to the physician before use with a patient.
(c) If birth tissue, contains naturally occurring growth factors and extracellular matrix elements that meet predetermined release criteria. The birth tissue must be accompanied by a certificate of conformance or a certificate of analysis indicating that the birth tissue, at a minimum, meets these criteria and has tested negative for communicable diseases required by the United States food and drug administration.
C. An individual may not obtain stem cells or birth tissue from any facility that does not have a valid certification or accreditation as required by subsection B, paragraph 3 of this section. Any contract or agreement by which a physician obtains stem cells or birth tissue for therapies from a certified or accredited facility must include the following information:
1. The name and address of the facility.
2. The facility's certifying or accrediting organization.
3. The type and scope of certification or accreditation.
4. The effective date and expiration date of the certification or accreditation.
5. Any limits or conditions imposed by the certifying or accrediting organization on the facility.
6. A statement indicating, with specificity, how, when and where the stem cells or birth tissue was obtained, such as adult stem cells, umbilical cord blood or amniotic fluid.
D. Any facility that provides stem cells or birth tissue to a physician for stem cell therapy or birth tissue therapy must notify the physician to whom the facility is providing stem cells or birth tissue within thirty days after any change in certification or accreditation status, including suspension, revocation, renewal or expiration.
E. A physician shall ensure that all products used in stem cell therapy or birth tissue therapy are obtained from a facility that complies with current good manufacturing practices in accordance with the federal food, drug, and cosmetic act (52 Stat. 1040; 21 United States Code section 301) and 21 Code of Federal Regulations part 1271.
F. Any physician advertising stem cell therapies or birth tissue therapies must include the following disclosure in any form of advertisement, in a type size of at least the largest type used elsewhere in the advertisement:
This notice is required by Arizona law. This physician offers one or more stem cell therapies or birth tissue therapies that are not approved by the United States food and drug administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy or birth tissue therapy.
G. Before performing any stem cell therapy or birth tissue therapy, the physician shall obtain a signed informed consent form from the patient or, if the patient is not legally competent, from the patient's authorized representative that clearly states:
1. The nature and character of the proposed treatment.
2. That the treatment has not been approved by the United States food and drug administration.
3. The anticipated results of the proposed treatment.
4. The recognized serious possible risks and complications of the treatment, the anticipated benefits of the treatment and any alternatives to the treatment, including the option of not undergoing treatment.
5. That the patient is encouraged to consult with the patient's primary care provider before proceeding with the treatment.
H. This section does not apply to a physician who either:
1. Has obtained approval for an investigational new drug or device from the United States food and drug administration for the use of human cells, tissues or cellular or tissue-based products.
2. Performs stem cell therapy or birth tissue therapy treatments under an employment or other contract on behalf of an institution that is certified or accredited by one of the following:
(a) The foundation for the accreditation of cellular therapy.
(b) The blood and marrow transplant clinical trials network.
(c) The association for the advancement of blood and biotherapies.
I. Any individual who receives a stem cell therapy or birth tissue therapy treatment that violates this section may bring a civil action to recover statutory damages in an amount of $10,000 per violation, plus attorney fees and costs.
J. A physician who wilfully performs or actively participates in the following acts is guilty of a class 5 felony and is subject to disciplinary action under this chapter:
1. Treatment or research using human cells or tissues derived from a fetus or an embryo after an elective abortion.
2. The development, deployment, sale, manufacture or distribution of computer products created using human cells, tissues or cellular or tissue-based products, including synthetic cognition systems.
K. The board may adopt rules necessary to implement this section pursuant to title 41, chapter 6.
L. For the purposes of this section:
1. "Birth tissue therapy":
(a) Means a treatment involving the use of afterbirth placental perinatal material, including amniotic fluid, that does not rely on cellular viability for the efficacy of the product but relies on the physical structures and the signaling factor of the proteins and extracellular matrix elements it contains.
(b) Does not include treatment or research using human tissues or fluids that were derived from a fetus or embryo after an elective abortion or pregnancy of less than thirty-six weeks' gestation.
2. "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.
(b) Does not include:
(i) Vascularized human organs for transplantation.
(ii) Whole blood or blood components or blood derivative products.
(iii) Secreted or extracted human products, such as milk, collagen and cell factors, other than semen and amniotic fluid.
(iv) Minimally manipulated bone marrow that is for homologous use and that is not combined with another article other than water, crystalloids or a sterilizing, preserving or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow.
(v) Ancillary products used in the manufacture of human cells, tissues or cellular or tissue-based products.
(vi) Cells, tissues and organs derived from animals other than humans.
(vii) In vitro diagnostic products.
(viii) Blood vessels recovered with an organ that are intended for use in organ transplantation and labeled "For use in organ transplantation only".
3. "Minimally manipulated" means:
(a) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair or replacement.
(b) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of the cells or tissues.
4. "Stem cell therapy":
(a) Means a treatment that involves the use of afterbirth placental perinatal stem cells or human cells, tissues or cellular or tissue-based products and that complies with the regulatory requirements provided in this section.
(b) Does not include treatment or research using human cells or tissues that were derived from a fetus or an embryo after an elective abortion.
Sec. 2. Title 32, chapter 17, Arizona Revised Statutes, is amended by adding article 5, to read:
ARTICLE 5. STEM CELL AND BIRTH TISSUE THERAPY
32-1872. Stem cell therapy; birth tissue therapy; ethical requirements; informed consent; advertising; violations; classification; rules; definitions
A. A physician may not perform or participate in any stem cell therapy or birth tissue therapy involving cells or tissues derived from an aborted fetus or embryo.
B. A physician may perform stem cell therapy or birth tissue therapy that is not approved by the United States food and drug administration if all of the following apply:
1. The stem cell therapy or birth tissue therapy is within the physician's lawful scope of practice.
2. The stem cell therapy or birth tissue therapy is related to orthopedics, wound care or pain management.
3. The stem cells or birth tissue being used meets the following requirements:
(a) Is retrieved, processed and stored in a facility that is either registered and regulated by the United States food and drug administration or certified or accredited by any of the following:
(i) The national marrow donor program.
(ii) The world marrow donor association.
(iii) The association for the advancement of blood and biotherapies.
(iv) The American association of tissue banks.
(b) If stem cells, contain viable or live cells on post-thaw analysis and are accompanied by a post-thaw viability analysis report provided to the physician before use with a patient.
(c) If birth tissue, contains naturally occurring growth factors and extracellular matrix elements that meet predetermined release criteria. The birth tissue must be accompanied by a certificate of conformance or a certificate of analysis indicating that the birth tissue, at a minimum, meets these criteria and has tested negative for communicable diseases required by the United States food and drug administration.
C. An individual may not obtain stem cells or birth tissue from any facility that does not have a valid certification or accreditation as required by subsection B, paragraph 3 of this section. Any contract or agreement by which a physician obtains stem cells or birth tissue for therapies from a certified or accredited facility must include the following information:
1. The name and address of the facility.
2. The facility's certifying or accrediting organization.
3. The type and scope of certification or accreditation.
4. The effective date and expiration date of the certification or accreditation.
5. Any limits or conditions imposed by the certifying or accrediting organization on the facility.
6. A statement indicating, with specificity, how, when and where the stem cells or birth tissue was obtained, such as adult stem cells, umbilical cord blood or amniotic fluid.
D. Any facility that provides stem cells or birth tissue to a physician for stem cell therapy or birth tissue therapy must notify the physician to whom the facility is providing stem cells or birth tissue within thirty days after any change in certification or accreditation status, including suspension, revocation, renewal or expiration.
E. A physician shall ensure that all products used in stem cell therapy or birth tissue therapy are obtained from a facility that complies with current good manufacturing practices in accordance with the federal food, drug, and cosmetic act (52 Stat. 1040; 21 United States Code section 301) and 21 Code of Federal Regulations part 1271.
F. Any physician advertising stem cell therapies or birth tissue therapies must include the following disclosure in any form of advertisement, in a type size of at least the largest type used elsewhere in the advertisement:
This notice is required by Arizona law. This physician offers one or more stem cell therapies or birth tissue therapies that are not approved by the United States food and drug administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy or birth tissue therapy.
G. Before performing any stem cell therapy or birth tissue therapy, the physician shall obtain a signed informed consent form from the patient or, if the patient is not legally competent, from the patient's authorized representative that clearly states:
1. The nature and character of the proposed treatment.
2. That the treatment has not been approved by the United States food and drug administration.
3. The anticipated results of the proposed treatment.
4. The recognized serious possible risks and complications of the treatment, the anticipated benefits of the treatment and any alternatives to the treatment, including the option of not undergoing treatment.
5. That the patient is encouraged to consult with the patient's primary care provider before proceeding with the treatment.
H. This section does not apply to A physician who either:
1. Has obtained approval for an investigational new drug or device from the United States food and drug administration for the use of human cells, tissues or cellular or tissue-based products.
2. Performs stem cell therapy or birth tissue therapy treatments under an employment or other contract on behalf of an institution that is certified or accredited by one of the following:
(a) The foundation for the accreditation of cellular therapy.
(b) The blood and marrow transplant clinical trials network.
(c) The association for the advancement of blood and biotherapies.
I. Any individual who receives a stem cell therapy or birth tissue therapy treatment that violates this section may bring a civil action to recover statutory damages in an amount of $10,000 per violation, plus attorney fees and costs.
J. A physician who wilfully performs or actively participates in the following acts is guilty of a class 5 felony and is subject to disciplinary action under this chapter:
1. Treatment or research using human cells or tissues derived from a fetus or an embryo after an elective abortion.
2. The development, deployment, sale, manufacture or distribution of computer products created using human cells, tissues or cellular or tissue-based products, including synthetic cognition systems.
K. The board may adopt rules necessary to implement this section pursuant to title 41, chapter 6.
L. For the purposes of this section:
(a) Means a treatment involving the use of afterbirth placental perinatal material, including amniotic fluid, that does not rely on cellular viability for the efficacy of the product but relies on the physical structures and the signaling factor of the proteins and extracellular matrix elements it contains.
(b) Does not include treatment or research using human tissues or fluids that were derived from a fetus or embryo after an elective abortion or pregnancy of less than thirty-six weeks' gestation.
2. "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.
(b) Does not include:
(i) Vascularized human organs for transplantation.
(ii) Whole blood or blood components or blood derivative products.
(iii) Secreted or extracted human products, such as milk, collagen and cell factors, other than semen and amniotic fluid.
(iv) Minimally manipulated bone marrow that is for homologous use and that is not combined with another article other than water, crystalloids or a sterilizing, preserving or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the bone marrow.
(v) Ancillary products used in the manufacture of human cells, tissues or cellular or tissue-based products.
(vi) Cells, tissues and organs derived from animals other than humans.
(vii) In vitro diagnostic products.
(viii) Blood vessels recovered with an organ that are intended for use in organ transplantation and labeled "For use in organ transplantation only".
3. "Minimally manipulated" means:
(a) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair or replacement.
(b) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of the cells or tissues.
4. "Stem cell therapy":
(a) Means a treatment that involves the use of afterbirth placental perinatal stem cells or human cells, tissues or cellular or tissue-based products and that complies with the regulatory requirements provided in this section.
(b) Does not include treatment or research using human cells or tissues that were derived from a fetus or an embryo after an elective abortion.
Sec. 3. Short title
This act may be cited as the "Arizona Stem Cell Therapy Act."