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SB1214 - 572R - H Ver
House Engrossed
Senate Bill
stem
cells; birth tissue; therapy
(now: stem
cells; regenerative therapy)
State of Arizona
Senate
Fifty-seventh Legislature
Second Regular Session
2026
SENATE BILL 1214
AN
ACT
Amending title 32, chapter 32, Arizona
Revised Statutes, by adding article 2.1; 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 32, Arizona
Revised Statutes, is amended by adding article 2.1, to read:
ARTICLE
2.1
. STEM
CELL AND
regenerative
THERAPY
START_STATUTE
32-3235.
Definitions
In this article, unless the context otherwise
requires:
1. "Provider" means any
health professional who is licensed pursuant to this title and whose scope of
practice includes stem cell or regenerative therapy.
2. "Stem cell or regenerative
therapy" means a treatment that involves the use of CELLS, TISSUES OR
BIOLOGIC MATERIALS THAT ARE DERIVED EXCLUSIVELY FROM ADULT DONORS OR FROM
afterbirth, including placental CELLS, perinatal cells, amniotic fluid OR
UMBILICAL CORD BLOOD, that may be autologous or allogeneic or culture expanded
and that complies with the requirements prescribed in this article.
END_STATUTE
START_STATUTE
32-3236.
Stem cell
therapy; regenerative therapy; ethical requirements; informed consent; records;
advertising; unprofessional conduct; civil action
A. A
provider
may perform stem cell
or regenerative therapy that is not
approved by the United States food and drug administration if all of the
following apply:
1. The stem cell
or regenerative therapy is within the
provider's
lawful scope of practice.
2. The provider has completed a
nationally recognized, accredited or board-recognized continuing
education training in stem cell or regenerative therapy.
3. The stem cell or regenerative
therapy complies with the sourcing requirements prescribed in subsection B of
this section.
4. The provider obtains written
informed consent pursuant to subsection H of this section before performing any
stem cell or regenerative therapy.
B. Any cells, exosomes or biologic
materials used for therapeutic purposes under this section must be sourced
exclusively from a facility that is registered, certified or accredited and
inspected in compliance with subsection C of this section and that operates in
compliance with current good manufacturing practice standards.
C. To ensure that the retrieval,
manufacture, storage and use of stem cell and regenerative medicines used for
therapies conducted pursuant to this section meet the highest standards, the
stem cells or
regenerative medicines being used
must meet the following requirements:
1. Be retrieved,
manufactured and stored in a facility that is either registered
, regulated
and inspected by the United States
food and drug administration or certified or accredited by any of the
following:
(
a
)
The
world marrow donor association.
(
b
)
The association for the advancement
of blood and biotherapies.
(
c
)
The American association of tissue
banks.
(
d
) The
AMERICAN academy of stem cell medicine.
2. Be supplied by the manufacturer
with appropriate validation of isolation techniques, including cell viability
and surface marker reports for cellular products, a viscosity report for
Wharton's jelly and exosome counts for exosome-based regenerative
products. Lot-specific sterility reports and certificates of
analysis must be provided with each product before use with the provider's
patient.
D.
A provider
who performs stem cell or regenerative therapy may not obtain stem cells or
regenerative medicines from any facility that does not have a valid
certification or accreditation as required by subsection
C
of this section. Any contract or agreement by which a
provider obtains stem cells or
regenerative
medicines for therapies from a certified or accredited
manufacturing
facility must include the following information:
1. The name and address of the
manufacturing facility.
2. The
manufacturing
facility's certifying or accrediting organization.
3. Proof of certification or
accreditation.
4. Proof of site inspection by the
United States food and drug administration or the certifying or accrediting
organization named in paragraph 2 of this subsection.
5. The type and scope of
certification or accreditation.
6. The effective date and expiration
date of the certification or accreditation.
7. Any limits or conditions imposed
by the certifying or accrediting organization on the
manufacturing
facility.
8. A statement indicating, with
specificity, how, when and where the stem cells
were obtained,
such as adult stem cells, umbilical cord blood or amniotic fluid.
E. Any
manufacturing
facility that provides stem cells or
regenerative
medicine to a
provider for stem cell
or regenerative therapy must notify the
provider
to whom the
manufacturing facility is providing stem
cells or
regenerative medicine within thirty days after
any change in certification or accreditation status, including suspension,
revocation, renewal or expiration.
F. A
provider
shall ensure that all products used in stem cell
or
regenerative therapy are obtained from a
manufacturing 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.
G. Any
provider advertising stem cell
or
regenerative therapy 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
provider
offers one or more stem cell
or regenerative 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
or regenerative therapy.
H. Before performing any stem cell
or regenerative therapy, the
provider 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.
I. A provider administering a stem
cell or regenerative therapy shall maintain accurate treatment records,
document clinical outcomes and any adverse events and report as follows:
1. The provider shall report any
serious adverse event that is reasonably suspected to be linked to the therapy
to the provider's respective health profession regulatory board within fifteen
calendar days after the Provider becomes aware of the serious adverse event.
2. The provider shall report any
serious adverse event to the supplier of the stem cell or regenerative therapy.
J. A provider may voluntarily submit
de-identified patient data to professional clinical registries.
K. A
provider who:
1. Violates
this section commits an act of unprofessional conduct pursuant to the chapter
of this title under which the provider is licensed.
2. Acts in good faith and in
compliance with this section is not subject to professional disciplinary action
or license revocation solely for the act of administering a stem cell or
regenerative therapy. This paragraph does not apply to cases involving gross
negligence, medical fraud or intentional misconduct.
L. Any individual who receives a stem
cell
or regenerative 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.
END_STATUTE
Sec. 2.
Legislative intent
The
purpose of this act is to authorize qualified providers in this state to
administer specific stem cell and regenerative therapies under clearly defined
safety conditions, to ensure comprehensive informed consent and advertising
transparency and to protect patient safety by ensuring compliance with
biological sourcing standards.
Sec. 3.
Short title
This act may be cited as the
"Arizona Stem Cell
and Regenerative Therapy
Act."