Bill > SB1214

This bill, titled the "Arizona Stem Cell and Regenerative Therapy Act," establishes regulations for licensed healthcare professionals, referred to as "providers," who administer stem cell or regenerative therapies, which are treatments using cells or tissues, including those from afterbirth like placental cells, that may be from the patient or another person, or grown in a lab. The bill permits providers to perform these therapies even if they are not yet approved by the U.S. Food and Drug Administration (FDA), provided the therapy is within their licensed scope of practice, they have completed accredited training, the biological materials used meet strict sourcing and manufacturing standards, and they obtain written informed consent from the patient. These sourcing standards require that cells, exosomes, or other biological materials come from facilities registered, certified, or accredited by the FDA or specific recognized organizations, and that these facilities adhere to current good manufacturing practice standards. Providers must also ensure their contracts with these facilities include detailed information about the facility and its accreditation, and manufacturing facilities must notify providers of any changes to their certification status. Advertisements for these therapies must include a disclosure stating that the treatment is not FDA-approved and patients are encouraged to consult their primary care provider. Informed consent must clearly outline the treatment's nature, lack of FDA approval, anticipated results, risks, benefits, alternatives, and the recommendation to consult a primary care provider. Providers must maintain records, report serious adverse events to their licensing board and the therapy supplier, and can voluntarily submit de-identified patient data. Violating these provisions constitutes unprofessional conduct, but providers acting in good faith and in compliance are protected from disciplinary action unless there is gross negligence, fraud, or intentional misconduct. Patients who receive therapy in violation of this act can bring a civil action for damages.