The bill CS/CS/HB 1617 introduces new regulations for stem cell therapy in Florida, establishing sections 458.3245 and 459.0127 of the Florida Statutes. It emphasizes the ethical sourcing of stem cells, explicitly prohibiting the use of stem cells derived from aborted fetuses. The legislation permits allopathic and osteopathic physicians to perform FDA-unapproved stem cell therapies in specific areas such as orthopedics, wound care, and pain management, provided they adhere to good manufacturing practices and obtain stem cells from accredited facilities. The bill also mandates that physicians include clear disclosures in advertisements and patient consent forms regarding the unapproved status of the therapies and potential risks.

Furthermore, the bill outlines the requirements for patient consent forms, ensuring patients are fully informed about the treatment and its implications. It defines key terms related to stem cell therapy and specifies that therapies must not involve human cells or tissues from aborted fetuses or embryos. Physicians are required to provide clear notices in advertisements and obtain informed consent from patients, detailing the nature of the treatment and encouraging consultation with primary care providers. The legislation allows for certain exemptions for physicians with FDA approval for investigational drugs or those employed by accredited institutions. Violations of these regulations may result in disciplinary actions by the relevant medical boards, which are also tasked with adopting rules for implementation. The act is set to take effect on July 1, 2025.