The bill introduces new regulations for stem cell therapy in Florida by creating sections 458.3245 and 459.0127 of the Florida Statutes. It emphasizes ethical sourcing of stem cells, explicitly prohibiting the use of stem cells derived from aborted fetuses. Physicians are permitted to perform non-FDA approved stem cell therapies in specific fields such as orthopedics, wound care, or pain management, provided that the stem cells are sourced from facilities that meet strict regulatory standards, including registration with the FDA and certification by recognized organizations. The bill also mandates that physicians must provide clear notices in advertisements about the unapproved status of these therapies and obtain informed consent from patients, detailing the treatment's nature, potential risks, and the importance of consulting with primary care providers.

Additionally, the bill requires that stem cells be retrieved, manufactured, and stored in FDA-registered and certified facilities, and mandates a post-thaw viability analysis report for the stem cells used. It specifies that the consent form must inform patients about the treatment's unapproved status by the FDA and potential risks. The regulations do not apply to physicians with FDA approval for investigational new drugs or those affiliated with accredited institutions. Violations of these regulations could result in disciplinary actions, including felony charges for serious infractions related to the use of human cells or tissues. The act is scheduled to take effect on July 1, 2025.