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 stringent regulatory standards, including FDA registration 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 encouraging consultation with primary care providers.
Additionally, the bill outlines penalties for violations, which may include disciplinary actions by the medical board and potential felony charges for serious infractions, such as using human cells derived from fetuses or embryos post-abortion. It clarifies that these regulations do not apply to physicians with FDA approval for investigational new drugs or those affiliated with accredited institutions. The act is set to take effect on July 1, 2025, and grants the Board of Medicine the authority to adopt necessary rules for implementation, ensuring compliance with current good manufacturing practices.