The proposed 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. Licensed physicians will be permitted to perform FDA-unapproved stem cell therapies under specific conditions, particularly in orthopedics, wound care, or pain management. The bill mandates that all stem cells used must be obtained and processed in compliance with strict manufacturing practices from certified facilities, ensuring safety and ethical standards.

Additionally, the bill requires physicians to provide patients with a detailed written notice before administering stem cell therapy, which must include information about the treatment's nature, FDA approval status, potential risks, and alternative options. This notice must be prominently displayed in the physician's office and included in advertisements. Physicians are also required to obtain informed consent from patients or their representatives. The legislation outlines specific requirements for the written notice, including size and font, and exempts physicians with FDA-approved investigational new drugs or those affiliated with certified institutions from certain requirements. Violations of these regulations may lead to disciplinary actions, and the Board of Osteopathic Medicine is responsible for developing implementation rules. The act is set to take effect on July 1, 2025.