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 certified facilities that comply with strict manufacturing practices. The bill mandates that physicians must clearly inform patients about the unapproved status of these therapies in advertisements and obtain informed consent, ensuring patients understand the treatment's nature, risks, and lack of FDA approval.

Additionally, the bill outlines stringent requirements for the facilities from which stem cells are sourced, mandating that they be registered and regulated by the FDA and accredited by recognized organizations. Physicians must also secure a post-thaw viability analysis report for the stem cells used in therapy. The consent form must detail the treatment's nature, its unapproved status, potential risks, and the importance of consulting with a primary care provider. The bill includes exemptions for physicians with FDA approval for investigational new drugs or those affiliated with accredited institutions. Violations of these regulations could result in disciplinary actions by the medical board or felony charges for severe infractions, such as using human cells derived from fetuses or embryos post-abortion. The act is set to take effect on July 1, 2025.