The proposed bill establishes a new section, 456.63, in the Florida Statutes, which authorizes licensed health care providers to perform stem cell therapy that has not been approved by the United States Food and Drug Administration (FDA) under specific conditions. The bill defines key terms related to stem cell therapy, including "health care provider," "human cells, tissues, or cellular or tissue-based products," and "minimally manipulated." It outlines the requirements for the stem cells used in therapy, mandating adherence to current good manufacturing practices and ensuring that the stem cells are retrieved and manufactured in FDA-certified facilities. Additionally, the bill requires health care providers to provide written notice to patients about the unapproved status of the therapy and to obtain informed consent before proceeding with treatment.

Furthermore, the bill stipulates that the written notice must be prominently displayed and included in advertisements for the therapy, ensuring patients are adequately informed. The consent form must detail the nature of the treatment, its FDA approval status, anticipated results, alternative treatments, and potential risks. The bill also specifies that it does not apply to providers who have received FDA approval for investigational new drugs or those working under certified institutions. Violations of this section may lead to disciplinary actions, and the Department of Health is tasked with adopting rules to implement these provisions. The act is set to take effect on July 1, 2025.