FL S1768

Licensed physicians in Florida are authorized to perform stem cell therapies not approved by the U.S. Food and Drug Administration for treatments related to orthopedics, wound care, or pain management, effective July 1, 2025.

Stem cells must be retrieved, manufactured, and stored in FDA-registered facilities that are also certified or accredited by designated organizations such as the National Marrow Donor Program or the American Association of Tissue Banks, and must contain viable cells verified by a post-thaw analysis report.

Physicians must include a prominent notice in all advertisements disclosing that the stem cell therapy has not been FDA-approved and must obtain a signed informed consent form from the patient detailing the treatment's nature, risks, benefits, alternatives, and unapproved status.

Use of stem cells derived from a fetus or embryo after an abortion is explicitly prohibited; physicians who willfully perform treatment or research using such cells commit a third-degree felony and face disciplinary action.

The law does not apply to physicians operating under FDA investigational new drug/device approvals or those performing stem cell therapy on behalf of institutions accredited by entities such as the Foundation for the Accreditation of Cellular Therapy or the Blood and Marrow Transplant Clinical Trials Network.