State experimental treatment laws

A small number of states have passed statutes addressing physician use of treatments that have not gone through FDA approval. Florida's SB 1768, codified at section 459.0127 and effective July 1, 2025, is one example: it allows MD and DO physicians to use certain non-FDA-approved stem cell therapies in specified practice areas, subject to informed consent and disclosure conditions set out in the statute. Other states, including Utah and Montana, have their own experimental-treatment statutes with different scope and conditions.

These laws address what a state will permit a licensed physician to do within that state's scope-of-practice framework. They do not reclassify a product under federal law, and they do not substitute for the federal requirements that apply to how an HCT/P or a biologic drug is manufactured, labeled, or marketed. A product's federal regulatory status, and any FDA enforcement interest in it, is unaffected by a favorable state statute.

Clinics operating in a state with an experimental-treatment law should still confirm their own compliance with the statute's specific consent and disclosure requirements, and should not treat the existence of a state law as resolving federal questions about a product. This is a legal determination for the clinic and its own counsel, not something a distributor can determine on the clinic's behalf.

Clinics should understand that a favorable state statute addresses state-level permission for physician conduct, not federal product status, and should confirm applicability with their own counsel rather than relying on a supplier's characterization.