State-by-State: Regenerative Medicine Compliance

There is no single national rule for regenerative medicine practice. The FDA sets the product framework; the states set the practice framework. And the states are moving. In the last two years, several have passed laws creating pathways for non-FDA-approved therapies, and the Supreme Court has signaled that federal oversight of cell therapies is here to stay.

Texas

Position: Texas was one of the first states to formally address regenerative medicine. The Texas Medical Board approved a set of regulations allowing physicians to offer autologous adult stem cell therapies under defined conditions. Texas is considered permissive relative to most states, but permissive is not unregulated.

• Autologous adult stem cell therapies have a defined regulatory lane
• Physician involvement is required; the board sets the standard of care
• Allogeneic products and investigational biologics still fall to the FDA framework
• Verify the current TMB rule text before relying on any summary

California

Position: California regulates through multiple layers: the California Department of Public Health monitors human stem cell research activity in the state, and the courts have enforced FDA oversight against unapproved clinics. California is generally considered stricter, with active scrutiny of clinics marketing unproven therapies.

• CDPH Human Stem Cell Research program collects reporting from stem cell researchers
• Court rulings have backed FDA authority over unapproved stem cell treatments
• Marketing unproven therapies draws attention from regulators and the press
• Scope of practice for NPs and PAs is defined by California law; verify collaborative requirements

Florida

Position: Florida passed a stem cell therapy law effective July 1, 2025 (Fla. Stat. § 458.3245). It creates a framework for stem cell therapy in the state, and it requires that informed consent advise patients that the products have not yet been approved by the FDA.

• Informed consent must disclose the product's regulatory status using "not yet" approved language
• Addresses orthopedics, wound care, and pain management applications
• The law does not authorize what the FDA prohibits; it creates a state lane with disclosure
• Verify the exact statutory text and any board rules implementing it

Scope of practice: the universal question

Whatever the state, the questions are the same. Does my license authorize this procedure? Do I need a collaborative or supervisory arrangement? What does my state board say about this specific therapy? What are my prescribing and delegation limits?

Physicians have the broadest scope. NPs and PAs are defined by state law and agreements. RNs are the most restricted and generally require physician delegation. Answer the four questions in writing before you offer anything.

This guide is for educational purposes and does not constitute legal or regulatory advice. State laws and board positions change and vary. Practitioners are responsible for verifying their own scope of practice, the current regulatory status of any product, and applicable law before clinical use. Genademy provides professional education for licensed healthcare practitioners.