What Is SB 1768? Florida's Stem Cell Law in 3 Patient-Facing Points

Florida Senate Bill 1768 is a state law, effective July 1, 2025, that establishes the legal framework authorizing non-FDA-approved stem cell therapies in Florida under defined physician-supervised conditions. Three requirements determine whether a provider is operating under SB 1768 compliance.

Point 1: Physician Supervision Is Mandatory

SB 1768 requires that non-FDA-approved stem cell therapy be supervised by a Florida-licensed physician holding a Chapter 458 (MD) or Chapter 459 (DO) license. Nurse practitioners, physician assistants, and other advanced practice providers cannot independently administer stem cell therapy under this law. The physician supervision requirement means a real physician, with the appropriate Florida license, is clinically overseeing the protocol.

At Rebuild Regen Medical Clinic, [MD_PLACEHOLDER] MD is the Medical Director and holds the required Florida physician license. [MD_PLACEHOLDER] MD supervises all stem cell protocols.

Point 2: Written Informed Consent Is Required

SB 1768 requires that patients provide written informed consent before receiving stem cell therapy. The consent must acknowledge that the therapy is not FDA-approved, that the therapy is investigational, and that the patient is voluntarily choosing to proceed with understanding of the risks, benefits, and alternatives.

This is not a form signature at the front desk. It is a clinical consent process that includes a discussion of the investigational status of the treatment. At Rebuild Regen, the informed consent process is part of the consultation before any stem cell treatment is scheduled.

Point 3: The Clinical Setting Must Meet Applicable Requirements

The clinical setting where stem cell therapy is administered must meet state and federal facility standards. For Rebuild Regen Medical Clinic at 3320 N Federal Hwy #101, Lighthouse Point, FL, this means a licensed medical office facility using biologics registered under 21 CFR Part 1271 (the FDA's HCT/P framework).

For a complete patient resource on SB 1768, see the Florida Stem Cell Law SB 1768 page.

Why SB 1768 Compliance Should Matter to Patients

A provider who offers stem cell therapy in Florida without physician supervision, without proper informed consent, or in an unqualified setting is not SB 1768 compliant. Patients should ask directly: Who is the supervising physician? What is their Florida license number? Was my consent form specific to the investigational status of the therapy? These are reasonable questions that any compliant provider will answer clearly.

Contact Rebuild Regen at (954) 953-4208 or visit 3320 N Federal Hwy #101, Lighthouse Point, FL 33064.