Florida Chapter 2025-185 (CS/CS/SB 1768)
Stem Cell Therapy – Informational Overview
Florida Chapter 2025-185 (2025), formerly CS/CS/SB 1768, addresses physician administration of certain stem cell therapies under defined statutory conditions.
This page provides a neutral legislative overview for educational purposes only.
Legislative Overview
The statute authorizes licensed physicians in Florida to perform specified stem cell therapies not approved by the United States Food and Drug Administration, subject to defined procedural safeguards.
Effective Date: July 1, 2025.
Key Statutory Requirements
The law includes, among other provisions:
- Performance by a licensed physician
- Execution of a signed informed consent form
- Inclusion of required advertising disclosures
- Documentation of patient acknowledgment prior to treatment
Physicians should review the full statutory language to ensure compliance with disclosure and consent requirements.
Interaction With Federal Regulatory Framework
This Florida statute does not modify, supersede, or preempt applicable federal law, including:
- The Federal Food, Drug, and Cosmetic Act
- 21 CFR Part 1271 (HCT/P regulatory framework)
- Section 351 and Section 361 classification standards
Physicians and clinics remain responsible for compliance with all applicable federal regulatory requirements.
Documentation and Compliance Considerations
Clinics evaluating tissue-based or cellular products should maintain structured documentation supporting:
- Donor eligibility determination where applicable
- Traceability and chain-of-custody controls
- Current Good Tissue Practice (cGTP) standards
- Advertising disclosure compliance
Regulatory alignment requires integrated evaluation of both state and federal requirements.
Related Regulatory Resources
Official Florida Senate Bill Page:
CS/CS/SB 1768 – Stem Cell Therapy
Professional Documentation Access
Not By Chance Life LLC facilitates structured regulatory education and credential-based documentation coordination for licensed healthcare professionals evaluating HCT/P compliance positioning.
Regulatory Notice
State authorization under Chapter 2025-185 does not constitute FDA approval, clearance, or evaluation of safety or effectiveness.
This content is provided for educational purposes only and does not constitute legal or medical advice.