Stem Cell Bill Florida

• National Marrow Donor Program (NMDP)
• World Marrow Donor Association (WMDA)
• Association for the Advancement of Blood and Biotherapies (AABB)
• American Association of Tissue Banks (AATB)

(3) In the performance of any procedure using or purporting to use stem cells or products containing stem cells, the health care provider shall adhere to the applicable current good manufacturing practices for the collection, removal, processing, implantation, and transfer of stem cells, or 1products containing stem cells, pursuant to the Federal Food, 109 Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 110 et seq.; and 21 C.F.R. part 1271, Human Cells, Tissues, and 111 Cellular and Tissue-Based Products.

Under SB 1768, the use of products that do not meet these requirements is not permitted. Providers are responsible for verifying that all products used are sourced from facilities that meet these standards. 

Patient Communication Requirements

Under SB 1768, physicians must follow specific disclosure and documentation procedures before administering non-FDA-approved stem cell therapy.

 Written Disclosure

Before treatment, the provider must present each patient with a written notice using the exact statutory language. This notice must be provided in the clinic, displayed clearly in the office, and printed in a legible font size. The required text is:

THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This health care practitioner performs one or more stem cell therapies that the United States Food and Drug Administration has not yet approved. You are encouraged to consult with your primary care provider before undergoing anystem cell therapy.”

Advertising Requirements

Any advertisement or promotional material for the therapy must include the same statutory notice in a font size no smaller than the largest text used in the advertisement. This requirement applies to all digital, print, and in-office signage formats.

Informed Consent

Physicians must obtain signed informed consent from the patient before treatment. The consent form must include the following:

1. A clear explanation of the nature and character of the proposed treatment, including its FDA approval status.
2. A description of the anticipated results of the proposed treatment.
3. A list of recognized possible alternative forms of treatment:
4. A full disclosure of recognized serious possible risks, complications, and anticipated benefits involved in the treatment and the recognized possible alternative forms of treatment, including nontreatment: Patients must be encouraged to consult their primary care physician (PCP) before undergoing any stem cell therapy.

Enforcement and Penalties

The Florida Department of Health is responsible for implementing and enforcing SB 1768. The Department is tasked with adopting rules to operationalize the statute and ensure provider compliance.Violations of any provision of the law may result in disciplinary action by the appropriate licensing board or regulatory agency. This includes failure to meet standards related to patient consent, advertising, clinical eligibility, product sourcing, or documentation.The statute exempts providers participating in FDA-approved investigational drug or device trials, or those operating under contract with accredited institutions recognized for their expertise in stem cell therapy. Providers outside these exemptions must fully comply with the statute to avoid disciplinary consequences.

Why RegenOMedix™?

RegenOMedix™ supplies adult-derived stem cell and exosome products, including those sourced from umbilical cord blood or Wharton’s Jelly, for use in accordance with Florida Senate Bill 1768. The U.S. Food and Drug Administration does not approve these therapies for general therapeutic use. Still, licensed physicians may administer them in Florida when all statutory conditions are met.

All products are processed in FDA-registered, cleanroom facilities that adhere to Current Good Manufacturing Practices (cGMP) and are accredited by organizations recognized in the statute, such as the American Association of Tissue Banks (AATB), Association for the Advancement of Blood & Biotherapies (AABB), and the National Marrow Donor Program (NMDP).

Each batch is accompanied by a Certificate of Analysis and a post-thaw viability report, confirming compliance with Florida’s sterility, potency, and clinical traceability standards.

Under SB 1768, physicians may only administer stem cell therapies using products sourced from facilities registered and accredited by the FDA. RegenOMedix™ offers biologics that meet these sourcing and documentation requirements, enabling providers to operate confidently within the bounds of Florida law.

For clinical or regulatory inquiries regarding SB 1768-compliant stem cell products, please get in touch with RegenOMedix™ directly.

View the full text of SB 1768: https://www.flsenate.gov/Session/Bill/2025/1768.