Compliance
The legal basis for this line is Florida Statutes 458.3245 (allopathic) and 459.0127 (osteopathic), created by CS/CS/SB 1768, effective July 1, 2025. This page holds the statute references, the advertising notice the physician must carry, the consent elements the physician must obtain, and the federal status statement.
Federal status
Federal law has not changed. The United States Food and Drug Administration treats these products as unapproved biologics, and the Florida statute does not bind FDA. The statute authorizes the physician only. It says nothing about suppliers and does not change federal law. A factual, gated, statute compliant catalog reduces that exposure without removing it.
Advertising notice, section 5
Any advertisement by the physician for the therapy must carry this text, clearly legible, in type no smaller than the largest type in the advertisement. Copy it as written.
THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.
Consent form, section 6
Signed by the patient or representative before the procedure, in plain language, covering the five elements below. The physician completes each section for their own practice and indication. We do not pre fill anticipated results or benefits; that is the physician's clinical statement.
1. The nature and character of the treatment
2. That the therapy has not yet been approved by the United States Food and Drug Administration
3. The anticipated results
4. The recognized serious risks, complications, and anticipated benefits of the treatment and of the alternatives, including no treatment
5. That the patient is encouraged to consult their primary care provider first
Supply agreement, section 3(c)
The supply agreement contains the facility disclosure block: the facility's name and address, its accrediting body, the type and scope of accreditation, the effective and expiration dates, and any limitations. It also contains the 30 day notice obligation on any change in the facility's status. Counsel drafts the agreement; the statute lists what it must contain.
This page is a plain language summary, not legal advice. The physician remains responsible for compliance with the statute in their own practice.
Products supplied under Florida Statutes 458.3245 and 459.0127. Not approved by the United States Food and Drug Administration.