Eligibility
Florida Statutes 458.3245 and 459.0127 authorize an MD or DO to perform stem cell therapy not approved by FDA only when all of the following hold. These are the tests every product in the catalog and every account on this site must meet.
The three statute tests
- Scope. The use is within the physician's scope of practice and relates to orthopedics, wound care, or pain management. Nothing else. Not aesthetics, not hair, not skin, not anti aging, not sexual wellness, not neurology.
- Facility. The cells were retrieved, manufactured, and stored in a facility registered and regulated by FDA, and certified or accredited by one of four named bodies: the National Marrow Donor Program, the World Marrow Donor Association, the Association for the Advancement of Blood and Biotherapies, or the American Association of Tissue Banks.
- Live cells. The product contains viable or live cells on post thaw analysis, and a post thaw viability analysis report for the product lot is delivered to the physician before use.
Two consequences
Exosome and secretome injectables do not qualify. The statute's definition of covered products excludes secreted or extracted human products, and the third test requires live cells on post thaw analysis. An exosome or secretome vial contains no live cells by design. Those products have no state law cover and are not in this catalog.
The manufacturer is disclosed by law. Section 3(c) requires the physician's supply contract to include the facility's name and address, its accrediting body, the type and scope of accreditation, the effective and expiration dates, any limitations, and a 30 day notice obligation on any change in status. On this line the physician receives the manufacturer's name and paperwork.
Who can buy
- A Florida license under chapter 458 (MD) or chapter 459 (DO), verified against the Florida Department of Health license lookup at signup and re verified quarterly.
- Nurse practitioners, physician assistants, chiropractors, naturopaths, and med spa owners are not eligible under the statute, even with a supervising physician.
- A declared scope of orthopedics, wound care, or pain management, with the physician's attestation that use will stay within it. Practices whose website or stated focus is aesthetics are refused.
- A signed supply agreement containing the section 3(c) facility disclosures and the 30 day status change notice, plus the physician's attestation to provide the section 5 advertising notice and obtain the section 6 consent.
- No shipment to any address other than the licensed practice location.
Products supplied under Florida Statutes 458.3245 and 459.0127. Not approved by the United States Food and Drug Administration.