Florida's statutory framework and what it does not change
Florida's SB 1768, effective July 1, 2025, permits MD and DO physicians to use certain non-FDA-approved stem cell therapies in pain management, orthopedics and wound care under informed consent and disclosure requirements. It is a state statute governing physician conduct; it does not alter the federal FDA framework that governs the product itself.
Miami pain management practices should confirm with the Florida Board of Medicine and their own counsel how SB 1768 and applicable FDA rules apply to their specific intended use. Precision Biologics does not make that determination.
Miami
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
238- Pain Medicine
- 90
- Physical Medicine & Rehabilitation
- 148
Documentation available before you order
Verified accounts can request a certificate of analysis, donor eligibility summary and lot release record for a given lot, along with full ingredient disclosure for the lyophilized exosome formats.
Account setup and shipment logistics
Account verification confirms an active NPI number before an order ships. Cryopreserved Wharton's jelly products arrive overnight on dry ice in validated containers for -80 degree Celsius storage; lyophilized exosome and Wharton's jelly formats are shelf-stable and ship with a product insert describing handling.
Practices should record the lot number at receipt to maintain patient-record-level traceability.
FDA has stated there are no FDA-approved exosome products. Exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act, not as 361 HCT/Ps. Purchase and clinical use decisions belong to the physician with their own regulatory counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Does SB 1768 apply to every pain management procedure in Miami?+
The statute's scope covers orthopedics, wound care and pain management under specific informed consent and disclosure conditions. Confirm applicability to your specific use with the Florida Board of Medicine and your counsel.
Can our Miami practice get pricing without an NPI number?+
No. Pricing and ordering require a verified NPI number tied to a licensed practice.
What is in the exosome products you distribute?+
Full ingredient disclosures and characterization data are available to verified accounts on request; we do not publish composition details for unverified visitors.