Miami
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
193- Orthopaedic Surgery
- 193
Vendor qualification steps for Miami orthopedic accounts
Orthopedic practices and ambulatory surgery centers generally qualify a new biologics vendor by requesting a certificate of analysis, a donor eligibility summary and confirmation of third-party sterility testing for the specific lot being purchased.
Precision Biologics provides this documentation to verified accounts, along with a lot release record showing the lot cleared quarantine and internal release criteria.
Florida's regulatory landscape
Florida enacted SB 1768, effective July 1, 2025, which allows MD and DO physicians to use certain non-FDA-approved stem cell therapies in orthopedics, wound care and pain management with informed consent and required disclosures. The statute does not override federal FDA regulation of the product itself, and it does not change how Precision Biologics classifies or markets any product.
Miami practices should confirm how SB 1768 and applicable federal HCT/P or biologic drug rules apply to their specific intended use with the Florida Board of Medicine and their own counsel; we do not make that determination for a practice.
NPI-verified accounts and receiving shipments
Ordering requires an active NPI number tied to a licensed practice. Cryopreserved formats ship overnight on dry ice in validated containers for storage at -80 degrees Celsius on arrival; lyophilized formats are shelf-stable and arrive with a product insert covering storage and reconstitution.
Miami practices should log the lot number on receipt and confirm storage conditions promptly, consistent with lot-level traceability.
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 mean Precision Biologics products are FDA-approved stem cell therapies?+
No. SB 1768 addresses how certain Florida physicians may use non-FDA-approved products in specific settings; it does not change the FDA approval status of any product. Our Wharton's jelly products are not labeled as stem cell therapies.
What documentation should a Miami orthopedic practice request before ordering?+
Verified accounts can request a certificate of analysis, donor eligibility summary and lot release record for the specific lot.
Do you advise on how SB 1768 applies to our practice?+
No. We recommend confirming applicability with the Florida Board of Medicine and your own legal counsel; Precision Biologics does not provide legal or clinical advice.