Lakeland
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
41- Orthopaedic Surgery
- 41
Florida's regulatory environment for cell and tissue products
Florida Statutes 459.0127 (SB 1768, effective July 1, 2025) allows physicians to use certain non-FDA-approved stem cell therapies in orthopedics, wound care, and pain management under informed consent and disclosure requirements set by the statute. That state law does not change federal FDA requirements that apply to the product itself, including how a tissue allograft or exosome product is regulated under section 361 or as a biologic drug.
Precision Biologics does not advise on whether a specific product or intended use qualifies under this statute; that determination belongs to the practice's physicians and their own counsel.
Vendor qualification steps for orthopedic surgery centers
Surgery centers typically fold a new biologics supplier into existing vendor qualification steps: reviewing registration and licensure documentation, requesting lot-specific records, and confirming sourcing and testing practices are documented.
Precision Biologics provides a certificate of analysis, donor eligibility summary, and lot release record for each lot on request, so a center's own compliance team can complete this review independently.
NPI verification and Southeast shipping logistics
Setting up an account requires a valid National Provider Identifier; pricing is shared only with verified accounts. Cryopreserved products ship overnight on dry ice in validated containers for storage at -80 degrees Celsius, and a Lakeland-area center should document receipt - dry ice condition, lot number, and time into storage - as part of its intake process.
Getting started
Account setup covers NPI verification, documentation delivery, and access to peer-to-peer calls focused on product paperwork, not clinical advice. We recommend confirming your intended use with the Florida medical board and your own counsel before adding a new product category to your practice.
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 Florida SB 1768 mean Precision Biologics products are approved for orthopedic use?+
No. SB 1768 addresses how Florida-licensed physicians may use certain non-FDA-approved stem cell therapies under state informed consent rules; it does not change federal FDA requirements on the product itself. Confirm applicability with your counsel.
Can an orthopedic surgery center in Lakeland open a single account for multiple surgeons?+
Yes. A practice typically designates one administrator to manage NPI verification and ordering for all providers under the account.
How quickly do cryopreserved shipments arrive in the Lakeland area?+
Cryopreserved products ship overnight on dry ice in validated containers; your receiving staff should confirm dry ice condition and lot number on arrival and move product into -80 degree Celsius storage promptly.