Pensacola
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
54- Orthopaedic Surgery
- 54
How orthopedic groups qualify a biologics supplier
Orthopedic practices and surgery centers typically route vendor qualification through a practice manager or compliance contact rather than an individual surgeon. That review commonly asks for a certificate of analysis, a donor eligibility summary, and sterility testing results before a product is added to an approved vendor list.
NPI-verified ordering accounts
Opening an account requires a valid NPI, checked against the NPPES registry before the first order ships. Pricing is not published and is available only to verified accounts. Precision Biologics offers peer-to-peer calls between physicians to walk through product documentation and specifications; these calls address paperwork, not treatment decisions.
Receiving cold-chain shipments along the Gulf Coast
Cryopreserved Wharton's jelly formats (Bio PRP Jelly, Bio Flex, Bio Flow) ship overnight on dry ice in validated containers and need immediate transfer into an on-site -80C freezer on arrival. The lyophilized format, Bio DPM, and both lyophilized exosome products are shelf-stable, which simplifies receiving for a practice without ultra-low freezer capacity.
Documentation and regulatory verification
A practice should independently verify its surgeons' license status with the Florida Board of Medicine or Board of Osteopathic Medicine and have its own counsel review how a specific intended use is classified. Florida's SB 1768, effective July 1, 2025, permits MD/DOs to use certain non-FDA-approved stem cell therapies in orthopedics, wound care, and pain management under informed consent, but it does not change the federal documentation that applies to the product itself. The same certificate of analysis, donor eligibility summary, and lot release record are relevant either way.
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 Precision Biologics work with solo orthopedic practices or only larger groups?+
Accounts are open to any licensed orthopedic practice or surgery center with a valid NPI, regardless of size. No volume commitment is required to open an account.
What documentation should an orthopedic practice request before adding a product to its formulary?+
Request the certificate of analysis, donor eligibility summary, and lot release record for the specific lot. These are available on request for every lot shipped.
How does shipping work for a practice in the Pensacola area?+
Cryopreserved products ship overnight on dry ice in validated containers; lyophilized formats ship at ambient temperature. Confirm someone can receive and store the product immediately on arrival.