El Paso
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
94- Orthopaedic Surgery
- 94
Vendor Qualification for Orthopedic Groups
Orthopedic practices and surgery centers typically route a new biologics vendor through a medical director or value analysis review before it reaches an approved list. That review tends to focus on whether the sourcing description, lot documentation format, and ordering process hold up to scrutiny, rather than on marketing claims.
- Sourcing and donor screening description
- Lot documentation format (certificate of analysis, lot release record)
- Shipping and storage requirements
- Replacement policy for temperature excursions in transit
NPI-Verified Accounts
Orders are limited to licensed professionals, and account setup requires an NPI number that can be checked against the public NPPES registry. This is the same verification step applied to every orthopedic account Precision Biologics opens, regardless of region.
Shipping and Cold-Chain Handling to the Southwest
Cryopreserved Wharton's jelly products such as Bio PRP Jelly are stored at -80C and ship overnight on dry ice in validated containers. Longer transit distances and higher ambient temperatures common to Southwest deliveries make scheduled, attended receiving important, so a dry ice shipment isn't left sitting past its validated window. Lyophilized Bio DPM, by contrast, is shelf-stable and doesn't require cold-chain receiving, which can simplify logistics for practices farther from a shipping hub.
Confirming Regulatory Fit With Counsel
Whether a specific Wharton's jelly product and intended use meets the minimal manipulation and homologous use criteria under 21 CFR 1271.10 is a determination for the practice's medical director and legal counsel, not Precision Biologics. For exosome products, FDA has stated that no exosome product is currently FDA-approved, and these are generally regulated as biologic drugs under section 351. Practices adding either product family are encouraged to verify their internal policy with the Texas Medical Board and their own counsel before proceeding.
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 ship Wharton's jelly and exosome products to El Paso, TX?+
Yes. Shipments go to verified accounts anywhere in the United States, including El Paso. Cryopreserved items ship overnight on dry ice in validated containers; lyophilized formats ship shelf-stable.
What documentation should our orthopedic practice request before adding a product to our formulary?+
A certificate of analysis, donor eligibility summary, and lot release record are available on request. Precision Biologics also offers peer-to-peer physician calls focused on documentation questions, not clinical advice.
Who decides whether a Wharton's jelly product qualifies as a section 361 HCT/P for our intended use?+
That determination belongs to the practice and its legal counsel under 21 CFR 1271.10. Precision Biologics does not make that determination on a clinic's behalf.