Documentation pain practices typically request
Pain management and physical medicine groups that bring on a new tissue or biologics vendor generally ask for the same baseline paperwork a hospital-affiliated program would: a certificate of analysis tied to the specific lot, a donor eligibility and screening summary, and a record showing the lot cleared sterility testing before release.
Some practices also ask whether registration and licensure documentation for the supplier can be made available for independent review. Precision Biologics makes that available to verified accounts rather than publishing it broadly.
Lincoln
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
38- Pain Medicine
- 10
- Physical Medicine & Rehabilitation
- 28
Opening an NPI-verified account
An account requires a licensed physician's NPI number, confirmed against the public registry, before pricing or ordering access is granted. Group practices with multiple providers typically register under the supervising physician who will be responsible for the account.
Receiving shipments and holding cold chain
Cryopreserved products arrive by overnight shipment on dry ice in a validated container and are stored at -80 degrees Celsius on arrival. Front-desk or clinical staff receiving the shipment should check that the container held temperature and log the lot number before the product goes into storage.
Lyophilized exosome and Wharton's jelly formats ship without that cold-chain requirement and are stored per the insert that accompanies each lot.
Confirming classification with the Nebraska medical board and counsel
Whether a specific use of a Wharton's jelly product is expected to meet the minimal manipulation and homologous use criteria in 21 CFR 1271.10 is a question for the practice's own counsel and the Nebraska medical board, not for Precision Biologics.
Physicians who want to talk through a lot's documentation, rather than its clinical use, can request a peer-to-peer call.
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
Can a multi-provider pain management group open one account for all its physicians?+
Accounts are tied to a supervising licensed physician's NPI number; group practices generally register under that physician and manage ordering centrally from there.
Is pricing listed for Wharton's jelly and exosome products?+
No. Pricing is available only to verified accounts after NPI confirmation.
Who can confirm whether our use case fits the federal framework for these products?+
Your own healthcare counsel and the Nebraska medical board are the appropriate parties to make that determination; Precision Biologics does not provide clinical or legal advice.