Separating the two product families during vendor review
Pain medicine and physical medicine practices in Washington typically review Wharton's jelly allografts and exosome products on different tracks. Wharton's jelly products are considered against the HCT/P framework and the practice's own determination of minimal manipulation and homologous use under 21 CFR 1271.10. Exosome products are reviewed separately, since FDA has stated there are no FDA-approved exosome products and these are generally regulated as biologic drugs; many practices route that review through counsel before ordering.
Washington
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
167- Pain Medicine
- 43
- Physical Medicine & Rehabilitation
- 124
Account setup tied to the DC Board of Medicine
An account is opened once the ordering physician's NPI has been checked against the NPPES registry. Washington practices should also confirm that the same physician of record is current with the DC Board of Medicine, which is typically part of a practice's own internal approval process for a new vendor rather than something Precision Biologics verifies on a practice's behalf.
Group practices with multiple ordering providers can register each physician separately, which keeps patient-record, lot-level traceability consistent at the clinic.
Receiving cold-chain and shelf-stable shipments
Cryopreserved Wharton's jelly formats and the cord blood-derived exosome product ship overnight on dry ice in validated containers for storage at -80 degrees Celsius, consistent with how shipments move to any address in the Southeast region. The lyophilized Wharton's jelly format and the lyophilized exosome options are shelf-stable and are handled per the product insert included with the lot.
- Log each shipment by lot number against the packing slip
- Store cryopreserved product immediately at -80 degrees Celsius
- Keep lyophilized product per the lot's product insert
- Request the certificate of analysis for any lot received
Documentation and support for verified accounts
Precision Biologics does not advise on dosing, protocols, or clinical indications; that determination sits with the ordering physician and the practice's counsel. These products are not FDA approved or licensed for any disease or condition, and information here is for licensed healthcare professionals and is not medical or legal advice.
Verified accounts can schedule a peer-to-peer call to review product documentation and specifications with Precision Biologics directly.
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
How does Precision Biologics treat Wharton's jelly and exosome orders differently?+
Wharton's jelly allografts are supplied under the HCT/P framework. Exosome products are not FDA approved and are generally regulated as biologic drugs, so we provide separate documentation for that family for a practice's counsel to review.
How many pain medicine and physical medicine providers are registered in Washington, DC?+
NPPES registry data retrieved October 27, 2026 show 43 providers with a primary taxonomy of Pain Medicine and 124 with a primary taxonomy of Physical Medicine and Rehabilitation in Washington. This is a registry count, not a measure of demand.
Does Precision Biologics verify our standing with the DC Board of Medicine?+
No. We verify the ordering physician's NPI against the NPPES registry. Confirming standing with the DC Board of Medicine is part of the practice's own internal vendor approval process.