What documentation accompanies each order
Pain management and physical medicine groups typically ask for lot-specific records before adding a new biologics line: a certificate of analysis, a donor eligibility summary, and a lot release record. Precision Biologics makes these available on request so a practice's compliance file reflects the specific lot received rather than a generic product description.
- Certificate of analysis for the shipped lot
- Donor eligibility summary
- Lot release record
- Supplier-reported characterization data for exosome products
Salem
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
29- Pain Medicine
- 9
- Physical Medicine & Rehabilitation
- 20
Setting up an NPI-verified account
Ordering requires an NPI number at account setup. For a pain management practice with multiple associates, one account can be tied to the supervising physician's NPI while additional staff are added as authorized ordering contacts.
Verification happens once; after that, reordering is straightforward and pricing, which is never published publicly, is shared directly with the verified account.
Cold-chain receiving in Oregon and the wider West
Cryopreserved Wharton's jelly ships overnight on dry ice in validated containers and should move directly into -80 degree C storage on arrival. Practices in the Salem area should assign a receiving contact and keep a short log of arrival time, dry ice remaining, and storage placement for each shipment.
Lyophilized exosome formats are shelf-stable and do not require this step, which some multi-location practices use to simplify stocking at smaller satellite offices.
Vendor review and medical-director sign-off
Before a pain management group adds a new supplier, most route the decision through a medical director for sign-off and confirm the regulatory posture of each product category with the Oregon Medical Board and the practice's own counsel. FDA has stated that no exosome product currently holds FDA approval, and Precision Biologics does not make clinical recommendations; peer-to-peer calls are limited to product documentation.
Our team supports new accounts through NPI verification, documentation requests, and first-shipment logistics so the practice can complete its internal review on its own timeline.
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 Salem, Oregon pain management practice order exosome products from Precision Biologics?+
Yes, through a verified account. No exosome product currently holds FDA approval; clinical use decisions rest with the treating physician and their counsel.
How does a multi-provider practice set up one account?+
One NPI-verified account can be established for the supervising physician, with additional ordering contacts added at setup.
What should a Salem practice confirm before its first order?+
Confirm the regulatory posture of the intended use with the Oregon Medical Board and your own counsel, and request the certificate of analysis and lot release record for the specific lot being shipped.