Documentation pain and PM&R groups typically request
Pain management and physical medicine practices generally request a certificate of analysis, a donor eligibility summary, and a lot release record before adding a biologics supplier to an approved list, and, for exosome products, the supplier's characterization data.
Precision Biologics makes this available to verified accounts, which supports a practice's own internal vendor qualification rather than replacing it.
- Certificate of analysis
- Donor eligibility summary
- Lot release record
- Supplier characterization data (exosome products)
Santa Barbara
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
40- Pain Medicine
- 21
- Physical Medicine & Rehabilitation
- 19
Where Wharton's jelly and exosome products sit under federal rules
Wharton's jelly products are offered under the supplier's HCT/P framework; whether a given intended use qualifies under 21 CFR 1271.10 is a determination for the practice and its counsel. Exosome products are not offered as 361 HCT/Ps, and the FDA has stated there are no FDA-approved exosome products.
Precision Biologics does not advise on dosing, protocols, or indications for either product family.
NPI-verified accounts
Orders are limited to accounts verified against an NPI number through the NPPES registry, which keeps purchasing restricted to licensed professionals at a specific facility.
Account setup is a short submission of NPI and facility details; pricing is released only once an account is verified.
Shipping to Santa Barbara and account support
Cryopreserved formats ship overnight on dry ice at -80 degrees Celsius in validated containers; lyophilized formats are shelf-stable per the handling instructions supplied with each lot. Each lot carries a unique identifier for tracking at the patient record level.
Precision Biologics supports account setup with peer-to-peer calls about documentation. Practices should route medical director oversight and scope questions to the California medical board and their own counsel.
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
Why does the Pain Medicine and Physical Medicine & Rehabilitation count matter for our account setup?+
It doesn't change account setup; the 40-provider NPPES figure is a registry count as of October 27, 2026, useful for context, not a factor in how your NPI-verified account is processed.
Can our practice request exosome characterization data before ordering?+
Yes. Supplier-reported characterization data, including particle analysis and marker testing, is available to verified accounts on request for exosome products.
Who determines whether a Wharton's jelly product fits our intended pain management use under federal rules?+
That determination belongs to your practice and its own regulatory counsel under 21 CFR 1271.10. Precision Biologics does not advise on clinical use.