Opening an NPI-verified account
Precision Biologics verifies the ordering physician's NPI before releasing pricing or product documentation, which keeps accounts limited to licensed professionals and physician-supervised practices. This is typically the first step a pain management practice completes before any purchasing decision, the same as it would be with any specialty pharmacy or biologics vendor.
San Diego
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
273- Pain Medicine
- 130
- Physical Medicine & Rehabilitation
- 143
What a pain practice's purchasing committee usually reviews
Most practices ask for the certificate of analysis, donor eligibility summary and lot release record for Wharton's jelly products, and for the supplier's characterization data for exosome products, before a purchasing committee signs off. A peer-level conversation about that documentation, not about dosing or protocol, is available on request.
- Certificate of analysis per lot
- Donor eligibility summary
- Lot release record
- Exosome characterization data where applicable
Receiving a shipment on the West Coast
Cryopreserved products are shipped overnight on dry ice in validated containers and are intended for immediate transfer to -80 degree C storage on arrival, a step practices on the West Coast follow the same way practices anywhere else do. Lyophilized exosome products ship shelf-stable and are stored and handled according to the insert included with the lot.
Confirming your practice's regulatory standing
The determination of whether a specific intended use for one of these products fits within applicable federal rules, including 21 CFR 1271.10 for Wharton's jelly products, is a decision for the practice and its own counsel. We recommend verifying your practice's standing directly with the California medical board.
FDA has stated there are no FDA-approved exosome products and that they are generally regulated as biologic drugs, a regulatory posture the physician and counsel should weigh before ordering. These products are not FDA approved or licensed for any disease or condition; information here is for licensed healthcare professionals and is not medical or legal advice.
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 pain management practice in San Diego open a direct account with Precision Biologics?+
Yes, once the ordering physician's NPI is verified. Accounts are limited to licensed clinics, physicians and physician-supervised practices.
What exosome documentation can we review before ordering?+
Verified accounts can request the supplier's characterization data, including ELISA, nanoparticle tracking analysis and SP-IRIS results, along with the certificate of analysis for the specific lot.
Who decides whether a Wharton's jelly product fits our intended use?+
That determination is made by the treating physician and the practice's regulatory counsel, not by Precision Biologics, with reference to 21 CFR 1271.10 and other applicable requirements.