Documentation pain practices typically request
Pain management and physical medicine groups evaluating a biologics source generally start with the certificate of analysis for the lot, a donor eligibility summary, and a description of how the tissue or exosome product was recovered, processed and screened.
For exosome products specifically, the supplier's characterization data — particle concentration, marker identification and the growth-factor and cytokine panel — is reasonable to request as part of a practice's own regulatory review, since exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act rather than as section 361 tissue.
Raleigh
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
96- Pain Medicine
- 43
- Physical Medicine & Rehabilitation
- 53
NPI-verified accounts
Accounts open only after we verify a National Provider Identifier against the NPPES registry. This applies uniformly to pain management and physical medicine practices in Raleigh and every other licensed buyer we work with.
Receiving shipments in the Southeast
Cryopreserved products ship overnight on dry ice in validated containers and need immediate -80 degree C storage; lyophilized formats are shelf-stable per the insert included with the lot. A practice should have a freezer ready and someone assigned to log the lot number when a cryopreserved order is due to arrive.
Verification and support for account setup
Pain management and physical medicine practices should verify their licensure and scope of practice with the North Carolina medical board and their own counsel, including whether a given intended use meets the minimal-manipulation and homologous-use criteria in 21 CFR 1271.10; we do not make that determination or advise on clinical use, dosing or protocols. Precision Biologics handles NPI verification, account setup and documentation delivery, and can set up a peer-to-peer call about paperwork. These products are not FDA approved or licensed for any disease or condition; this page 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 Raleigh pain management practice request characterization data before ordering an exosome product?+
Yes. Supplier-supplied characterization data and the growth-factor panel are available on request to verified accounts for review before a purchasing decision.
Is there a minimum order size for a Raleigh physical medicine practice opening its first account?+
Account setup is based on NPI verification, not order size. Pricing and order details are available to verified accounts.
Who should a Raleigh pain management clinic consult about whether a product fits its intended use?+
Its own counsel and the North Carolina medical board. Precision Biologics provides documentation but does not advise on clinical use or regulatory classification.