Documentation pain management and PM&R practices typically request
Because pain management and physical medicine practices often work across multiple product families, documentation requests commonly span both the Wharton's jelly and exosome categories: a certificate of analysis per lot, a donor eligibility summary, and a lot release record showing the quarantine and sterility testing result before release.
For exosome products specifically, practices should also request the supplier's characterization data, since FDA has stated there are no FDA-approved exosome products and these are generally regulated as biologic drugs under section 351.
Boston
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
295- Pain Medicine
- 146
- Physical Medicine & Rehabilitation
- 149
Verified account setup
An NPI number checked against NPPES is required to open an account, whether the practice bills as pain medicine, physical medicine and rehabilitation, or both. Verification is a one-time setup step; it does not need to be repeated per order.
Receiving shipments in the Northeast
Cryopreserved lots ship overnight on dry ice in validated containers after slow-rate freezing and storage at -80 degrees Celsius; lyophilized formats ship at ambient temperature per the product insert. Practices should assign someone to confirm the shipment on arrival and record the lot number against the patient file, which supports the lot-level traceability expected of HCT/P handling.
- Confirm dry ice and packaging integrity at receipt
- Record lot number per patient record
- Retain shipment documentation alongside the certificate of analysis
Board and counsel verification
Intended-use and regulatory questions, including whether a given use falls under 21 CFR 1271.10 or how an exosome product should be treated under section 351, are determinations for the practice and its counsel. Boston-area pain management and PM&R practices should confirm their own posture with the Massachusetts Board of Registration in Medicine before adding any new biologics vendor.
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 physical medicine and rehabilitation practice and a pain medicine practice share one account?+
Account verification is based on the NPI number submitted, so this depends on how your practice is structured and billed. Contact us to confirm the right account setup for a multi-specialty group.
What records do you provide for exosome products specifically?+
Supplier-reported characterization data, including ELISA, nanoparticle tracking analysis, and SP-IRIS results, along with a full ingredient disclosure, are available to verified accounts, plus the certificate of analysis for each lot.
Do you offer clinical guidance on dosing or injection protocol?+
No. Precision Biologics provides product documentation and account support; dosing, technique, and protocol decisions belong to the treating physician and the practice's own regulatory counsel.