Documentation pain and rehab practices typically request
Before adding a biologics vendor, a pain management or physical medicine practice commonly asks for the certificate of analysis tied to a specific lot, a donor eligibility summary, and confirmation that the lot was held in quarantine until third-party sterility testing cleared.
- Certificate of analysis, by lot
- Donor eligibility summary
- Lot release record
- Supplier characterization data for exosome formats, on request
Hartford
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
41- Pain Medicine
- 13
- Physical Medicine & Rehabilitation
- 28
Receiving shipments into the Northeast
Cryopreserved Wharton's jelly formats ship overnight on dry ice in validated containers and are stored at -80 degrees C on arrival. For practices without dedicated ultra-low freezer space, the lyophilized Wharton's jelly product and both lyophilized exosome products are shelf-stable and handled per the insert supplied with the lot.
NPI verification and account setup
A Pain Medicine or Physical Medicine & Rehabilitation practice opens an account the same way any licensed practice does: by verifying an NPI and designating which staff are authorized to order. Precision Biologics can walk a medical director or office manager through the documentation available for a given lot as part of setup.
Confirming regulatory posture
Precision Biologics does not provide clinical, dosing, or procedural guidance. Exosome products are not FDA approved, and whether a given use of a Wharton's jelly product falls within 21 CFR 1271.10 is a determination for the treating physician and counsel, confirmed as needed with the Connecticut medical board.
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
Do Pain Medicine and Physical Medicine & Rehabilitation practices go through the same account process?+
Yes. Account verification is based on a practice's NPI rather than its specific taxonomy, so the setup process is the same across both.
What if our practice doesn't have cold storage for cryopreserved products?+
A lyophilized Wharton's jelly format and two lyophilized exosome products are shelf-stable and do not require cryogenic storage; they are handled per the insert supplied with the lot.
Can our medical director speak with someone about the documentation before we order?+
Yes. Precision Biologics offers physician-level conversations about product documentation as part of account setup; this is not clinical advice.