Documentation pain management and physical medicine practices request
Before a pain management or physical medicine practice adds a new biologics vendor, staff typically ask for the same category of records a hospital-based pharmacy or ambulatory center would request: donor screening summary, processing description, and sterility testing tied to the specific lot being shipped.
Precision Biologics makes a certificate of analysis, donor eligibility summary, and lot release record available to verified accounts for every lot. Full ingredient disclosure for exosome products is also available on request.
Philadelphia
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
376- Pain Medicine
- 123
- Physical Medicine & Rehabilitation
- 253
NPI verification and account setup
Opening an account starts with NPI verification against the NPPES registry. This confirms the ordering party is a licensed physician, a group practice, or a clinic operating under physician supervision before any order is processed.
Because exosome products are not FDA approved and are generally regulated as biologic drugs, purchase decisions and any decision about clinical use sit with the ordering physician and that physician's own regulatory counsel.
Receiving shipments into the Philadelphia-Camden-Wilmington region
Cryopreserved Wharton's jelly products are shipped overnight on dry ice in validated containers and moved to -80 degree C storage on arrival. Lyophilized exosome and Wharton's jelly formats are shelf-stable and ship without cryogenic packaging.
Practices generally log each incoming shipment by lot number at receipt, which feeds the lot-level traceability most clinics already maintain at the patient record level.
Medical director and board verification
Pain management and physical medicine groups typically confirm regulatory posture with the Pennsylvania State Board of Medicine, or the applicable osteopathic board, and with independent counsel before incorporating any new biologic into a practice. Precision Biologics supports that process with peer-to-peer physician calls focused on documentation, not clinical advice.
These products are not FDA approved or licensed for any disease or condition. Information on 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
Are Bio Xsomes or other exosome products FDA approved?+
No. The FDA has stated there are no FDA-approved exosome products, and these products are generally regulated as biologic drugs. Purchase and use decisions belong to the ordering physician and their own regulatory counsel.
Can a multi-site pain management group use one account?+
Accounts are tied to a verified NPI. Multi-location groups should contact Precision Biologics to discuss how verification applies across locations.
What is the lead time for cryopreserved orders shipped to Philadelphia?+
Cryopreserved orders ship overnight on dry ice in validated containers once an account is verified and an order is placed; lyophilized formats ship as shelf-stable product.