What documentation to request before ordering
Pain management and physical medicine practices generally ask a new biologics supplier for the certificate of analysis for the specific lot, a donor eligibility summary, and a lot release record confirming the lot cleared third-party sterility testing and internal release criteria.
Precision Biologics provides this documentation to verified accounts and can arrange a peer-to-peer conversation between a physician and Precision Biologics about the documentation; this is not clinical or legal advice.
St. Louis
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
190- Pain Medicine
- 72
- Physical Medicine & Rehabilitation
- 118
Confirming regulatory posture before purchase
Exosome products are regulated as biologic drugs under section 351 of the Public Health Service Act, and the FDA has stated there are no FDA-approved exosome products. For Wharton's jelly products, whether a given intended use meets the section 361 criteria in 21 CFR 1271.10 is a determination the practice and its own counsel make.
Practices should also confirm any licensing or scope-of-practice questions with the Missouri State Board of Registration for the Healing Arts and their own counsel.
NPI-verified accounts and ordering
Account setup requires an NPI number, checked against the NPPES registry, along with practice contact details. Orders are restricted to licensed physicians and practice entities.
Cold-chain receiving for Midwest practices
Cryopreserved products ship overnight on dry ice from -80 degree C storage in validated containers; lyophilized products ship shelf-stable. Each unit carries a lot identifier so the receiving practice can log it at the patient record level for traceability.
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 St. Louis pain management practice order Wharton's jelly and exosome products together?+
Yes, both product families are available to the same verified account, each with separate lot documentation.
Are exosome products FDA-approved for pain management use?+
No. The FDA has stated there are no FDA-approved exosome products. Purchase and use decisions remain with the treating physician and their own regulatory counsel.
What state-level verification should a Missouri pain management practice complete before ordering?+
Confirm licensing and scope-of-practice questions with the Missouri State Board of Registration for the Healing Arts and your own counsel; Precision Biologics does not make this determination.