Documentation pain management groups typically request
Pain management and physical medicine groups in this region commonly ask for the same core documentation before opening an account: a certificate of analysis for the lot in question, a donor eligibility summary, and a lot release record showing the product cleared quarantine and third-party sterility testing.
Because a pain management practice may carry both Wharton's jelly and exosome products on its formulary, it is common for the compliance lead to request documentation on both product families separately, since the two carry distinct regulatory frameworks.
Denver
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
109- Pain Medicine
- 26
- Physical Medicine & Rehabilitation
- 83
NPI verification and multi-provider accounts
A practice with several physical medicine providers under one tax ID can register a single account verified against the group's NPI number, or separate accounts per prescribing physician if that better matches its internal recordkeeping. Precision Biologics confirms NPI status through the public NPI Registry before activating any account.
Receiving cold-chain shipments in the West region
Cryopreserved Wharton's jelly and cord blood-derived exosome products ship overnight on dry ice in validated containers and must move to -80 degree C storage promptly on arrival; lyophilized exosome formats are shelf-stable and do not require that step. Each lot carries its own identifier so a clinic's intake staff can match the shipment to its certificate of analysis on receipt.
Confirming regulatory posture before ordering
Whether a specific intended use for a Wharton's jelly product falls under the minimal manipulation and homologous use criteria in 21 CFR 1271.10 is a determination for the clinic and its counsel, not something Precision Biologics can advise on. Exosome products are generally regulated as biologic drugs, and FDA has stated there are no FDA-approved exosome products; practices should confirm their own regulatory posture with the Colorado medical board and counsel before adding either product family to formulary.
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 multi-provider pain management group in Denver use one account for all its physicians?+
Yes, accounts can be opened at the group level and verified against a single NPI number, or split by individual prescriber if your practice prefers separate lot traceability per provider.
Are Wharton's jelly and exosome products regulated the same way?+
No. Wharton's jelly products are offered under the supplier's HCT/P framework, while exosome products are generally regulated as biologic drugs; confirm which applies to your intended use with your counsel before ordering.
What should our intake team check when a shipment arrives?+
Match the lot identifier on the shipment to the certificate of analysis, confirm cryopreserved product goes directly into -80 degree C storage, and log the lot against the patient record for traceability.