Documentation pain management and physical medicine groups typically request
Pain management and physical medicine practices considering a Wharton's jelly or exosome product generally ask for the certificate of analysis tied to the specific lot, a donor eligibility summary, and, for exosome formats, the available characterization data such as particle concentration and marker testing.
Because exosome products are not FDA-approved and are generally regulated as biologic drugs, we state this plainly to every account and direct clinical use and regulatory questions to the practice's own physician and counsel rather than offering guidance ourselves.
Tallahassee
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
28- Pain Medicine
- 16
- Physical Medicine & Rehabilitation
- 12
NPI-verified ordering accounts
Every Precision Biologics account is tied to a National Provider Identifier verified through the NPPES registry. For a multi-provider pain management group, we ask the practice to designate which licensed provider or medical director is the account's ordering physician of record.
Receiving shipments in the Southeast
Cryopreserved Wharton's jelly formats are shipped overnight on dry ice in validated containers and tracked by lot from release through delivery. Lyophilized exosome and Wharton's jelly formats ship at ambient temperature with handling instructions in the product insert.
We ask Tallahassee practices to confirm a staffed receiving window in advance of any cryopreserved shipment so the product is not left at an unattended location.
Confirming licensure and account setup support
We ask every Florida account to verify its own licensure directly with the Florida Board of Medicine or Board of Osteopathic Medicine and to confirm with its own counsel how a given intended use is classified under federal tissue regulations.
Our account team can schedule a physician-level call to walk through available documentation for a product under consideration; this call addresses documentation and sourcing questions only and is not clinical 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
Can a physical medicine and rehabilitation practice in Tallahassee open an account directly?+
Yes, provided the ordering provider's NPI can be verified through NPPES and the practice confirms its own state licensure. Accounts are limited to licensed physicians and clinics operating under physician supervision.
Are exosome products like Bio Xsomes FDA approved?+
No. The FDA has stated there are no FDA-approved exosome products, and these products are generally regulated as biologic drugs. Decisions about purchase and use rest with the ordering physician and their own regulatory counsel.
What should a group practice request before adding a product for use by multiple providers?+
Verified accounts can request the certificate of analysis for the applicable lot, donor eligibility documentation, and, where relevant, available particle characterization or ingredient disclosure before any provider begins using a product.