Confirming regulatory standing before ordering
Pain management and physical medicine groups that add a biologics line typically start by confirming their own house is in order: that the ordering physician's license is active with the North Carolina Medical Board, and that whoever is making the purchasing decision has looped in the practice's compliance counsel on how a given product fits their intended use.
That review happens on the practice side. Precision Biologics does not advise on licensure or on how a specific use should be classified under federal rules; we provide the underlying product documentation so the practice and its counsel can make that call.
Winston-Salem
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
11- Pain Medicine
- 7
- Physical Medicine & Rehabilitation
- 4
Receiving cold-chain shipments
Cryopreserved Wharton's jelly and exosome products ship overnight on dry ice in validated containers; lyophilized formats arrive shelf-stable and are handled differently on receipt. A practice's first order is a reasonable time to confirm who on staff checks an inbound shipment against its lot number before it is logged into inventory.
We coordinate delivery timing with the practice rather than shipping to an unconfirmed address, which matters for multi-location pain management groups that route deliveries to a single receiving site.
NPI-verified ordering
Accounts are opened against an NPI number, not a general business address. That keeps ordering tied to a licensed provider and mirrors how most pain management practices already track product by lot at the patient record level internally.
How we support account setup
A new account starts with a short intake covering the practice name, NPI, and a physician point of contact, followed by a documentation exchange. Certificates of analysis, donor eligibility summaries, and lot release records are available on request. From there, ongoing support is limited to documentation and logistics questions; clinical and dosing decisions stay with the treating physician.
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
Is Bio Flex or Bio Flow available in a format suited to our practice?+
Format and documentation vary by product and lot. Bio Flex and Bio Flow are supplied as 1 mL and 2 mL vials with lot-specific documentation; the practice and its clinical staff determine which format and use fit their own protocols.
How does a Winston-Salem practice confirm it qualifies for an account?+
Account qualification is based on NPI verification and practice documentation, not location. Any licensed pain management or physical medicine practice can start the same intake process.
What happens if our practice has more than one location in the region?+
Each receiving location should be confirmed during intake so shipments and lot documentation are routed to the correct site.