Setting Up an NPI-Verified Ordering Account
Pain management and physical medicine practices open an account the same way any licensed professional does: by providing an NPI number tied to the ordering provider. Precision Biologics does not sell to the public, and account access is gated on that verification step before any order can be placed.
Group practices with multiple pain physicians can register under the practice NPI, with individual providers added as the account is reviewed.
Memphis
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
81- Pain Medicine
- 32
- Physical Medicine & Rehabilitation
- 49
Documentation a Practice Should Request Before Ordering
Before a pain management practice adds a new biologics category to its purchasing, most compliance staff ask for lot-specific paperwork rather than general marketing material.
Precision Biologics makes this documentation available to verified accounts, and offers peer-to-peer calls where a physician can discuss the paperwork directly - these calls cover documentation, not clinical use.
- Certificate of analysis for the specific lot
- Donor eligibility and screening summary
- Sterility testing results from the third-party lab
Receiving Cold-Chain Shipments in the Memphis Region
Cryopreserved products ship overnight on dry ice in validated containers and are stored at -80 degrees C prior to shipment; that cold-chain standard applies to deliveries into Memphis the same as anywhere else Precision Biologics ships.
Each lot has a unique identifier, so staff receiving a shipment can log it against that lot number for the practice's own traceability records.
Confirming Regulatory Posture for Exosome and Tissue Products
Exosome products are not FDA approved, and FDA has stated there are no FDA-approved exosome products on the market; these products are generally regulated as biologic drugs. Whether a tissue allograft qualifies under the section 361 framework for a specific intended use is a determination the practice makes with its own counsel, not something a supplier can certify.
Memphis-area practices should verify their regulatory posture with the Tennessee medical board and qualified legal counsel before adding either product category to their purchasing.
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 exosome products FDA approved?+
No. FDA has stated there are no FDA-approved exosome products, and these products are generally regulated as biologic drugs under section 351. Any purchasing or clinical-use decision involving exosome products should be made with your own regulatory counsel.
Does a multi-provider pain practice need separate accounts for each physician?+
Accounts are organized around a verified NPI, so a group practice can typically register under one practice-level account and add individual ordering providers as they are verified.
How are lots tracked once a shipment arrives at a Memphis practice?+
Each lot carries a unique identifier assigned before release; practices use that identifier for their own internal, patient-level traceability records after receiving a shipment.