How pain and rehabilitation practices vet a new supplier
Pain management and physical medicine groups that bring in regenerative biologics typically start with a documentation review rather than a sample order: donor eligibility screening, processing timeline, and third-party sterility testing results for the lot in question. A practice operating under multiple physicians often routes this review through a medical director before any purchase order is cut.
Precision Biologics keeps this documentation attached to the lot, not the product line in general, so a practice can request a certificate of analysis and a lot release record for the specific lot it intends to order rather than a generic data sheet.
Louisville
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
182- Pain Medicine
- 89
- Physical Medicine & Rehabilitation
- 93
Account verification and ordering
Orders are limited to accounts verified against an NPI number through the NPPES registry. This gives a multi-physician practice a consistent onboarding record and keeps ordering authority with licensed staff rather than general administrative accounts.
Shipping and storage for a Louisville practice
Cryopreserved Wharton's jelly formats ship overnight on dry ice in validated containers and are held at -80 degrees C once they arrive, so a practice should have a freezer and a logging step ready before the first order lands. Lyophilized formats, including the freeze-dried Wharton's jelly product and the lyophilized exosome products, are shelf-stable and store without a cryogenic step, which gives a practice flexibility in how much freezer capacity it needs to commit.
Regulatory posture and setup support
Exosome products are not FDA-approved; FDA has stated there is no FDA-approved exosome product on the market, and these products are generally regulated as biologic drugs. Whether a given use of a Wharton's jelly allograft meets the minimal-manipulation and homologous-use criteria under 21 CFR 1271.10 is a determination the practice and its counsel make, not something a distributor certifies. A practice should also verify its physicians' standing directly with the Kentucky medical board as part of its own compliance process.
Precision Biologics supports account setup with physician-level calls focused on product documentation and an NPI-based verification step for new accounts, rather than clinical guidance.
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
Our practice has several physicians. Can each one hold a separate account?+
Each account is tied to an individual verified NPI number, so a multi-physician practice can set up a separate account per physician or route ordering through whichever physician the practice designates.
What happens if a lot's sterility testing isn't complete yet?+
Each lot is held in quarantine until third-party sterility testing and internal release criteria are met. Documentation reflects the specific lot shipped, not a general product average.
Do you provide guidance on injection technique or protocols?+
No. Precision Biologics distributes products and documentation. Decisions about technique, protocol, and intended use are made by the ordering physician and their own regulatory counsel.