Documentation Pain Management Groups Typically Request
Each tissue lot carries a unique identifier and is held in quarantine until a sample has been sent to a third-party laboratory for sterility testing and internal release criteria are met. Practices evaluating a new vendor commonly ask to see how that process is documented before the first order.
- Certificate of analysis
- Donor eligibility summary
- Lot release record
- Sterility testing confirmation
El Paso
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
68- Pain Medicine
- 35
- Physical Medicine & Rehabilitation
- 33
Setting Up an NPI-Verified Account
Account verification is tied to an NPI number, checked against the public NPPES registry, consistent with how any licensed professional's status can be confirmed. Onboarding includes access to peer-to-peer physician calls about product documentation, which is not a substitute for clinical advice.
Who Determines Regulatory Fit
Whether a given Wharton's jelly use falls within the minimal manipulation and homologous use criteria of 21 CFR 1271.10 is a determination for the practice and its counsel, not Precision Biologics. Exosome products are a separate category: FDA has stated no exosome product is currently FDA-approved, and these are generally handled as biologic drugs under section 351. Practices are encouraged to confirm their own policy with the Texas Medical Board and legal counsel before adding either family.
Shipping Into the Southwest
Cryopreserved products such as Bio PRP Jelly ship overnight on dry ice in validated containers held at -80C. Lyophilized formats, including Bio DPM in the Wharton's jelly family and Bio EX or Bio AER in the exosome family, are shelf-stable and may reduce receiving logistics for practices farther from a regional shipping hub. Either way, confirming a receiving contact for scheduled delivery avoids a shipment sitting unattended.
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 pain management practice in El Paso open a verified account directly?+
Yes. Account setup is based on NPI verification for licensed professionals. Precision Biologics does not provide clinical advice as part of that process.
Do you provide sterility and lot testing records for each shipment?+
Yes. A certificate of analysis and lot release record are available on request, and each lot is uniquely identified and quarantined until release criteria are satisfied.
Does Precision Biologics tell us how to use these products clinically?+
No. Dosing, protocol, and intended-use decisions rest with the practice and its medical director. Precision Biologics provides product documentation only.