Pain Management Supplier for Richmond, Virginia Practices

Overnight Cold-Chain Shipping

Cryopreserved tissue products are stored at -80 degrees C and shipped overnight on dry ice in validated containers; lyophilized exosome formats are shelf-stable and ship without that cold-chain requirement.

Each lot is assigned a unique identifier before shipment, which a Richmond-area practice can log against its own patient-level traceability records on receipt.

Lot Documentation for Compliance Review

Before adding a new biologics line, most pain management and physical medicine practices want to see lot-specific documentation rather than general marketing claims.

This documentation is available to verified accounts, and Precision Biologics can set up a peer-to-peer call so a physician can go through it directly; the call covers paperwork, not dosing or clinical protocols.

• Certificate of analysis
• Donor eligibility and serology screening summary
• Third-party sterility testing results

Regulatory Review with the Virginia Board and Counsel

Exosome products carry no FDA approval, and FDA has stated there are no FDA-approved exosome products; these are generally regulated as biologic drugs. For Wharton's jelly tissue products, whether a specific intended use falls within the section 361 framework is a determination the practice and its counsel make.

Richmond-area practices should confirm their regulatory posture with the Virginia Board of Medicine and their own legal counsel before purchasing or using either category of product.

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.