Greeley, CO Medspas and Dermatology Practices: Biologics Sourcing

Opening a physician-supervised account

Precision Biologics sells only to licensed physicians and to medspas that operate under their supervision. An account is opened under the supervising physician's NPI number, verified against the public registry before any pricing is shared.

Practices with multiple locations typically assign one supervising physician's account to cover ordering for all sites and document that assignment internally.

What to request before adding a biologics line

Aesthetic practices evaluating a new supplier should request the certificate of analysis for the lot, the donor eligibility summary, and confirmation that the lot cleared third-party sterility testing and quarantine release.

For exosome products, also request the supplier's characterization data. There is no FDA-approved exosome product on the market, so reviewing that documentation directly, rather than relying on marketing claims, is the only way to evaluate a lot.

Storage formats and shipping

Cryopreserved formats ship overnight on dry ice in validated containers and are stored at -80 degrees Celsius on arrival. Lyophilized exosome and Wharton's jelly formats are shelf-stable and do not require freezer space, which smaller practices sometimes prefer.

Confirming your regulatory posture

A practice's own counsel, together with Colorado's medical board where relevant, is the right party to confirm how a specific product and use case fits within the practice's regulatory posture. Precision Biologics does not advise on clinical use, dosing, or protocol design.

Physicians can request a peer-to-peer call to go through documentation before committing to an account.

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.