Biologics Procurement for Medspas and Dermatology Practices in Provo, UT

How aesthetic practices and medspas typically qualify a new supplier

Dermatology practices, plastic surgery practices, and medspas operating under physician supervision tend to run new biologics suppliers through the same type of document review used for any clinical product line: certificate of analysis, donor eligibility summary, and lot release record. Because exosome products are not FDA-approved and are generally regulated as biologic drugs, we are direct about that status rather than letting it come up only after a sale.

We also point practices to the primary FDA consumer guidance on regenerative medicine products, including stem cells and exosomes, so staff reviewing a new vendor have the agency's own language in front of them, not a paraphrase.

Account verification and ordering

Every Precision Biologics account is matched to an NPI through the NPPES registry before it can place an order. For medspas, that means the account is tied to the supervising physician's credentials, consistent with the requirement that these products be sold only to licensed clinics, physicians, and medspas operating under physician supervision.

Shipping and storage in the Mountain West

Practices should confirm they have the appropriate storage on hand, cryogenic or ambient depending on the format, before the first order ships.

• Cryopreserved formats are stored at -80 C and shipped overnight on dry ice in validated containers
• Lyophilized formats are shelf-stable and handled per the insert provided with the lot
• Each lot carries a unique identifier for tracking at the patient record level

Verifying regulatory standing

Whether a specific use of a Wharton's jelly or exosome product by a dermatology practice, plastic surgery practice, or supervising physician at a medspa fits within the applicable regulatory framework is a determination for the practice and its own counsel, not something Precision Biologics advises on. We recommend verifying standing with the Utah medical board as part of any vendor review before ordering.

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.