Exosome and Wharton's Jelly Supplier for Stockton, CA Medspas

Physician-supervised ordering accounts

Medspas purchasing biologic products are expected to operate under physician supervision, and Precision Biologics verifies each account against an NPI number before any order is released. This applies equally to dermatology and plastic surgery practices adding a new biologic to their procurement list.

Because pricing is not published, a verified account is also how a practice gets current pricing and lot availability.

Documentation aesthetic practices tend to request

Exosome products carry additional documentation expectations because they are not represented as HCT/Ps and are generally regulated as biologic drugs. Precision Biologics discloses full ingredient lists and available characterization data to verified accounts.

• Certificate of analysis for the lot being ordered
• Donor eligibility summary
• Full ingredient disclosure for exosome products, including the disclosed composition
• Available characterization data, such as particle concentration and marker testing, where applicable

Cold chain and shelf-stable receiving

Cryopreserved Wharton's jelly products ship overnight on dry ice in validated containers and require immediate transfer to -80 degree C storage on arrival. Lyophilized exosome and Wharton's jelly formats are shelf-stable and do not require cryogenic storage, which some aesthetic practices in the West prefer for simpler inventory management.

Confirming regulatory posture before adding a product

Dermatology and plastic surgery practices in California should verify current requirements with the California medical board and with their own counsel before offering any Wharton's jelly or exosome product, since FDA has stated there are no FDA-approved exosome products and intended-use determinations under 21 CFR 1271.10 belong to the practice and its counsel, not the distributor. These products are not represented as FDA approved or licensed for any disease or condition.

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.