Wharton's Jelly and Exosome Supplier for Charleston Medspas

Confirming physician supervision for medspa accounts

Because medspas range from physician-owned practices to med-director arrangements, Precision Biologics confirms that each account is tied to a licensed physician or documented physician supervision, in addition to a National Provider Identifier. This verification does not replace any state licensing or supervision requirement already in place for the practice.

Documentation aesthetic practices commonly request

Dermatology, plastic surgery and medspa accounts generally request the same base documentation as other specialties, plus full ingredient disclosures for exosome products that include added peptides or growth factors. Lot certificates of analysis, donor eligibility summaries and sterility testing results are also available to verified accounts.

• Lot-specific certificate of analysis
• Full ingredient disclosure for exosome formulations
• Donor eligibility and sterility testing summaries

Logistics for cold-chain and shelf-stable orders

Wharton's jelly formats generally ship cryopreserved, overnight on dry ice, with storage at -80 degrees Celsius on arrival. Several exosome formats are shelf-stable under normal storage conditions and are handled differently at intake. A practice stocking both categories should plan separate receiving steps for each rather than a single shared procedure.

Regulatory verification before purchase

FDA has stated that there are no FDA-approved exosome products, and exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act. Whether a specific intended use of a Wharton's jelly product fits the applicable HCT/P framework under 21 CFR 1271.10 is a determination for the practice and its own counsel. South Carolina aesthetic practices should verify current licensing and supervision requirements with the South Carolina Board of Medical Examiners and legal counsel.

These products are not FDA approved or licensed for any disease or condition.

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.