Philadelphia
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
312- Dermatology
- 234
- Plastic Surgery
- 78
Physician supervision and account verification
Medspas are required to operate under physician supervision, and Precision Biologics verifies every account against the supervising or ordering physician's NPI number before an order is processed. This applies whether the ordering entity is a dermatology practice, a plastic surgery practice, or a medspa.
Account verification confirms licensure status; it does not determine whether a given product or intended use fits the practice's regulatory posture. That determination belongs to the practice and its own counsel.
Vendor qualification for aesthetic practices
Aesthetic practices evaluating a new biologics vendor typically request the same documentation an ambulatory surgical practice would: a certificate of analysis, a donor eligibility summary, and a lot release record for the specific lot being ordered. For exosome products, full ingredient disclosure is provided to verified accounts.
Because Wharton's jelly and exosome products sit in different regulatory categories, practices should review documentation for each product line separately rather than assuming one vendor review covers both.
- Certificate of analysis
- Donor eligibility summary
- Lot release record
- Full ingredient disclosure (exosome products)
Cold chain logistics into the Northeast
Cryopreserved Wharton's jelly products ship overnight on dry ice in validated shipping containers and are stored at -80 degrees C once received. Lyophilized exosome products are shelf-stable and do not require cryogenic storage, with handling details provided in the product insert for that lot.
A medspa or aesthetic practice receiving its first shipment generally designates a single staff member to log the lot number on arrival, matching the lot-level traceability already expected at the patient record level.
Regulatory verification and support
Before carrying any Wharton's jelly or exosome product, aesthetic practices in Pennsylvania typically confirm their regulatory posture with the Pennsylvania State Board of Medicine, or the applicable licensing board for the supervising physician, and with independent counsel. Precision Biologics supports account setup through peer-to-peer physician conversations about documentation, not clinical guidance.
These products are not FDA approved or licensed for any disease or condition. Information here is for licensed healthcare professionals and is not medical or legal advice.
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.
Frequently asked questions
Can a medspa order directly, or does it need a supervising physician on the account?+
Accounts are verified against the NPI of the supervising or ordering physician. A medspa operating under physician supervision opens its account through that physician's verification.
Is Bio EX or Bio AER FDA approved?+
No. FDA has stated there are no FDA-approved exosome products. These are supplied for licensed professionals to evaluate under their own regulatory review.
What documentation ships with a lyophilized product?+
Lyophilized formats include a product insert covering storage and handling for that lot, and verified accounts can request the certificate of analysis and full ingredient disclosure separately.