Opening and shipping an Oregon account
Opening an account starts with NPI verification against the NPPES registry; no order ships until that check clears. From there, cryopreserved products move overnight on dry ice in validated shipping containers and arrive ready for -80 degree Celsius storage, while lyophilized formats ship at ambient temperature with reconstitution and handling instructions in the insert that accompanies the lot.
Every lot is assigned a unique identifier, and a certificate of analysis, donor eligibility summary, and lot release record can be requested so the product can be logged at the patient record level on your side. We can also schedule a peer-to-peer conversation between your medical director and our team focused on documentation, not clinical guidance.
Questions worth raising with your own counsel
Before placing an order, confirm your practice's or provider's current standing with the board that licenses you, and confirm that any medspa location has a medical director who documents supervision of biologic product use.
Check whether a state pharmacy board or public health agency has issued guidance on receiving and storing human cell and tissue products, since it can affect how your intake workflow should be structured. Separately, ask counsel to assess how 21 CFR 1271.10 applies to your intended use of a Wharton's jelly product, and, if you are also considering an exosome product, note that FDA has stated no exosome product is FDA-approved and that exosome products are generally regulated as biologic drugs under section 351 of the Public Health Service Act.
- Licensure standing with your governing board
- Documented medical director supervision at medspa locations
- Any state guidance on HCT/P receiving and storage
- Counsel's determination on 21 CFR 1271.10 and the biologic-drug status of exosome products
Portland and Salem registry snapshot
Combined NPPES registry counts for providers located in Portland and Salem show roughly 227 orthopedic, 189 pain management, and 214 aesthetic medicine registrations. These figures reflect only providers registered in those two named cities, not a statewide total and not a measure of purchasing or prescribing activity. We recommend confirming current figures directly against the NPPES registry before relying on them for planning.
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 an individual practitioner without a clinic affiliation open an account in Oregon?+
Accounts are opened for licensed physicians and physician-supervised medspas with a verifiable NPI number. The NPI, not a particular business structure, is what we check first.
Do you provide dosing or injection protocols for Oregon clinics?+
No. We supply tissue and biologic products with accompanying documentation. Dosing, technique, and intended use are clinical decisions that belong to the treating physician and their own regulatory counsel.
What should we ask about an exosome product before ordering?+
Ask for the available characterization data and ingredient disclosure for the specific lot, and ask your own counsel how the product's regulatory status as a biologic drug affects your intended use, since FDA has stated no exosome product is currently FDA-approved.