Start with the business decision, not the product catalog
Clinics adding a regenerative biologics line can make the operational decisions before the product decisions: deciding who holds the purchasing account, how cold chain storage will be handled, how informed consent will be documented, and how lot numbers will be tracked in the patient record, before selecting a specific Wharton's jelly or exosome product to carry.
This sequencing matters because products in this category arrive with documentation obligations attached: donor eligibility summaries, certificates of analysis, lot release records. A clinic that has not built the operational capacity to request, store and act on that documentation is not ready to place an order, regardless of how appealing a particular product line looks.
Setting up a verified purchasing account
Account verification requires an NPI number, since these products are sold only to licensed clinics, medspas operating under physician supervision, and physicians, not to the public. Confirm whether the account must be tied to an individual physician's NPI or an organizational NPI, and which account details are accepted.
Confirm account requirements early to avoid preventable ordering delays.
Building the regulatory and documentation file before the first order
Wharton's jelly products are offered under the supplier's HCT/P framework. Whether a specific intended use at a specific clinic qualifies for regulation solely under section 361 of the PHS Act, which turns on minimal manipulation, homologous use and the other criteria set out at 21 CFR 1271.10, is a determination that belongs to the clinic and its counsel, not to the supplier's marketing material.
Exosome products sit in a different position: FDA has stated that no exosome product is FDA approved. These products are generally regulated as biologic drugs under section 351, and purchase and clinical-use decisions belong to the physician with their own regulatory counsel. Before the first order, a clinic should have a documentation file that holds the certificate of analysis, donor eligibility summary and lot release record it requests for each lot, plus a note of who on staff is responsible for reviewing each one.
Cold chain, storage and inventory operations
Cryopreserved Wharton's jelly products are stored at -80 degrees Celsius and shipped overnight on dry ice in validated containers, which means a clinic needs a freezer rated for that range and a documented process for checking shipments on arrival, including temperature indicators where the supplier provides them. Lyophilized formats are shelf-stable and do not need cryogenic storage, but still need a defined storage location and a reconstitution or handling procedure that follows the product insert supplied with the lot.
Running both formats side by side means the inventory system needs to distinguish them clearly, since a freezer-stored vial and a shelf-stored vial have different handling rules and different failure modes if something goes wrong. Building this distinction into the inventory process before the first mixed order avoids confusion later.
Staff training and patient-facing materials
Every person who touches a biologic shipment, from the front desk staff who signs for a dry ice delivery to the physician who discusses it with a patient, should be working from the same understanding of what the product is and is not. That means training on regulatory status language, not just handling procedures: no one on staff should be describing a product as approved, as a cure, or as something that treats a named condition, whether in a patient conversation, on social media or in marketing copy.
FTC guidance on health product claims requires competent and reliable scientific evidence behind any health-related claim, and FDA's recent warning letters to distributors in this category specifically cited website and social media content as evidence of how a product was being promoted. A short written policy on what staff can and cannot say about these products, reviewed with everyone who has patient contact, reduces the risk of an employee's social media post creating a problem the clinic did not anticipate.
Review cadence and scaling the program
If your practice considers adding a second format, or moving between Wharton's jelly and exosome products, run the addition through the same operational checklist rather than treating it as a quick add-on to an existing order, because documentation, storage and consent requirements can differ meaningfully between families of products.
Because FDA's posture toward this category has continued to shift, with new warning letters issued through 2026, a practical operations calendar includes a periodic review, at least annually, of vendor documentation, consent templates and staff training against whatever guidance is current at that time.
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
Who should hold the supplier purchasing account, the practice or the physician?+
Confirm with the supplier whether the account must be tied to an individual physician's NPI or may use an organizational NPI; name the account holder who has authority over clinical use decisions.
Do we need different storage for Wharton's jelly and exosome products?+
Often yes. Cryopreserved formats need -80 degree Celsius freezer storage, while lyophilized formats are shelf-stable; check each product's storage requirement rather than assuming one setup covers every format.
How do we know if our intended use qualifies under section 361?+
That determination, based on minimal manipulation, homologous use and the other criteria in 21 CFR 1271.10, belongs to the clinic and its regulatory counsel, not to the supplier.
How often should we revisit our program's compliance setup?+
At least annually, and sooner if FDA issues new warning letters in this category or state law affecting non-FDA-approved therapies changes.