Cell Therapy Products

Cell therapy products often require cryogenic storage (liquid nitrogen or ultra-low temperature) throughout transit, and FDA expects importers to provide continuous temperature-monitoring records demonstrating the cold chain was unbroken from manufacture to US entry. Chain-of-identity documentation — tracing the product from donor or patient to the final product lot — is also required for autologous and some allogeneic therapies. Any deviation can result in FDA detention.

Yes, FDA's expanded access (compassionate use) program allows importation of unapproved cell therapy products for individual patients with serious conditions when no comparable alternative exists. The treating physician must submit an expanded access request to FDA, and the foreign manufacturer must cooperate with FDA's review. This pathway does not exempt the product from CBER oversight or standard CBP entry requirements.