[Anonymous]

Reply To: API brought in as Import for Export prior to IND

It depends on whether they imported as Import For Export (IFE) or IFE Temporary Import Bond (TIB).

IFE is an FDA importation method. FDA allows material that must remain in the US (due to FDA Regulations) to stay in the US. However, it must be accounted for in the Reconciliation document. Stability Samples (remaining at the manufacturing site) is an FDA requirement, so these would be allowed to remain; as long as they are documented/ accounted for.

IFE TIB uses both the FDA importation method (IFE), and the Customs import regime of TIB. Unfortunately, the regulations for TIB mandate 100% accountability through either export or destruction.