How does the U.S. Customs and Border Protection (CBP) notify FDA of entries of FDA-regulated products?
FDA receives electronic information about most FDA related entries from CBP. FDA currently receives this information through its Operational and Administrative System for Import Support (OASIS). When submitting an entry notification, a filer will determine the appropriate Harmonized Tariff Schedule (tariff) code for each product being offered for importation. CBP uses the tariff code, in part, to determine if other government agencies also need to make an admissibility determination. However, a tariff code may cover a wide range of products and may include both products that are subject to FDA jurisdiction and products that are not subject to FDA jurisdiction. When this is the case, filers are usually given the option of “disclaiming” FDA jurisdiction. This is accomplished by disclaiming the “line” in the entry that applies to those products. (Each distinct category of product in an entry will have its own “line” in the entry. For example, if a shipment of a vaccine consisted of both m
FDA receives electronic information about most FDA related entries from CBP. FDA currently receives this information through its Operational and Administrative System for Import Support (OASIS). When submitting an entry notification, a filer will determine the appropriate Harmonized Tariff Schedule (tariff ) code for each product being offered for importation. CBP uses the tariff code, in part, to determine if other government agencies also need to make an admissibility determination. However, a tariff code may cover a wide range of products and may include both products that are subject to FDA jurisdiction and products that are not subject to FDA jurisdiction. When this is the case, filers are usually given the option of “disclaiming” FDA jurisdiction. This is accomplished by disclaiming the “line” in the entry that applies to those products. (Each distinct category of product in an entry will have its own “line” in the entry. For example, if a shipment of a vaccine consisted of both
