The Final Rule issued by the Food and Drug Administration (FDA) on 29th November 2016 established very important new customs entry regulations for the electronic filing of FDA-regulated products in line with the operations of the Automated Commercial Environment (ACE).
The provisions of this legislation now became fully effective. These involve the following significant requirements and consequences:
- the FDA has increased the number of mandatory data elements that are required to make a shipping entry.
- the Final Rule has a particularly important impact on the shipment of FDA-controlled commodities such as human and animal drugs, biological products, and especially medical devices.
- in addition, the FDA has practically eliminated the use of UNKNOWN (UNK) as an accepted response for any required data element.
- shipments arriving in the USA that are not accompanied by paperwork correctly reflecting the required FDA data elements will be stopped and held by customs at the FedEx port of entry.
How this affects FedEx and you
Entries can only be submitted by FedEx to the U.S. FDA for their review with this critical information being provided by you preferably as part of the accompanying invoice, alternatively as a separate information sheet. In addition, if we cannot provide FDA with these details within 5 days of a shipment being detained by USA customs, the shipment will be abandoned, destroyed, or returned.
It is therefore important that you and your suppliers take action now to ensure that you always provide accurate, consistent, complete and fully compliant data for all FDA-regulated items.
To make sure that you complete your shipping paperwork correctly, please verify all the required shipment data on the FDA website.