December 04, 2013

FDA Sued After Refusing Shipment of Bulk Drug Product

By Dara Katcher Levy –We recently became aware of a lawsuit filed against FDA in the Eastern District of New York over the importation of bulk drug product.  In this suit, which also names an individual FDA Compliance Officer, the importer argues that FDA’s actions in refusing a shipment of bulk acetaminophen are overreaching, arbitrary and capricious, unlawful and discriminatory.  The importer is requesting a temporary restraining order that would stay U.S. Customs and Border Patrol’s request for redelivery of the refused shipment, and a declaratory judgment that the acetaminophen that is the subject of the import is exempt from misbranding provisions of section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act. Continue yo read here