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.

FDA apparently refused the shipment because of some unidentified policy against importing lawful product for future use or inventory, as well as a failure to document every customer that would be purchasing the finished goods (from the importer’s customer, not the importer).  According to the Complaint, the importer, was seeking to import bulk acetaminophen to distribute to its contract manufacturer customer.  The contract manufacturer provided an end-use letter that stated the acetaminophen would be further manufactured into over-the-counter drug products, and identified one of the brands that would be manufactured from the bulk product.  The bulk acetaminophen, as proposed for import, had been labeled with the statement, “Caution: For manufacturing, processing, or repacking” in accordance with 21 C.F.R. § 201.122.  In addition, the ultimate customer of the contract manufacturer also contacted the FDA prior to the refusal.

After over a month of correspondence, FDA refused the shipment through a formal FDA Notice of Refusal that stated, “DOCUMENTATION NEEDED TO REMOVE THE APPEARANCE OF VIOLATION, SUCH AS, APPROVED USE DOCUMENTATION.  NO APPLICATION, USE OR END-USER TRANSMITTED.  REQUIRED END-USE DOCUMENTATION NOT RECEIVED TO DATE.”  Separately, by email, the Compliance Officer stated that it appeared the active pharmaceutical ingredient would be for future or stock/inventory use and “[c]urrent guidance for bulk APIs does not permit importation for stock/inventory use.” 

OTC drug products are often manufactured by a single manufacturer for many private label distributors.  As long as the finished product is ultimately compliant, FDA’s refusal to permit the import of otherwise lawful bulk drug product simply because a customer for the finished product had not yet been identified at the time of import is difficult to understand, and does not appear to be consistent with the agency’s regulations on drugs intended to be further manufactured.  It would be interesting to see whether an end-use statement that simply stated that the product would be manufactured and labeled in accordance with the pending OTC monograph would have sufficed in securing the release of this shipment.