What Customer? Importer Sues FDA For Blocking Ingredient Shipment

In an unusual development, an importer has filed a lawsuit against the FDA for detaining a shipment of bulk acetaminophen that was destined for a customer – a contract manufacturer, specifically. And the refusal by the agency to clear the shipment is raising questions about how an ‘end user’ is defined. The lawsuit, which was first reported by the FDA Law Blog, was filed by H&M USA, and hoped to sell the active pharmaceutical ingredient to Gemini Pharmaceuticals, which provided a so-called ‘end-use letter’ that stated the acetaminophen would later be made into over-the-counter drugs and identified one  brand that would be manufactured from the bulk product, according to court documents. Both companies contacted the FDA, but the agency refused shipment because of an unspecified policy against importing product for future use or inventory, as well as a failure to document every customer that would purchase the finished goods, the law blog writes. An FDA compliance officer wrote in an e-mail that “current guidance for bulk APIs does not permit importation for stock/inventory use.”  In its lawsuit, H&M charges that the FDA was “overreaching, arbitrary and capricious, unlawful and discriminatory” in refusing to allow the shipment to proceed. The importer wants a temporary restraining order that would allow shipments and a ruling that the acetaminophen would not be considered misbranded (here is the lawsuit). “OTC drug products are often manufactured b...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs