Tag Archives: Acetris

What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to interpret the country of origin requirements under the Trade Agreements Act of 1979 (“TAA”) and related regulations. For … Continue Reading

Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

Selling drugs to the Government just got a lot simpler.  In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured, weighed, mixed, and compounded—in the United States, regardless of where the active pharmaceutical ingredient (“API”) originates.  This is a vast … Continue Reading
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