Court Rules that a Drug’s API Doesn't Impact ‘U.S. Made’ Designation

Drug distributor Acetris Health prevailed in an appeals court ruling that the company can call its products U.S.-made even though the active pharmaceutical ingredients are sourced elsewhere.

The decision by the Federal Circuit Court of Appeals stemmed from a two-year dispute between Acetris and the Department of Veteran’s Affairs over the department’s decision to not purchase ten of its drugs, including the generic Hepatitis B drug entecavir, because the APIs were sourced from India.

The VA argued that buying “products of India” would violate the federal law dictating that the department can only purchase “U.S.-made end products.”

Acetris, a subsidiary of New York-based ACETO, sued the VA in 2018, arguing that the products were in fact U.S.-made because the finished forms were manufactured in New Jersey by Aurolife Pharma. The U.S. Court of Federal Claims ruled in the company’s favor.