Court Challenge of CBP's Drug Country of Origin Policies to Proceed as Test Case
A recent set of court challenges to CBP’s country of origin treatment for pharmaceuticals will proceed as a consolidated “test case,” according to recent filings at the Court of International Trade. Acetris had filed the set of 11 cases in…
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March, contesting CBP’s determination that the Indian active pharmaceutical ingredients in its U.S.-made pharmaceuticals determined the finished drugs’ country of origin, despite a purportedly complex production process in the U.S. and the unsuitability of the raw APIs for use as pharmaceuticals (see 1804030065). The fate of all 11 of those cases will now be decided under a single challenge on the country of origin of Acetris’ rosuvastatin calcium tablets. Other rulings challenged by Acetris involved simvastatin tablets, donepezil hydrochloride tablets, montelukast sodium tablets, paroxetine hydrochloride tablets, carvedilol tablets, metoprolol tartrate tablets, gabapentin capsules, lavetiracetam tablets, levofloxacin tablets and entecavir tablets.