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# Court Changes Drug Country of Origin Determination: Attorney
- URL: https://www.fdaweb.com/court-changes-drug-country-of-origin-determination-attorney/
- Published: 2020-02-12T12:00:00.000Z
- Updated: 2026-09-14T16:02:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146075

Attorney **Curtis Dombeck** (SheppardMullins) says a 2/10 Federal Circuit Court of Appeals decision has revised the country of origin determination for drugs to be purchased by U.S. government entities. Dombeck [writes](https://www.fdalawblog.com/2020/02/articles/enforcement-actions/country-of-origin-analysis-pharmaceuticals/?utm%5Fmedium=email&utm%5Fcampaign=FDA%20Law%20Update%20Blog&utm%5Fcontent=FDA%20Law%20Update%20Blog+CID%5Fe14f1539b71b06d5044aea2d46080181&utm%5Fsource=Create%20Send%20campaigns&utm%5Fterm=here) in an *FDA Law Update Blog* that the case involved an Acetris Health drug where the active pharmaceutical ingredient was made in India and shipped in bulk to the U.S. to be manufactured into tablets.

U.S. Customs and Border Protection had ruled that the tablets were of Indian origin because the API was manufactured there and that the U.S. processing was not sufficient to constitute a “substantial transformation” and thus did not convey a new country of origin, meaning the product could not be sold to the Department of Veterans Affairs.

However, the court rejected the government’s position and held that the API was an ingredient or part of tablets produced in New Jersey. “By its decision, the court has revolutionized country of origin analysis in the pharmaceutical industry by holding that processing into tablets in the U.S. is enough to constitute ‘manufacturing’ and qualify the resulting products for U.S. government procurement,” Dombeck writes. “By leaving legally open the question of whether such ‘manufacturing’ constitutes a ‘substantial transformation,’ however, the decision leaves a lingering uncertainty that is bound to cause compliance nightmares for pharmaceutical manufacturers.”

He poses a situation in which an API is manufactured in India and made into tablets in the UK and suggests that under the decision, the resulting drug may be considered a UK product. He says the decision seems assured to spawn further litigation over the issue of country of origin for drugs.