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CBP Identifies Country of Origin of Pharmaceutical Products

Tuesday, February 06, 2018
Sandler, Travis & Rosenberg Trade Report

U.S. Customs and Border Protection has issued 11 final determinations concerning the country of origin of certain pharmaceutical products that may be offered to the U.S. government under an undesignated government procurement contract. Any party-at-interest may seek judicial review of these determinations by March 7. CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. government.

The drugs at issue are designated for such uses as reducing cholesterol and triglyceride levels;  preventing heart attacks, strokes, asthma, and allergic rhinitis; and treating infections, seizures, hypertension, myocardial infarction, post-herpetic neuralgia, heart failure, depression, obsessive compulsive disorder, anxiety, post-traumatic stress, dementia, and hepatitis B. They are produced in the U.S. from active and inactive ingredients procured domestically and abroad. The active pharmaceutical ingredients in each product are sourced from India.

CBP concludes that the processing in the U.S. does not result in a substantial transformation because the APIs retain their chemical and physical properties. As a result, the country of origin of these products for purposes of U.S. government procurement is India, where the APIs were produced.

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