Processing Drug Ingredients Into Dosage Form Not Substantial Transformation, CBP Says
U.S. Customs and Border Protection has issued a final determination concerning the country of origin of 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 this determination by Sept. 27. 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 products at issue consist of active pharmaceutical ingredients produced in various countries that are combined with inactive ingredients into dosage form in India. In determinations HQ H284690, HQ H284961, HQ H284692, HQ H284694, HQ H284695, and HQ H284697, CBP concludes that the processing in India does not result in a substantial transformation, as there is no change to the APIs in name, chemical or physical properties, or use. As a result, the country of origin of the finished pharmaceutical products for purposes of U.S. government procurement is the country in which the API was produced.