U.S. Customs and Border Protection has issued a final determination concerning the country of origin of a pharmaceutical product that may be offered to the U.S. government. Any party-at-interest may seek judicial review of this determination by Aug. 11.
According to CBP, the items at issue are pirfenidone tablets, which are used for the treatment if idiopathic pulmonary fibrosis (scarring of the lungs with an unknown cause). These tablets have one active pharmaceutical ingredient that is manufactured in Italy and shipped to India for final processing, which includes mixing with inactive materials, forming tablets, and packaging.
In ruling HQ H342828 CBP concludes that the country of origin of the tablets is Italy, the country of origin of the API. CBP states that in determining whether a substantial transformation occurs in the manufacture of chemical products like pharmaceuticals it has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. Using that criterion CBP determines that in this case the processing in India does not result in a change in the medicinal use of the finished tablets because the API retains its chemical and physical properties and is merely put into a tablet form and packaged.
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. For more information on BAA requirements or restrictions, please contact Mark Segrist or Mark Tallo.
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