On August 24, AAEI submitted a letter to the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) requesting clarification on several unresolved issues related to Proclamation 11020, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States,” and related CBP implementation guidance.
The letter identifies eight areas where additional guidance is needed, including the definitions of patented and generic pharmaceutical articles; treatment of specialty, orphan, U.S.-origin, clinical-stage, and R&D products; conflicting tariff treatment within Annexes I and IV; and the impact of mandatory privileged foreign status on pharmaceutical products entered through Foreign Trade Zones.
With significant duty exposure at stake—potentially ranging from 0% to 100% ad valorem depending on classification—AAEI is urging Commerce to provide written clarification or supplemental public guidance to support consistent classification and predictable compliance for U.S. importers and exporters.