Practical Compliance Readiness Ahead of New Pharmaceutical Tariffs

Section 232 Investigation into Pharmaceuticals

Beginning Tuesday, September 29, 2026, all patented pharmaceuticals and associated active pharmaceutical ingredients (APIs) imported into the United States will be subject to a 100 percent tariff under Section 232 of the Trade Expansion Act of 1962 unless they qualify for specific exemptions.

Notably, the tariffs established under Proclamation 11020 apply only to articles that are also products, or ingredients of products, subject to a valid and unexpired US patent and listed in publications maintained by the Food and Drug Administration (FDA) as approved for marketing in the United States. Generics and biosimilars are excluded from these tariffs at this time, but the secretary of Commerce is scheduled to reassess this treatment within one year.

Heather Bates, Joshua Galuska, Mason Pan, and Tina Seale break down the new tariffs, key exemptions, and reduced rates. They also share steps companies can take to prepare for increasing classification and country-of-origin risk.