U.S. BIS identifies specialty pharmaceuticals eligible for 0% Section 232 tariff rate
Certain specialty pharmaceutical products may qualify for a 0% tariff based on jurisdiction or an urgent U.S. health need.
The U.S. Department of Commerce’s Bureau of Industry and Security (BIS) today released a notice defining pharmaceutical products eligible for a 0% ad valorem tariff rate under Presidential Proclamation 11020, listing eligible jurisdictions, and establishing procedures for companies to request approval based on an urgent U.S. health need.
Proclamation 11020 (April 2, 2026) imposed a 100% tariff on certain patented pharmaceuticals and associated pharmaceutical ingredients, effective July 31, 2026, for companies listed in Annex III of the proclamation and September 29, 2026, for all other companies. Different rates apply to products from certain jurisdictions and companies with Commerce-approved onshoring agreements. Generic pharmaceutical products and associated ingredients currently are not subject to the Section 232 pharmaceutical tariffs.
The notice defines specialty products potentially eligible for the 0% rate, including drugs for which all approved or licensed indications are designated as orphan, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapy products, antibody drug conjugates, certain medical countermeasures, and animal healthcare products. The 0% rate applies when an eligible product is from a jurisdiction identified in the notice or Commerce determines that the import meets an urgent U.S. health need.
Companies seeking an urgent-health-need determination may submit product-specific requests to BIS on an ongoing basis beginning September 23, 2026, the scheduled publication date. Requests must include company and product information and a rationale explaining why the import meets an urgent U.S. health need. Commerce, in consultation with the U.S. Trade Representative and Department of Health and Human Services, will make an individual, fact-specific, company-specific decision for each request.
The notice also makes technical corrections to the Harmonized Tariff Schedule of the United States (HTSUS), effective for goods entered for consumption, or withdrawn from warehouse for consumption, on or after September 29, 2026. Among other changes, the corrections clarify the definitions of pharmaceutical and generic pharmaceutical articles and establish new HTSUS heading 9903.04.70, which provides a 0% additional tariff for covered pharmaceutical articles and associated ingredients solely for use in clinical trials, research and development, or other non-commercial applications.