Notice / Sep 23, 2026

Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020

This notice defines the pharmaceutical products and lists the jurisdictions that are eligible to receive an ad valorem tariff rate of zero pursuant to Presidential Proclamation 11020 of April 2, 2026, "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States," (Proclamation 11020). These pharmaceutical products include drugs and associated ingredients where all approved indications are designated as orphan; nuclear medicines; plasma derived therapies; fertility drugs; cell therapy product; gene therapy product; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; and animal health. Proclamation 11020 states that such products and associated ingredients receive the Section 232 zero tariff rate if they are products of a jurisdiction that has a current or forthcoming trade and security framework agreement or if they meet an urgent U.S. health need. This notice also includes procedures for the public to submit information for the Department of Commerce's (Commerce) approval to determine if imports of the pharmaceutical products and associated ingredients meet an urgent U.S. health need. This notice also issues five technical corrections to Annex I and one technical correction to Annex IV of the Proclamation.