Federal Register #2026-19498

Tariff Adjustment Opportunity for Specialty Pharmaceuticals and Ingredients

The Bureau of Industry and Security (BIS), U.S. Department of Commerce, is inviting submissions for tariff adjustments on specialty pharmaceuticals and their ingredients under Presidential Proclamation 11020. - Eligible products include: - Orphan drugs - Nuclear medicines - Plasma derived therapies - Fertility drugs - Cell therapy products - Gene therapy products - Antibody drug conjugates - Medical countermeasures for chemical, biological, radiological, and nuclear threats - Animal health products - No specific OEMs or vendors are named; the notice applies broadly to pharmaceutical manufacturers and importers. - Procedures allow public submission of information to determine if imports meet urgent U.S. health needs. - Technical corrections to the Harmonized Tariff Schedule are included. - Opportunity is open to producers, handlers, processors, dehydrators, cooperatives, manufacturers, importers, and public members seeking tariff adjustments for eligible products.

Description

This notice defines the pharmaceutical products and lists the jurisdictions eligible for an ad valorem tariff rate of zero pursuant to Presidential Proclamation 11020 of April 2, 2026. Eligible products include orphan drugs, nuclear medicines, plasma derived therapies, fertility drugs, cell and gene therapy products, antibody drug conjugates, medical countermeasures, and animal health products. The notice outlines procedures for public submission of information to the Department of Commerce for approval to determine if imports meet an urgent U.S. health need. It also issues technical corrections to the Harmonized Tariff Schedule related to the Proclamation.

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