Commerce defines zero-rate specialty pharma products and eligible jurisdictions

This notice implements part of Proclamation 11020 for specialty pharmaceuticals and associated pharmaceutical ingredients. Commerce defines the covered product categories, identifies eligible jurisdictions for a zero ad valorem tariff rate, and sets procedures for companies to request approval when imports meet an urgent U.S. health need. The notice also makes technical corrections to Annex I and Annex IV of the proclamation.

The zero rate applies to products in the categories named in clause 3(d) of Proclamation 11020, including orphan-only drugs, nuclear medicines, plasma derived therapies, fertility drugs, cell therapy products, gene therapy products, antibody drug conjugates, certain medical countermeasures, and animal health products. Commerce states these products and associated ingredients can receive the Section 232 zero tariff rate if they are products of an eligible jurisdiction or if Commerce determines they meet an urgent U.S. health need in consultation with USTR and HHS. The notice lists eligible jurisdictions and says changes to that list may be published later.

Companies seeking urgent U.S. health need approval must submit product-specific information to Commerce by email, including HTSUS classification, product identity, category, origin and export country, importer of record details, manufacturer information, and the rationale for urgent health need. Commerce says submissions will be accepted on an ongoing basis starting September 23, 2026, and that CBP will administer the tariff adjustment at entry summary filing. Annex I changes are effective for goods entered or withdrawn for consumption on or after 12:01 a.m. eastern time on September 29, 2026.

The technical corrections include a revised definition of generic pharmaceutical articles to specifically include unpatented animal health products, a new Chapter 99 heading with a zero rate for products solely intended for clinical trials, research and development, or other non-commercial applications, and clarifications on the scope of pharmaceutical and non-pharmaceutical articles under Annex I. The notice also removes five HTSUS codes from Annex IV because they overlap with Annex I.