U.S. details 0% tariff rules for specialty medicines

Recent U.S. Commerce Department guidance spells out which specialty medicines may qualify for a 0% tariff under the pharmaceutical tariff rules. The zero rate is not a blanket exemption for all medicines.

Eligible categories include drugs for which all approved indications are designated orphan; nuclear medicines; plasma-derived therapies; fertility drugs; cell and gene therapies; antibody-drug conjugates; certain medical countermeasures against chemical, biological, radiological or nuclear threats; and animal-health pharmaceuticals. Associated ingredients are included.

Qualifying products from 19 named trading partners are eligible:
Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom, and Vietnam.

Products from other jurisdictions may still qualify if Commerce determines they meet an urgent U.S. health need. Companies can submit product-specific requests to Commerce’s Bureau of Industry and Security, with product and tariff-classification details, manufacturer and importer information, and evidence explaining the health need.

The rules are part of a broader Section 232 regime imposing a 100% tariff on certain patented pharmaceutical products and associated ingredients. The reported effective date for the broader tariff is September 29, 2026, though some listed companies were covered earlier. Generic pharmaceuticals are reported as outside these tariffs.