On September 23, 2026, the U.S. Department of Commerce, Bureau of Industry and Security (BIS), published a Federal Register notice (91 FR 60360) implementing the specialty-pharmaceutical provisions of Proclamation 11020, which imposed Section 232 tariffs on patented pharmaceuticals and associated ingredients. The notice defines the specialty products and lists the jurisdictions eligible for a zero Section 232 rate, establishes a procedure for company-specific requests based on an urgent U.S. health need, and makes technical corrections to the Proclamation’s annexes.
The notice arrives days before a broader change. Under Proclamation 11020, the 100% Section 232 tariff on patented pharmaceuticals applied from July 31, 2026 only to products of the companies listed in Annex III. For products of all other companies, the tariff takes effect for goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on September 29, 2026.
What changes on September 29
- End of the temporary zero rate. According to U.S. Customs and Border Protection (CBP) CSMS # 69395344, importers of patented pharmaceuticals from companies not listed in Annex III have filed under the zero-duty heading 9903.04.61 since July 31. That heading applies only to entries made before 12:01 a.m. eastern time on September 29.
- Applicable rates. After that point, the heading and rate depend on the product, its origin, and the company. The CSMS guidance identifies a 100% combined rate under 9903.04.60; a 15% combined rate under 9903.04.62 for qualifying products of Japan, EU member states, South Korea, Switzerland, and Liechtenstein; a 10% additional rate under 9903.04.63 for qualifying U.K. products; and 0% additional rates under 9903.04.65–9903.04.69 where their conditions are met (including generic pharmaceutical articles under 9903.04.67). Where more than one rate applies, the lowest applicable rate governs.
- Generics. The BIS notice confirms that, at this time, the Section 232 pharmaceutical tariffs do not apply to generic pharmaceutical products and associated ingredients.
Specialty pharmaceuticals eligible for a zero rate
Clause 3(d) of Proclamation 11020 provides a zero Section 232 rate for specified specialty products if Commerce, in consultation with the U.S. Trade Representative (USTR) and the Department of Health and Human Services, determines that they are products of a jurisdiction with a current or forthcoming trade and security framework agreement, or that they meet an urgent U.S. health need. The notice defines the covered categories, which apply to investigational as well as approved drugs:
- Drugs and associated ingredients where all approved or licensed indications are designated as orphan;
- Nuclear medicines;
- Plasma-derived therapies;
- Fertility drugs;
- Cell therapy and gene therapy products;
- Antibody drug conjugates;
- Medical countermeasures related to chemical, biological, radiological, and nuclear threats; and
- Animal healthcare products.
The eligible jurisdictions are Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, the Republic of Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom, and Vietnam. Commerce states that the list may change in a future notice.
Urgent-health-need requests
Companies may request Commerce approval of a zero rate for a listed category or other specialty product on the ground that the import meets an urgent U.S. health need. Requests are limited to patented products under the HTSUS codes in Annex I of Proclamation 11020, one product per application, and are submitted by email to BIS on an ongoing basis. Each request must identify the product and its classification, origin, importers, and manufacturer, and explain the health need (for example, the disease treated and the availability of alternative therapies). Commerce will make an individual, company-specific decision in writing and transmit approvals to CBP, which will administer the adjustment at entry summary and may request supporting documentation.
Other changes
- New heading 9903.04.70. Pharmaceutical articles and associated ingredients used solely for clinical trials, research and development, or other non-commercial applications receive a 0% additional rate.
- Revised definitions. The notice revises the definitions of “pharmaceutical articles” (confirming that inactive ingredients and excipients are excluded) and “generic pharmaceutical article.”
- Annex corrections. The notice makes five technical corrections to Annex I and removes five HTSUS codes from Annex IV because they overlapped with Annex I.
Immediate Considerations
In practical terms, importers of Chapter 29 and 30 products should confirm before September 29 which Chapter 99 heading applies to each product, supplier, and origin; update entry instructions to brokers accordingly; and assess whether any product falls within a specialty category or the new research-use heading. Companies with products that may qualify on health-need grounds should consider preparing a request now, because approval is product- and company-specific and the notice does not state a decision timeline.
Please contact us should you wish to discuss the impact on your products or prepare a request to Commerce.