AUTHOR: Reynaldo Roman - Senior Director, Regulatory Compliance
Date: August 2026
On July 31, 2026, U.S. Customs and Border Protection (CBP) issued guidance implementing new Section 232 tariffs on certain patented pharmaceutical products and related pharmaceutical ingredients imported into the United States. The guidance outlines the products covered, applicable tariff rates, reporting requirements, and available exceptions established under Presidential Proclamation 11020.
The new tariffs took effect in phases beginning July 31, 2026, with added tariff provisions scheduled to take effect on September 29, 2026, depending on the manufacturer. For covered products, the new Section 232 tariffs can be as high as 100%, making it important for importers to determine whether their products fall within the scope of the new requirements. The guidance also establishes new Chapter 99 reporting requirements for covered entries.
Importantly, these new Section 232 tariffs are limited in scope and do not apply to all pharmaceutical imports. They primarily affect patented pharmaceutical products and related pharmaceutical ingredients. Generic pharmaceutical products are generally excluded from the additional duties, and importers of investigational pharmaceutical products used in clinical research are unlikely to be affected.
What Products Are Covered?
The new Section 232 measures primarily apply to imports of:
- Patented finished pharmaceutical products
- Active pharmaceutical ingredients (APIs) used in patented pharmaceuticals
- Certain key starting materials used in patented pharmaceuticals
Importers of patented pharmaceutical products and related ingredients should review the CBP guidance to determine whether their products fall within the scope of the new requirements. The guidance includes detailed information on product eligibility, applicable tariff rates, reporting requirements, and available exceptions.
Please send any questions about this trade update to TradeCompliance@marken.com.
