October 1st, 2026 – CBP has issued updated guidance on the implementation of additional duties imposed on certain pharmaceuticals and pharmaceutical ingredients under Proclamation 11020 and the September 23rd Federal Register Notice (91 FR 60360). The update reflects new Commerce Department guidance, revised HTSUS provisions and tariff treatment that took effect for products of all remaining companies on September 29th, 2026.
- Expanded effective date: Additional duties previously took effect July 31st, 2026, for products of companies listed in Annex III. Effective September 29th, 2026, the duties apply to covered products of all other companies. If a product is subject to more than one rate under the Proclamation, the lowest applicable rate applies.
- 100% duty for certain patented pharmaceuticals: HTSUS 9903.04.60 applies to covered patented pharmaceutical articles and carries a 100% additional ad valorem duty rate, calculated as the combined Column 1 and Section 232 duty rate. The previously applicable 9903.04.61 is no longer in effect for goods entered after September 29th.
- Reduced rate for certain trading partners: Covered patented pharmaceuticals from Japan, EU member countries, South Korea, Switzerland and Liechtenstein fall under HTSUS 9903.04.62 and are subject to a 15% additional ad valorem duty rate, calculated as the combined Column 1 and Section 232 rate.
- United Kingdom products: Covered patented pharmaceutical articles from the United Kingdom are eligible for a 0% additional duty rate under HTSUS 9903.04.63.
- Onshoring incentives: Patented pharmaceutical articles subject to a qualifying onshoring plan are subject to a 20% additional duty under HTSUS 9903.04.64. This rate is scheduled to increase to 100% on April 2nd, 2030. Companies with both a qualifying Commerce Department onshoring agreement and an MFN pharmaceutical pricing agreement may qualify for a 0% rate under 9903.04.65, which expires January 20th, 2029.
- Certain specialty pharmaceuticals qualify for 0%: HTSUS 9903.04.66 provides a 0% additional duty rate for qualifying drugs and pharmaceutical articles from specified jurisdictions, including the EU, India, Japan, South Korea, Switzerland, Taiwan, the United Kingdom, Vietnam and several other countries.
- Generics remain at 0%: Generic pharmaceutical articles covered by HTSUS 9903.04.67 receive a 0% additional duty rate. The updated definition specifically includes unpatented animal health products.
- Additional 0% categories: Pharmaceutical products with a U.S.-origin active pharmaceutical ingredient packaged in dosage form qualify for 0% under 9903.04.68. Certain Chapter 29 and 30 products that do not meet the definitions of patented or generic pharmaceutical articles qualify for 0% under 9903.04.69. Products solely for clinical trials, research and development, or other non-commercial applications qualify for 0% under new HTSUS 9903.04.70.
- U.S.-origin pharmaceuticals are exempt: Imports of U.S.-origin pharmaceutical products are not subject to the tariffs imposed by Proclamation 11020.
- Technical HTSUS corrections: Commerce made several corrections to Annex I, including clarifying the definitions and coverage of pharmaceutical products and adding HTSUS 9903.04.70 at a 0% rate. Five HTSUS codes were also removed from Annex IV: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00 and 3004.49.00.
- Drawback remains available: Importers may claim drawback on duties imposed under Proclamation 11020.
- Foreign Trade Zone treatment: Covered merchandise admitted into a U.S. FTZ on or after the applicable effective date generally must be admitted in privileged foreign status, unless eligible for domestic status, and will remain subject to applicable duties when entered for consumption.
Read the Full CSMS here: CSMS # 70054007
Should you have any questions, please contact our Import Compliance team or give us a call at 518-785-6000.
