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On September 28, 2026, U.S. Customs and Border Protection (CBP) issued CSMS #70054007, providing updated guidance on the implementation of the Section 232 duties on imported pharmaceuticals and pharmaceutical ingredients imposed under Presidential Proclamation 11020. The guidance also incorporates the Department of Commerce’s (DOC) September 23, 2026 Federal Register notice (91 FR 60360), which identifies products and jurisdictions eligible for certain duty-free treatment and implements several technical corrections to the pharmaceutical tariff regime.

Background:

On April 2, 2026, the President issued Proclamation 11020, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States” imposing additional duties on imports of patented pharmaceuticals and related ingredients. The additional duties took effect on July 31, 2026 for the companies listed in Annex III to the Proclamation, and on September 29, 2026 for all other companies (see the remaining Annexes). 

On September 23, 2026, the Department of Commerce (DOC) published guidance (91 FR 60360) identifying products and jurisdictions eligible for the zero duty provision under HTSUS 9903.04.66 and making several technical corrections to Annexes I and IV of the Proclamation (11020).

The September 23, 2026 FR Notice – Technical Corrections:

Most notably, the DOC amended the definition of “generic pharmaceutical articles” to include unpatented animal health products, added a new HTSUS provision (9903.04.70) providing a zero percent duty rate for qualifying research, clinical trial, and other non-commercial pharmaceutical products, clarified the scope of “pharmaceutical articles” and certain Chapter 99 provisions, updated the tariff schedule to reflect recent HTSUS amendments, and removed several HTSUS provisions from Annex IV. Please reference the CSMS for additional technical details.

Guidance:

The latest CSMS provides instructions for importers, brokers, and filers on submitting entries to CBP for imports of pharmaceutical products and ingredients classified under HTSUS 9903.04.60 through 9903.04.70. As part of that guidance, CBP outlines the applicable Chapter 99 tariff provisions and corresponding duty rates, including:

  • 100% Standard Duty (Heading 9903.04.60): Applies to patented pharmaceutical articles without qualifying exemptions.
  • 15% Preferential Partner Rate (Heading 9903.04.62): Applies to patented pharmaceuticals originating from designated partner jurisdictions, including the EU, Japan, South Korea, Switzerland, and Liechtenstein.
  • 0% Tariff Rate Categories:
    • United Kingdom Products (Heading 9903.04.63): Patented articles originating from the UK.
    • Specialty Drugs & Regional List (Heading 9903.04.66): Specialty drugs from an extensive list of qualifying nations (including EU member states, UK, Japan, South Korea, India, Taiwan, Thailand, Vietnam, and others).
    • Generic & Animal Health (Heading 9903.04.67): Generic pharmaceuticals and unpatented animal health goods.
    • U.S.-Packaged Dosage Forms (Heading 9903.04.68): Products containing active ingredients packaged in dosage form in the United States.
    • Clinical & R&D Imports (Heading 9903.04.70): Articles restricted to research, trial, or non-commercial purposes.
    • Other Chapter 29/30 Non-Patented Goods (Heading 9903.04.69): Non-patented, non-generic chemicals/pharmaceuticals in Chapters 29 and 30.
  • Onshoring Incentives:
    • 20% Rate (Heading 9903.04.64): Applies to patented pharmaceuticals subject to an approved qualifying onshoring plan. (Rate increases to 100% on April 2, 2030).
    • 0% Rate (Heading 9903.04.65): Available to companies maintaining both an approved onshoring plan and an MFN pricing agreement with Commerce. (Expires January 20, 2029).

CBP also confirmed that U.S. origin pharmaceutical products remain outside the scope of the tariffs. In addition, products eligible for preferential treatment under a free trade agreement or preference program remain subject to applicable Section 232 duties, which are collected in addition to any preferential duty rate. The guidance further confirms that drawback remains available for duties paid under Proclamation 11020 and provides instructions regarding Chapter 98 claims and the treatment of covered merchandise admitted into foreign trade zones.

The Husch Blackwell International Trade and Supply Chain team will continue to monitor and provide updates as they become available. If you have questions, please contact your Husch Blackwell attorney.