U.S. Imposes Section 232 Tariffs on Patented Pharmaceuticals (Updated CBP Guidance)

Published April 2, 2026 | Sept. 28, 2026

Key Points

• 100% tariff: Applies to patented pharmaceuticals and associated active pharmaceutical ingredients (APIs) listed in Annex I.
• Effective dates: July 31, 2026 for certain large companies listed in Annex III; September 29, 2026 for all other companies.
• Trade deal countries: 15% rate for EU, Japan, South Korea, and Switzerland/Liechtenstein; reduced rate for the UK under the recently concluded pharmaceutical agreement.
• Onshoring + MFN pricing: 0% rate through January 20, 2029 for companies that enter into both MFN pharmaceutical pricing agreements with HHS and onshoring agreements with Commerce.
• Onshoring only: 20% rate for companies with Commerce-approved onshoring plans; increases to 100% on April 2, 2030.
• Generics exempt: Generic pharmaceuticals, biosimilars, and their ingredients are not subject to Section 232 tariffs at this time. Reassessment due within one year.
• Specialty products exempt: Orphan drugs, nuclear medicines, plasma-derived therapies, fertility treatments, cell and gene therapies, antibody drug conjugates, CBRN medical countermeasures, and animal health products may qualify for a 0% rate.
  
• CBP issued additional guidance on August 1, 2026, confirming that qualifying patented pharmaceuticals and pharmaceutical ingredients from the United Kingdom are subject to a 0% additional duty rate under HTSUS 9903.04.63.
• Previously, Commerce issued guidance on specialty pharmaceuticals, eligible jurisdictions, and tariff adjustments..
• Updated CBP Guidance: CBP issued updated entry filing guidance for importers, brokers, and filers, including the HTSUS classifications and filing treatment under 9903.04.60–9903.04.70. Section 232 Pharmaceutical HTSUS Classification List attached.

P​​​​​​​​​​​​​​​​resident Trump signed a proclamation on April 2, 2026, imposing Section 232 tariffs on patented pharmaceuticals and associated active pharmaceutical ingredients (APIs), citing national security concerns over US dependence on foreign production.

In this Update: Click any section below to jump directly to the update you need.

• Latest: Updated Entry Filing Guidance
• BIS Specialty Pharmaceutical Tariff Guidance
• Background Info on April 2 Proclamation
• Why Were the Section 232 Tariffs Imposed

Latest: Updated CBP Guidance

On September 28, 2026, CBP issued updated entry filing guidance covering pharmaceutical imports under HTSUS headings 9903.04.60–9903.04.70. The guidance incorporates the July 30 CBP guidance and updates the Chapter 29 and 30 HTSUS classifications to reflect the July 1, 2026 HTSUS changes and the Commerce Department’s September 23, 2026 Federal Register notice.

Entry Filing Requirements

• Importers of goods classified under the applicable HTSUS provisions in Chapters 29 and 30 must report the applicable Chapter 99 HTSUS classification.
• CBP’s updated guidance covers entries under HTSUS headings 9903.04.60–9903.04.70.
• The Chapter 29 and 30 HTSUS classification list has been updated to reflect the July 1 HTSUS changes and the September 23 Commerce Department notice.
• HTSUS 9903.04.61 is no longer in effect for goods entered after 12:01 a.m. Eastern time on September 29, 2026.

For the applicable Chapter 29 and 30 HTSUS classifications, see the attached Section 232 Pharmaceutical HTSUS Classification List.

Effective Dates

• Section 232 duties apply beginning July 31, 2026, for products of companies listed in Annex III of Proclamation 11020.
• Section 232 duties apply beginning September 29, 2026, for products of all other companies.
• If a product is subject to more than one rate under Proclamation 11020, the lowest applicable rate applies.

Chapter 99 Duty Classifications

• 9903.04.60: 100% additional ad valorem duty rate for covered patented pharmaceutical articles.
• 9903.04.62: 15% additional ad valorem duty rate for patented pharmaceutical articles that are products of Japan, EU member countries, South Korea, Switzerland, or Liechtenstein.
• 9903.04.63: 0% additional ad valorem duty rate for qualifying patented pharmaceutical articles that are products of the United Kingdom.
• 9903.04.64: 20% additional ad valorem duty rate for patented pharmaceutical articles subject to a qualifying onshoring plan. The rate increases to 100% on April 2, 2030.
• 9903.04.65: 0% additional ad valorem duty rate for pharmaceutical articles from companies with qualifying onshoring plan and MFN pharmaceutical pricing agreements. This classification expires January 20, 2029.
• 9903.04.66: 0% additional ad valorem duty rate for eligible drugs and pharmaceutical articles for specified uses under the September 23 Commerce Department guidance.
• 9903.04.67: 0% additional ad valorem duty rate for generic pharmaceutical articles.
• 9903.04.68: 0% additional ad valorem duty rate for pharmaceutical products with a U.S.-origin active pharmaceutical ingredient packaged in dosage form.
• 9903.04.69: 0% additional ad valorem duty rate for qualifying Chapter 29 and 30 articles that are not pharmaceutical products or are neither patented nor generic pharmaceutical articles.
• 9903.04.70: 0% additional ad valorem duty rate for pharmaceutical articles and associated ingredients used solely for clinical trials, research and development, or other non-commercial applications.

Additional CBP Clarifications

• U.S.-origin pharmaceutical products are not subject to the tariffs imposed by Proclamation 11020.
• For products eligible for special tariff treatment under applicable free trade agreements or preference programs, the Section 232 duties under HTSUS headings 9903.04.60–9903.04.68 are collected in addition to the applicable special tariff rate.
• Goods entered under Chapter 98 remain subject to the applicable Chapter 98 provisions and CBP regulations. Other applicable duties, including antidumping and countervailing duties, continue to apply.
• Drawback is available for duties imposed under Proclamation 11020.
• Covered products admitted into a U.S. foreign trade zone generally must be admitted under privileged foreign status unless eligible for domestic status.

Previous Updates

Commerce Issues Specialty Pharmaceutical Tariff Guidance

On September 21, 2026, the Bureau of Industry and Security (BIS) issued guidance defining the specialty pharmaceutical products and jurisdictions eligible for a 0% ad valorem tariff rate under clause 3(d) of Proclamation 11020.

The covered products include:

• Drugs where all approved or licensed indications are designated as orphan
• Nuclear medicines
• Plasma-derived therapies
• Fertility drugs
• Cell therapy products
• Gene therapy products
• Antibody drug conjugates
• Medical countermeasures related to chemical, biological, radiological, and nuclear (CBRN) threats
• Animal healthcare products

The 0% rate applies when Commerce determines, in consultation with the U.S. Trade Representative and the Secretary of Health and Human Services, that the products are from a jurisdiction with a current or forthcoming trade and security framework agreement or that they meet an urgent U.S. health need.

Eligible Jurisdictions for 0% Specialty Pharmaceutical Tariff Rate

BIS lists the following eligible jurisdictions: Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom, and Vietnam.

Request 0% Tariff Treatment for Urgent U.S. Health Needs

Companies may request Commerce approval for specialty pharmaceutical products that meet an urgent U.S. health need by submitting information to pharma232@bis.doc.gov. Each application may cover only one specific product and must include the product’s HTSUS classification, product and active ingredient information, applicable category, country of origin and export, importer of record information, manufacturer information, and the rationale for the urgent U.S. health need.

HTSUS Corrections for Pharmaceutical Tariffs

BIS also made five technical corrections to Annex I and one correction to Annex IV of Proclamation 11020. The changes include:

1. Adding HTSUS 9903.04.70 for covered pharmaceutical articles and associated ingredients used solely for clinical trials, research and development, or other non-commercial applications, with a 0% additional duty.
2. Clarifying that pharmaceutical articles include finished pharmaceutical products, active pharmaceutical ingredients, and key starting materials, while inactive ingredients and excipients are not pharmaceutical articles.
3. Adding unpatented animal health products to the definition of generic pharmaceutical articles.
4. Clarifying the scope of HTSUS 9903.04.69.
5. Updating Annex I to reflect HTSUS changes made July 1, 2026.
6. Removing HTSUS codes 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00 from Annex IV.

For the updated HTSUS provisions and tariff classifications, see Annex I and Annex II of the notice.

The HTSUS changes take 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.

Background Info on the April 2 Proclamation

Rate Structure

The applicable rate for any given company or product depends on origin, whether an onshoring plan has been approved by Commerce, and whether a Most Favored Nation pricing agreement has been executed with HHS.

100% – Standard rate
Applies to all patented pharmaceuticals and APIs in Annex I where no reduced rate applies. Default for companies without onshoring or pricing agreements. Effective September 29, 2026 for most companies.

20% – Onshoring plan approved
For companies with Commerce-approved onshoring plans, or those assessed as likely to have one soon. Rate increases to 100% on April 2, 2030. Subject to periodic reporting, external audits, and enforcement. Fraud or misrepresentation may result in retroactive tariff reimposition.

15% – Trade deal countries
Applies to products of the EU, Japan, South Korea, and Switzerland/Liechtenstein.

The United Kingdom previously qualified for a reduced 10% rate under the U.S.-UK pharmaceutical agreement. An August 1, 2026 CBP guidance confirms that qualifying UK products now receive a 0% additional duty rate effective July 31, 2026.

0% – United Kingdom
Products of the United Kingdom that meet the requirements under Proclamation 11020 qualify for a 0% additional duty rate under HTSUS 9903.04.63 effective July 31, 2026.

0% – Onshoring + MFN pricing
Companies that execute both a Commerce onshoring plan and an HHS MFN pharmaceutical pricing agreement pay zero tariff through January 20, 2029. Also applies to companies with agreements in principle assessed as likely to qualify soon.

Exempt – Generics & specialty products
Not subject to Section 232 tariffs at this time. Commerce to review and report to the President within one year on whether action on generics is warranted.

Specialty & orphan products
Orphan drugs, nuclear medicines, plasma-derived therapies, fertility treatments, cell and gene therapies, antibody drug conjugates, CBRN countermeasures, and animal health products. Exemption requires the product to be from a trade deal country or meet an urgent US health need, as determined by Commerce in consultation with USTR and HHS.

If a product is subject to both a Section 232 tariff and a Column 1 HTSUS duty, the combined rate is capped at the applicable Section 232 rate. If the Column 1 rate exceeds the Section 232 rate, only the Column 1 rate applies. Where more than one Section 232 rate could apply, the lowest applicable rate governs.

The information presented is general in nature, and is not intended to constitute legal advice with respect to any event or occurrence, and may not be considered as such.​​ Information has been obtained from sources believed to be reliable. However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.​ Due to the complexity of Customs Regulations, valuations are based on information currently available and should not be considered binding, we recommend obtaining National Customs Rulings in areas of uncertainty.​

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