CBP Issues Guidance on Section 232 on Pharmaceuticals Duties and Ingredients

Section 232 Pharma Duties: What Importers Need to Know

On April 2, 2026, the President issued Proclamation 11020, Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States, following a Section 232 investigation into whether imports of pharmaceuticals and pharmaceutical ingredients threaten to impair U.S. national security. The Proclamation establishes a tariff framework for certain patented pharmaceutical articles and associated pharmaceutical ingredients, while generic pharmaceuticals and their associated ingredients are not subject to the additional Section 232 duties at this time.

The new guidance from U.S. Customs and Border Protection (CBP) provides operational instructions for importers, brokers, and filers submitting entries for covered pharmaceutical articles under HTSUS headings 9903.04.60 through 9903.04.69. The guidance also confirms that, effective July 31 2026, all importers of merchandise classified under the subject Chapter 29 and Chapter 30 HTSUS classifications must begin reporting the applicable Chapter 99 heading, even where no additional duty is immediately due.

Key Takeaways for Section 232

• Additional Section 232 duties apply to certain patented pharmaceutical articles and associated ingredients, while generic pharmaceuticals and their associated ingredients are not subject to the additional duties.
• For pharmaceutical articles of companies listed in Annex III to Proclamation 11020, duties apply to covered entries made on or after 12:01 a.m. EDT on July 31, 2026.
• For pharmaceutical articles of all other companies, duties apply beginning September 29, 2026; however, importers must still report the applicable Chapter 99 classification beginning July 31, 2026.
• Covered pharmaceutical articles may be subject to duty rates ranging from 0% to 100%, depending on the product, company, country of origin, and any applicable onshoring or pricing provisions.
• Importers should review product classifications, patent status, company eligibility, country of origin, and entry procedures immediately to reduce the risk of misclassification, underpayment, or delayed clearance.

When New Section 232 Pharma Duties Apply: Effective Dates and Filing Requirements

The new Section 232 duties apply to covered goods entered for consumption, or withdrawn from warehouse for consumption, on or after the following dates:

• July 31, 2026: Covered pharmaceutical articles of companies listed in Annex III to Proclamation 11020 become subject to the applicable Section 232 duty rate.
• September 29, 2026: Covered pharmaceutical articles of all other companies become subject to the applicable Section 232 duty rate.
• July 31, 2026 onward: All importers of goods classified under the subject Chapter 29 and Chapter 30 HTSUS classifications must report the applicable Chapter 99 HTSUS heading, regardless of whether additional duties are immediately payable.

For imports from companies not listed in Annex III, CBP instructs importers to report HTSUS 9903.04.61 for covered patented pharmaceuticals and ingredients entered from July 31, 2026 through September 28, 2026. This provision carries a 0% additional ad valorem duty rate during that interim period.

Summary of Chapter 99 Duty Provisions

How Pharma Importers Should Prepare for Section 232

• Identify potentially covered articles. Review all pharmaceutical articles, APIs, key starting materials, and related inputs classified in Chapters 29 and 30 against the subject HTSUS classifications identified in the guidance.
• Confirm patent and regulatory status. Determine whether articles are patented pharmaceutical articles or qualify as generic pharmaceutical articles or other 0% categories.
• Review company-specific applicability. Determine whether the manufacturer or relevant company is listed in Annex III or may be eligible for a reduced or 0% duty provision.
• Validate country of origin. Confirm the origin of covered articles, particularly for articles potentially eligible for the 15% rate for Japan, European Union member countries, South Korea, Switzerland, or Liechtenstein, or the 10% rate for the United Kingdom.
• Review Valuation. Review declared values and supporting documentation to confirm the appropriate customs valuation methodology has been applied.
• Update entry procedures. Coordinate with customs brokers so the correct Chapter 99 headings are reported beginning July 31, 2026.
• Preserve documentation. Maintain records supporting classification, origin, generic status, U.S.-origin status, onshoring eligibility, and any claimed 0% or reduced duty treatment.
• Evaluate duty mitigation options. Consider drawback, supply chain restructuring, sourcing changes, FTZ procedures, and available exclusions or preferential provisions where appropriate.

Other Considerations Pharma Importers Should Know

• S. Origin Pharmaceuticals: Imports of U.S.-origin pharmaceutical articles are not subject to the tariffs imposed by Proclamation 11020. Importers should maintain documentation supporting any U.S.-origin claim, including manufacturing records, supplier certifications, and origin analyses where appropriate.
• Trade Agreements and Preference Programs: For imported articles subject to headings 9903.04.60 through 9903.04.68 that are otherwise eligible for special tariff treatment under a free trade agreement or preference program, CBP confirms that the Section 232 duties must be collected in addition to any special rate otherwise applicable under the ordinary HTSUS subheading.
• Chapter 98 Claims: Goods entered under Chapter 98 that are subject to additional duties remain eligible for treatment under the applicable Chapter 98 provision and CBP regulations. However, CBP states that importers may not use a Chapter 99 provision to claim a lower rate of duty or duty-free treatment where the Section 232 pharmaceutical provisions apply. Antidumping, countervailing, and other duties and charges continue to apply where applicable.
• Drawback: CBP confirms that drawback is available with respect to duties imposed under Proclamation 11020. Importers and exporters should evaluate whether drawback may be available for covered entries, particularly where pharmaceutical articles or ingredients are subsequently exported or destroyed under CBP supervision.
• Foreign Trade Zones: Covered non-domestic pharmaceutical articles admitted into a U.S. foreign trade zone on or after the effective date must generally be admitted in privileged foreign status, unless eligible for domestic status under 19 C.F.R. § 146.43. Such goods will be subject to the applicable Section 232 duty rate when entered for consumption.