On August 6, 2026, U.S. Customs and Border Protection issued CSMS #69395344, implementation guidance for the Section 232 tariffs on patented pharmaceutical products and pharmaceutical ingredients established under the April 2, 2026 Presidential Proclamation 11020. The guidance confirms new reporting requirements are already in effect and lays out a phased schedule for when the additional duties actually apply — importers of products classified under HTSUS Chapters 29 and 30 should review it closely.
Reporting Requirement: Already in Effect
Effective July 31, 2026, importers of products classified under the affected HTSUS Chapters 29 and 30 must report the appropriate Chapter 99 HTSUS classification on all applicable entries. This reporting requirement applies regardless of whether additional duties are currently owed on the entry — meaning even importers who won’t see a rate increase yet still have a new classification obligation to meet now.
Duty Phase-In Schedule
- July 31, 2026 — Additional Section 232 duties begin for patented pharmaceutical products manufactured by companies specifically listed in Annex III of Proclamation 11020.
- September 29, 2026 — Additional duties expand to patented pharmaceutical products from all other companies not listed in Annex III.
Duty Rates
The new Chapter 99 classifications apply different duty treatment depending on product type, country of origin, and manufacturer status:
- 100% duty on certain patented pharmaceutical products.
- 15% duty for qualifying products originating from Japan, European Union member countries, South Korea, Switzerland, and Liechtenstein.
- 10% duty for qualifying products originating from the United Kingdom.
- 0% additional duty continues to apply to several categories, including generic pharmaceuticals, certain U.S.-origin pharmaceutical products, qualifying products covered by onshoring or pricing agreements, and pharmaceutical products with U.S.-origin active pharmaceutical ingredients.
Where more than one rate could apply to a given product, CBP will apply the lowest applicable rate.
Generics Remain Exempt — But Still Must Report
Generic pharmaceutical products and their associated ingredients are not subject to the new tariffs. However, importers of generics are still required to report the appropriate Chapter 99 classification on affected entries, even though no additional duty applies.
Other Key Details
- U.S.-origin pharmaceutical products are not subject to these tariffs.
- The new duties apply in addition to any preferential rates available under applicable free trade agreements.
- Duty drawback remains available for duties paid under this program.
- Products admitted into a Foreign Trade Zone that are subject to these tariffs must generally be entered under Privileged Foreign Status.
- Existing antidumping, countervailing, and other applicable duties continue to apply where relevant.
What Importers Should Do
- Review product classifications now and confirm the correct Chapter 99 HTSUS code for all affected entries — the reporting requirement is already in effect regardless of duty liability.
- Verify whether your suppliers appear on Annex III, since that determines whether the additional duty applies starting July 31 or not until September 29.
- Confirm generic product classifications separately to ensure the correct 0%-duty Chapter 99 code is reported, even though no additional duty is owed.
- Review Foreign Trade Zone entries for affected products to confirm Privileged Foreign Status is properly applied.
Need help classifying pharmaceutical entries?
ASK Alba™ — Alba’s trade compliance team can help you confirm the correct Chapter 99 classification and verify supplier status under Annex III.
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