White House Issues Dual Section 232 Proclamations On Pharmaceuticals And Metals

On April 2, 2026, President Trump signed two presidential proclamations invoking Section 232 of the Trade Expansion Act of 1962 and Section 604 of the Trade Act of 1974 to impose significant new tariffs on imports of patented pharmaceuticals and pharmaceutical ingredients, and to restructure the existing tariff regime for aluminum, steel, and copper articles and their derivatives. The pharmaceutical proclamation targets patented drugs and active pharmaceutical ingredients (APIs), citing the Secretary of Commerce’s finding that approximately 53 percent of patented pharmaceutical products distributed domestically are produced outside the country, and only 15 percent of patented APIs by volume are domestically produced for the U.S. market. The metals proclamation amends three prior Section 232 actions — Proclamation 9704 of March 8, 2018 (aluminum), Proclamation 9705 of March 8, 2018 (steel), and Proclamation 10962 of July 30, 2025 (copper) — to restructure how tariffs are calculated and which derivative articles are covered. The administration also issued two separate fact sheets for these actions.

Pharmaceuticals Proclamation: Key Points

• A 100 percent ad valorem duty rate applies to imports of patented pharmaceuticals and associated pharmaceutical ingredients, as listed in Annex I to the proclamation, except as otherwise provided.
• Effective with respect to goods entered for consumption on or after 12:01 a.m. eastern time on July 31, 2026, new HTSUS headings 9903.04.60 through 9903.04.69 in subchapter III of chapter 99 provide the customs duty treatment of imported articles classifiable in the provisions enumerated in U.S. Note 40.
• “Patented pharmaceutical articles” are pharmaceutical articles subject to a valid, unexpired U.S. patent and listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) or the FDA’s Lists of Licensed Biological Products (Purple Book), and associated APIs and key starting materials.
• The rate is 15 percent for products of Japan, the European Union, the Republic of Korea, and Switzerland and Liechtenstein, and 10 percent for products of the United Kingdom, reducible to zero to the extent required by any future U.S.–UK pharmaceutical pricing agreement.
• Companies with onshoring plans approved by the Secretary are subject to a reduced 20 percent rate, which increases to 100 percent on April 2, 2030.
• For companies with approved onshoring plans that have also entered into Most-Favored-Nation (MFN) pharmaceutical pricing agreements with the Secretary of Health and Human Services (HHS), the applicable ad valorem rate is zero until January 20, 2029.
• A zero rate applies to orphan drugs (21 U.S.C. § 360aa et seq.), nuclear medicines, plasma-derived therapies, fertility treatments, cell and gene therapies, antibody drug conjugates, medical countermeasures for chemical, biological, radiological, and nuclear (CBRN) threats, and certain animal health pharmaceutical products, subject to a Secretary determination that they are products of a jurisdiction with a current or forthcoming trade and security framework agreement or meet an urgent U.S. health need.
• Generic pharmaceuticals and their associated ingredients, including biosimilars, are not subject to Section 232 tariffs at this time.
• Annex III lists 17 named companies whose tariff treatment is effective 120 days from the date of the proclamation (i.e., July 31, 2026), including AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, EMD Serono, Genentech, Gilead Sciences, GlaxoSmithKline/ViiV Healthcare, Johnson & Johnson, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Regeneron, and Sanofi.
• Annex II ratifies 13 pre-existing company-specific tariff agreements entered into by the Secretary prior to the proclamation.
• Drawback is available with respect to duties imposed pursuant to the pharmaceutical proclamation.
• Products subject to the pharmaceutical tariff admitted into a U.S. foreign trade zone (FTZ) on or after the effective date must be admitted under “privileged foreign status” as described in 19 CFR § 146.41, and will be subject upon entry for consumption to ad valorem rates applicable at the time of the HTSUS classification.

Metals Proclamation: Key Points

• Effective for goods entered for consumption on or after 12:01 a.m. eastern daylight time on April 6, 2026, the additional ad valorem Section 232 duty on aluminum, steel, and copper articles and their derivatives applies to the full customs value of the imported product, regardless of metal content.
• Annex I-A articles — covering primary steel mill products, aluminum articles, and most copper articles and certain steel and aluminum derivatives — are subject to a 50 percent ad valorem rate on their full value.
• For Annex I-A articles, a reduced rate of 25 percent applies to United Kingdom products the aluminum content of which is composed entirely of aluminum smelted or most recently cast in the UK, or the steel content of which is composed entirely of steel melted and poured in the UK.
• A further reduced rate of 10 percent applies to Annex I-A derivative articles the aluminum, steel, or copper content of which is composed entirely of metals smelted/cast or melted/poured in the United States.
• Annex I-B articles — covering certain copper articles and certain aluminum and steel derivative articles — are subject to a 25 percent ad valorem rate on their full value.
• Annex II articles are removed from the scope of the aluminum and steel Section 232 duties; additionally, any motorcycle part classifiable in Chapters 84, 85, or 87 and listed in Annex I-B shall not be subject to Section 232 tariffs when imported exclusively for use in manufacturing motorcycles.
• Annex III provides a temporary rate reduction for certain steel and aluminum derivative articles through December 31, 2027. For Annex III products with a Column 1 duty rate below 15 percent, the combined rate shall total 15 percent; for products with a Column 1 duty rate of 15 percent or above, no additional Section 232 duty applies.
• Effective January 1, 2028, Annex III products revert to the Annex I-B rates prescribed in clause (3) of the proclamation.
• All imports of aluminum articles and derivatives in Annex I-A, I-B, or III that are the product of Russia, or where any amount of primary aluminum was smelted or cast in Russia, remain subject to the 200 percent ad valorem rate established in Proclamation 10522 of February 24, 2023.
• Products made of 15 percent or less steel, aluminum, or copper will no longer be subject to Section 232 metals tariffs.
• The prior BIS derivative inclusions processes established under Proclamation 10895, Proclamation 10896, and Proclamation 10962 are terminated; the Secretary and the U.S. Trade Representative (USTR) are authorized jointly to include additional derivative articles on a rolling basis, without a formal notice-and-comment window, when they determine that imports threaten to undermine the national security objectives of the prior proclamations.
• Manufacturing drawback under 19 U.S.C. § 1313(a)–(b) is available for Annex I-B and Annex III articles, subject to conditions: the article must not be subject to an antidumping or countervailing duty order; it must be a product of a Trade Agreement Partner (the UK, EU, Japan, South Korea, Mexico, Canada, or any country with a final Reciprocal Trade Agreement); and its metal content must be composed entirely of metals smelted/cast or melted/poured in a Trade Agreement Partner country.
• U.S. Customs and Border Patrol (CBP) is authorized to issue rules, regulations, and guidance to address illegal transshipment, undervaluation, and tariff evasion; importers of copper articles must provide CBP with information identifying the countries where copper used in covered imports was smelted and cast.
• Products covered by the metals proclamation admitted into an FTZ on or after April 6, 2026 may be admitted only under “privileged foreign status” under 19 CFR § 146.41.

Implications

Importers of pharmaceutical products should immediately determine whether their products qualify as “patented pharmaceutical articles” under HTSUS headings 9903.04.60 through 9903.04.69, as the applicable rate ranges from zero to 100 percent depending on company agreement status and country of origin. Companies with qualifying onshoring plans must submit periodic progress reports to the Secretary, subject to potential external audit, and face prospective and retroactive tariff reimposition in cases of fraud or deliberate misrepresentation. The Secretary must also, within one year of the date of the proclamation, report to the President on any circumstances that might indicate the need to adjust imports of generic pharmaceuticals and their associated ingredients — confirming that the current generic carve-out is subject to review.

For metals importers, the proclamation clarifies that tariffs are assessed on the full value of imported steel, aluminum, and copper products — not an artificially low foreign price based solely on metal content. This represents a material change in landed cost calculations for all derivative articles in Annex I-A, Annex I-B, and Annex III, and requires immediate re-benchmarking of duty exposure across all affected product lines. Compliance teams should also establish robust supply-chain documentation for copper articles, as importers are required to identify the countries of smelting and casting to CBP, with CBP authorized to implement those requirements as soon as practicable. For UK-origin articles to qualify for the reduced 25 percent Annex I-A rate or the 15 percent Annex I-B rate, at least 95 percent of the aluminum must have been smelted or most recently cast in the UK, or at least 95 percent of the steel must have been melted and poured in the UK.

The termination of the prior BIS inclusions process and its replacement with a joint Secretary/USTR rolling-inclusion authority — without a formal notice-and-comment window — narrows the window for interested parties to oppose or challenge the addition of new derivative articles. The Secretary and USTR are required to provide a joint 90-day update on the metals regime, covering the national security status of imports, U.S. production of aluminum, steel, and copper, any actions taken by foreign trading partners, and any other relevant recommendations. Similarly, the Secretary and HHS are directed to report within 90 days on the progress of pharmaceutical negotiations under Section 232(c)(3)(A)(i), (19 U.S.C. § 1862(c)(3)(A)(i)).

Procedural Deadlines and Rolling-Scope Considerations

• April 6, 2026: Metals proclamation effective date for entries for consumption. Tariffs apply to the full customs value of aluminum, steel, and copper articles and their derivatives.
• July 31, 2026: Pharmaceutical tariffs take effect for companies listed in Annex III.
• September 29, 2026: Pharmaceutical tariffs take effect for all other companies not party to Annex III or Annex II agreements.
• April 2, 2030: Pharmaceutical rate for companies with approved onshoring plans escalates from 20 percent to 100 percent.
• January 20, 2029: Zero tariff rate for companies with both an approved onshoring plan and an MFN pricing agreement expires.
• December 31, 2027: Annex III temporary reduced rate period ends. Effective January 1, 2028, Annex III products revert to Annex I-B rates.
• Rolling BIS Inclusions Cycle: Inclusion requests can be submitted to BIS during a two-week period at the beginning of May, September, and January. Clients should calendar these windows and monitor Federal Register notices for newly added derivative products that may affect their import profiles.
• 90-Day Reporting Obligations: Both proclamations require the Secretary of Commerce (and, for metals, USTR; for pharmaceuticals, HHS) to submit joint reports within 90 days, which may include scope adjustments, new annexes, or updated guidance. The Secretary of Commerce and, where applicable, the USTR may expand or revoke coverage through Federal Register notices without further Presidential action, meaning the scope of both regimes may shift on a rolling basis.

Crowell will continue to monitor developments under both proclamations, including CBP implementation guidance, Federal Register notices expanding or modifying annex scope, and further agency action by the Secretary of Commerce, HHS, and the USTR, and will provide updates as the compliance landscape evolves.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.