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Section 232 pharmaceutical duties now apply to all companies as of September 29, 2026

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IORUSA
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Commercial invoice and packing list with a calculator and reading glasses, the documents behind customs valuation under 19 U.S.C. §1401a

In brief

Proclamation 11020 duties on patented pharmaceuticals and ingredients reached all companies on September 29, 2026. CBP CSMS #70054007 sets the Chapter 99 headings, from 100 percent to zero, and the entry rules for FTZ, drawback, and trade agreements.

Section 232 duties on patented pharmaceuticals and their ingredients now apply to products of all companies. Under Proclamation 11020 of April 2, 2026, the duties took effect July 31, 2026 for the companies listed in Annex III of the proclamation, and for all other companies on goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on September 29, 2026. CBP issued updated filing guidance on September 28, 2026 in CSMS #70054007.

What happened

Proclamation 11020, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States,” was issued under section 232 of the Trade Expansion Act of 1962, 19 U.S.C. §1862, and published at 91 FR 18183. It set a 100 percent ad valorem tariff on patented pharmaceuticals and associated ingredients listed in Annex I, with a two-date start: July 31 for Annex III companies, September 29 for everyone else.

On September 23, 2026, the Bureau of Industry and Security published a notice at 91 FR 60360 (FR Doc. 2026-19498). It defines the specialty products eligible for a zero rate under clause 3(d) of the proclamation, lists the eligible jurisdictions, opens a process for submitting information on products that meet an urgent United States health need, and makes five technical corrections to Annex I and one to Annex IV. The United States International Trade Commission published the matching tariff schedule changes as 2026 HTS Revision 20 on September 28, 2026, effective September 29.

What the rates are

CBP’s guidance assigns each rate to a Chapter 99 heading, 9903.04.60 through 9903.04.70:

  • 9903.04.60, patented pharmaceutical articles: 100 percent. CBP describes this rate as combined column one and Section 232.
  • 9903.04.61: no longer in effect for goods entered after 12:01 a.m. on September 29, 2026.
  • 9903.04.62, products of Japan, European Union member countries, South Korea, Switzerland, or Liechtenstein: 15 percent, also described as combined.
  • 9903.04.63, products of the United Kingdom: 0 percent.
  • 9903.04.64, products subject to a qualifying onshoring plan: 20 percent, rising to 100 percent on April 2, 2030.
  • 9903.04.65, companies with both an onshoring plan agreement and a most favored nation pricing agreement with Commerce: 0 percent, expiring January 20, 2029.
  • 9903.04.66, the specialty categories defined in the September 23 notice (orphan drugs, nuclear medicines, plasma derived therapies, fertility drugs, cell and gene therapies, antibody drug conjugates, certain medical countermeasures, and animal health) from listed jurisdictions: 0 percent.
  • 9903.04.67, generic pharmaceutical articles, now including unpatented animal health products: 0 percent.
  • 9903.04.68, products with an active ingredient packaged in dosage form that is a product of the United States: 0 percent.
  • 9903.04.69, articles in the covered Chapter 29 and 30 classifications that are not patented or generic pharmaceutical articles: 0 percent.
  • 9903.04.70, new, articles solely for clinical trials, research and development, or other non-commercial use: 0 percent.

Where more than one rate could apply, CBP states that the lowest applicable rate applies. A corrected definition limits “pharmaceutical articles” to finished products, their active pharmaceutical ingredients, and the key starting materials for those ingredients. Five classifications (2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00) were removed from Annex IV.

Entry treatment

The CSMS sets out several filing rules. For goods eligible for a free trade agreement or preference program, the Section 232 duty is collected in addition to the special rate. Goods admitted to a foreign trade zone must be admitted in privileged foreign status under 19 C.F.R. §146.41, unless eligible for domestic status. Drawback is available. Antidumping, countervailing, and other duties continue to apply. Imports of United States origin pharmaceutical products are not subject to the duties.

What is in effect and what is not

The duties are in effect for all companies as of September 29, 2026. The urgent health need submission process opened September 23 and runs on an ongoing basis; the notice sets no decision deadline. The proclamation states that generic pharmaceuticals are not subject to Section 232 duties at this time.

Why it matters to importers

The Section 232 duty is owed by the Importer of Record at entry, and the Chapter 99 heading reported on the entry summary determines the rate. A zero or lower rate depends on facts the IOR declares: country of origin, patent status, onshoring or pricing agreement status, or end use. This is one of the tariff actions that shape what a US Importer of Record must show and pay in 2026.

Questions about how an Importer of Record structure applies to your imports can go to ship@iorusa.com or through the contact page.

Sources

This post summarizes publicly available federal actions for general information. It is not legal advice. Requirements are subject to rulemaking and change. Verify current requirements against the Federal Register and CBP guidance.

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