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Section 232 Pharmaceuticals: CBP Updated Filing Guidance; Duties Extended to All Companies Sept. 29

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CBP has issued updated filing guidance in CSMS# 70054007 for Section 232 duties on pharmaceuticals and pharmaceutical ingredients under Proclamation 11020 of April 2, 2026. The guidance implements the Commerce Department notice published September 23, 2026 at 91 FR 60360, which defines the products and jurisdictions eligible for a zero rate under HTSUS 9903.04.66 and makes technical corrections to Annexes I and IV.


Effective dates

The duties have applied since 12:01 a.m. eastern time on July 31, 2026 to products of companies listed in Annex III. They apply to products of all other companies entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on September 29, 2026. Heading 9903.04.61 is no longer in effect for goods entered after that time. Where more than one rate applies, the lowest applicable rate governs.


Chapter 99 headings (additional ad valorem rates)

  • 9903.04.60: patented pharmaceutical articles, 100% (combined column one and Section 232 rate).

  • 9903.04.62: patented articles of Japan, EU member states, South Korea, Switzerland, or Liechtenstein, 15% (combined rate).

  • 9903.04.63: patented articles of the United Kingdom, 0%.

  • 9903.04.64: patented articles under a qualifying onshoring plan, 20%, rising to 100% on April 2, 2030.

  • 9903.04.65: companies with both an onshoring plan agreement and an MFN pricing agreement, 0% (heading expires January 20, 2029).

  • 9903.04.66 through 9903.04.70: 0% for specified-use products from listed jurisdictions, generic articles (now including unpatented animal health products), products with a U.S.-origin active ingredient in dosage form, non-pharmaceutical or non-patented, non-generic articles, and articles solely for clinical trials, R&D, or other non-commercial use.


Other filing points

Duties under 9903.04.60 through 9903.04.68 apply in addition to any FTA or preference rate. Drawback is available. Covered products admitted to an FTZ must be admitted in privileged foreign status, unless eligible for domestic status. U.S.-origin pharmaceuticals are not subject to the duties. The Annex IV correction removes HTSUS 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00, and the CSMS attachment maps the covered Chapter 29 and 30 classifications to each Chapter 99 heading.


For more information, visit: Commerce notice, 91 FR 60360: federalregister.gov/d/2026-19498


This update is provided by Concord Solutions Group for informational purposes and does not constitute legal advice.

 
 

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