Updated Section 232 pharma guidance changes Chapter 99 coverage, rates, effective dates, and HTS classifications for pharmaceutical imports.

CSMS #70054007 updates implementation of Proclamation 11020 and provides entry instructions for pharmaceutical articles and ingredients under HTSUS 9903.04.60–9903.04.70. This is a critical duty-calculation update for brokers and importers.

Covered patented pharmaceutical articles generally use HTSUS 9903.04.60 at a 100% combined Column 1 and Section 232 rate. A 15% rate applies under 9903.04.62 to qualifying products of Japan, specified European Union countries, South Korea, Switzerland, and Liechtenstein. United Kingdom products under 9903.04.63 receive a 0% additional rate. Qualifying onshoring-plan products under 9903.04.64 currently receive 20%, but the rate increases to 100% for entries on or after April 2, 2030. Provisions 9903.04.65–9903.04.70 provide specified zero-rate treatment, subject to eligibility conditions; 9903.04.65 expires January 20, 2029.

Additional duties apply to Annex III company products entered on or after July 31, 2026, and to all other companies on or after September 29, 2026. HTSUS 9903.04.61 is no longer effective after September 29, 2026. The notice also adds zero-rate HTSUS 9903.94.70, clarifies generic pharmaceutical coverage to include unpatented animal health products, narrows the pharmaceutical definition, and removes HTSUS 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00 from Annex IV.

Trade agreement preference rates do not replace the applicable Chapter 99 duties for 9903.04.60–9903.04.68. Brokers should update ACE filing logic, product databases, origin and company eligibility controls, use-based exclusions, Chapter 29 and 30 statistical suffixes, FTZ procedures, and drawback calculations.