Section 232 Pharmaceutical Tariffs Expand to Every Importer on September 29, 2026 — the 0% Placeholder Code Expires, and Any Seller Importing Under HTS Chapters 29 or 30 Has Had to Declare a Chapter 99 Code Since July 31
CBP issued CSMS #69395344 on July 30, 2026 implementing the Presidential proclamation "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States," which puts Section 232 duties of up to 100% on patented pharmaceutical articles and ingredients. The rollout is in two stages: duties started July 31, 2026 for the companies named in Annex III to the proclamation, and they apply to products of all other companies from 12:01 a.m. eastern time on September 29, 2026. Until that moment, covered articles from non-Annex III companies enter under HTSUS 9903.04.61 at a 0% rate — that provisional code only covers goods entered before 12:01 a.m. ET on September 29, so entries after the cutover have to carry a real rate code instead. The part that reaches well beyond drug importers is the reporting rule: since July 31, 2026 every importer of goods classified under the subject Chapter 29 and Chapter 30 HTSUS lines must report an applicable Chapter 99 classification on the entry, even when the duty owed is zero. CBP created 9903.04.69 specifically for non-pharmaceutical articles falling in those chapters and 9903.04.67 for generic pharmaceuticals, both at 0%.
Real-World Impact
A covered patented pharmaceutical article with a USD 10,000 customs value entered on September 28, 2026 files under 9903.04.61 and owes USD 0 in Section 232 duty. The identical shipment entered on September 29 falls to the 100% rate under 9903.04.60 and owes USD 10,000 on top of ordinary customs duties. If the same goods are a product of the EU, Japan, South Korea, Switzerland or Liechtenstein, the 15% tier under 9903.04.62 applies instead and the duty is USD 1,500.
Key Points
- Two-stage effective date: July 31, 2026 for products of companies listed in Annex III to the proclamation, and September 29, 2026 at 12:01 a.m. eastern time for products of all other companies
- HTSUS 9903.04.61 is the 0% provisional code that covers patented pharmaceutical articles entered before 12:01 a.m. ET on September 29, 2026 — it stops being available at the cutover
- The headline rate is 100% ad valorem under 9903.04.60, with reduced tiers of 15% for products of Japan, the EU member states, South Korea, Switzerland and Liechtenstein (9903.04.62) and 10% for United Kingdom products (9903.04.63)
- 9903.04.64 sets 20% for articles covered by a qualifying onshoring plan, rising to 100% on April 2, 2030, and 9903.04.65 sets 0% for Annex II companies with onshoring and pricing agreements, expiring January 20, 2029
- Generic pharmaceuticals (9903.04.67), articles made with US-origin active ingredients (9903.04.68), drugs for specified uses (9903.04.66) and non-pharmaceutical articles classified in Chapters 29 and 30 (9903.04.69) all carry a 0% rate — but they still require a Chapter 99 code on the entry
- The reporting obligation is the broadest piece: effective July 31, 2026, all importers of goods under the subject Chapter 29 and 30 classifications must report an applicable Chapter 99 HTSUS classification, regardless of whether any duty is due
What You Should Do Now
- 1Ask your customs broker to list every SKU you import that classifies in HTS Chapter 29 or Chapter 30 — this is the trigger for the reporting requirement, not whether you think of your product as a drug
- 2For each of those SKUs, confirm which Chapter 99 code your broker is declaring, and check that entries currently riding on the 0% 9903.04.61 code have a correct destination code lined up for entries on or after September 29, 2026
- 3Cross-reference your products against Annex I (covered articles) and Annex IV (zero-rate articles) of the proclamation rather than assuming a 0% outcome
- 4If a product is genuinely generic, US-origin in its active ingredient, or non-pharmaceutical, make sure the matching zero-rate code (9903.04.67, 9903.04.68 or 9903.04.69) is on the entry so the filing is not rejected for a missing declaration
- 5Rebuild landed cost for any SKU that moves off 9903.04.61 before you commit to Q4 inbound quantities, since a 100% or 15% duty applied at the September 29 cutover changes the unit economics after the goods are already on the water