Section 232 Pharma Tariffs: Zero-Rate Specialty Drug List and Beef TRQ Tranche 2

Key Points

• A September 24, 2026 Federal Register notice identifies specific pharmaceutical product categories eligible for a zero percent ad valorem tariff rate under Proclamation 11020, covering orphan drugs, nuclear medicines, plasma-derived therapies, fertility drugs, cell and gene therapy products, antibody drug conjugates, and medical countermeasures.
• The notice also specifies which jurisdictions are eligible for the zero rate, meaning country of origin matters for claiming the exemption.
• CBP published Quota Bulletin 26-231, opening Tranche 2 of the "Further Ensuring Affordable Beef for the American Consumer" tariff-rate quota under HTSUS Chapter 2, Additional U.S. Note 3.
• Licensed customs brokers must complete 20 hours of Continuing Education by January 31, 2027, and file the Triennial Status Report between mid-December 2026 and February 28, 2027.
• CBP is conducting a voluntary two-year ACE Electronic Export Manifest test for truck cargo, requiring a 24-hour advance filing followed by a complete manifest no later than two hours before arrival at the final port of export.

On this page

1. What changed: Proclamation 11020 zero-rate pharma guidance
2. Eligible product categories and jurisdictions
3. Beef TRQ Tranche 2: Quota Bulletin 26-231
4. Broker Continuing Education deadline: January 31, 2027
5. ACE Electronic Export Manifest truck test
6. What importers and brokers should do now
7. Key references

A September 24, 2026 Federal Register notice translates Proclamation 11020 into operational filing guidance, identifying which specialty pharmaceutical categories qualify for a zero percent ad valorem rate and which exporting jurisdictions are covered. At the same time, CBP opened Beef TRQ Tranche 2 under Quota Bulletin 26-231, a move that directly affects beef importers managing HTSUS Chapter 2 quota exposure. The links throughout this article go to the primary documents: the Federal Register notice, CBP bulletins, and CSMS messages themselves. Read the source.

What changed: Proclamation 11020 zero-rate pharma guidance

Presidential Proclamation 11020 of April 2, 2026, "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States," established a framework for tariff adjustments on pharmaceutical products. The September 24, 2026 Federal Register notice provides the operational layer: it defines which products qualify for the zero rate and names the eligible jurisdictions. It also makes technical corrections to the Harmonized Tariff Schedule of the United States to reflect these adjustments.

For importers and brokers, this notice is the document that determines whether a specific entry can claim the zero rate. Relying on the proclamation text alone is not sufficient; the Federal Register guidance governs the filing mechanics.

Eligible product categories and jurisdictions

The notice identifies eight specialty pharmaceutical categories qualifying for the zero percent ad valorem rate under Proclamation 11020:

• Drugs and associated ingredients where all approved indications are designated as orphan
• Nuclear medicines
• Plasma-derived therapies
• Fertility drugs
• Cell therapy products
• Gene therapy products
• Antibody drug conjugates
• Medical countermeasures

The notice specifies which jurisdictions are eligible. Country of origin is therefore a material fact for every entry claiming this zero rate. Importers and brokers should verify both product classification and origin before applying the exemption.

Beef TRQ Tranche 2: Quota Bulletin 26-231

CBP published Quota Bulletin 26-231 on September 23, 2026, announcing the opening of Tranche 2 of the "Further Ensuring Affordable Beef for the American Consumer" tariff-rate quota. The TRQ covers beef classified under HTSUS Chapter 2 subheadings addressed by Additional United States Note 3 and an associated Presidential Proclamation.

Beef importers should check current quota fill levels and entry timing. Tranche 2 availability is time-sensitive; TRQ quantities are allocated on a first-come, first-served basis under standard quota procedures, and entries filed after a tranche closes are subject to over-quota rates.

Broker Continuing Education deadline: January 31, 2027

CSMS #69990316 reminds individually licensed customs brokers with an active license that 20 hours of Continuing Education must be completed no later than January 31, 2027, pursuant to 19 CFR requirements. CE credits must be certified when filing the Triennial Status Report (TSR). The TSR filing window opens mid-December 2026 and closes February 28, 2027. CBP's message emphasizes not waiting until the deadline to certify credits or file the TSR.

ACE Electronic Export Manifest truck test

CSMS #70005765 announces a voluntary two-year ACE Electronic Export Manifest (EEM) test for truck cargo. Participating truck carriers would be required to electronically submit limited export manifest data at least 24 hours before departure from the United States, with a complete manifest due no later than two hours before arrival at the final port of export. Participation is voluntary during the test period. Carriers and exporters who move high volumes by truck should evaluate the operational impact now, before any mandate takes effect.

What importers and brokers should do now

• Review the Federal Register notice for Proclamation 11020 to confirm whether your pharmaceutical products and their countries of origin appear in the eligible categories and jurisdictions before claiming the zero rate.
• If you import beef under HTSUS Chapter 2, monitor CBP's quota web page for Tranche 2 fill levels and coordinate entry timing to capture available TRQ quantities under Quota Bulletin 26-231.
• Licensed brokers: log and certify CE hours now, ahead of the January 31, 2027 completion deadline, and prepare for TSR filing when the window opens in mid-December 2026.
• Truck carriers and exporters: review the ACE EEM test parameters in CSMS #70005765 and assess whether voluntary participation makes operational sense given the 24-hour pre-departure filing requirement.

Key references

• Federal Register, Sept. 24, 2026: Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals under Proclamation 11020, including eligible product categories, jurisdictions, and HTS technical corrections.
• CSMS #70003236: Quota Bulletin 26-231, Beef TRQ Tranche 2 under HTSUS Chapter 2, Additional U.S. Note 3.
• CSMS #69990316: Customs Broker Continuing Education, 20-hour requirement due January 31, 2027; Triennial Status Report filing window mid-December 2026 through February 28, 2027.
• CSMS #70005765: ACE Electronic Export Manifest voluntary two-year test for truck cargo, 24-hour advance and 2-hour pre-arrival filing requirements.