Section 232 Pharmaceutical Tariffs: Which Specialty Drugs Pay Zero From September 29

On September 23, 2026, the Bureau of Industry and Security published “Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients” at 91 FR 60360 (Docket No. 260918-0006, RIN 0694-XC154). It puts clause 3(d) of Proclamation 11020 of April 2, 2026 into practice. That proclamation imposed Section 232 duties of up to 100% on patented pharmaceuticals and their ingredients.

The timing is tight. The duties have applied since July 31, 2026 to the companies listed in Annex III of the proclamation. For every other company they start with goods entered at 12:01 a.m. eastern time on September 29, 2026, six days after this notice.

Generic drugs and biosimilars are still outside the tariff. The duties fall on patented products: drugs with a valid, unexpired U.S. patent that are listed in FDA's Orange Book or Purple Book, together with the active ingredients and key starting materials used to make them.

Which heading applies

Since July 31, every entry under the covered Chapter 29 and 30 codes has had to report one of the Chapter 99 headings below, even when no duty is owed (CBP CSMS #69395344). The headings are mutually exclusive. A patented drug falls under 9903.04.60 unless another heading applies.

Two details are easy to miss. The 15% rate for products of the EU, Japan, South Korea, Switzerland and Liechtenstein includes the normal duty: the two together come to 15%. And trade agreement preferences do not cancel the Section 232 duty. The tariff schedule collects it on top of any preferential rate. The UK rate fell to zero under a separate BIS notice at 91 FR 49406, effective July 31, 2026.

The nine specialty categories

The notice sets out definitions agreed with FDA and the USDA Center for Veterinary Biologics. They apply only to this tariff, they cover investigational drugs as well as approved ones, and Commerce says it may change them. The proclamation also lets Commerce name other specialty products later. This notice names none.

• Orphan drugs. Every approved or licensed indication must be designated orphan under section 526 of the Federal Food, Drug, and Cosmetic Act. A drug with one non-orphan indication does not qualify.
• Nuclear medicines. Radioactive drugs under 21 CFR 310.3(n) and radioactive biological products under 21 CFR 600.3(ee), including the reagent kits and nuclide generators used to prepare them.
• Plasma-derived therapies. Biological products derived from human whole blood or plasma.
• Fertility drugs. Drugs or biological products for treating infertility, including drugs approved for ovulatory dysfunction.
• Cell therapy products. Cellular immunotherapies, cellular cancer vaccines and other autologous or allogeneic cellular products, including stem cell products.
• Gene therapy products. Biological products that modify or manipulate the expression of a gene, or alter the biological properties of living cells, for therapeutic use.
• Antibody-drug conjugates. A small-molecule drug joined to an antibody or antibody fragment by a chemical linker.
• Medical countermeasures. Drugs and biological products that diagnose, prevent or treat conditions caused by chemical, biological, radiological or nuclear agents, including emerging infectious diseases.
• Animal health products. Veterinary drugs, and biologics such as vaccines, bacterins and diagnostics. Devices and combination products for animals are excluded.

The 19 jurisdictions

A specialty product qualifies through the country route if it is a product of Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom and Vietnam. The proclamation ties this route to jurisdictions with a current or forthcoming trade and security framework agreement under Executive Order 14346. Commerce says the list may change in a later notice.

Two points matter for European companies. Norway and Iceland are in the European Economic Area but not the EU, and neither is on the list. And the test is the product's country of origin under customs rules. Where the company is headquartered does not count. The country where the active ingredient is made and the country where the dosage form is finished can differ, so settle the origin of each product before you file under 9903.04.66.

China, Canada, Mexico, Singapore, Israel and Australia are not on the list either. Specialty products from those countries need the urgent-need route below, or they pay the rate that would otherwise apply.

Outside the list: the urgent U.S. health need route

Companies can ask Commerce to approve a zero rate for a specialty product on the grounds that its imports meet an urgent U.S. health need. Requests go by email to pharma232@bis.doc.gov, one product per request, and are accepted on a rolling basis from September 23, 2026. Each request needs:

• The company's legal name and address, and the name, title and contact details of the person submitting it.
• The 10-digit HTSUS code where possible, the brand name or IND number, and the active ingredient or ingredients.
• The category the product falls in.
• The country of origin and the country of export.
• The name and IOR number of each importer of record.
• The manufacturer's name and address.
• The case for urgent need: the disease the product treats, alternative therapies or the lack of them, the number of U.S. patients, and whether the product is available in other jurisdictions.

Requests are limited to patented products under the HTSUS codes in Annex I of the proclamation. Commerce consults the U.S. Trade Representative and HHS, decides each request company by company, and gives its decision in writing. CBP then applies the rate at entry summary and may ask for documents to support individual entries. Commerce says it will protect confidential business information under the Trade Secrets Act and FOIA exemptions 3 and 4.

The notice gives no processing time. BIS obtained emergency approval for the form because it wants to evaluate requests before the 100% rate starts on September 29. File early.

Clinical trial and R&D shipments get their own zero heading

For goods entered from 12:01 a.m. eastern time on September 29, 2026, new heading 9903.04.70 covers pharmaceutical articles and ingredients in the covered codes that are “solely for use in clinical trials, research and development, or other non-commercial applications.” The rate is the normal duty plus 0%. The heading has no country condition, so it applies to trial and research material from any country, including those outside the 19.

The heading says “solely.” Keep trial and research material separate from commercial stock, and keep records that show what each line is for.

Four corrections that change how lines are filed

These also take effect for goods entered from September 29, 2026.

1. Excipients are out. “Pharmaceutical articles” now means finished pharmaceutical products, their active ingredients and the key starting materials for those ingredients. Inactive ingredients and excipients are not pharmaceutical articles. They go under 9903.04.69, with no Section 232 duty.
2. Unpatented animal health products count as generic. They enter under 9903.04.67, with no Section 232 duty.
3. The Annex I code list was rebuilt to pick up the HTSUS statistical changes of July 1, 2026. Recheck your 10-digit codes against the new list.
4. Five codes came off Annex IV, the list of products subject to a zero Section 232 rate, because they also appear in Annex I: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00 and 3004.49.00. Goods under those codes now follow the Annex I treatment.

What to do before September 29

1. Confirm patent status for every product line against its Orange Book or Purple Book listing.
2. Check each specialty product against the definitions. The orphan test is the strict one: every approved indication must be orphan-designated.
3. Confirm the country of origin of each product, separately from where your company is based.
4. Recheck your 10-digit codes against the updated Annex I list.
5. Agree the heading for each line with your broker, including trial and R&D material on 9903.04.70, and what support they will keep on file for 9903.04.66 and 9903.04.70 claims.
6. Send urgent-need requests now for specialty products made outside the 19 jurisdictions.
7. Plan for drawback and zones. Drawback is available on these duties. Goods admitted to a foreign-trade zone on or after the effective date must be admitted in privileged foreign status.

Frequently asked questions

Does the Section 232 pharmaceutical tariff apply to generic drugs?

Not at this time. Proclamation 11020 leaves generic drugs, biosimilars and their ingredients outside the tariff, and they enter under heading 9903.04.67. From September 29, 2026, unpatented animal health products are treated as generic as well.

Which specialty drugs pay a zero rate?

Patented products in nine categories: orphan drugs where every approved indication is orphan-designated, nuclear medicines, plasma-derived therapies, fertility drugs, cell therapies, gene therapies, antibody-drug conjugates, medical countermeasures for chemical, biological, radiological and nuclear threats, and animal health products. They must be products of one of the 19 listed jurisdictions, or be approved by Commerce as meeting an urgent U.S. health need. They enter under heading 9903.04.66.

Which countries are on the list?

Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, South Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom and Vietnam. Commerce says the list may change in a future notice.

How do I apply if my product is made somewhere else?

Email pharma232@bis.doc.gov, one product per request, with your company details, the HTSUS code, the brand name or IND number, the active ingredients, the category, the countries of origin and export, the importer of record's name and IOR number, the manufacturer, and the reasons the product meets an urgent U.S. health need. Commerce consults USTR and HHS and decides each request in writing.

Do clinical trial shipments pay the tariff?

From September 29, 2026, pharmaceutical articles imported solely for clinical trials, research and development, or other non-commercial use enter under new heading 9903.04.70 at the normal duty plus 0%, whatever their country of origin.

When does the 100% rate start?

It has applied since July 31, 2026 to the companies listed in Annex III of Proclamation 11020. For all other companies it applies to goods entered on or after 12:01 a.m. eastern time on September 29, 2026. Lower rates apply by origin and by company agreement.

The bottom line

For specialty drugs made in the EU, Switzerland, Japan or another listed jurisdiction, a zero Section 232 rate is now available, on heading 9903.04.66, for products that meet the definitions. Specialty products from anywhere else pay the rate that would otherwise apply, up to 100% from September 29, unless Commerce approves them. Clinical-trial and research material has its own zero heading from the same date. Check the patent status, category and origin of each product line this week, and send any urgent-need requests now.

Greenwich coordinates U.S. customs brokerage through licensed customs broker partners. Before any filing, a licensed U.S. customs broker verifies classification and entry details.

Primary sources: BIS, “Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020,” 91 FR 60360, September 23, 2026 (Federal Register; govinfo PDF); Proclamation 11020, 91 FR 18183; BIS, UK rate reduction, 91 FR 49406; BIS, onshoring agreement procedures, 91 FR 26989; CBP CSMS #69395344; HTSUS Chapter 99, U.S. note 40. Confirm the current HTSUS Chapter 99 instructions and exact product line before filing. This article is operational guidance for importers and is not legal advice.