Section 232 tariffs on covered patented pharmaceuticals and associated pharmaceutical ingredients expanded on September 29, 2026, as scheduled under Proclamation 11020. U.S. Customs and Border Protection (CBP) issued updated filing guidance, CSMS #70054007, on September 28 to implement the change.
The tariffs now apply to covered products from companies that were not included in the initial July 31 implementation. Depending on the product, company, country of origin, and available exception, an imported pharmaceutical article may face a combined duty rate as high as 100%.
CBP’s updated guidance also incorporates the Commerce Department’s September 23 specialty-pharmaceutical guidance and technical corrections, adds a zero-rate provision for products used solely in clinical trials or research, and updates the applicable Chapter 29 and 30 tariff classifications. For background on the original filing requirements, see our August article, CBP Issues Implementation Guidance for Section 232 Pharmaceutical Tariffs.
Temporary Zero-Rate Treatment Has Ended
From July 31 through September 28, covered products from companies not identified in Annex III to the pharmaceutical proclamation could be reported under HTSUS 9903.04.61 at a zero percent additional duty rate.
That temporary provision is no longer available for goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. Eastern on September 29.
Importers must now determine which of the remaining pharmaceutical Chapter 99 provisions applies to each entry.
The relevant date is the date of entry for consumption or withdrawal from warehouse, not the shipment, export, or arrival date. Products already stored in a bonded warehouse may therefore be subject to the new treatment when withdrawn.
Pharmaceutical Tariff Rates Vary by Product, Origin, and Company
The applicable Chapter 99 classifications now include:
- HTSUS 9903.04.60: Applies to covered patented pharmaceutical articles that do not qualify for another provision. The combined Column 1 and Section 232 duty rate is 100%.
- HTSUS 9903.04.62: Applies to qualifying patented pharmaceutical articles from Japan, EU member countries, South Korea, Switzerland, or Liechtenstein. The combined Column 1 and Section 232 rate is 15%.
- HTSUS 9903.04.63: Applies to qualifying patented pharmaceutical articles from the United Kingdom. The additional duty rate is 0%.
- HTSUS 9903.04.64: Applies to patented pharmaceutical articles subject to a qualifying onshoring plan. The additional duty rate is 20% and is scheduled to increase to 100% on April 2, 2030.
- HTSUS 9903.04.65: Applies to pharmaceutical articles from companies with both a qualifying Commerce onshoring agreement and a Most-Favored-Nation pharmaceutical-pricing agreement. The additional duty rate is 0%. This provision expires January 20, 2029.
- HTSUS 9903.04.66: Applies to qualifying specialty pharmaceuticals and associated ingredients for specified uses. The additional duty rate is 0%.
- HTSUS 9903.04.67: Applies to generic pharmaceutical articles. The additional duty rate is 0%.
- HTSUS 9903.04.68: Applies to qualifying dosage-form pharmaceutical products containing a U.S.-origin active pharmaceutical ingredient. The additional duty rate is 0%.
- HTSUS 9903.04.69: Applies to covered Chapter 29 and 30 articles that are not pharmaceutical articles, or that are pharmaceutical articles but are neither patented nor generic pharmaceutical articles. The additional duty rate is 0%.
- HTSUS 9903.04.70: Applies to pharmaceutical articles and associated ingredients used solely in clinical trials, research and development, or other noncommercial applications. The additional duty rate is 0%.
If a product qualifies for more than one tariff rate under the proclamation, the lowest applicable rate applies.
UK Pharmaceutical Products Remain at Zero Additional Duty
CBP’s original July 30 filing guidance assigned qualifying UK products a 10% additional duty rate. Two days later, CBP issued CSMS #69415934 implementing a Commerce reduction of that rate to 0%, retroactive to July 31. The September 28 guidance carries the zero rate forward under HTSUS 9903.04.63.
Importers should confirm that classification databases, broker instructions, and landed-cost calculations no longer reflect the earlier 10% treatment, and review any UK entries filed at that rate.
The zero-rate provision applies only to products that satisfy the governing origin and product requirements. Shipment from the United Kingdom alone does not necessarily establish eligibility.
Specialty Pharmaceuticals May Qualify for Zero Additional Duty
Commerce has defined the specialty-pharmaceutical categories potentially eligible for zero additional duty treatment under HTSUS 9903.04.66. These categories include:
- Drugs for which all approved or licensed indications are designated orphan (rare-disease) uses
- Nuclear medicines
- Plasma-derived therapies
- Fertility drugs
- Cell therapy products
- Gene therapy products
- Antibody-drug conjugates
- Medical countermeasures for chemical, biological, radiological, and nuclear threats
- Animal healthcare products, including veterinary biologics
Commerce notes that these definitions cover investigational drugs as well as FDA-approved or FDA-authorized products.
Eligibility also depends on either the product’s country of origin (a jurisdiction with a current or forthcoming trade and security framework agreement) or a Commerce determination that it meets an urgent U.S. health need.
Commerce currently identifies the following jurisdictions as eligible for the specialty-pharmaceutical treatment:
- Argentina
- Bangladesh
- Cambodia
- Ecuador
- El Salvador
- European Union member countries
- Guatemala
- India
- Indonesia
- Japan
- Jordan
- Malaysia
- North Macedonia
- South Korea
- Switzerland
- Liechtenstein
- Taiwan
- Thailand
- United Kingdom
- Vietnam
Commerce has said it may publish changes to this list in a future notice.
A company seeking zero-rate treatment for a specialty pharmaceutical that meets an urgent U.S. health need may submit a product-specific request to Commerce at pharma232@bis.doc.gov. Requests are accepted on an ongoing basis, and each application may cover only one product.
The application must identify the company and its authorized representative, and address the product, active ingredient, tariff classification, manufacturer, importer of record (including IOR number), country of origin and export, relevant specialty category, and the basis for the claimed urgent health need. Requests should cover only patented products classified under the HTSUS codes in Annex I of the proclamation. Commerce will decide each request individually and notify the company in writing.
Generics and Certain Animal-Health Products Remain at Zero Additional Duty
Generic pharmaceuticals and their associated ingredients remain subject to a zero percent additional duty rate under HTSUS 9903.04.67.
Commerce’s technical corrections clarify that unpatented animal-health products are included in the definition of generic pharmaceutical articles.
However, importers using one of the covered Chapter 29 or 30 classifications must still report the appropriate Chapter 99 heading. Generic status is therefore both a product determination and an entry-filing requirement.
Importers should maintain documentation demonstrating why a product is generic rather than patented.
Clinical-Trial and Research Products Receive a New Zero-Rate Provision
The updated tariff schedule creates HTSUS 9903.04.70 for pharmaceutical articles and associated ingredients used solely for:
- Clinical trials
- Research and development
- Other noncommercial applications
The additional duty rate is zero.
The term “solely” is important. Importers should be prepared to document the product’s intended use, recipient, quantity, project, and noncommercial disposition.
Possible supporting records may include clinical-trial documentation, research protocols, purchase orders, end-use statements, institutional records, and inventory controls.
Products imported for both research and commercial sale may not qualify for this provision.
Commerce Clarifies What Counts as a Pharmaceutical Article
Commerce’s technical corrections clarify that “pharmaceutical articles” include:
- Finished pharmaceutical products
- Active pharmaceutical ingredients
- Key starting materials used to produce active pharmaceutical ingredients
Inactive ingredients and excipients are not pharmaceutical articles for these measures.
To remove overlap with Annex I, Commerce also removed the following HTSUS codes from Annex IV:
- 2937.23.50
- 3002.13.00
- 3002.14.00
- 3002.15.00
- 3004.49.00
Importers should use CBP’s updated pharmaceutical classification list rather than relying on the original April annexes or the July filing guidance.
Other Duties and Entry Rules Continue to Apply
The Section 232 treatment does not replace other applicable import requirements. CBP’s guidance confirms that:
- Applicable antidumping and countervailing duties continue to apply.
- Preferential treatment under a free-trade agreement does not eliminate applicable Section 232 duties.
- Chapter 98 entries remain subject to the terms of the applicable provision and CBP regulations.
- Drawback is available for duties imposed under the pharmaceutical proclamation.
- Covered merchandise admitted into a U.S. foreign-trade zone generally must enter in privileged foreign status unless eligible for domestic status.
- U.S.-origin pharmaceutical products are not subject to the tariffs.
Importers should calculate total duty exposure rather than considering the Section 232 rate in isolation.
What Pharmaceutical Importers Should Do Now
Importers and customs brokers should:
- Identify all pharmaceutical entries and warehouse withdrawals occurring on or after September 29.
- Review the updated Chapter 29 and 30 classification list issued by CBP.
- Determine whether each product is patented, generic, or outside the definition of a pharmaceutical article.
- Confirm the producer, company affiliation, and country of origin.
- Review eligibility for UK, allied-country, specialty-product, onshoring, U.S.-ingredient, clinical-trial, or research treatment.
- Confirm UK tariff instructions reflect the 0% rate in effect since July 31.
- Document any claim that a product is generic, intended solely for research, or eligible as a specialty pharmaceutical.
- Review bonded-warehouse inventory before withdrawing merchandise for consumption.
- Recalculate landed costs, bond exposure, and working-capital requirements.
- Confirm the proper Chapter 99 reporting sequence with the customs broker.
The commercial invoice alone may not contain enough information to support the appropriate tariff treatment. Importers may need patent-status records, active-ingredient information, manufacturing records, end-use statements, regulatory documentation, or company-specific eligibility information.
Need help with pharmaceutical classifications? Contact the ASK Alba™ team for assistance reviewing pharmaceutical classifications, determining the correct Chapter 99 provision, documenting zero-rate eligibility, or calculating potential duty exposure. Subscribe to the ASK Alba™ Trade Brief for timely updates on tariffs, FDA-regulated products, and U.S. import requirements.
References
- U.S. Customs and Border Protection, CSMS #70054007, Updated Guidance: Section 232 Duties on Imports of Pharmaceutical Articles and Ingredients (September 28, 2026), with Section 232 pharmaceutical HTSUS list
- Bureau of Industry and Security, Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the HTSUS for Duties Imposed Under Proclamation 11020, 91 FR 60360 (September 23, 2026)
- Proclamation 11020, Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States, 91 FR 18183 (April 9, 2026)
- U.S. Customs and Border Protection, CSMS #69395344, Guidance: Section 232 Duties on Imports of Patented Pharmaceutical Articles and Ingredients (July 30, 2026)
- U.S. Customs and Border Protection, CSMS #69415934, Guidance: Reduction of Tariffs on Patented Pharmaceuticals and Pharmaceutical Ingredients for Products of the United Kingdom (August 1, 2026)
