24.09.2026 Regulation #USA #Import #Duties #Codes & nomenclature
BIS details zero-tariff drug categories ahead of September 29 tariff
The U.S. Department of Commerce's Bureau of Industry and Security (BIS) on September 23, 2026 published guidance in the Federal Register on applying a zero tariff rate to specialty pharmaceuticals (FR 2026-19498). The notice implements a mechanism set out in Proclamation 11020 of April 2, 2026, which imposed a 100 percent ad valorem tariff on certain patented pharmaceuticals and associated pharmaceutical ingredients, effective July 31, 2026 for companies listed in Annex III of the proclamation and September 29, 2026 for all other companies. The zero rate for some products was provided by the proclamation itself; the BIS notice specifies which categories it covers and how to obtain it.
Which drug categories qualify for the zero rate
BIS lists nine categories of specialty pharmaceuticals:
- drugs where all approved or licensed indications are designated as orphan;
- nuclear medicine products meeting the definition of a "radioactive drug";
- therapies derived from human whole blood or plasma;
- fertility drugs and biological products for the treatment of infertility;
- cell therapy products (cellular immunotherapies);
- gene therapy products that modify or manipulate gene expression;
- antibody-drug conjugates (a small-molecule drug combined with an antibody);
- medical countermeasures related to chemical, biological, radiological and nuclear (CBRN) threats;
- animal health products used to diagnose, treat or mitigate disease in animals.
Two grounds for relief
The zero rate applies if the Secretary of Commerce, in consultation with the USTR and the Secretary of Health and Human Services (HHS), determines that a product meets one of two conditions: it is a product of a jurisdiction with a current or forthcoming trade and security framework agreement with the United States, or it meets an urgent U.S. health need.
The notice lists the jurisdictions as Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, the European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, the Republic of Korea, Switzerland and Liechtenstein, Taiwan, Thailand, the United Kingdom and Vietnam. It sets out no separate procedure for applying to BIS for products of these jurisdictions.
Making the case for an urgent health need
The request procedure covers only the second ground. A company emails BIS with information on the organization, the product's HTSUS classification, brand name, active ingredients, product category, country of origin, importer and manufacturer. The justification must explain the disease the product treats, whether alternative therapies exist and how many U.S. patients use the product. Commerce consults with the USTR and HHS and notifies the company of its decision in writing. Submissions are accepted on an ongoing basis starting September 23, 2026; the notice sets no specific filing deadline.
A clinical-trial subheading and technical corrections
The notice creates subheading 9903.04.70, which adds a zero additional duty to the applicable subheading rate for pharmaceutical articles and ingredients covered by subdivision (c) of U.S. note 40 when they are used solely for clinical trials, research and development, or other non-commercial applications. In note 40, the range "9903.04.60-9903.04.69" is replaced with "9903.04.60-9903.04.70", the definition of "pharmaceutical articles" is clarified to cover finished products, their active pharmaceutical ingredients and key starting materials, and the definition of a generic pharmaceutical article is expanded to include unpatented animal health products. HTSUS codes 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00 and 3004.49.00 are removed from Annex IV (headings 2937, 3002 and 3004).
The corrected Annex I and Annex II apply to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on September 29, 2026 — the same day the 100 percent tariff extends to companies outside Annex III.
Primary sources
- Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals (Federal Register 2026-19498, govinfo)
- Federal Register: Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals
Mentioned codes
This material is for information only and does not constitute legal advice or customs consulting. Verify changes against the primary sources before acting.