Specialty Pharmaceutical Tariff Exemption Covers Nine Classes and 19 Jurisdictions

The Bureau of Industry and Security has identified the medicines that qualify for the specialty pharmaceutical tariff exemption created by Proclamation 11020. The agency named nine product classes and 19 jurisdictions that can import them at a zero ad valorem rate rather than the 100 percent tariff applied to most patented pharmaceuticals.

The notice appeared in the Federal Register on 23 September 2026 (91 FR 60360, FR Doc. 2026-19498, Docket No. 260918-0006). It defines each eligible category, lists the qualifying jurisdictions, and explains how companies can request that the Department of Commerce treat an import as meeting an urgent U.S. health need. Submissions have been accepted since 23 September 2026. The tariff schedule corrections in the annexes take effect at 12:01 a.m. eastern time on 29 September 2026.

What the specialty pharmaceutical tariff exemption covers

Proclamation 11020, signed on 2 April 2026 and published at 91 FR 18183, imposed a 100 percent ad valorem tariff on imports of patented pharmaceuticals and associated ingredients under Section 232 of the Trade Expansion Act of 1962 (19 U.S.C. 1862). That tariff took effect on 31 July 2026 for the companies listed in Annex III of the proclamation and applies to all other companies from 29 September 2026. Generic pharmaceutical products and their ingredients are not currently caught by the Section 232 duties.

Clause 3(d) of the proclamation created an ad valorem rate of zero for nine categories of specialty products, provided the Secretary of Commerce, in consultation with the U.S. Trade Representative and the Secretary of Health and Human Services, determines that the goods come from a jurisdiction with a current or forthcoming trade and security framework agreement under Executive Order 14346 (90 FR 43737, 5 September 2025), or that they meet an urgent U.S. health need.

Commerce wrote the definitions with the Food and Drug Administration and the USDA Center for Veterinary Biologics. They cover investigational drugs as well as FDA-approved or FDA-authorized products, and Commerce says it may modify them later. Inactive ingredients and excipients are not treated as pharmaceutical articles.

Category	Definition in the notice
Drug where all approved or licensed indications are designated as orphan	A drug or biological product designated under Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for one or more rare diseases, and for which every approved indication under Section 505 (21 U.S.C. 355) or licensed under Section 351 of the Public Health Service Act (42 U.S.C. 262) is for such a rare disease.
Nuclear medicine	A drug meeting the definition of radioactive drug in 21 CFR 310.3(n), or a biological product meeting the definition of radioactive biological product in 21 CFR 600.3(ee), which covers products labeled with a radionuclide or intended solely to be labeled with one.
Plasma derived therapy	A biological product derived from human whole blood or plasma, as set out in 42 U.S.C. 1320f-1(e)(3)(C).
Fertility drug	A drug or biological product for the treatment of infertility, including drugs approved for ovulatory dysfunction in women desiring pregnancy.
Cell therapy product	A cellular immunotherapy, cellular cancer vaccine, or other autologous or allogeneic cellular product approved for one or more therapeutic indications, including hematopoietic stem cell products and adult and embryonic stem cell products.
Gene therapy product	A biological product intended to modify or manipulate the expression of a gene, or to alter the biological properties of living cells, for therapeutic use.
Antibody drug conjugates	A combination product made of a small-molecule drug payload and an antibody or antibody fragment, conjugated by a chemical linker.
Medical countermeasures for chemical, biological, radiological, and nuclear threats	A drug under 21 U.S.C. 321(g)(1) or a biological product under 42 U.S.C. 262(i) for use in diagnosing, preventing, or treating diseases or conditions caused by CBRN agents, including emerging infectious diseases, and it takes in qualified countermeasures, qualified pandemic or epidemic products, and security countermeasures as those terms are defined in the Public Health Service Act.
Animal healthcare products	Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, or intended to affect the structure or function of an animal’s body, plus components of such products and biologics such as vaccines, bacterins, and diagnostic products regulated by the USDA Center for Veterinary Biologics. Devices and combination products for animals are excluded.

Source: Federal Register, 91 FR 60360, 23 September 2026.

Which jurisdictions qualify

Nineteen jurisdictions appear on the eligible list: 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. The notice says changes to the list may be published in a future notice.

Source: 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, Federal Register, 23 September 2026.