Section 232 Pharmaceutical Tariffs Announced

On April 2, 2026, U.S. President Trump issued an Executive Order announcing Section 232 tariffs on pharmaceuticals and their ingredients starting July 31, 2026. Patented pharmaceuticals are hit hard with a 100% duty rate unless they qualify for a discounted rate.

Details

Effective Date 

Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on July 31, 2026.

Section 232 Pharma Tariff List

Find a list of HTS subject to Section 232 Pharma tariffs in Annex I (c)

Duty Rates

Patented pharmaceutical articles

9903.04.60, 100%

• For articles for which the applicable column 1 tariff rate is less than the additional duties provided by heading 9903.04.60 (100%), the sum of the column 1 duty rate and the additional ad valorem rate of duty shall be the rate of duty provided by heading 9903.04.60 (100%).

• For articles for which the applicable column 1 tariff rate is greater than the additional duties provided by heading 9903.04.60 (100%), then no additional duty is due pursuant to heading 9903.04.60.

9903.04.61, No additional duty

Patented pharmaceutical articles imported for companies identified by the Secretary and imported before 12:01 am ET on September 29, 2026.

9903.04.62, 15%

Patented pharmaceutical articles products of Japan, EU, Korea, Switzerland, or of Liechtenstein.

• For articles for which the applicable column 1 tariff rate is less than the additional duties provided by heading 9903.04.62 (15%), the sum of column 1 duty rate and the additional ad valorem rate of duty shall be the rate of duty provided by heading 9903.04.62 (15%).
• For articles for which the applicable column 1 tariff rate is greater than the additional duties (15%) provided by heading 9903.04.62, no additional duty is due pursuant to heading 9903.04.62.

9903.04.63, 10%

Patented pharmaceutical articles that are a product of the U.K.

9903.04.64, 20%

Patented pharmaceutical articles imported for companies subject to an onshoring plan approved by the Secretary of Commerce in accordance with a process to be established in a Federal Register notice.

9903.04.65, 0%

Patented pharmaceutical articles that meet the requirements of subdivision (h)(i) of this note and are imported for companies that have entered into a Most-Favored-Nation pharmaceutical pricing agreement with the Secretary of Health and Human Services.

9903.04.66, 0%

Drugs and associated ingredients for all approved indications that are designated as orphan pursuant to the Orphan Drug Act, 21 U.S.C. 360aa et seq. and its implementing regulations; nuclear medicines; plasma derived therapies; fertility treatments; cell and gene therapies; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological and nuclear threats; or other specialty pharmaceutical products identified by the Secretary of Commerce or pharmaceutical products for animal health imported from a jurisdiction that has a current or forthcoming trade and security framework or that meet an urgent U.S. health need. The Secretary shall publish a Federal Register notice when the conditions above are met and shall notify CBP of all such products.

Exclusions

9903.04.67: Generic pharmaceutical articles

9903.04.68: Imports of United States-origin pharmaceutical products shall not be subject to the tariffs imposed by this proclamation at this time.

9903.04.69: Articles classifiable under provisions of the HTSUS but that are not pharmaceutical articles.

Definitions

“Pharmaceutical articles” refers to imported articles classifiable in the provisions enumerated in this subdivision that are pharmaceutical products or that are ingredients (active pharmaceutical ingredients and key starting materials) classifiable in the provisions enumerated in this subdivision used to make pharmaceutical products.

“Patented pharmaceutical articles” are pharmaceutical articles that are subject to a valid, unexpired U.S. patent and are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) or in the FDA’s Lists of Licensed Biological Products (“Purple Book”); and ingredients (active pharmaceutical ingredients and key starting materials) for such articles.

“Generic pharmaceutical articles” are FDA-approved pharmaceutical articles, and associated ingredients, that are not subject to a valid, unexpired U.S. patent and are off exclusivity. A generic pharmaceutical article is an active pharmaceutical ingredient or any component in a finished dosage form product that is used in a drug product or biosimilar biological product approved pursuant to a qualifying application; or a drug product or biosimilar biological product approved or licensed pursuant to a qualifying application. A qualifying application is: (a) an abbreviated new drug application submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (“FDCA”); (b) a new drug application submitted under section 505(b)(2) of the FDCA that has been requested to be or that has been deemed therapeutically equivalent to a listed drug; (c) a biosimilar biologics application submitted under section 351(k) of the Public Health Services Act; or (d) an application for an authorized generic drug or authorized biological product, as those terms are described in section 505(t) of the FDCA and 42 U.S.C. § 1320f1(e)(2)(B)(ii), provided that the products are imported by a generic or biosimilar manufacturer.

FTZ

Any product described in clause (4) of this proclamation, except those eligible for admission as “domestic status” as described in 19 CFR 146.43, that is subject to a duty imposed by this proclamation and that is admitted into a United States foreign trade zone on or after the effective date of this proclamation, must be admitted as “privileged foreign status” as described in 19 CFR 146.41 and will be subject upon entry for consumption to any ad valorem rates of duty related to the classification under the applicable HTSUS subheading.

Drawback

Drawback shall be available with respect to the duties imposed pursuant to this proclamation.

Additional Information

Pharmaceuticals-Imports-ANNEXES-I-II-III-IV.pdf

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