Heading 9903

9903.04.65

Pharmaceutical articles subject to a qualifying onshoring plan and a Most-Favored-Nation pharmaceutical pricing agreement, as provided for in subdivisions (c) and (h)(ii) of U.S. note 40 to this subchapter

Calculate a product's duty

Duty rates

General
The duty provided in the applicable subheading + 0%
The base rate for goods from most countries.
Special
The duty provided in the applicable subheading
Lower rates under trade agreements and programs, for goods that meet their rules of origin; each symbol names one.
Column 2
The duty provided in the applicable subheading
The higher rate for the few countries without normal trade relations with the United States.

Base columns of the 2026 HTS Revision 22, in force from Oct. 30, 2026 (official source).

The U.S. notes it refers to

As the 2026 HTS Revision 22 writes them (official notes); each code opens its page. Whether this heading applies to goods depends on the origin, the date and the product: the calculator says it.

U.S. note 40(c)

(c) The headings provided in subdivision (a) of this note and the defined terms of this subdivision apply to articles that are classifiable in the following provisions of the HTSUS: 2918.99.3000 2921.49.3800 2921.49.4300 2922.19.0910 2922.19.0990 2922.29.2700 2922.49.2600 2922.50.1400 2922.50.2500 2924.29.6250 2925.29.2000 2928.00.3000 2930.90.9235 2931.90.2200 2932.20.2000 2933.19.3500 2933.19.4500 2933.29.2000 2933.29.4500 2933.39.4100 2933.49.2600 2933.59.2100 2933.59.3600 2933.59.4600 2933.59.5300 2933.59.5900 2933.79.0800 2933.79.8500 2933.99.4600 2933.99.5300 2933.99.5590 2933.99.6100 2933.99.6500 2933.99.7000 2933.99.7500 2933.99.9000 2934.30.2300 2934.30.2700 2934.99.3000 2934.99.4720 2934.99.4730 2934.99.4740 2934.99.4790 2935.90.4800 2935.90.6000 2937.11.0000 2937.12.0000 2937.19.0000 2937.22.0010 2937.22.0090 2937.23.1010 2937.23.1050 2937.23.5010 2937.23.5020 2937.23.5050 2937.29.9040 2937.29.9050 2937.29.9095 2937.50.0000 2937.90.4500 2937.90.9000 2938.90.0000 2939.11.0000 2939.19.2000 2939.19.5000 2941.10.5000 2941.90.1050 2941.90.3030 2941.90.3090 2941.90.5030 2941.90.5090 2942.00.0500 3002.12.0040 3002.13.0010 3002.13.0090 3002.14.0010 3002.14.0090 3002.15.0011 3002.15.0091 3002.41.0000 3002.42.0000 3002.49.0050 3002.51.0000 3002.59.0000 3002.90.1000 3002.90.5220 3002.90.5250 3003.20.0000 3003.31.0000 3003.39.1000 3003.39.5000 3003.49.0000 3003.90.0120 3003.90.0140 3003.90.0180 3003.90.0190 3004.10.1010 3004.10.5010 3004.20.0010 3004.20.0042 3004.20.0058 3004.20.0073 3004.20.0074 3004.20.0078 3004.20.0085 3004.31.0010 3004.31.0090 3004.32.0020 3004.32.0080 3004.39.0010 3004.39.0015 3004.39.0080 3004.41.0000 3004.49.0005 3004.49.0010 3004.49.0020 3004.49.0030 3004.49.0040 3004.49.0050 3004.49.0060 3004.49.0070 3004.50.5005 3004.90.1000 3004.90.9201 3004.90.9206 3004.90.9208 3004.90.9210 3004.90.9211 3004.90.9212 3004.90.9215 3004.90.9216 3004.90.9217 3004.90.9218 3004.90.9226 3004.90.9236 3004.90.9243 3004.90.9246 3004.90.9249 3004.90.9251 3004.90.9252 3004.90.9253 3004.90.9260 3004.90.9263 3004.90.9267 3004.90.9268 3004.90.9270 3004.90.9271 3004.90.9273 3004.90.9276 null null null For the purposes of this note:

(i) “Pharmaceutical articles” refers to imported articles classifiable in the provisions enumerated in this subdivision that are finished pharmaceutical products or that are active pharmaceutical ingredients (including key starting materials for active pharmaceutical ingredients) classifiable in the provisions enumerated in this subdivision used to make finished pharmaceutical products. Inactive ingredients and excipients are not pharmaceutical articles.

(ii) “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.

(iii) “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; or an unpatented animal health product. 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. § 1320f-1(e)(2)(B)(ii), provided that the products are imported by a generic or biosimilar manufacturer.

U.S. note 40(h)(ii)

(ii) Heading 9903.04.65 applies to 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. The Secretary of Commerce shall notify CBP of all such agreements.

History in the official tariff

In the tariff since the 2026 HTS Revision 14, in force from July 31, 2026.

Its description and rates have not changed since.

Official notices

Actions of the President, the USTR or U.S. Customs and Border Protection (CBP) that name this code.

In the tariff

  1. 9903.04.65Pharmaceutical articles subject to a qualifying onshoring plan and a Most-Favored-Nation pharmaceutical pricing agreement, as provided for in subdivisions (c) and (h)(ii) of U.S. note 40 to this subchapterThe duty provided in the applicable subheading + 0%