BACKGROUND
On April 2, 2026, the President issued Proclamation 11020, imposing additional duties on certain imports of patented pharmaceuticals and ingredients for patented pharmaceuticals for the products of companies listed in Annex III effective July 31, 2026, and for products of all other companies effective September 29, 2026. See 91 FR 18183 and CSMS #69395344 and #69415934.
On September 23, 2026, the U.S. Department of Commerce published “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 for Duties Imposed Under Proclamation 11020,” providing guidance and procedures for implementing additional duties on imports of specialty pharmaceuticals and associated ingredients and technical corrections to the Harmonized Tariff Schedule of the United States (HTSUS) for duties imposed under Proclamation 11020. See 91 FR 60360.
The September 23, 2026 Federal Register Notice
This notice defines the pharmaceutical products and lists the jurisdictions that are eligible to receive a tariff rate of zero under clause 3(d) of Proclamation 11020 and HTSUS 9903.04.66. The notice also provides five technical corrections to Annex I and one technical correction to annex IV
Technical Corrections:
Annex I Technical Corrections:
The first correction amends the definition of “generic pharmaceutical articles” in subdivision (c)(iii) with respect to heading 9903.04.67 to specifically include “unpatented animal health products.”
The second correction includes a new heading, HTSUS 9903.94.70, with an ad valorem tariff rate of zero.
The third correction amends the definition of “pharmaceutical articles” in subdivision (c)(i) to clarify that this definition only encompasses finished pharmaceutical products, their active pharmaceutical ingredients, and the key starting materials of said active pharmaceutical ingredients.
The fourth correction amends the text of subdivision (i) with respect to heading 9903.04.69 to clarify the coverage of this provision.
The fifth correction amends Annex I to incorporate recent HTSUS changes made by the Committee for the Statistical Annotation of Tariff Schedules on July 1, 2026 (this correction was previously included in the HTSUS list attached to CSMS #69395344).
Annex IV Technical Correction: The technical correction to Annex IV removes five HTSUS codes from Annex IV: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00.
For more information, see 91 FR 60360.
GUIDANCE
This guidance provides instructions for importers, brokers, and filers on submitting entries to U.S. Customs and Border Protection (CBP) on imports of pharmaceuticals and associated pharmaceutical ingredients from all countries as provided in Harmonized Tariff Schedule of the United States (HTSUS) headings 9903.04.60–9903.04.70. See the attachment for the classifications in Chapters 29 and 30 of the HTSUS which correspond to each Chapter 99 heading, as specified in subdivision (c) of U.S. note 40 to subchapter III of the HTSUS, and as updated by the July 1, 2026 Committee for the Statistical Annotation of Tariff Schedules Changes to the HTSUS (see List of 484(f) Committee Changes for July 1, 2026 - Final) and the Commerce Department’s September 23, 2026 Federal Register notice.
The additional duties were effective for goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on July 31, 2026 for products of companies listed in Annex III of the Proclamation. The additional duties will take effect with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on September 29, 2026, for products of all other companies.
If a product is subject to more than one rate of duty under the Proclamation, then the lowest applicable rate shall apply.
9903.04.60: Except as provided for in heading 9903.04.61, applies to patented pharmaceutical articles as provided for in subdivisions (c) and (d) of U.S. note 40 to subchapter III.
100% additional ad valorem duty rate (combined column one and Section 232 duty rate)
9903.04.61: No longer in effect for goods entered after 12:01 am on September 29, 2026.
9903.04.62: Applies to patented pharmaceutical articles that are the product of Japan, a European Union member country (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia (Czech Republic), Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden), South Korea, Switzerland, or Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to subchapter III.
15% additional ad valorem duty rate (combined column one and Section 232 duty rate)
9903.04.63: Applies to patented pharmaceutical articles that are the product of the United Kingdom, as defined in U.S. note 40(c) and (g) to subchapter III.
0% additional ad valorem duty rate.
9903.04.64: Applies to patented pharmaceutical articles subject to a qualifying onshoring plan, as provided for in subdivisions (c) and (h)(i) of U.S. note 40 to subchapter III.
20% additional ad valorem duty rate.
Effective for goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on April 2, 2030, the duty rate for 9903.04.64 increases to 100%.
9903.04.65: Applies to pharmaceutical articles from companies with a qualifying onshoring plan agreement with the Commerce Department and Most-Favored-Nation (MFN) pharmaceutical pricing agreement, as provided for in subdivisions (c) and (h)(ii) of U.S. note 40 to subchapter III.
0% additional ad valorem rate of duty.
(NOTE: 9903.04.65 expires on January 20, 2029)
9903.04.66: Applies to drugs and pharmaceutical articles for the specific uses provided in subdivisions (c) and (h)(iii) of U.S. note 40 to subchapter III, as defined by 91 FR 60360.
0% additional ad valorem rate of duty.
Products of the following jurisdictions are eligible to use 9903.04.66:
Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden), Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea, Switzerland, Liechtenstein, Taiwan, Thailand, United Kingdom, and Vietnam.
9903.04.67: Applies to generic pharmaceutical articles, as provided for in subdivision (c) of U.S. note 40 to subchapter III, as amended by 91 FR 60360.
0% additional ad valorem rate of duty.
9903.04.68: Applies to pharmaceutical products with an active pharmaceutical ingredient packaged in dosage form that is a product of the United States.
0% additional ad valorem rate of duty.
9903.04.69: Applies to articles as provided for in subdivision (i) of U.S. note 40 to subchapter III, as amended by 91 FR 60360 (those products classified under the subject Chapter 29 and 30 HTSUS classifications that are not pharmaceutical products or are “pharmaceutical articles” but are neither “patented pharmaceutical articles” nor “generic pharmaceutical articles”).
0% additional ad valorem rate of duty
9903.04.70: Applies to pharmaceutical articles and associated ingredients provided for in subdivision (c) of U.S. note 40 to subchapter III that are solely for use in clinical trials, research and development, or other non-commercial applications.
0% additional ad valorem rate of duty
U.S. Origin Pharmaceuticals
Imports of United States-origin pharmaceutical products are not subject to the tariffs imposed by the Proclamation.
Trade Agreements
For imported articles subject to headings 9903.04.60–9903.04.68 that are eligible for special tariff treatment under any of the free trade agreements or preference programs listed in general note 3(c)(i) to the tariff schedule, the duties provided in these headings shall be collected in addition to any special rate of duty otherwise applicable under the appropriate tariff subheading.
Chapter 98
Goods for which entry is claimed under a provision of chapter 98 to the HTSUS and that are subject to the additional duties prescribed herein shall be eligible for and subject to the terms of such provision and applicable CBP regulations. No claim for entry or for any duty exemption or reduction shall be allowed under a provision of chapter 99 to the HTSUS that may set forth a lower rate of duty or provide duty-free treatment, taking into account information supplied by CBP. All antidumping, countervailing or other duties and charges applicable to such goods shall continue to be imposed.
Drawback
Drawback shall be available with respect to the duties imposed pursuant to Proclamation 11020.
Foreign Trade Zone (FTZ)
Any product described in clause (4) of Proclamation 11020, except those eligible for admission as ‘‘domestic status’’ as described in 19 CFR 146.43, that is subject to a duty imposed by Proclamation 11020 and that is admitted into a United States foreign trade zone on or after the effective date of Proclamation 11020, 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.
For questions regarding Section 232 entry filing, contact the Trade Remedy Branch at TradeRemedy@cbp.dhs.gov.
If you encounter technical errors while filing an entry summary, please contact your assigned CBP client representative or the ACE Help Desk.
Related Messages: 69395344, 69415934
