SUPPLEMENTARY INFORMATION:

I. Background

On April 2, 2026 the President issued Proclamation 11020, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States,” (91 FR 18183) (Proclamation 11020) concurring with the Secretary of Commerce's (Secretary) finding that pharmaceuticals and associated pharmaceutical ingredients are being imported into the United States in such quantities and under such circumstances that threaten to impair the national security of the United States and imposing tariffs to adjust imports of such products pursuant to section 232 of the Trade Expansion Act of 1962, as amended (19 U.S.C. 1862) (Section 232). Proclamation 11020 imposed a 100 percent ad valorem tariff on certain imports of patented pharmaceuticals and associated pharmaceutical ingredients, effective July 31, 2026 for the companies listed in Annex III of Proclamation 11020, and September 29, 2026 for all other companies. Different rates apply to patented pharmaceutical products and associated ingredients from certain jurisdictions and from companies with Commerce-approved onshoring agreements (Bureau of Industry and Security, “Procedures To Apply for Company-Specific Onshoring Agreements To Obtain Tariff Adjustments for Pharmaceuticals and Pharmaceutical Ingredients Under Proclamation 11020” (92 FR 26989; May 13, 2026)). At this time, Section 232 Pharmaceutical Tariffs do not apply to generic pharmaceutical products and associated ingredients.

In clause 3(d) of Proclamation 11020, the President directed an ad valorem tariff rate of zero to apply for pharmaceuticals and associated ingredients 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 drugs; cell therapy product; gene therapy product; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; or other specialty pharmaceutical products to be identified by the Secretary, as well as pharmaceutical products for animal health, provided that the Secretary, in consultation with the United States Trade Representative (USTR) and the Secretary of Health and Human Services (HHS), determines that: (1) they are products of a jurisdiction that has a current or forthcoming trade and security framework agreement as referenced in Executive Order 14346, “Modifying the Scope of Reciprocal Tariffs and Establishing Procedures for Implementing Trade and Security Agreements” of September 5, 2025 (90 FR 43737) (Executive Order 14346), or (2) they meet an urgent U.S. health need.

Proclamation 11020 directs the Secretary, in consultation with the Chair of the United States International Trade Commission and the Commissioner of U.S. Customs and Border Protection (CBP), to determine whether any modifications to the HTSUS or other ( printed page 60361) administrative measures are necessary to effectuate or implement the Proclamation or any actions taken pursuant to the Proclamation. Any changes are to be published in a notice in the Federal Register .

II. Definitions of Pharmaceutical Products Listed in Clause 3(d) of Proclamation 11020

Commerce consulted with the Food and Drug Administration (FDA) and U.S. Department of Agriculture Center for Veterinary Biologics to provide the following definitions of the pharmaceutical products listed in clause 3(d) of Proclamation 11020. The definitions are solely for purposes of determining eligibility of the ad valorem tariff rate of zero pursuant to Proclamation 11020 and should not be construed as binding guidance for any other purpose unrelated to Proclamation 11020. This list of definitions covers imports of investigational drugs as well as FDA-approved or FDA-authorized drugs. Commerce reserves the right to modify these definitions in the future.

• Drug where all approved or licensed indications are designated as orphan: A drug or biological product that is designated under Section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb) for one or more rare diseases or conditions, and for which all approved indications under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of this title or licensed under Section 351 of the Public Health Service Act (42 U.S.C. 262), are for one or more such rare diseases or conditions.
• Nuclear medicine: A drug that meets the definition of “radioactive drug” in 21 CFR 310.3(n) or a biological product that meets the definition of “radioactive biological product” as defined in 21 CFR 600.3(ee).
  • 21 CFR 301.3(n): Radioactive drug means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term `radioactive drug' includes a `radioactive biological product' as defined in 21 CFR 600.3(ee).
  • 21 CFR 600.3(ee): Radioactive biological product means a biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide.
• Plasma derived therapy: A biological product that is derived from human whole blood or plasma. (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 the treatment of ovulatory dysfunction in women desiring pregnancy.
• Cell therapy product: A biological product that is a cellular immunotherapy, cellular cancer vaccine, or other type of 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 that is 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 composed of a small-molecule drug (payload) and an antibody or antibody fragment, conjugated together by a chemical linker.
• Medical countermeasures related to chemical, biological, radiological, and nuclear threats: A drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), or a biological product as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)), that is for use to diagnose, prevent, or treat diseases or conditions caused by chemical, biological, radiological, or nuclear threat (CBRN) agents, including emerging infectious diseases, and include qualified countermeasures as defined in section 319F-(a)(2)(A) of the Public Health Service Act (42 U.S.C. 247d-6a), qualified pandemic or epidemic products as defined in section 319F-3(i)(7) of the Public Health Service Act (42 U.S.C. 247d-6d); and security countermeasures as defined in section 319F-2(c)(1)(B) of the Public Health Service Act (42 U.S.C. 247d-6b).
• Animal Healthcare Products: Animal healthcare products include articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals; articles (other than food) intended to affect the structure or any function of an animal's body; or articles intended for use as components of such products. The definition includes veterinary pharmaceuticals intended to manage diseases, conditions, or injuries in animals but does not include devices or combination products for animals. Animal healthcare products also include biologics (vaccines, bacterins, and diagnostic products) used in the treatment of diseases in animals and is regulated by USDA-CVB (Center for Veterinary Biologics).

III. List of Eligible Jurisdictions

The following jurisdictions are eligible for the tariff adjustment described in clause 3(d) of Proclamation 11020: Argentina, Bangladesh, Cambodia, Ecuador, El Salvador, European Union, Guatemala, India, Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea, Switzerland and Liechtenstein, Taiwan, Thailand, United Kingdom, and Vietnam. Changes to the list of eligible jurisdictions may be published in a future notice.

IV. Procedures for Requesting Commerce Approval for Pharmaceuticals That Meet an Urgent U.S. Health Need

Companies can request approval from Commerce for imports of pharmaceutical products listed in clause 3(d) of Proclamation 11020 or other specialty products if such imports meet an urgent U.S. health need. Companies should email the Bureau of Industry and Security (BIS) at pharma232@bis.doc.gov with the following information for each requested product or ingredient:

1. Section 1—Organization Information: Full legal name and address of the company. The name, title, and contact information of the authorized representative submitting the application should also be included.

2. Section 2—Tariff Adjustment for Urgent U. S. Health Need: Companies should provide the following information, with respect to the product for which they request preferential treatment to meet an urgent health need in the United States. Only one specific product may be submitted per application form.

• HTSUS Classification (10-digit, if possible)
• Advertised name and brand of product or Investigational New Drug Application number, as applicable, as well as active ingredient (or combination of active ingredients)
• Indicate the category of the requested product: orphan, nuclear medicine, plasma derived therapies, fertility drugs, cell therapy product, gene therapy product, antibody drug conjugates, medical countermeasures related to CBRN threats, or animal health
• Country of origin and country of export of products imported under each HTSUS Classification ( printed page 60362)
• Name and IOR Number of Importer(s) of Record
• Name and address of manufacturer

3. Section 3—Rationale for why the import meets an urgent U.S. health need: The rationale can include information such as the type of disease the product treats and an assessment of alternative therapies or lack of alternative therapies for the type of disease the product treats, the number of U.S. patients that use the product, and whether or not the product is available in other jurisdictions. The requests for approval should only be for patented pharmaceutical products and associated ingredients that are covered under the HTSUS codes listed in Annex I of Proclamation 11020. Submission of information will be received on an ongoing basis.

Review and Approval Process

Commerce may request supplemental documentation or clarification. As directed in Proclamation 11020, Commerce will consult with the USTR and HHS to determine if the requested product meets an urgent U.S. health need. Commerce will make an individual, fact-specific, company-specific decision for each request. Companies will be notified in writing of Commerce's decision. Relevant information from the request will be transmitted by Commerce to CBP. CBP will administer the tariff adjustment at the time of entry summary filing and may request additional documentation to validate entries.

Confidentiality

Commerce will protect the confidentiality of all information submitted by companies requesting approval of specialty pharmaceutical product imports that meet an urgent U.S. health need.

Commerce will protect the confidentiality of confidential, trade secret, and/or proprietary information excluding information in the public domain (“confidential information”) provided by the Drug Manufacturer to the fullest extent allowed by law. For example, subject to applicable laws, such information would be protected from disclosure by the Trade Secrets Act (18 U.S.C. 1905) and under Exemptions 3 and/or 4 of the Freedom of Information Act (“FOIA”) (5 U.S.C. 552(b)(3), (4)). Commerce shall limit dissemination of a Drug Manufacturer's confidential information to those persons within its organization, USTR, and other executive branch agencies and entities who have a need to know such information to fulfill the purpose of determining whether imports of requested specialty pharmaceutical products meet an urgent U.S. health need.

V. Technical Corrections to the HTSUS

This notice and its accompanying annexes provide for five technical corrections to Annex I and one technical correction to Annex IV of Proclamation 11020.

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. The definition of “generic pharmaceutical articles” is modified to specifically include “unpatented animal health products.”

The second correction includes a new heading in Chapter 99 of the HTSUS with an ad valorem tariff rate of zero. Filers should use this new heading for pharmaceutical products and associated ingredients that are imported under HTSUS Classifications listed in subpart (c) of U.S. note 40 which are solely intended for clinical trials, research and development, or other non-commercial applications.

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 that this provision encompasses any pharmaceutical or non-pharmaceutical articles imported under an HTSUS Classification listed in subpart (c) of U.S. note 40 that are not finished pharmaceutical products, their active pharmaceutical ingredients, or the key starting materials of said active pharmaceutical ingredients.

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 interagency committee includes representatives from the U.S. International Trade Commission, CBP, and the U.S. Census Bureau.

Annex IV Technical Correction: The technical correction to Annex IV corrects an inconsistency of certain HTSUS Classifications listed in Annex IV that overlap with Annex I. The following HTSUS codes are removed from Annex IV: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00, and 3004.49.00.

VI. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) provides that an agency generally cannot conduct or sponsor a collection of information, and no person is required to respond to nor be subject to a penalty for failure to comply with a collection of information, unless that collection has obtained Office of Management and Budget (OMB) approval and displays a currently valid OMB Control Number.

In Proclamation 11020, the President determined it was necessary and appropriate to apply an ad valorem tariff rate of zero for the following specialty pharmaceutical products and associated ingredients when certain conditions are met pursuant to clause 3(d) of Proclamation 11020: drugs and associated ingredients where all approved indications are designated as orphan; nuclear medicines; plasma derived therapies; fertility drugs; cell therapy product; gene therapy product; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; and animal health. The President authorized the Secretary of Commerce, in consultation with the USTR and the Secretary of HHS, to determine that: (1) they are products of a jurisdiction that has a current or forthcoming trade and security framework agreement as referenced in Executive Order 14346; or (2) they meet an urgent United States health need.

Because the Proclamation requires timely implementation of the specialty pharmaceutical tariff adjustments to further U.S. economic and national security interests by making pharmaceuticals more accessible and affordable in the United States, BIS cannot reasonably comply with the normal clearance procedures. Delaying this collection would impede the ability of companies to request approval for imports of specialty pharmaceutical products that meet an urgent United States health need and compromise the effectiveness of the Proclamation's implementation. The Department has determined the following conditions have been met:

a. The collection of information is needed prior to the expiration of time periods normally associated with a routine submission for review under the provisions of the Paperwork Reduction Act in view of Proclamation 11020, www.federalregister.gov/​documents/​2026/​04/​09/​2026-06956/​adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states. (5 CFR 1320.13(a)(1)(i)). ( printed page 60363)

b. The collection of information is essential to the mission of the Department, in particular to allow companies seeking to obtain the zero ad valorem tariff by requesting approval for imports of specialty pharmaceutical products that meet an urgent United States health need to effectuate the terms outlined by Proclamation 11020 (5 CFR 1320.13(a)(1)(ii)). These collection requirements include a description of the specialty pharmaceutical product, country of origin information, and rationale for why the import meets an urgent United States health need. The information must be submitted in electronic form via email to the BIS Section 232 Pharmaceuticals Investigation Inbox ( pharma232@bis.doc.gov). Requests for approval of imports that meet an urgent United States health need may be submitted at any time following publication of this FRN publication and all submissions are entirely voluntary on the part of the requesting companies.

c. Public harm is reasonably likely to result if BIS were to follow the normal clearance procedures before issuing this information collection (5 CFR 1320.13(a)(2)(i)). BIS needs time to receive and evaluate requests for specialty pharmaceutical products that meet an urgent United States health need before September 29, 2026, when the Section 232 tariffs for most companies will become effective. A delay in Commerce's ability to begin immediate information collection from companies seeking approval to import specialty pharmaceutical products that meet an urgent United States health need and inability to issue decisions before the 100 percent tariff rate is in effect creates uncertainty for companies' understanding of their tariff liability and could also cause supply chain disruptions.

For the reasons stated above, BIS has requested, and OMB has granted, a new information collection for this rule under OMB control number 0694-0150 with the title Section 232 National Security Adjustments to Imports of Specialty Pharmaceuticals. All materials for the currently approved collection can be accessed at www.reginfo.gov. Separately, BIS will be publishing a 60 day notice to take comment on the emergency collection.

Annex I

Effective 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, subchapter III of chapter 99 of the Harmonized Tariff Schedule of the United States (“HTSUS”) is modified as follows:

1. U.S. note 40 is modified:

a. In subdivision (a), by deleting “9903.04.60-9903.04.69” and inserting “9903.04.60-9903.04.70” in lieu thereof;

b. In subdivision (c), by deleting the enumerated HTSUS provisions and inserting the following in lieu thereof:

c. In subdivision (c), by deleting item (i) and inserting the following in lieu thereof:

“(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.”;

d. In subdivision (c)(iii), by deleting the second sentence and inserting the following sentence in lieu thereof: ( printed page 60364)

“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.”; and

e. By deleting subdivision (i) and inserting the following in lieu thereof:

“(i) Heading 9903.04.69 applies to entries of articles that are classifiable under provisions of the HTSUS enumerated in subdivision (c) of this note that are either: (1) not “pharmaceutical articles” as defined in subdivision (c)(i) of this note, or (2) are “pharmaceutical articles” but are neither “patented pharmaceutical articles” nor “generic pharmaceutical articles” as those terms are defined in subdivisions (c)(ii) and (c)(iii) of this note.”

2. The following new heading is inserted in numerical sequence, with the material for the new heading inserted in the columns of the HTSUS labeled “Heading/Subheading”, “Article Description”, “Rates of Duty 1-General”, “Rates of Duty 1-Special” and “Rates of Duty 2”, respectively:

Annex II

Effective 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, Annex IV of Presidential Proclamation 11020 of April 2, 2026, “Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States,” (Proclamation 11020) is modified by deleting the enumerated HTSUS provisions and inserting the following in lieu thereof:

91 FR 60360