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Trump announces pharmaceutical import tariffs with phased implementation and conditional exceptions
Trade Deficit & Tariff EscalationWhat was said
Trump announces pharmaceutical import tariffs under Proclamation 11020 with phased implementation and conditional exceptions.
Title 3— The President Proclamation 11020 of April 2, 2026 Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States By the President of the United States of America A Proclamation 1. The Secretary of Commerce (Secretary) recently transmitted to me a report on his investigation into the effects of imports of pharmaceuticals and pharmaceutical ingredients on the national security of the United States under section 232 of the Trade Expansion Act of 1962, as amended, 19 U.S.C. 1862 (section 232). Based on the facts considered in that investigation, and taking into account the close relation of the economic welfare of the Nation to our national security and other relevant factors, see 19 U.S.C. 1862(d), the Secretary found and advised me of his opinion that pharmaceuticals and associated active pharmaceutical ingredients (APIs), including key starting materials, are being imported into the United States in such quantities and under such circumstances as to threaten to impair the national security of the United States. 2. The Secretary found that the present quantities and circumstances of imports of pharmaceuticals and pharmaceutical ingredients threaten to impair the national security and economy. Despite being the world leader in research and development (R&D) for most innovative pharmaceuticals (those that are typically patented and branded, as compared to generic pharmaceuticals or pharmaceuticals approved pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(j)), the United States is heavily reliant on imports, threatening to limit United States access to life-saving medications in the event of global supply chain disruption due to geopolitical or economic disruption. According to the Food and Drug Administration, as of 2025, approximately 53 percent of patented pharmaceutical products distributed domestically are produced outside the country. The degree of import reliance is significant at the API level with only 15 percent of patented APIs by volume domestically produced for the United States market. 3. The Secretary found that patented pharmaceuticals and associated pharmaceutical ingredients are essential to the United States' military and civilian healthcare. A self-sufficient domestic manufacturing and industrial base for pharmaceutical products is vital for the ability to support national defense requirements and maintain public health security during a national emergency or wartime. Patented pharmaceuticals are pivotal for treating cancer, rare diseases, autoimmune disorders, infectious diseases, and other critical health challenges. The Secretary further found that foreign government intervention has undermined the competitiveness of the United States patented pharmaceutical industry. This intervention has led to further dependence on foreign production of patented pharmaceuticals that have fragile supply chains. 4. In light of these findings, the Secretary recommended actions to adjust imports of patented pharmaceuticals and associated pharmaceutical ingredients, including continuing to negotiate onshoring agreements related to Most-Favored-Nation (MFN) pharmaceutical pricing agreements; imposing significant tariffs on pharmaceuticals and pharmaceutical ingredients, so that such imports will not threaten to impair the national security of the United States; and granting preferential treatment to those companies that commit to onshore production of pharmaceuticals and pharmaceutical ingredients. 5. After considering the Secretary's report, the factors in section 232(d) (19 U.S.C. 1862(d)), and other relevant factors and information, among other things, I concur with the Secretary's finding that pharmaceuticals and associated pharmaceutical ingredients are being imported into the United States in such quantities and under such circumstances as to threaten to impair the national security of the United States. In my judgment, and in light of the Secretary's report, the factors in section 232(d) (19 U.S.C. 1862(d)), and other relevant factors and information, I have also determined that it is necessary and appropriate to adopt a plan of action, as described below, to adjust such imports of pharmaceuticals and associated pharmaceutical ingredients so that such imports will not threaten to impair the national security of the United States. 6. I have decided to direct the Secretary and the Secretary of Health and Human Services to pursue negotiations of agreements or continue any current negotiations of agreements, such as agreements contemplated in section 232(c)(3)(A)(i) (19 U.S.C. 1862(c)(3)(A)(i)), to address the threatened impairment of the national security with respect to imported patented pharmaceuticals and associated pharmaceutical ingredients, with any party the Secretary and the Secretary of Health and Human Services deem appropriate, and to update me on the progress of such negotiations within 90 days of the date of this proclamation. Under current circumstances and in light of future requirements of the United States, this action is necessary and appropriate to address the threatened impairment of the national security. 7. I have determined that it is necessary and appropriate to impose a 100 percent ad valorem duty rate on the import of patented pharmaceuticals and associated pharmaceutical ingredients, as identified in Annex I to this proclamation, and except as otherwise provided in this proclamation. Pharmaceutical products and ingredients that are subject to the section 232 zero tariff at this time are listed in Annex IV to this proclamation. 8. I have determined that it is necessary and appropriate that the ad valorem duty rate be 20 percent on imports of patented pharmaceuticals and associated pharmaceutical ingredients produced by companies that have plans, approved by the Secretary, to onshore production of such pharmaceuticals and pharmaceutical ingredients. The aforementioned 20 percent rate shall increase to 100 percent 4 years after the date of this proclamation. 9. I have further determined that it is necessary to implement pharmaceutical-related commitments in existing trade deals with the European Union, Japan, the Republic of Korea, and Switzerland and Liechtenstein jointly, as well as a future pharmaceutical-related deal with the United Kingdom (on which the United States and the United Kingdom have reached an agreement in principle as of December 1, 2025). These deals further United States economic and national security interests. 10. I further find that it is necessary and appropriate to impose no tariffs on imports of patented pharmaceuticals and associated pharmaceutical ingredients produced by companies that have fully executed agreements or are negotiating agreements with the Secretary and the Secretary of Health and Human Services regarding MFN pricing and onshoring of production and R&D of patented pharmaceuticals and pharmaceutical ingredients. Such agreements further United States economic and national security interests by making pharmaceuticals more accessible and affordable in the United States and by strengthening the domestic manufacturing base. 11. I have further determined not to adjust imports of generic pharmaceuticals and their associated ingredients, including biosimilar products, at this time. This determination includes purchases of generic pharmaceuticals and ingredients for the Strategic API Reserve. I find that such products should not be subject to section 232 tariffs at this time. 12. In my judgment, based on current circumstances as well as the future needs of the United States, the actions in this proclamation are necessary and appropriate to address the threatened impairment of the national security posed by imports of pharmaceuticals and pharmaceutical ingredients. 13. Section 232 authorizes the President to take action to adjust the imports of an article and its derivatives that are being imported into the United States in such quantities or under such circumstances as to threaten to impair the national security. Section 232 includes the authority to adopt and carry out a plan of action, with adjustments over time, to address the national security threat. This plan of action may include negotiations of agreements along with other actions to adjust imports to address the national security threat, including tariffs. If action under section 232 includes the negotiation of an agreement, such as one contemplated in section 232(c)(3)(A)(i) (19 U.S.C. 1862(c)(3)(A)(i)), the President may also take other actions he deems necessary to adjust imports to eliminate the threat that the imported article poses to the national security, including if such an agreement is not entered into within 180 days of the date of this proclamation, is not being carried out, or is ineffective. See 19 U.S.C. 1862(c)(3)(A). 14. Section 604 of the Trade Act of 1974, as amended (19 U.S.C. 2483) (section 604), authorizes the President to embody in the Harmonized Tariff Schedule of the United States (HTSUS) the substance of statutes affecting import treatment, and actions thereunder, including the removal, modification, continuance, or imposition of any rate of duty or other import restriction. NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by the authority vested in me by the Constitution and the laws of the United States, including section 232, 19 U.S.C. 1862; section 604, 19 U.S.C. 2483; and section 301 of title 3, United States Code, do hereby proclaim as follows: (1) The Secretary and the Secretary of Health and Human Services, and any senior official they deem appropriate, shall pursue or continue pursuing negotiations of agreements, as contemplated in section 232(c)(3)(A)(i) (19 U.S.C. 1862(c)(3)(A)(i)), to address the threatened impairment of the national security with respect to imported pharmaceuticals and pharmaceutical ingredients. (2) I hereby ratify, and delegate to the Secretary the authority necessary to enter into, the company-specific tariff agreements listed in Annex II to this proclamation that the Secretary entered into prior to this proclamation. I also hereby delegate to the Secretary the authority to enter into and implement similar agreements in the future, as referenced in clause (1) of this proclamation. The Secretary is authorized to monitor and enforce these agreements as he deems appropriate, consistent with clause (6) of this proclamation and applicable law. (3)(a) Imports of patented pharmaceuticals and associated pharmaceutical ingredients, as listed in Annex I to this proclamation, will be subject to a 100 percent ad valorem duty rate. (b) The ad valorem duty rate for patented pharmaceuticals and associated pharmaceutical ingredients, as listed in Annex I to this proclamation, shall be 20 percent for products of companies that have, or that the Secretary assesses are likely soon to have (e.g., based on agreements in principle), onshoring plans approved by the Secretary. The aforementioned 20 percent rate shall increase to 100 percent on April 2, 2030. (c) The ad valorem duty rate for patented pharmaceuticals and associated pharmaceutical ingredients, as listed in Annex I to this proclamation, shall be 15 percent for products of Japan, the European Union, the Republic of Korea, and Switzerland and Liechtenstein jointly, unless a lower rate applies under clause (3) of this proclamation. The tariff rate on patented pharmaceuticals and associated pharmaceutical ingredients for products of the United Kingdom shall be 10 percent and then reduce to zero to the extent required by any future agreement between the United States and the United Kingdom on pharmaceutical pricing. The Secretary shall publish a Federal Register notice should the rate for the United Kingdom be reduced to zero. (d) The ad valorem tariff rate shall be zero for drugs and associated ingredients, where all approved indications 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 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 (Trade Representative) and the Secretary of Health and Human Services, 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 of September 5, 2025 (Modifying the Scope of Reciprocal Tariffs and Establishing Procedures for Implementing Trade and Security Agreements), or (2) they meet an urgent United States health need. The Secretary shall publish a Federal Register notice whenever he makes such a determination. (e) For companies that are eligible for the tariff treatment outlined in clause (3)(b) of this proclamation, and that have entered into MFN pharmaceutical pricing agreements with the Secretary of Health and Human Services, the applicable ad valorem tariff rate for pharmaceuticals and associated pharmaceutical ingredients shall be zero until January 20, 2029. The Secretary shall apply this zero tariff rate to companies that he determines are likely to be eligible soon (e.g., because they have agreements in principle with the Secretary and the Secretary of Health and Human Services). For avoidance of doubt, this zero tariff rate shall also apply per the terms of the agreements listed in Annex II to this proclamation. (f) The Secretary may increase the tariff rates referenced in clause (2) of this proclamation, and in clauses (3)(b) and (3)(e) of this proclamation, to address companies' failure to fulfill commitments under the relevant plans and agreements. The Secretary, in consultation with the Trade Representative, may increase the tariff rates referenced in clause (3)(c) of this proclamation to address foreign jurisdictions' failure to fulfill commitments under agreements with the United States. The Secretary shall publish a Federal Register notice when tariff rates are increased. (4) The tariffs and tariff treatment imposed by this proclamation shall be effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern daylight time on July 31, 2026, for the companies listed in Annex III to this proclamation and September 29, 2026, for other companies and shall continue in effect, unless such actions are expressly reduced, modified, or terminated. (5) Generic pharmaceuticals and their associated ingredients shall not be subject to tariffs pursuant to section 232 at this time. Within 1 year of the date of this proclamation, the Secretary shall, in consultation with any senior executive branch officials the Secretary deems appropriate, inform the President of any circumstances that, in the Secretary's opinion, might indicate the need to take action to adjust the imports of generic pharmaceuticals and their associated ingredients. (6) The Secretary, in consultation with the Secretary of Health and Human Services, shall establish criteria for onshoring plans referenced in clause (3)(b) of this proclamation, to be published in the Federal Register . All onshoring plans shall be subject to approval, monitoring, and enforcement by the Secretary. The Secretary shall require companies with qualifying onshoring plans to submit periodic reports to the Secretary regarding progress towards fulfilling onshoring milestones. The Secretary may require that such reports be audited by an external auditing firm. In cases where the executive branch assesses that a company engaged in fraud or deliberately misled the United States Government with respect to onshoring commitments, the Secretary may reimpose tariffs discussed in this proclamation both prospectively and retroactively on imports from relevant companies, and he may impose other tariffs and penalties to the extent consistent with applicable law. (7) If a product is subject to tariffs under this proclamation and Column 1 of the HTSUS (Column 1 Duty Rate), then the sum of the additional section 232 tariff imposed pursuant to this proclamation and the applicable Column 1 Duty Rate shall be equal to the applicable rate listed in clause (3) of this proclamation, unless the Column 1 Duty Rate is greater than the applicable rate listed in clause (3) of this proclamation, in which case only the Column 1 Duty Rate shall apply. This clause does not apply to the tariff treatment for products of the United Kingdom described in clause (3)(c) of this proclamation. (8) If a product is subject to more than one rate of duty under this proclamation, then the lowest applicable rate shall apply. (9) 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), shall determine whether any modifications to the HTSUS or other administrative measures are necessary to effectuate or implement this proclamation or any actions taken pursuant to this proclamation. Any changes shall be published in a notice in the Federal Register . (10) Drawback shall be available with respect to the duties imposed pursuant to this proclamation. (11) Imports of United States-origin pharmaceutical products shall not be subject to the tariffs imposed by this proclamation at this time. (12) To the extent permitted by applicable law, CBP may take any necessary or appropriate measure to administer the tariffs imposed or altered by this proclamation. Importers shall provide to CBP information necessary to carry out this proclamation. (13) 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. (14) The Secretary shall continue to monitor imports of patented and generic pharmaceuticals and pharmaceutical ingredients. The Secretary also shall, from time to time, in consultation with any senior executive branch officials the Secretary deems appropriate, review the status of such imports with respect to the national security. The Secretary shall inform me of any circumstances that, in the Secretary's opinion, might indicate the need for further action by the President under section 232. The Secretary shall also inform me of any circumstance that, in the Secretary's opinion, might indicate that the tariff imposed in this proclamation is no longer necessary. (15) To the extent consistent with applicable law and the purpose of this proclamation, the Secretary, the Secretary of Health and Human Services, and the Secretary of Homeland Security are directed and authorized to take all actions that are appropriate to implement and effectuate this proclamation and any actions contemplated by this proclamation, including, consistent with applicable law, the issuance of regulations, rules, guidance, and procedures and the temporary suspension or amendment of regulations, within their respective jurisdictions, and to employ all powers granted to me under section 232. (16) The Secretary, the Trade Representative, and the Secretary of Homeland Security may, consistent with applicable law, including section 301 of title 3, United States Code, redelegate any of these functions within their respective executive departments or agencies. (17) Any provision of previous proclamations and Executive Orders that is inconsistent with this proclamation is superseded to the extent of such inconsistency. If any provision of this proclamation or the application of any provision of this proclamation to any individual or circumstance is held to be invalid, the remainder of this proclamation and the application of its provisions to any other individual or circumstance shall not be affected. IN WITNESS WHEREOF, I have hereunto set my hand this second day of April, in the year of our Lord two thousand twenty-six, and of the Independence of the United States of America the two hundred and fiftieth. Billing code 3395-F4-P [FR Doc. 2026-06956 Filed 4-8-26; 11:15 am] Billing code 7020-02-C [Annexes I–IV: White House textual transcription reused after complete word/code comparison with Federal Register PDF pages18189–18200 and visual correction of OCR/table differences; original PDFs retained] Annex I MODIFICATIONS TO THE HARMONIZED TARIFF SCHEDULE OF THE UNITED STATES A. 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, subchapter III of chapter 99 of the Harmonized Tariff Schedule of the United States (“HTSUS”) is modified as follows: 1. The following new U.S. note 40 is inserted in numerical order: “(a) Headings 9903.04.60–9903.04.69 provide the customs duty treatment of imported articles classifiable in one of the provisions of the HTSUS enumerated in subdivision (c) of this note. These headings are mutually exclusive, such that an imported article will be subject to no more than one of these headings. Pharmaceutical articles, as defined in subdivisions (c)(i)–(iii) of this note, are subject to heading 9903.04.60 unless another of these headings applies. (b) 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. Goods for which entry is claimed under a provision of chapter 98 of the HTSUS and which are subject to the additional duties prescribed herein shall be eligible for and subject to the terms of such provision and applicable U.S. Customs and Border Protection (“CBP”) regulations. No claim for entry or for any duty exemption or reduction shall be allowed under a provision of chapter 99 of 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. (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 2922.19.0900 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 2934.99.4700 2935.90.4800 2935.90.6000 2937.11.0000 2937.12.0000 2937.19.0000 2937.22.0000 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 2941.90.3000 2941.90.5000 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 3004.20.0083 3004.31.0000 3004.32.0060 3004.39.0010 3004.39.0055 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 3004.90.9215 3004.90.9216 3004.90.9225 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 For the purposes of this note: (i) “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. (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. 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. (d) Heading 9903.04.60 applies to patented pharmaceutical articles provided for in subdivision (c) of this note. For articles for which the applicable column 1 tariff rate is less than the additional duties provided by heading 9903.04.60, 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. For articles for which the applicable column 1 tariff rate is greater than the additional duties provided by heading 9903.04.60, then no additional duty is due pursuant to heading 9903.04.60. (e) Heading 9903.04.61 applies to patented pharmaceutical articles imported for companies identified by the Secretary and imported before 12:01 am eastern time on September 29, 2026. The Secretary shall notify CBP of all such companies. (f) Heading 9903.04.62 applies to patented pharmaceutical articles that are the product of Japan, of a member country of the European Union, of South Korea, of Switzerland, or of Liechtenstein that would otherwise be subject to the additional duties imposed under heading 9903.04.60. For articles for which the applicable column 1 tariff rate is less than the additional duties provided by heading 9903.04.62, 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 9903.04.62. For articles for which the applicable column 1 tariff rate is greater than the additional duties provided by heading 9903.04.62, no additional duty is due pursuant to heading 9903.04.62. (g) Heading 9903.04.63 applies to patented pharmaceutical articles that are the product of the United Kingdom that would otherwise be subject to the additional duties imposed under heading 9903.04.60. (h) Headings 9903.04.64–9903.04.66 apply to patented pharmaceutical articles described in this subdivision. Any importer entering pharmaceutical articles under any of these headings shall provide any information that may be required, and in such form, as is deemed necessary by CBP to permit the administration of these headings. (i) Heading 9903.04.64 applies to 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. The Secretary shall notify CBP of all such agreements. (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. (iii) Heading 9903.04.66 applies to 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. (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 but that are not pharmaceutical articles described in subdivisions (c)(i)(iii) of this note. 2. The following new headings are inserted in numerical sequence, with the material in each 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: Heading/ Subheading Article Description Rates of Duty 1 2 General Special “9903.04.60 Except as provided in heading 9903.04.61, patented pharmaceutical articles as provided for in subdivisions (c) and (d) of U.S. note 40 to this subchapter….. 100% 100% The duty provided in the applicable subheading 9903.04.61 Patented pharmaceutical articles entered before 12:01 a.m. eastern time on September 29, 2026 as provided for in subdivisions (c) and (e) of U.S. note 40 to this subchapter….. The duty provided in the applicable subheading The duty provided in the applicable subheading The duty provided in the applicable subheading 9903.04.62 Patented pharmaceutical articles that are the product of Japan, of a European Union member country, of South Korea, of Switzerland, or of Liechtenstein as provided for in subdivisions (c) and (f) of U.S. note 40 to this subchapter…… 15% 15% The duty provided in the applicable subheading 9903.04.63 Patented pharmaceutical articles that are the product of the United Kingdom as defined in subdivisions (c) and (g) of U.S. note 40 to this subchapter…… The duty provided in the applicable subheading + 10% The duty provided in the applicable subheading + 10% The duty provided in the applicable subheading 9903.04.64 Patented pharmaceutical articles subject to a qualifying onshoring plan, as provided for in subdivisions (c) and (h)(i) of U.S. note 40 to this subchapter…… The duty provided in the applicable subheading + 20% The duty provided in the applicable subheading + 20% The duty provided in the applicable subheading 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…… The duty provided in the applicable subheading + 0% The duty provided in the applicable subheading The duty provided in the applicable subheading 9903.04.66 Drugs and pharmaceutical articles for the specific uses provided in subdivisions (c) and (h)(iii) of U.S. note 40 to this subchapter…… The duty provided in the applicable subheading + 0% The duty provided in the applicable subheading The duty provided in the applicable subheading 9903.04.67 Generic pharmaceutical articles, as provided for in subdivision (c) of U.S. note 40 to this subchapter…… The duty provided in the applicable subheading The duty provided in the applicable subheading The duty provided in the applicable subheading 9903.04.68 Pharmaceutical products with an active pharmaceutical ingredient packaged in dosage form that is a product of the United States…… The duty provided in the applicable subheading The duty provided in the applicable subheading The duty provided in the applicable subheading 9903.04.69 Articles as provided for in subdivision (i) of U.S. note 40 to this subchapter…… The duty provided in the applicable subheading The duty provided in the applicable subheading The duty provided in the applicable subheading” 3. U.S. note 2(aa)(v) is modified by: a. redesignating subdivisions (a)(k) as (2)(12); and b. inserting “(1) patented pharmaceutical articles provided for in headings 9903.04.60, 9903.04.61, 9903.04.62, 9903.04.63, 9903.04.64, 9903.04.65 and 9903.04. 66;” in numerical order. 4. Heading 9903.03.06 is modified by deleting “, or medium- and heavy-duty vehicles or medium- and heavy-duty vehicle parts,” and inserting “, medium- and heavy-duty vehicles or medium- and heavy-duty vehicle parts, or patented pharmaceutical articles,” in lieu thereof. B. Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on January 20, 2029, subchapter III of chapter 99 of the HTSUS is modified as follows: a. subdivision (h)(ii) of U.S. note 40 to this subchapter is deleted; b. subdivision (h)(iii) of U.S. note 40 to this subchapter is renumbered as subdivision (h)(ii); c. heading 9903.04.65 is terminated and deleted; and d. the article description of heading 9903.04.66 is modified by deleting “(h)(iii)” and inserting “(h)(ii)” in lieu thereof. C. Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern time on April 2, 2030, heading 9903.04.64 is amended by deleting “20%” each place that it appears and inserting “100%” in lieu thereof. Annex II Below are the company-specific agreements related to Section 232 tariffs on pharmaceutical products and ingredients that the Secretary of Commerce entered into prior to this proclamation. 1. AbbVie Inc. dated March 20, 2026 2. Amgen Inc. dated December 19, 2025 3. AstraZeneca Pharmaceuticals, LP dated March 20, 2026 4. Bristol Myers Squibb dated December 19, 2025 5. Boehringer Ingelheim Pharmaceuticals, Inc. dated December 19, 2025 6. Eli Lilly and Company dated February 23, 2026 7. EMD Serono, Inc. dated February 12, 2026 8. Genentech, Inc. dated December 19, 2025 9. Gilead Sciences, Inc. dated December 19, 2025 10. Merck Sharp & Dohme LLC dated February 11, 2026 11. Novartis Pharmaceuticals Corporation dated February 12, 2026 12. Novo Nordisk Inc. dated February 23, 2026 13. Sanofi S.A. dated December 19, 2025 Annex III Annex III of this proclamation lists the companies whose tariff treatment shall be effective 120 days from the date of this proclamation. 1. AbbVie Inc. 2. Amgen Inc. 3. AstraZeneca Pharmaceuticals, LP 4. Bristol Myers Squibb 5. Boehringer Ingelheim Pharmaceuticals, Inc. 6. Eli Lilly and Company 7. EMD Serono, Inc. 8. Genentech, Inc. 9. Gilead Sciences, Inc. 10. GlaxoSmithKline LLC and ViiV Healthcare Company 11. Johnson & Johnson 12. Merck Sharp & Dohme LLC 13. Novartis Pharmaceuticals Corporation 14. Novo Nordisk Inc. 15. Pfizer Inc. 16. Regeneron Pharmaceuticals, Inc. 17. Sanofi S.A. Annex IV This annex includes the list of HTSUS codes that are not covered under the Annex I actions of this proclamation and are subject to the Section 232 action related to pharmaceuticals and pharmaceutical ingredients with a tariff rate of zero. Pursuant to section (4) of Proclamation 11012 of February 20, 2026, “Imposing a Temporary Import Surcharge to Address Fundamental International Payments Problems,” these codes are not subject to the surcharge imposed by Proclamation 11012. 2903.45.1000 2919.90.5010 2926.90.4801 2933.49.6000 2936.26.0000 3004.20.0076 2903.51.1000 2919.90.5050 2926.90.5010 2933.49.7000 2936.27.0000 3004.20.0080 2903.59.9000 2920.90.5100 2926.90.5050 2933.52.1000 2936.28.0000 3004.32.0010 2903.69.9000 2921.19.1100 2927.00.4000 2933.52.9000 2936.29.1000 3004.32.0040 2903.78.0000 2921.29.0010 2927.00.5000 2933.53.0000 2936.29.1610 3004.39.0020 2903.79.9030 2921.29.0020 2928.00.2500 2933.54.0000 2936.29.1620 3004.39.0030 2903.79.9070 2921.29.0030 2929.90.2000 2933.59.1000 2936.29.1630 3004.39.0040 2903.89.1500 2921.29.0055 2929.90.5015 2933.59.1500 2936.29.2000 3004.39.0045 2903.89.2000 2921.30.1000 2929.90.5018 2933.59.1800 2936.29.5020 3004.42.0000 2903.89.7010 2921.30.5000 2929.90.5020 2933.59.2200 2936.29.5030 3004.49.00 2903.89.7090 2921.42.9000 2929.90.5030 2933.59.7000 2936.29.5050 3004.50.1000 2903.92.0000 2921.46.0000 2929.90.5040 2933.59.8000 2936.90.0110 3004.50.2000 2904.99.4000 2921.49.4500 2929.90.5095 2933.59.8500 2936.90.0150 3004.50.3000 2905.29.9000 2921.49.5000 2930.20.2010 2933.59.9500 2937.21.0010 3004.50.4000 2905.39.9000 2921.59.8010 2930.20.2050 2933.69.6010 2937.21.0020 3004.50.5010 2905.59.1000 2921.59.8090 2930.20.9010 2933.69.6021 2937.21.0030 3004.50.5020 2905.59.9000 2922.11.0000 2930.20.9020 2933.69.6030 2937.21.0040 3004.50.5030 2906.19.5000 2922.14.0000 2930.20.9050 2933.69.6050 2937.23.1020 3004.50.5040 2906.29.6000 2922.19.2000 2930.30.6000 2933.72.0000 2937.23.2500 3004.60.0000 2907.29.9000 2922.19.3300 2930.90.2900 2933.79.1500 2937.23.50 3004.90.9203 2908.19.6000 2922.19.6000 2930.90.4910 2933.91.0010 2937.29.1000 3004.90.9204 2909.19.1800 2922.19.7000 2930.90.4920 2933.91.0050 2937.29.9020 3004.90.9205 2909.20.0000 2922.19.9000 2930.90.4950 2933.99.0100 2937.29.9030 3004.90.9207 2909.30.6000 2922.19.9610 2930.90.9208 2933.99.0200 2937.90.0500 3004.90.9209 2909.49.1000 2922.19.9619 2930.90.9210 2933.99.0500 2937.90.1000 3004.90.9212 2909.49.1500 2922.19.9690 2930.90.9212 2933.99.0600 2937.90.2000 3004.90.9213 2909.49.2000 2922.29.6100 2930.90.9222 2933.99.0800 2937.90.4000 3004.90.9217 2909.49.6000 2922.29.8110 2930.90.9225 2933.99.1100 2938.10.0000 3004.90.9218 2909.50.4010 2922.29.8190 2930.90.9231 2933.99.1200 2939.19.1000 3004.90.9219 2909.50.4050 2922.31.0000 2930.90.9251 2933.99.1600 2939.20.0010 3004.90.9220 2909.50.4500 2922.39.2500 2931.49.0005 2933.99.1701 2939.20.0050 3004.90.9222 2909.50.5000 2922.39.4500 2931.49.0008 2933.99.2200 2939.30.0000 3004.90.9223 2912.19.5000 2922.39.5000 2931.49.0010 2933.99.2400 2939.41.0000 3004.90.9224 2912.49.2600 2922.41.0010 2931.49.0015 2933.99.2600 2939.42.0000 3004.90.9226 2914.19.0000 2922.41.0090 2931.49.0020 2933.99.4200 2939.44.0000 3004.90.9227 2914.40.9000 2922.42.5000 2931.49.0025 2933.99.5100 2939.45.0000 3004.90.9228 2914.50.3000 2922.44.0000 2931.49.0055 2933.99.5510 2939.49.0300 3004.90.9229 2914.50.5000 2922.49.1000 2931.49.0080 2933.99.5520 2939.59.0000 3004.90.9230 2914.62.0000 2922.49.3000 2931.53.0000 2933.99.5530 2939.62.0000 3004.90.9232 2914.69.2100 2922.49.3700 2931.90.9010 2933.99.5800 2939.63.0000 3004.90.9233 2914.69.9000 2922.49.4910 2931.90.9021 2933.99.7900 2939.69.0000 3004.90.9234 2914.79.4000 2922.49.4915 2931.90.9025 2933.99.8210 2939.72.0000 3004.90.9235 2915.29.3000 2922.49.4950 2931.90.9029 2933.99.8220 2939.79.0000 3004.90.9237 2915.39.3100 2922.49.8000 2931.90.9030 2933.99.8290 2939.80.0010 3004.90.9238 2915.39.3500 2922.50.0700 2931.90.9035 2933.99.8500 2939.80.0050 3004.90.9239 2915.39.4700 2922.50.1000 2931.90.9040 2933.99.8900 2940.00.6000 3004.90.9240 2915.39.9000 2922.50.1100 2931.90.9052 2933.99.9701 2941.10.1000 3004.90.9241 2915.90.1010 2922.50.1300 2932.14.0000 2934.10.1000 2941.10.2000 3004.90.9242 2915.90.1050 2922.50.1700 2932.19.5100 2934.10.2000 2941.10.3000 3004.90.9244 2915.90.1400 2922.50.3500 2932.20.3000 2934.10.9000 2941.20.1000 3004.90.9245 2915.90.1810 2922.50.4000 2932.20.5010 2934.20.4000 2941.20.5000 3004.90.9247 2915.90.1890 2922.50.5000 2932.20.5020 2934.20.8000 2941.30.0000 3004.90.9248 2915.90.2000 2923.10.0000 2932.20.5030 2934.30.4300 2941.40.0000 3004.90.9250 2915.90.5010 2923.20.2010 2932.20.5050 2934.30.5000 2941.50.0000 3004.90.9254 2915.90.5050 2923.20.2050 2932.99.6100 2934.91.0000 2941.90.1010 3004.90.9255 2916.19.3000 2924.11.0000 2932.99.7000 2934.92.0000 2942.00.3500 3004.90.9256 2916.19.5000 2924.19.1110 2932.99.9010 2934.99.0100 2942.00.5000 3004.90.9257 2916.20.5000 2924.19.1120 2932.99.9090 2934.99.0300 3001.20.0000 3004.90.9258 2916.31.5000 2924.19.1130 2933.11.0000 2934.99.0500 3001.90.0110 3004.90.9261 2916.39.4600 2924.19.1150 2933.19.9000 2934.99.0600 3001.90.0150 3004.90.9262 2916.39.7900 2924.19.8000 2933.21.0000 2934.99.0700 3001.90.0165 3004.90.9264 2917.13.0030 2924.21.1600 2933.29.0500 2934.99.0800 3001.90.0195 3004.90.9265 2917.13.0090 2924.21.5000 2933.29.3500 2934.99.0900 3002.12.0010 3004.90.9266 2917.19.1000 2924.29.0100 2933.29.4300 2934.99.1100 3002.12.0020 3004.90.9269 2917.19.7020 2924.29.0300 2933.29.6000 2934.99.1200 3002.12.0030 3004.90.9272 2917.19.7050 2924.29.1000 2933.29.9000 2934.99.1500 3002.12.0090 3004.90.9274 2917.34.0110 2924.29.2300 2933.33.0100 2934.99.1600 3002.13.00 3004.90.9275 2917.34.0150 2924.29.2600 2933.34.0000 2934.99.1800 3002.14.00 3006.30.1000 2917.39.3000 2924.29.2800 2933.35.0000 2934.99.2000 3002.15.00 3006.30.5000 2918.11.5100 2924.29.3300 2933.37.0000 2934.99.3900 3002.49.0010 3006.60.0000 2918.13.5000 2924.29.5700 2933.39.0800 2934.99.4400 3002.90.5210 3006.70.0000 2918.16.5010 2924.29.6210 2933.39.1000 2934.99.7000 3003.10.0000 3006.93.1000 2918.16.5020 2924.29.6220 2933.39.2000 2934.99.9001 3003.41.0000 3006.93.2000 2918.16.5090 2924.29.7100 2933.39.2100 2935.50.0000 3003.42.0000 3006.93.5000 2918.19.6000 2924.29.7710 2933.39.2300 2935.90.0600 3003.90.0160 3006.93.6000 2918.19.9000 2924.29.7720 2933.39.2500 2935.90.1000 3004.10.1020 3006.93.8000 2918.22.1000 2924.29.7730 2933.39.2700 2935.90.1300 3004.10.1045 2918.22.5000 2924.29.7790 2933.39.3100 2935.90.1500 3004.10.5048 2918.23.3000 2924.29.8000 2933.39.6110 2935.90.2000 3004.10.5049 2918.23.5000 2924.29.9500 2933.39.6120 2935.90.3000 3004.10.5055 2918.29.2000 2925.12.0000 2933.39.6130 2935.90.3200 3004.10.5065 2918.29.6500 2925.19.4200 2933.39.6191 2935.90.3300 3004.10.5075 2918.29.7500 2925.19.9100 2933.39.9200 2935.90.4200 3004.20.0020 2918.30.2500 2925.21.0000 2933.41.0000 2935.90.7500 3004.20.0030 2918.30.3000 2925.29.6000 2933.49.0800 2935.90.9500 3004.20.0045 2918.30.9000 2925.29.9000 2933.49.1000 2936.21.0000 3004.20.0055 2918.99.4300 2926.30.1000 2933.49.1500 2936.22.0000 3004.20.0065 2918.99.4700 2926.40.0000 2933.49.1700 2936.23.0000 3004.20.0070 2918.99.5000 2926.90.1400 2933.49.2000 2936.24.0100 3004.20.0071 2919.90.3000 2926.90.4300 2933.49.3000 2936.25.0000 3004.20.0072View official source
