Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients into the United States
This Presidential Proclamation directs adjustments to the importation of patented pharmaceuticals and associated active pharmaceutical ingredients (APIs) based on a finding that current import levels threaten national security by creating overreliance on foreign supply chains for critical medications.
The President imposes a 100% ad valorem tariff on these imports, while simultaneously offering reduced rates (20% or 0%) to companies that commit to or achieve onshoring of production and pricing agreements, and grants zero tariffs to certain specialized pharmaceutical categories.
The action also directs federal departments to pursue negotiation agreements to further secure domestic supply and requires monitoring of generic drug imports, though no immediate tariffs are placed on generics.
Arguments For
Citing the Secretary of Commerce's report finding that high import reliance for pharmaceuticals and APIs threatens national security by limiting access to life-saving medications during global supply chain disruptions.
Asserting that a self-sufficient domestic manufacturing base for pharmaceuticals is vital for both national defense requirements and maintaining public health security during emergencies or wartime.
Implementing measures, such as significant tariffs and incentives for onshoring production, directly address the identified national security vulnerability created by foreign government undermining of the domestic patented pharmaceutical industry.
Utilizing existing statutory authority under Section 232 of the Trade Expansion Act of 1962 and Section 604 of the Trade Act of 1974 to proactively adjust import levels through tariffs and negotiated agreements.
Arguments Against
Imposing a 100% ad valorem duty rate on listed patented pharmaceuticals and APIs could drastically increase costs for consumers and healthcare providers, potentially limiting access to necessary medications despite the stated national security goal.
Tariffs and the requirement for companies to commit to specific onshoring plans could disrupt established, efficient global supply chains, leading to retaliatory trade actions or immediate product shortages if domestic capacity cannot scale quickly.
Exempting generic pharmaceuticals and ingredients from these tariffs may not fully address underlying supply chain risks if essential precursor materials are sourced from the same high-risk jurisdictions affecting patented drugs.
The reliance on negotiated agreements for reduced tariffs creates uncertainty, as the ultimate duty rate depends on future compliance and successful implementation of complex administrative criteria for onshoring and MFN pricing.
Presidential Actions
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.
DONALD J. TRUMP
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The introductory preamble officially establishes the document as a Proclamation based on a Section 232 investigation by the Commerce Secretary, concluding that the high volume of imported pharmaceuticals and Active Pharmaceutical Ingredients (APIs) jeopardizes U.S. national security.
The document asserts that heavy import reliance limits access to vital medications during global crises, noting that over half of patented drugs distributed domestically are made abroad, with very low domestic API production.
The core justification stresses that a strong domestic pharmaceutical manufacturing base is essential for both military readiness and civilian public health security, particularly because foreign government actions have eroded U.S. industry competitiveness.
The President agrees with the findings and announces a specific plan of action involving both pressure and incentives.
Negotiations are ordered with the Secretary of Health and Human Services to address supply chain vulnerabilities within 90 days.
Major tariff actions follow: a blanket 100% ad valorem duty is placed on listed patented pharmaceuticals and APIs (Annex I).
However, incentives are established: a 20% rate applies to companies committing to onshoring production (rising to 100% in four years), and a 0% rate applies to those securing MFN pricing and R&D onshoring agreements.
The proclamation also integrates agreements regarding trade partners like the EU and the UK.
Crucially, generic pharmaceuticals and biosimilars are temporarily exempted from these tariffs, pending a one-year review.
The operational details cover tariff stacking rules, effective dates (starting July/September 2026), enforcement mechanisms for onshoring commitments (including penalties for fraud), and provisions for special/orphan drugs to receive zero tariffs based on specific health needs or trade frameworks.
The action concludes by delegating authority for implementation, defining how duties apply to goods in Foreign Trade Zones, and affirming that the Secretary will continue to monitor the situation for future adjustments.
BY THE PRESIDENT OF THE UNITED STATES OF AMERICA
This line formally indicates that the following decree originates from the President of the United States.
A PROCLAMATION
This title designates the document as a Presidential Proclamation, which is a formal declaration having the force of law.
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.
The Commerce Secretary provided the President with a report concerning imports of pharmaceuticals and their ingredients.
This investigation was conducted under Section 232 of the Trade Expansion Act of 1962.
The Secretary concluded that the current levels and circumstances of these imports pose a threat to U.S. national security, recognizing that economic welfare is closely linked to national security interests.
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.
The Secretary determined that import levels endanger both national security and the economy.
Although the U.S. excels in developing patented drugs, the country relies significantly on imports, which poses a risk to access to essential medications if global supply chains face geopolitical or economic shocks.
The document notes that by 2025, roughly 53% of patented pharmaceuticals sold in the U.S. are made abroad, and only 15% of patented APIs by volume originate domestically.
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.
Patented drugs and their ingredients are considered vital for U.S. military and civilian medical needs.
Maintaining a domestic manufacturing base is necessary to support national defense and ensure public health security, especially during emergencies.
The Secretary also determined that foreign government actions have harmed the competitiveness of the U.S. patented pharmaceutical industry, leading to increased and less secure dependence on foreign suppliers.
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.
Based on the findings, the Secretary suggested several actions to regulate the influx of patented pharmaceuticals and their ingredients.
These recommendations included continuing negotiations for onshoring production linked to Most-Favored-Nation (MFN) pricing agreements, applying substantial tariffs to imports deemed a national security threat, and offering favorable treatment to companies that commit to moving production back to the U.S.
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.
The President reviewed the Secretary's report and the statutory considerations found in Section 232(d).
The President concurs with the Secretary's conclusion that imports of pharmaceuticals and APIs jeopardize U.S. national security.
Therefore, the President has decided to implement the plan of action described in the following sections to adjust these imports and eliminate the national security impairment.
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.
The President directs the Secretary of Commerce and the Secretary of Health and Human Services to continue or start negotiating agreements designed to resolve the national security threat posed by imported patented drugs and APIs.
These negotiations must target any appropriate party, and the Secretaries must provide an update on their progress within 90 days of the proclamation's issuance.
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.
The President establishes a mandatory 100 percent ad valorem duty on the importation of patented pharmaceuticals and associated APIs listed in Annex I, unless another provision in this proclamation specifies a different treatment.
Products designated for a zero tariff under existing Section 232 rules are listed separately in Annex IV.
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.
A reduced ad valorem duty rate of 20% is established for patented pharmaceuticals and ingredients produced by companies whose plans to move production onshore have received approval from the Secretary of Commerce.
This reduced rate is temporary and will automatically increase to the standard 100% duty rate four years after this proclamation is issued.
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.
The President finds it essential to enforce the pharmaceutical provisions established within existing trade agreements involving the European Union, Japan, the Republic of Korea, and a joint agreement with Switzerland and Liechtenstein.
Additionally, necessary pharmaceutical provisions in the anticipated trade deal with the United Kingdom (agreement in principle reached December 1, 2025) must be implemented to advance U.S. economic and security goals.
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.
Tariffs will be entirely waived for imports from companies that have finalized or are currently discussing agreements related to MFN pricing and the domestic onshoring of R&D and production of patented pharmaceuticals.
These specific agreements are deemed beneficial as they enhance national security while simultaneously making necessary medications more accessible and affordable for Americans.
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.
The President explicitly decides against applying Section 232 adjustments to generic pharmaceuticals, their associated ingredients, and biosimilar products right now.
This exemption also covers the procurement of these items for the Strategic API Reserve.
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.
Based on the current situation and anticipated future national requirements, the President judges the measures outlined in this proclamation to be necessary and suitable for addressing the national security threat posed by pharmaceutical and API imports.
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).
This paragraph cites the legal basis under Section 232, which empowers the President to modify imports threatening national security through a plan that may include tariffs or negotiations.
If a negotiated agreement under Section 232(c)(3)(A)(i) is not concluded within 180 days, is not being implemented, or proves ineffective, the President retains the authority to take further necessary actions to remove the import threat.
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.
Section 604 of the Trade Act of 1974 grants the President the authority to legally incorporate the substance of statutes affecting import conditions—including imposing, changing, or removing duty rates—into the official Harmonized Tariff Schedule of the United States (HTSUS).
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:
This is the formal enacting section where the President, Donald J. Trump, invokes constitutional authority and specific laws—Section 232, Section 604, and Section 301 of title 3—to issue the proclamations that follow.
(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.
The Secretary of Commerce and the Secretary of Health and Human Services, along with any supporting officials they select, are directed to pursue or continue negotiations for agreements under the framework of Section 232(c)(3)(A)(i).
These negotiations aim to resolve the national security risk posed by imported pharmaceuticals and their 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.
The President formally confirms any company-specific agreements already made by the Secretary (listed in Annex II) and assigns the Secretary the authority to create and implement future similar agreements mentioned in Clause (1).
The Secretary is authorized to oversee and enforce these agreements according to the stipulations in Clause (6) and other relevant laws.
(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.
A mandatory 100 percent duty rate based on the item's value (ad valorem) is imposed on patented pharmaceuticals and associated APIs listed in Annex I, unless an exception overrides it.
(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.
Companies with Secretary-approved plans, or those likely to soon have them, will pay a reduced 20% ad valorem duty on listed patented pharmaceuticals and ingredients.
This preferential 20% rate is not permanent; it automatically escalates to 100% 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.
Products from Japan, the European Union, the Republic of Korea, and Switzerland/Liechtenstein will be subject to a 15% ad valorem duty, provided no lower rate applies elsewhere in Clause (3).
Products from the United Kingdom face a 10% tariff, which will drop to zero if future pricing agreements are fulfilled; the Secretary must announce this reduction publicly via the Federal Register.
(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.
A zero tariff rate applies to numerous specialty pharmaceuticals, including orphan drugs, nuclear medicines, fertility treatments, and biological countermeasures, as well as animal health products.
For this exemption to take effect, the Secretary, in consultation with the Trade Representative and HHS, must confirm either that the product comes from a jurisdiction with a specified trade/security framework (referenced in a 2025 Executive Order) or that the product addresses an immediate U.S. health crisis.
Any such determination must be published.
(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.
Companies qualifying for the reduced 20% onshoring rate in clause (3)(b) can receive a zero tariff rate until January 20, 2029, if they have also finalized Most-Favored-Nation (MFN) pricing agreements with HHS. The Secretary may also extend this zero rate to companies near finalizing agreements.
This zero rate also applies to agreements ratified under Annex II.
(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.
The Secretary has the authority to increase tariff rates applied to companies or foreign jurisdictions if they fail to honor the commitments made in their respective onshoring plans or trade agreements.
This includes increasing the rates established in clauses (2), (3)(b), (3)(e), and (3)(c).
Any such tariff rate increase must be formally announced in the Federal Register.
(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.
The revised tariffs and associated treatment become effective for goods entered for consumption starting at 12:01 a.m. eastern daylight time on July 31, 2026, for companies listed in Annex III, and on September 29, 2026, for all other relevant companies.
These rates remain active unless specifically altered or ended.
(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.
Currently, generic pharmaceuticals and their ingredients are exempt from Section 232 tariffs.
Within one year from this date, the Secretary must notify the President if any circumstances suggest that import action regarding generic drugs may become necessary.
(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.
The Secretary, collaborating with HHS, must define and publish the criteria for onshoring plans referenced in clause (3)(b) in the Federal Register.
The Secretary must approve, track, and enforce all plans, requiring periodic progress reports which may necessitate external audits.
If a company is found to have committed fraud or intentionally misled the government about its onshoring commitments, the Secretary can retroactively and prospectively reinstate tariffs and apply other penalties per 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.
When a product is currently subject to both a tariff under this proclamation and a standard Column 1 Duty Rate from the HTSUS, the combined rate equals the rate specified in Clause (3).
However, if the existing Column 1 Duty Rate is already higher than the rate in Clause (3), only the Column 1 Duty Rate will be applied.
This calculation rule specifically excludes tariff treatment for United Kingdom products mentioned in Clause (3)(c).
(8) If a product is subject to more than one rate of duty under this proclamation, then the lowest applicable rate shall apply.
If any imported product qualifies for multiple different duty rates established within this proclamation, the most favorable rate—the lowest applicable one—will be used.
(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.
The Secretary of Commerce must collaborate with the Chairs of the International Trade Commission and the Commissioner of U.S. Customs and Border Protection to decide if changes to the HTSUS or other regulatory steps are needed to implement this proclamation's directives.
Any official adjustments made must be published in the Federal Register.
(10) Drawback shall be available with respect to the duties imposed pursuant to this proclamation.
Importers are eligible to receive a refund, known as drawback, for the specific duties that have been newly imposed under the authority of this proclamation.
(11) Imports of United States-origin pharmaceutical products shall not be subject to the tariffs imposed by this proclamation at this time.
Pharmaceutical products that originated in the United States are explicitly exempt from the tariffs established by this proclamation for the time being.
(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.
U.S. Customs and Border Protection (CBP) is empowered, within legal bounds, to take any necessary measure to manage the tariffs established or modified by the proclamation.
Importers are also required to supply CBP with all information necessary for the effective execution of the 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.
Any product subject to the proclamation's tariffs that enters a U.S. foreign trade zone after the effective date must be classified as "privileged foreign status" (under 19 CFR 146.41), unless it qualifies for "domestic status." Upon entry for actual consumption, these goods will be subject to the applicable ad valorem duty rates based on their HTSUS classification.
(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.
The Secretary must perpetually monitor imports of both patented and generic pharmaceuticals and ingredients, periodically reviewing the national security implications with executive branch consultation.
The Secretary must report back to the President if further Section 232 action seems warranted or, conversely, if the current tariffs are judged to be no longer required.
(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.
The Secretaries of Commerce, Health and Human Services, and Homeland Security are directed, consistent with law and the proclamation's purpose, to take all appropriate implementation steps.
This authority includes issuing necessary regulations, guidance, and procedures, as well as temporarily modifying existing rules, utilizing all powers granted to the President 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.
The Secretary of Commerce, the Trade Representative, and the Secretary of Homeland Security have the authority, consistent with statute (including Section 301 of title 3), to delegate their assigned functions under this proclamation to subordinate officials within their respective 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.
Any terms in previous Executive Orders or proclamations that conflict with the contents of this proclamation are superseded to the extent of the contradiction.
If any single provision of this proclamation is legally deemed invalid for any reason, the rest of the proclamation and its application to other individuals or circumstances must remain in full force and effect.
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.
DONALD J. TRUMP
This is the formal closing, stating the document was signed on April 2, 2026, marking the 250th year of American Independence, and is signed by President Donald J. Trump.
The document concludes with a clickable link directing the audience to the specific annexes detailing the products covered by the tariffs, prior agreements, and affected companies.
This is followed by archival information indicating the post's original title and source on The White House website.
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