Presidential Document2026-06956
Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States
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Published
April 9, 2026
Signed
April 2, 2026
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 91 Issue 68 (Thursday, April 9, 2026)</title>
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[Federal Register Volume 91, Number 68 (Thursday, April 9, 2026)]
[Presidential Documents]
[Pages 18183-18200]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06956]
[[Page 18181]]
Vol. 91
Thursday,
No. 68
April 9, 2026
Part V
The President
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Proclamation 11020--Adjusting Imports of Pharmaceuticals and
Pharmaceutical Ingredients Into the United States
Proclamation 11021--Strengthening Actions Taken To Adjust Imports of
Aluminum, Steel, and Copper Into the United States
Executive Order 14400--Urgent National Action To Save College Sports
Order of April 3, 2026--Sequestration Order for Fiscal Year 2027
Pursuant to Section 251A of the Balanced Budget and Emergency Deficit
Control Act, as Amended
Presidential Documents
Federal Register / Vol. 91 , No. 68 / Thursday, April 9, 2026 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 18183]]
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
[[Page 18184]]
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.
[[Page 18185]]
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
[[Page 18186]]
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
[[Page 18187]]
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
[[Page 18188]]
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.
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[FR Doc. 2026-06956
Filed 4-8-26; 11:15 am]
Billing code 7020-02-C
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