Notice2026-19498
Guidance and Procedures for Implementing Tariff Adjustments for Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and Technical Corrections to the Harmonized Tariff Schedule of the United States for Duties Imposed Under Proclamation 11020
Primary source
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Published
September 23, 2026
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
This notice defines the pharmaceutical products and lists the jurisdictions that are eligible to receive an ad valorem tariff rate of zero pursuant to Presidential Proclamation 11020 of April 2, 2026, "Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients Into the United States," (Proclamation 11020). These pharmaceutical products include drugs and associated ingredients where all approved indications are designated as orphan; nuclear medicines; plasma derived therapies; fertility drugs; cell therapy product; gene therapy product; antibody drug conjugates; medical countermeasures related to chemical, biological, radiological, and nuclear threats; and animal health. Proclamation 11020 states that such products and associated ingredients receive the Section 232 zero tariff rate if they are products of a jurisdiction that has a current or forthcoming trade and security framework agreement or if they meet an urgent U.S. health need. This notice also includes procedures for the public to submit information for the Department of Commerce's (Commerce) approval to determine if imports of the pharmaceutical products and associated ingredients meet an urgent U.S. health need. This notice also issues five technical corrections to Annex I and one technical correction to Annex IV of the Proclamation.
Full Text
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<title>Federal Register, Volume 91 Issue 183 (Wednesday, September 23, 2026)</title>
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[Federal Register Volume 91, Number 183 (Wednesday, September 23, 2026)]
[Notices]
[Pages 60360-60366]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19498]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 260918-0006]
RIN 0694-XC154
Guidance and Procedures for Implementing Tariff Adjustments for
Specialty Pharmaceuticals and Associated Pharmaceutical Ingredients and
Technical Corrections to the Harmonized Tariff Schedule of the United
States for Duties Imposed Under Proclamation 11020
AGENCY: Bureau of Industry and Security, Office of Strategic Industries
and Economic Security, U.S. Department of Commerce.
ACTION: Notice.
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SUMMARY: This notice defines the pharmaceutical products and lists the
jurisdictions that are eligible to receive an ad valorem tariff rate of
zero pursuant to Presidential Proclamation 11020 of April 2, 2026,
``Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients
Into the United States,'' (Proclamation 11020). These pharmaceutical
products include drugs and associated ingredients where all approved
indications are designated as orphan; nuclear medicines; plasma derived
therapies; fertility drugs; cell therapy product; gene therapy product;
antibody drug conjugates; medical countermeasures related to chemical,
biological, radiological, and nuclear threats; and animal health.
Proclamation 11020 states that such products and associated ingredients
receive the Section 232 zero tariff rate if they are products of a
jurisdiction that has a current or forthcoming trade and security
framework agreement or if they meet an urgent U.S. health need. This
notice also includes procedures for the public to submit information
for the Department of Commerce's (Commerce) approval to determine if
imports of the pharmaceutical products and associated ingredients meet
an urgent U.S. health need. This notice also issues five technical
corrections to Annex I and one technical correction to Annex IV of the
Proclamation.
DATES: Submission of information will be received on an ongoing basis
starting September 23, 2026.
ADDRESSES: Information requesting Commerce's approval for
pharmaceutical products that meet an urgent U.S. health need must be
submitted electronically to: <a href="/cdn-cgi/l/email-protection#46362e27342b2774757406242f356822292568212930"><span class="__cf_email__" data-cfemail="3f4f575e4d525e0d0c0d7f5d564c115b505c11585049">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: Stephen Astle, Director, Defense
Industrial Base Division, Office of Strategic Industries and Economic
Security, Bureau of Industry and Security, U.S. Department of Commerce
(202) 482-2533, <a href="/cdn-cgi/l/email-protection#dbabb3baa9b6bae9e8e99bb9b2a8f5bfb4b8f5bcb4ad"><span class="__cf_email__" data-cfemail="a7d7cfc6d5cac6959495e7c5ced489c3c8c489c0c8d1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On April 2, 2026 the President issued Proclamation 11020,
``Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients
Into the United States,'' (91 FR 18183) (Proclamation 11020) concurring
with the Secretary of Commerce's (Secretary) finding that
pharmaceuticals and associated pharmaceutical ingredients are being
imported into the United States in such quantities and under such
circumstances that threaten to impair the national security of the
United States and imposing tariffs to adjust imports of such products
pursuant to section 232 of the Trade Expansion Act of 1962, as amended
(19 U.S.C. 1862) (Section 232). Proclamation 11020 imposed a 100
percent ad valorem tariff on certain imports of patented
pharmaceuticals and associated pharmaceutical ingredients, effective
July 31, 2026 for the companies listed in Annex III of Proclamation
11020, and September 29, 2026 for all other companies. Different rates
apply to patented pharmaceutical products and associated ingredients
from certain jurisdictions and from companies with Commerce-approved
onshoring agreements (Bureau of Industry and Security, ``Procedures To
Apply for Company-Specific Onshoring Agreements To Obtain Tariff
Adjustments for Pharmaceuticals and Pharmaceutical Ingredients Under
Proclamation 11020'' (92 FR 26989; May 13, 2026)). At this time,
Section 232 Pharmaceutical Tariffs do not apply to generic
pharmaceutical products and associated ingredients.
In clause 3(d) of Proclamation 11020, the President directed an ad
valorem tariff rate of zero to apply for pharmaceuticals and associated
ingredients that are designated as orphan pursuant to the Orphan Drug
Act (21 U.S.C. 360aa et seq.) and its implementing regulations; nuclear
medicines; plasma derived therapies; fertility drugs; cell therapy
product; gene therapy product; antibody drug conjugates; medical
countermeasures related to chemical, biological, radiological, and
nuclear threats; or other specialty pharmaceutical products to be
identified by the Secretary, as well as pharmaceutical products for
animal health, provided that the Secretary, in consultation with the
United States Trade Representative (USTR) and the Secretary of Health
and Human Services (HHS), determines that: (1) they are products of a
jurisdiction that has a current or forthcoming trade and security
framework agreement as referenced in Executive Order 14346, ``Modifying
the Scope of Reciprocal Tariffs and Establishing Procedures for
Implementing Trade and Security Agreements'' of September 5, 2025 (90
FR 43737) (Executive Order 14346), or (2) they meet an urgent U.S.
health need.
Proclamation 11020 directs the Secretary, in consultation with the
Chair of the United States International Trade Commission and the
Commissioner of U.S. Customs and Border Protection (CBP), to determine
whether any modifications to the HTSUS or other
[[Page 60361]]
administrative measures are necessary to effectuate or implement the
Proclamation or any actions taken pursuant to the Proclamation. Any
changes are to be published in a notice in the Federal Register.
II. Definitions of Pharmaceutical Products Listed in Clause 3(d) of
Proclamation 11020
Commerce consulted with the Food and Drug Administration (FDA) and
U.S. Department of Agriculture Center for Veterinary Biologics to
provide the following definitions of the pharmaceutical products listed
in clause 3(d) of Proclamation 11020. The definitions are solely for
purposes of determining eligibility of the ad valorem tariff rate of
zero pursuant to Proclamation 11020 and should not be construed as
binding guidance for any other purpose unrelated to Proclamation 11020.
This list of definitions covers imports of investigational drugs as
well as FDA-approved or FDA-authorized drugs. Commerce reserves the
right to modify these definitions in the future.
<bullet> Drug where all approved or licensed indications are
designated as orphan: A drug or biological product that is designated
under Section 526 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bb) for one or more rare diseases or conditions, and for
which all approved indications under Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) of this title or licensed under
Section 351 of the Public Health Service Act (42 U.S.C. 262), are for
one or more such rare diseases or conditions.
<bullet> Nuclear medicine: A drug that meets the definition of
``radioactive drug'' in 21 CFR 310.3(n) or a biological product that
meets the definition of ``radioactive biological product'' as defined
in 21 CFR 600.3(ee).
[cir] 21 CFR 301.3(n): Radioactive drug means any substance defined
as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic
Act which exhibits spontaneous disintegration of unstable nuclei with
the emission of nuclear particles or photons and includes any
nonradioactive reagent kit or nuclide generator which is intended to be
used in the preparation of any such substance but does not include
drugs such as carbon-containing compounds or potassium-containing salts
which contain trace quantities of naturally occurring radionuclides.
The term `radioactive drug' includes a `radioactive biological product'
as defined in 21 CFR 600.3(ee).
[cir] 21 CFR 600.3(ee): Radioactive biological product means a
biological product which is labeled with a radionuclide or intended
solely to be labeled with a radionuclide.
<bullet> Plasma derived therapy: A biological product that is
derived from human whole blood or plasma. (42 U.S.C. 1320f-1(e)(3)(C)).
<bullet> Fertility drug: A drug or biological product for the
treatment of infertility, including drugs approved for the treatment of
ovulatory dysfunction in women desiring pregnancy.
<bullet> Cell therapy product: A biological product that is a
cellular immunotherapy, cellular cancer vaccine, or other type of
autologous or allogeneic cellular product approved for one or more
therapeutic indications, including hematopoietic stem cell products and
adult and embryonic stem cell products.
<bullet> Gene therapy product: A biological product that is
intended to modify or manipulate the expression of a gene or to alter
the biological properties of living cells for therapeutic use.
<bullet> Antibody drug conjugates: A combination product composed
of a small-molecule drug (payload) and an antibody or antibody
fragment, conjugated together by a chemical linker.
<bullet> Medical countermeasures related to chemical, biological,
radiological, and nuclear threats: A drug as defined in section 201(g)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), or a
biological product as defined in section 351(i) of the Public Health
Service Act (42 U.S.C. 262(i)), that is for use to diagnose, prevent,
or treat diseases or conditions caused by chemical, biological,
radiological, or nuclear threat (CBRN) agents, including emerging
infectious diseases, and include qualified countermeasures as defined
in section 319F-(a)(2)(A) of the Public Health Service Act (42 U.S.C.
247d-6a), qualified pandemic or epidemic products as defined in section
319F-3(i)(7) of the Public Health Service Act (42 U.S.C. 247d-6d); and
security countermeasures as defined in section 319F-2(c)(1)(B) of the
Public Health Service Act (42 U.S.C. 247d-6b).
<bullet> Animal Healthcare Products: Animal healthcare products
include articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in animals; articles (other than
food) intended to affect the structure or any function of an animal's
body; or articles intended for use as components of such products. The
definition includes veterinary pharmaceuticals intended to manage
diseases, conditions, or injuries in animals but does not include
devices or combination products for animals. Animal healthcare products
also include biologics (vaccines, bacterins, and diagnostic products)
used in the treatment of diseases in animals and is regulated by USDA-
CVB (Center for Veterinary Biologics).
III. List of Eligible Jurisdictions
The following jurisdictions are eligible for the tariff adjustment
described in clause 3(d) of Proclamation 11020: Argentina, Bangladesh,
Cambodia, Ecuador, El Salvador, European Union, Guatemala, India,
Indonesia, Japan, Jordan, Malaysia, North Macedonia, Republic of Korea,
Switzerland and Liechtenstein, Taiwan, Thailand, United Kingdom, and
Vietnam. Changes to the list of eligible jurisdictions may be published
in a future notice.
IV. Procedures for Requesting Commerce Approval for Pharmaceuticals
That Meet an Urgent U.S. Health Need
Companies can request approval from Commerce for imports of
pharmaceutical products listed in clause 3(d) of Proclamation 11020 or
other specialty products if such imports meet an urgent U.S. health
need. Companies should email the Bureau of Industry and Security (BIS)
at <a href="/cdn-cgi/l/email-protection#97e7fff6e5faf6a5a4a5d7f5fee4b9f3f8f4b9f0f8e1"><span class="__cf_email__" data-cfemail="56263e37243b3764656416343f257832393578313920">[email protected]</span></a> with the following information for each
requested product or ingredient:
1. Section 1--Organization Information: Full legal name and address
of the company. The name, title, and contact information of the
authorized representative submitting the application should also be
included.
2. Section 2--Tariff Adjustment for Urgent U.S. Health Need:
Companies should provide the following information, with respect to the
product for which they request preferential treatment to meet an urgent
health need in the United States. Only one specific product may be
submitted per application form.
<bullet> HTSUS Classification (10-digit, if possible)
<bullet> Advertised name and brand of product or Investigational New
Drug Application number, as applicable, as well as active ingredient
(or combination of active ingredients)
<bullet> Indicate the category of the requested product: orphan,
nuclear medicine, plasma derived therapies, fertility drugs, cell
therapy product, gene therapy product, antibody drug conjugates,
medical countermeasures related to CBRN threats, or animal health
<bullet> Country of origin and country of export of products imported
under each HTSUS Classification
[[Page 60362]]
<bullet> Name and IOR Number of Importer(s) of Record
<bullet> Name and address of manufacturer
3. Section 3--Rationale for why the import meets an urgent U.S.
health need: The rationale can include information such as the type of
disease the product treats and an assessment of alternative therapies
or lack of alternative therapies for the type of disease the product
treats, the number of U.S. patients that use the product, and whether
or not the product is available in other jurisdictions. The requests
for approval should only be for patented pharmaceutical products and
associated ingredients that are covered under the HTSUS codes listed in
Annex I of Proclamation 11020. Submission of information will be
received on an ongoing basis.
Review and Approval Process
Commerce may request supplemental documentation or clarification.
As directed in Proclamation 11020, Commerce will consult with the USTR
and HHS to determine if the requested product meets an urgent U.S.
health need. Commerce will make an individual, fact-specific, company-
specific decision for each request. Companies will be notified in
writing of Commerce's decision. Relevant information from the request
will be transmitted by Commerce to CBP. CBP will administer the tariff
adjustment at the time of entry summary filing and may request
additional documentation to validate entries.
Confidentiality
Commerce will protect the confidentiality of all information
submitted by companies requesting approval of specialty pharmaceutical
product imports that meet an urgent U.S. health need.
Commerce will protect the confidentiality of confidential, trade
secret, and/or proprietary information excluding information in the
public domain (``confidential information'') provided by the Drug
Manufacturer to the fullest extent allowed by law. For example, subject
to applicable laws, such information would be protected from disclosure
by the Trade Secrets Act (18 U.S.C. 1905) and under Exemptions 3 and/or
4 of the Freedom of Information Act (``FOIA'') (5 U.S.C. 552(b)(3),
(4)). Commerce shall limit dissemination of a Drug Manufacturer's
confidential information to those persons within its organization,
USTR, and other executive branch agencies and entities who have a need
to know such information to fulfill the purpose of determining whether
imports of requested specialty pharmaceutical products meet an urgent
U.S. health need.
V. Technical Corrections to the HTSUS
This notice and its accompanying annexes provide for five technical
corrections to Annex I and one technical correction to Annex IV of
Proclamation 11020.
Annex I Technical Corrections: The first correction amends the
definition of ``generic pharmaceutical articles'' in subdivision
(c)(iii) with respect to heading 9903.04.67. The definition of
``generic pharmaceutical articles'' is modified to specifically include
``unpatented animal health products.''
The second correction includes a new heading in Chapter 99 of the
HTSUS with an ad valorem tariff rate of zero. Filers should use this
new heading for pharmaceutical products and associated ingredients that
are imported under HTSUS Classifications listed in subpart (c) of U.S.
note 40 which are solely intended for clinical trials, research and
development, or other non-commercial applications.
The third correction amends the definition of ``pharmaceutical
articles'' in subdivision (c)(i) to clarify that this definition only
encompasses finished pharmaceutical products, their active
pharmaceutical ingredients, and the key starting materials of said
active pharmaceutical ingredients.
The fourth correction amends the text of subdivision (i) with
respect to heading 9903.04.69 to clarify that this provision
encompasses any pharmaceutical or non-pharmaceutical articles imported
under an HTSUS Classification listed in subpart (c) of U.S. note 40
that are not finished pharmaceutical products, their active
pharmaceutical ingredients, or the key starting materials of said
active pharmaceutical ingredients.
The fifth correction amends Annex I to incorporate recent HTSUS
changes made by the Committee for the Statistical Annotation of Tariff
Schedules on July 1, 2026. This interagency committee includes
representatives from the U.S. International Trade Commission, CBP, and
the U.S. Census Bureau.
Annex IV Technical Correction: The technical correction to Annex IV
corrects an inconsistency of certain HTSUS Classifications listed in
Annex IV that overlap with Annex I. The following HTSUS codes are
removed from Annex IV: 2937.23.50, 3002.13.00, 3002.14.00, 3002.15.00,
and 3004.49.00.
VI. Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
provides that an agency generally cannot conduct or sponsor a
collection of information, and no person is required to respond to nor
be subject to a penalty for failure to comply with a collection of
information, unless that collection has obtained Office of Management
and Budget (OMB) approval and displays a currently valid OMB Control
Number.
In Proclamation 11020, the President determined it was necessary
and appropriate to apply an ad valorem tariff rate of zero for the
following specialty pharmaceutical products and associated ingredients
when certain conditions are met pursuant to clause 3(d) of Proclamation
11020: drugs and associated ingredients where all approved indications
are designated as orphan; nuclear medicines; plasma derived therapies;
fertility drugs; cell therapy product; gene therapy product; antibody
drug conjugates; medical countermeasures related to chemical,
biological, radiological, and nuclear threats; and animal health. The
President authorized the Secretary of Commerce, in consultation with
the USTR and the Secretary of HHS, to determine that: (1) they are
products of a jurisdiction that has a current or forthcoming trade and
security framework agreement as referenced in Executive Order 14346; or
(2) they meet an urgent United States health need.
Because the Proclamation requires timely implementation of the
specialty pharmaceutical tariff adjustments to further U.S. economic
and national security interests by making pharmaceuticals more
accessible and affordable in the United States, BIS cannot reasonably
comply with the normal clearance procedures. Delaying this collection
would impede the ability of companies to request approval for imports
of specialty pharmaceutical products that meet an urgent United States
health need and compromise the effectiveness of the Proclamation's
implementation. The Department has determined the following conditions
have been met:
a. The collection of information is needed prior to the expiration
of time periods normally associated with a routine submission for
review under the provisions of the Paperwork Reduction Act in view of
Proclamation 11020, <a href="https://www.federalregister.gov/documents/2026/04/09/2026-06956/adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states">https://www.federalregister.gov/documents/2026/04/09/2026-06956/adjusting-imports-of-pharmaceuticals-and-pharmaceutical-ingredients-into-the-united-states</a>. (5 CFR 1320.13(a)(1)(i)).
[[Page 60363]]
b. The collection of information is essential to the mission of the
Department, in particular to allow companies seeking to obtain the zero
ad valorem tariff by requesting approval for imports of specialty
pharmaceutical products that meet an urgent United States health need
to effectuate the terms outlined by Proclamation 11020 (5 CFR
1320.13(a)(1)(ii)). These collection requirements include a description
of the specialty pharmaceutical product, country of origin information,
and rationale for why the import meets an urgent United States health
need. The information must be submitted in electronic form via email to
the BIS Section 232 Pharmaceuticals Investigation Inbox
(<a href="/cdn-cgi/l/email-protection#e4948c85968985d6d7d6a4868d97ca808b87ca838b92"><span class="__cf_email__" data-cfemail="fb8b939a89969ac9c8c9bb999288d59f9498d59c948d">[email protected]</span></a>). Requests for approval of imports that meet an
urgent United States health need may be submitted at any time following
publication of this FRN publication and all submissions are entirely
voluntary on the part of the requesting companies.
c. Public harm is reasonably likely to result if BIS were to follow
the normal clearance procedures before issuing this information
collection (5 CFR 1320.13(a)(2)(i)). BIS needs time to receive and
evaluate requests for specialty pharmaceutical products that meet an
urgent United States health need before September 29, 2026, when the
Section 232 tariffs for most companies will become effective. A delay
in Commerce's ability to begin immediate information collection from
companies seeking approval to import specialty pharmaceutical products
that meet an urgent United States health need and inability to issue
decisions before the 100 percent tariff rate is in effect creates
uncertainty for companies' understanding of their tariff liability and
could also cause supply chain disruptions.
For the reasons stated above, BIS has requested, and OMB has
granted, a new information collection for this rule under OMB control
number 0694-0150 with the title Section 232 National Security
Adjustments to Imports of Specialty Pharmaceuticals. All materials for
the currently approved collection can be accessed at <a href="http://www.reginfo.gov">www.reginfo.gov</a>.
Separately, BIS will be publishing a 60 day notice to take comment on
the emergency collection.
Jessica Curyto,
Deputy Assistant Secretary for Technology Security.
Annex I
Effective with respect to goods entered for consumption, or
withdrawn from warehouse for consumption, on or after 12:01 a.m.
eastern time on September 29, 2026, subchapter III of chapter 99 of
the Harmonized Tariff Schedule of the United States (``HTSUS'') is
modified as follows:
1. U.S. note 40 is modified:
a. In subdivision (a), by deleting ``9903.04.60-9903.04.69'' and
inserting ``9903.04.60-9903.04.70'' in lieu thereof;
b. In subdivision (c), by deleting the enumerated HTSUS
provisions and inserting the following in lieu thereof:
``2918.99.3000 2921.49.3800 2921.49.4300 2922.19.0910
2922.19.0990 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 2934.99.4720
2934.99.4730 2934.99.4740 2934.99.4790 2935.90.4800
2935.90.6000 2937.11.0000 2937.12.0000 2937.19.0000
2937.22.0010 2937.22.0090 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 2941.90.3030
2941.90.3090 2941.90.5030 2941.90.5090 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 3004.20.0042
3004.20.0058 3004.20.0073 3004.20.0074 3004.20.0078
3004.20.0085 3004.31.0010 3004.31.0090 3004.32.0020
3004.32.0080 3004.39.0010 3004.39.0015 3004.39.0080
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
3004.90.9212 3004.90.9215 3004.90.9216 3004.90.9217
3004.90.9218 3004.90.9226 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''
c. In subdivision (c), by deleting item (i) and inserting the
following in lieu thereof:
``(i) ``Pharmaceutical articles'' refers to imported articles
classifiable in the provisions enumerated in this subdivision that
are finished pharmaceutical products or that are active
pharmaceutical ingredients (including key starting materials for
active pharmaceutical ingredients) classifiable in the provisions
enumerated in this subdivision used to make finished pharmaceutical
products. Inactive ingredients and excipients are not pharmaceutical
articles.'';
d. In subdivision (c)(iii), by deleting the second sentence and
inserting the following sentence in lieu thereof:
[[Page 60364]]
``A generic pharmaceutical article is an active pharmaceutical
ingredient or any component in a finished dosage form product that
is used in a drug product or biosimilar biological product approved
pursuant to a qualifying application; or a drug product or
biosimilar biological product approved or licensed pursuant to a
qualifying application; or an unpatented animal health product.'';
and
e. By deleting subdivision (i) and inserting the following in
lieu thereof:
``(i) Heading 9903.04.69 applies to entries of articles that are
classifiable under provisions of the HTSUS enumerated in subdivision
(c) of this note that are either: (1) not ``pharmaceutical
articles'' as defined in subdivision (c)(i) of this note, or (2) are
``pharmaceutical articles'' but are neither ``patented
pharmaceutical articles'' nor ``generic pharmaceutical articles'' as
those terms are defined in subdivisions (c)(ii) and (c)(iii) of this
note.''
2. The following new heading is inserted in numerical sequence,
with the material for the new heading inserted in the columns of the
HTSUS labeled ``Heading/Subheading'', ``Article Description'',
``Rates of Duty 1-General'', ``Rates of Duty 1-Special'' and ``Rates
of Duty 2'', respectively:
----------------------------------------------------------------------------------------------------------------
Rates of duty
---------------------------------------------------------------
Heading/ subheading Article description 1
------------------------------------------- 2
General Special
----------------------------------------------------------------------------------------------------------------
``9903.04.70......... Pharmaceutical articles The duty provided in The duty provided The duty provided
and associated the applicable in the applicable in the applicable
ingredients provided for subheading + 0%. subheading + 0%. subheading + 0%''.
in subdivision (c) of
U.S. note 40 to this
subchapter that are
solely for use in
clinical trials,
research and
development, or other
non-commercial
applications.
----------------------------------------------------------------------------------------------------------------
Annex II
Effective with respect to goods entered for consumption, or
withdrawn from warehouse for consumption, on or after 12:01 a.m.
eastern time on September 29, 2026, Annex IV of Presidential
Proclamation 11020 of April 2, 2026, ``Adjusting Imports of
Pharmaceuticals and Pharmaceutical Ingredients Into the United
States,'' (Proclamation 11020) is modified by deleting the
enumerated HTSUS provisions and inserting the following in lieu
thereof:
``2903.45.1000 2903.51.1000 2903.59.9000 2903.69.9000
2903.78.0000 2903.79.9030 2903.79.9070 2903.89.1500
2903.89.2000 2903.89.7010 2903.89.7090 2903.92.0000
2904.99.4000 2905.29.9000 2905.39.9000 2905.59.1000
2905.59.9000 2906.19.5000 2906.29.6000 2907.29.9000
2908.19.6000 2909.19.1800 2909.20.0000 2909.30.6000
2909.49.1000 2909.49.1500 2909.49.2000 2909.49.6000
2909.50.4010 2909.50.4050 2909.50.4500 2909.50.5000
2912.19.5000 2912.49.2600 2914.19.0000 2914.40.9000
2914.50.3000 2914.50.5000 2914.62.0000 2914.69.2100
2914.69.9000 2914.79.4000 2915.29.3000 2915.39.3100
2915.39.3500 2915.39.4700 2915.39.9000 2915.90.1010
2915.90.1050 2915.90.1400 2915.90.1810 2915.90.1890
2915.90.2000 2915.90.5010 2915.90.5050 2916.19.3000
2916.19.5000 2916.20.5000 2916.31.5000 2916.39.4600
2916.39.7900 2917.13.0030 2917.13.0090 2917.19.1000
2917.19.7020 2917.19.7050 2917.34.0110 2917.34.0150
2917.39.3000 2918.11.5100 2918.13.5000 2918.16.5010
2918.16.5020 2918.16.5090 2918.19.6000 2918.19.9000
2918.22.1000 2918.22.5000 2918.23.3000 2918.23.5000
2918.29.2000 2918.29.6500 2918.29.7500 2918.30.2500
2918.30.3000 2918.30.9000 2918.99.4300 2918.99.4700
2918.99.5000 2919.90.3000 2919.90.5010 2919.90.5050
2920.90.5100 2921.19.1100 2921.29.0010 2921.29.0020
2921.29.0030 2921.29.0055 2921.30.1000 2921.30.5000
2921.42.9000 2921.46.0000 2921.49.4500 2921.49.5000
2921.59.8010 2921.59.8090 2922.11.0000 2922.14.0000
2922.19.2000 2922.19.3300 2922.19.6000 2922.19.7000
2922.19.9000 2922.19.9610 2922.19.9619 2922.19.9690
2922.29.6100 2922.29.8110 2922.29.8190 2922.31.0000
2922.39.2500 2922.39.4500 2922.39.5000 2922.41.0010
2922.41.0090 2922.42.5000 2922.44.0000 2922.49.1000
2922.49.3000 2922.49.3700 2922.49.4910 2922.49.4915
2922.49.4950 2922.49.8000 2922.50.0700 2922.50.1000
2922.50.1100 2922.50.1300 2922.50.1700 2922.50.3500
2922.50.4000 2922.50.5000 2923.10.0000 2923.20.2010
2923.20.2050 2924.11.0000 2924.19.1110 2924.19.1120
2924.19.1130 2924.19.1150 2924.19.8000 2924.21.1600
2924.21.5000 2924.29.0100 2924.29.0300 2924.29.1000
2924.29.2300 2924.29.2600 2924.29.2800 2924.29.3300
2924.29.5700 2924.29.6210 2924.29.6220 2924.29.7100
2924.29.7710 2924.29.7720 2924.29.7730 2924.29.7790
2924.29.8000 2924.29.9500 2925.12.0000 2925.19.4200
2925.19.9100 2925.21.0000 2925.29.6000 2925.29.9000
2926.30.1000 2926.40.0000 2926.90.1400 2926.90.4300
2926.90.4801 2926.90.5010 2926.90.5050 2927.00.4000
2927.00.5000 2928.00.2500 2929.90.2000 2929.90.5015
[[Page 60365]]
2929.90.5018 2929.90.5020 2929.90.5030 2929.90.5040
2929.90.5095 2930.20.2010 2930.20.2050 2930.20.9010
2930.20.9020 2930.20.9050 2930.30.6000 2930.90.2900
2930.90.4910 2930.90.4920 2930.90.4950 2930.90.9208
2930.90.9210 2930.90.9212 2930.90.9222 2930.90.9225
2930.90.9231 2930.90.9251 2931.49.0005 2931.49.0008
2931.49.0010 2931.49.0015 2931.49.0020 2931.49.0025
2931.49.0055 2931.49.0080 2931.53.0000 2931.90.9010
2931.90.9021 2931.90.9025 2931.90.9029 2931.90.9030
2931.90.9035 2931.90.9040 2931.90.9052 2932.14.0000
2932.19.5100 2932.20.3000 2932.20.5010 2932.20.5020
2932.20.5030 2932.20.5050 2932.99.6100 2932.99.7000
2932.99.9010 2932.99.9090 2933.11.0000 2933.19.9000
2933.21.0000 2933.29.0500 2933.29.3500 2933.29.4300
2933.29.6000 2933.29.9000 2933.33.0100 2933.34.0000
2933.35.0000 2933.37.0000 2933.39.0800 2933.39.1000
2933.39.2000 2933.39.2100 2933.39.2300 2933.39.2500
2933.39.2700 2933.39.3100 2933.39.6110 2933.39.6120
2933.39.6130 2933.39.6191 2933.39.9200 2933.41.0000
2933.49.0800 2933.49.1000 2933.49.1500 2933.49.1700
2933.49.2000 2933.49.3000 2933.49.6000 2933.49.7000
2933.52.1000 2933.52.9000 2933.53.0000 2933.54.0000
2933.59.1000 2933.59.1500 2933.59.1800 2933.59.2200
2933.59.7000 2933.59.8000 2933.59.8500 2933.59.9500
2933.69.6010 2933.69.6021 2933.69.6030 2933.69.6050
2933.72.0000 2933.79.1500 2933.91.0010 2933.91.0050
2933.99.0100 2933.99.0200 2933.99.0500 2933.99.0600
2933.99.0800 2933.99.1100 2933.99.1200 2933.99.1600
2933.99.1701 2933.99.2200 2933.99.2400 2933.99.2600
2933.99.4200 2933.99.5100 2933.99.5510 2933.99.5520
2933.99.5530 2933.99.5800 2933.99.7900 2933.99.8210
2933.99.8220 2933.99.8290 2933.99.8500 2933.99.8900
2933.99.9701 2934.10.1000 2934.10.2000 2934.10.9000
2934.20.4000 2934.20.8000 2934.30.4300 2934.30.5000
2934.91.0000 2934.92.0000 2934.99.0100 2934.99.0300
2934.99.0500 2934.99.0600 2934.99.0700 2934.99.0800
2934.99.0900 2934.99.1100 2934.99.1200 2934.99.1500
2934.99.1600 2934.99.1800 2934.99.2000 2934.99.3900
2934.99.4400 2934.99.7000 2934.99.9001 2935.50.0000
2935.90.0600 2935.90.1000 2935.90.1300 2935.90.1500
2935.90.2000 2935.90.3000 2935.90.3200 2935.90.3300
2935.90.4200 2935.90.7500 2935.90.9500 2936.21.0000
2936.22.0000 2936.23.0000 2936.24.0100 2936.25.0000
2936.26.0000 2936.27.0000 2936.28.0000 2936.29.1000
2936.29.1610 2936.29.1620 2936.29.1630 2936.29.2000
2936.29.5020 2936.29.5030 2936.29.5050 2936.90.0110
2936.90.0150 2937.21.0010 2937.21.0020 2937.21.0030
2937.21.0040 2937.23.1020 2937.23.2500 2937.29.1000
2937.29.9020 2937.29.9030 2937.90.0500 2937.90.1000
2937.90.2000 2937.90.4000 2938.10.0000 2939.19.1000
2939.20.0010 2939.20.0050 2939.30.0000 2939.41.0000
2939.42.0000 2939.44.0000 2939.45.0000 2939.49.0300
2939.59.0000 2939.62.0000 2939.63.0000 2939.69.0000
2939.72.0000 2939.79.0000 2939.80.0010 2939.80.0050
2940.00.6000 2941.10.1000 2941.10.2000 2941.10.3000
2941.20.1000 2941.20.5000 2941.30.0000 2941.40.0000
2941.50.0000 2941.90.1010 2942.00.3500 2942.00.5000
3001.20.0000 3001.90.0110 3001.90.0150 3001.90.0165
3001.90.0195 3002.12.0010 3002.12.0020 3002.12.0030
3002.12.0090 3002.49.0010 3002.90.5210 3003.10.0000
3003.41.0000 3003.42.0000 3003.90.0160 3004.10.1020
3004.10.1045 3004.10.5048 3004.10.5049 3004.10.5055
3004.10.5065 3004.10.5075 3004.20.0020 3004.20.0030
3004.20.0045 3004.20.0055 3004.20.0065 3004.20.0070
3004.20.0071 3004.20.0072 3004.20.0076 3004.20.0080
3004.32.0010 3004.32.0040 3004.39.0020 3004.39.0030
3004.39.0040 3004.39.0045 3004.42.0000 3004.50.1000
3004.50.2000 3004.50.3000 3004.50.4000 3004.50.5010
3004.50.5020 3004.50.5030 3004.50.5040 3004.60.0000
3004.90.9203 3004.90.9204 3004.90.9205 3004.90.9207
3004.90.9209 3004.90.9212 3004.90.9213 3004.90.9217
3004.90.9218 3004.90.9219 3004.90.9220 3004.90.9222
3004.90.9223 3004.90.9224 3004.90.9226 3004.90.9227
3004.90.9228 3004.90.9229 3004.90.9230 3004.90.9232
3004.90.9233 3004.90.9234 3004.90.9235 3004.90.9237
3004.90.9238 3004.90.9239 3004.90.9240 3004.90.9241
[[Page 60366]]
3004.90.9242 3004.90.9244 3004.90.9245 3004.90.9247
3004.90.9248 3004.90.9250 3004.90.9254 3004.90.9255
3004.90.9256 3004.90.9257 3004.90.9258 3004.90.9261
3004.90.9262 3004.90.9264 3004.90.9265 3004.90.9266
3004.90.9269 3004.90.9272 3004.90.9274 3004.90.9275
3006.30.1000 3006.30.5000 3006.60.0000 3006.70.0000
3006.93.1000 3006.93.2000 3006.93.5000 3006.93.6000
3006.93.8000''
[FR Doc. 2026-19498 Filed 9-21-26; 4:15 pm]
BILLING CODE 3510-33-P
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</html>Indexed from Federal Register on September 23, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.