[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 5043 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
2d Session
S. 5043
To direct the Food and Drug Administration to prevent the importation
of counterfeit, unapproved, misbranded, or adulterated drugs from the
People's Republic of China or other foreign countries, to establish
enhanced safeguards for imported drug products, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 21, 2026
Mr. Budd introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To direct the Food and Drug Administration to prevent the importation
of counterfeit, unapproved, misbranded, or adulterated drugs from the
People's Republic of China or other foreign countries, to establish
enhanced safeguards for imported drug products, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Secure Drug Supply Chain Act of
2026''.
SEC. 2. PURPOSE.
The purposes of this Act are--
(1) to prevent the unlawful importation of counterfeit,
unapproved, misbranded, or adulterated drugs from the People's
Republic of China and other countries that are known to engage
in intellectual property theft, forced labor, or the
distribution of counterfeit and illicit pharmaceutical products
that undermine the public health and economic interests of the
United States;
(2) to increase visibility into the United States
pharmaceutical supply chain; and
(3) to reduce the direct and indirect dependence of the
United States on active pharmaceutical ingredients and key
starting materials sourced from the People's Republic of China
or that are of Chinese origin and sourced through third
countries, in order to strengthen the resilience of the United
States drug supply and protect public health and national
security.
SEC. 3. PREVENTION OF IMPORTATION OF UNLAWFUL COUNTERFEIT PRESCRIPTION
AND OVER-THE-COUNTER DRUGS.
(a) In General.--The Secretary of Health and Human Services
(referred to in this Act as the ``Secretary'') shall utilize
authorities under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) to prevent the importation of drugs, including active
pharmaceutical ingredients and key starting materials, that are
counterfeit, unapproved, misbranded, or adulterated and manufactured,
prepared, propagated, compounded, and processed in a foreign
establishment, with particular emphasis on preventing importation of
such drugs, including active pharmaceutical ingredients and key
starting materials, from the People's Republic of China and other
countries that are designated as adversarial by the Secretary of State.
(b) Enforcement Actions.--In carrying out subsection (a), the
Secretary shall--
(1) conduct compliance and enforcement actions directed at
entities involved in the manufacture, preparation, propagation,
compounding, processing, or distribution of unapproved,
adulterated, or misbranded drugs, including active
pharmaceutical ingredients and key starting materials, that are
offered for import;
(2) in cooperation with the Attorney General, initiate
civil and criminal enforcement actions, including injunctions
and seizures, under sections 301, 302, 303, 304, and 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 332, 333,
334, 381);
(3) refuse entry into the United States of such drugs,
including active pharmaceutical ingredients or key starting
materials; and
(4) conduct inspections of, or use alternative tools with
respect to, as appropriate, facilities engaged in compounding
to monitor for unauthorized receipt, use, or handling of drugs
from the People's Republic of China and other countries
designated as adversarial by the Secretary of State that were
imported into the United States in violation of applicable laws
and regulations.
(c) Annual Reporting.--Beginning with fiscal year 2027, not later
than 180 days after the end of each fiscal year, the Secretary shall
submit a report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and Commerce of the
House of Representatives, detailing enforcement actions described in
subsection (b) that were taken in the previous fiscal year, including
information on the number and type of drugs, active pharmaceutical
ingredients, and key starting materials that were the subjects of such
actions during the previous fiscal year.
(d) Guidance; Recommendations.--Not later than 180 days after the
submission of each report under subsection (c), based on the
information compiled in the report, the Secretary shall--
(1) issue or update guidance for importers of drugs to
comply with the requirements of this Act, including the
amendments made by this Act; and
(2) submit to Congress legislative proposals relating to
resources and policies that would facilitate carrying out this
Act, including the amendments made by this Act.
SEC. 4. SUPPLY CHAIN TRANSPARENCY AND RESILIENCE.
(a) Reporting Requirements for Active Pharmaceutical Ingredients
and Key Starting Materials.--
(1) In general.--Section 510(j)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(j)(3)) is amended--
(A) in the first sentence of subparagraph (A)--
(i) by striking ``annually'' and inserting
``quarterly''; and
(ii) by inserting ``and the information
described in subparagraph (C)'' before the
period at the end; and
(B) by adding at the end the following:
``(C)(i) The annual report required under subparagraph (A)
shall include the information described in clause (ii) with
respect to drugs, in accordance with the following:
``(I) In the 1-year period beginning on the
effective date of the final regulations described in
section 4(c) of the Secure Drug Supply Chain Act of
2026, the information described in clause (ii) shall be
included in the report under subparagraph (A) with
respect to any drug that--
``(aa) is included on the Essential
Medicines List maintained by the Food and Drug
Administration pursuant to Executive Order
13944 (85 Fed. Reg. 49929); and
``(bb) is a drug for which any active
pharmaceutical ingredient, key starting
material, or acquired intermediate is sourced
from the People's Republic of China or another
foreign country of concern.
``(II) Beginning on the day after the last day of
the 1-year period described in subclause (I), the
information described in clause (ii) shall be included
in the report under subparagraph (A) if it is a drug
for which any active pharmaceutical ingredient, key
starting material, or acquired intermediate is sourced
from the People's Republic of China or another foreign
country of concern.
``(ii) The information described in this clause is the
following, as applicable:
``(I) The identity of each active pharmaceutical
ingredient, key starting material, and acquired
intermediate used by the registrant to manufacture the
listed drug.
``(II) The total amount of each such active
pharmaceutical ingredient, key starting material, and
acquired intermediate used by the registrant to
manufacture the listed drug during the reporting
period, expressed in such units as the Secretary shall
specify.
``(III) The country of origin of each such active
pharmaceutical ingredient, key starting material, and
acquired intermediate, including the name, address, and
unique facility identifier (as applicable) of each
establishment at which such active pharmaceutical
ingredient, key starting material, or acquired
intermediate was manufactured.
``(iii) Information reported under this subparagraph shall
include the country of origin without regard to any
distribution or shipment through a country other than the
country of origin.
``(iv) A person required to report information under this
subparagraph shall maintain such records and supporting
documentation as the Secretary shall require to verify the
accuracy and completeness of information submitted under this
paragraph, for a period of not less than 5 years, and shall
make such records available to the Secretary upon request.
``(D) Not later than 18 months after the 1-year period
described in subparagraph (C)(i)(I) ends, and annually
thereafter, the Secretary shall, based on the reports submitted
under subparagraph (A), issue a confidential report to Congress
that--
``(i) analyzes United States vulnerabilities
arising from dependence on active pharmaceutical
ingredients and key starting materials sourced from the
People's Republic of China or other foreign countries
of concern, including any such ingredients or materials
with origins in the People's Republic of China or
another foreign country of concern that are sourced
through third countries;
``(ii) identifies the proportion of drugs
manufactured, prepared, propagated, compounded, or
processed for commercial distribution in the United
States that depend on active pharmaceutical ingredients
and key starting materials sourced from the People's
Republic of China or other foreign countries of
concern, disaggregated by country of origin to the
extent practicable;
``(iii) determines specific supply chain
vulnerabilities, including drug classes or therapeutic
categories for which dependence on active
pharmaceutical ingredients and key starting materials
sourced from the People's Republic of China or another
foreign country of concern, poses a risk to public
health or national security; and
``(iv) tracks trends over time in dependence on
active pharmaceutical ingredients and key starting
materials sourced from the People's Republic of China
or another foreign country of concern, including
anonymized aggregate data reflecting increases or
decreases in such dependence.
``(E) In this paragraph:
``(i) The term `acquired intermediate' means a
material produced during steps in the manufacture of an
active pharmaceutical ingredient that undergoes further
molecular change or purification before it becomes an
active pharmaceutical ingredient and is manufactured at
an establishment other than the establishment at which
the active pharmaceutical ingredient is manufactured.
``(ii) The term `country of origin' means, with
respect to an active pharmaceutical ingredient, key
starting material, or acquired intermediate, each
country in which such ingredient, intermediate, or
material was manufactured into its chemical identity
through chemical synthesis, fermentation, extraction,
purification, or other manufacturing process including
each country at which such active pharmaceutical
ingredient, key starting material, or acquired
intermediate was repackaged, relabeled, finished,
blended, or tested.
``(iii) The term `foreign country of concern' has
the meaning given such term in section 10612(a) of the
Research and Development, Competition, and Innovation
Act.''.
(2) Confidentiality.--Nothing in the amendment made by
paragraph (1) shall be construed as authorizing the Secretary
to disclose any information that is a trade secret or
confidential information subject to section 552(b)(4) of title
5, United States Code, or section 1905 of title 18, United
States Code.
(b) Regulatory Gap Analysis.--Not later than 180 days after the
date of enactment of this Act, the Secretary shall identify and submit
to Congress a report describing--
(1) existing regulatory authorities available to the
Secretary to support or incentivize the sourcing of active
pharmaceutical ingredients and key starting materials from
countries other than the People's Republic of China, or from
sources with no People's Republic of China origin content; and
(2) any deficiencies in existing regulatory authorities
that limit the ability of the Secretary to support or
incentivize such sourcing, together with recommendations for
legislative or administrative action to address such
deficiencies.
(c) Regulations.--The Secretary of Health and Human Services
shall--
(1) not later than 90 days after the date of enactment of
this Act, issue proposed regulations implementing the
amendments made by subsection (a); and
(2) not later than 180 days after issuance of the proposed
regulations described in paragraph (1), finalize such
regulations.
SEC. 5. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
(a) Ban on Imports of Drugs From Establishments Using Forced Labor
or Violating Sanctions.--Section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) is amended, in the third sentence--
(1) by inserting ``or (6) such article is a drug and the
safety of such drug is based solely on information or
certifications provided by a foreign government, including any
inspection described in section 704(i), without routine
inspections conducted by United States inspectors to verify
compliance with this Act, or (7) such article is a drug and was
manufactured, prepared, propagated, compounded, processed in an
establishment known to have used forced labor (as defined in
section 307 of the Tariff Act of 1930) or to have been in
violation of sanctions imposed by the Federal Government under
the International Emergency Economic Powers Act or other
applicable law, as determined by the Secretary in consultation
with the Secretary of Homeland Security,'' after ``301(cc),'';
and
(2) by striking ``clauses (1) through (5)'' and inserting
``clauses (1) through (7)''.
(b) Destruction of Refused Articles Presenting Significant Public
Health Concerns.--Section 801 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381) is amended by adding at the end the following:
``(v) Destruction of Refused Articles Presenting Significant Public
Health Concerns.--
``(1) In general.--If the Secretary determines that an
article that has been refused admission under subsection (a)
presents a significant public health concern, the Secretary may
issue to the owner or consignee of the article an order to
destroy the article, without the opportunity for export.
``(2) Deadline; costs.--Not later than 90 days after the
issuance of an order under paragraph (1), the owner or
consignee shall destroy the article. The owner or consignee
shall be responsible for the costs of such destruction.
``(3) Due process.--The Secretary shall provide to the
owner or consignee of an article subject to an order under
paragraph (1) appropriate due process prior to the destruction
of the article. Such due process shall include notice and an
opportunity to appear before the Secretary and introduce
testimony on the destruction, in combination with the notice
and opportunity to appear and introduce testimony on the
refusal of admission of the article under subsection (a) or
separately.''.
(c) Prohibition on Registration of Certain Foreign
Establishments.--Section 510(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(i)) is amended by adding at the end the following:
``(6) Notwithstanding any other provision of this section, any
establishment that knowingly used, or partnered with, contracted with,
or purchased from an entity that has used, forced labor (as defined in
section 307 of the Tariff Act of 1930) or that knowingly violated
sanctions imposed by the Federal Government under the International
Emergency Economic Powers Act or other applicable law, as determined by
the Secretary in consultation with the Secretary of Homeland Security,
shall not be eligible for registration under this section, and the
Secretary shall revoke any registration of such an establishment that
was accepted prior to the date of enactment of the Secure Drug Supply
Chain Act of 2026.''.
(d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the
following:
``(jjj) The unauthorized movement, or introduction or delivery for
introduction into interstate commerce, including export, of an article
that is subject to an order for destruction under section 801(v).
``(kkk) The knowing provision of a materially false, fictitious, or
fraudulent statement or representation to the Secretary that
accompanies or relates to a drug imported or offered for import into
the United States.
``(lll) The import or offering for import into the United States of
a drug that previously has been refused admission under section 801(a)
or exported during the pendency of a detention, unless the person
reimporting or reoffering the drug affirmatively makes reference to the
original refusal or detention and establishes that the drug complies
with the applicable requirements of this Act, as determined by the
Secretary.''.
(e) Misbranded Drugs.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(hh) If it is a drug, including an active pharmaceutical
ingredient and key starting material, imported or offered for import
and the drug is accompanied by a materially false, fictitious, or
fraudulent statement or representation knowingly made by the person
importing the drug or offering the drug for import.''.
(f) Adulterated Drugs.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the
following:
``(k) If it is an active pharmaceutical ingredient that has not
been approved as part of an application under section 505 of this Act
or 351 of the Public Health Service Act, or otherwise approved or
authorized for use in a drug or device, and it was manufactured,
prepared, propagated, compounded, or processed in--
``(1) an establishment that was not inspected within the
immediately preceding 3-year period; or
``(2) in the case of an establishment located in a foreign
country with which the Secretary has an arrangement or
agreement under section 809 to recognize the inspection of
establishments by the government or an agency of the government
of such country, within the immediately preceding 5-year
period.
``(l) If it is a drug that was manufactured, prepared, propagated,
compounded, or processed in an establishment that the Secretary, in
consultation with the Secretary of Homeland Security, determines--
``(1) knowingly utilizes forced labor (as defined in
section 307 of the Tariff Act of 1930); or
``(2) is in violation of sanctions imposed by the Federal
Government under the International Emergency Economic Powers
Act or other applicable law, including an establishment that is
designated to the list of specially designated nationals and
blocked persons maintained by the Office of Foreign Assets
Control of the Department of the Treasury or owned 50 percent
more or more, directly or indirectly, by one or more such
designated persons.''.
(g) Regulations.--The Secretary of Health and Human Services
shall--
(1) not later than 90 days after the date of enactment of
this Act, issue proposed regulations implementing the
amendments made by this section; and
(2) not later than 180 days after issuance of the draft
guidance described in paragraph (1), finalize such guidance.
(h) Applicability.--The amendments made by this section shall apply
beginning on the date that is 180 days after the final guidance under
section 6(2) is issued.
SEC. 6. DEFINING KEY STARTING MATERIAL.
The Secretary of Health and Human Services shall--
(1) not later than 90 days after the date of enactment of
this Act, issue draft guidance defining the term ``key starting
material'' for purposes of this Act and the amendments made by
this Act; and
(2) not later than 180 days after the date of enactment of
this Act, issue final guidance defining such term for such
purposes.
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