[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3134 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 3134
To amend the Fentanyl Sanctions Act to address trafficking of copy-cat
and counterfeit drugs and active pharmaceutical ingredients, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
November 6, 2025
Mr. Cotton (for himself and Mr. Ricketts) introduced the following
bill; which was read twice and referred to the Committee on Banking,
Housing, and Urban Affairs
_______________________________________________________________________
A BILL
To amend the Fentanyl Sanctions Act to address trafficking of copy-cat
and counterfeit drugs and active pharmaceutical ingredients, 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 ``Combating Counterfeit
Pharmaceuticals Act of 2025''.
SEC. 2. DEFINITIONS.
Section 7203 of the Fentanyl Sanctions Act (21 U.S.C. 2302) is
amended--
(1) by redesignating paragraphs (4) through (10) as
paragraphs (5) through (11), respectively;
(2) by inserting after paragraph (3) the following:
``(4) Copy-cat ingredient.--The term `copy-cat ingredient',
with respect to a drug, means an ingredient that is intended,
including through the container or labeling of the ingredient,
to mimic, knockoff, or otherwise purports to be a drug
substance that is a component of a prescription drug approved
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262), and--
``(A) the ingredient is manufactured by a different
process than specified for the drug substance in the
approval or licensure of the drug; or
``(B) the purity or quality of the ingredient falls
below that of the drug substance that is a component of
the approved or licensed drug.
``(5) Counterfeit drug.--The term `counterfeit drug' has
the meaning given that term in section 201(g)(2) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(2)).'';
(3) in paragraph (6), as redesignated by paragraph (1)--
(A) in the paragraph heading, by striking
``opioid'' and inserting ``illicit drug''; and
(B) by striking ``opioid'' each place it appears
and inserting ``illicit drug''; and
(4) by striking paragraph (9), as so redesignated--
(A) in the paragraph heading, by striking
``Opioid'' and inserting ``Illicit drug'';
(B) in the matter preceding subparagraph (A), by
striking ``opioid'' and inserting ``illicit drug''; and
(C) in subparagraph (A)--
(i) in clause (i), by striking ``; or'' and
inserting a semicolon; and
(ii) by adding at the end the following:
``(iii) counterfeit drugs; or
``(iv) copy-cat ingredients;''.
SEC. 3. MODIFICATION OF REQUIREMENTS FOR DIRECTOR OF NATIONAL
INTELLIGENCE.
(a) Authority To Delegate.--
(1) Identification of foreign drug traffickers.--Section
7211 of the Fentanyl Sanctions Act (21 U.S.C. 2311) is amended,
in subsections (d) and (e), by inserting ``(or a designee of
the Director)'' after ``Director of National Intelligence''
each place it appears.
(2) Briefings on implementation.--Section 7216 of the
Fentanyl Sanctions Act (21 U.S.C. 2316) is amended by inserting
``(or a designee of the Director)'' after ``Director of
National Intelligence''.
(b) Program on Use of Intelligence Resources.--Section 7231 of the
Fentanyl Sanctions Act (21 U.S.C. 2331) is amended--
(1) in the section heading, by striking ``opioid'' and
inserting ``illicit drug'';
(2) in subsection (a)--
(A) in paragraph (1), by striking ``, in
consultation'' and all that follows through
``Policy,''; and
(B) in paragraph (2)(A), by striking ``narcotics''
and inserting ``illicit drug'';
(3) by striking subsections (b) and (c); and
(4) by redesignating subsection (d) as subsection (b).
SEC. 4. WAIVER FOR ACCESS TO PRESCRIPTION MEDICATIONS.
Section 7214(b)(1)(B) of the Fentanyl Sanctions Act (21 U.S.C.
2314(b)(1)(B)) is amended by inserting after ``medications'' the
following: ``on the current drug shortage list maintained by the
Secretary of Health and Human Services under section 506E of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356e)''.
SEC. 5. TECHNICAL AND CONFORMING AMENDMENTS.
(a) Fentanyl Sanctions Act.--The Fentanyl Sanctions Act (21 U.S.C.
2301 et seq.) is amended--
(1) in section 7202(3) (21 U.S.C. 2301(3)), by inserting
``and other illicit drugs'' after ``fentanyl'';
(2) in the subtitle heading for subtitle A, by striking
``Opioid'' and inserting ``Illicit Drug'';
(3) in section 7211 (21 U.S.C. 2311), in the section
heading, by striking ``opioid'' and inserting ``illicit drug'';
(4) in section 7214 (21 U.S.C. 2314)--
(A) in subsection (a)(2)(B)(ii), by striking
``opioids'' and inserting ``illicit drugs''; and
(B) in subsection (b)(2), by striking ``illicit
opioids'' and inserting ``illicit drugs'';
(5) in section 7217(a) (Public Law 116-91; 133 Stat. 2269),
in the matter preceding paragraph (1), by striking ``illicit
opioids'' and inserting ``illicit drugs'';
(6) in section 7233 (21 U.S.C. 2333), by striking ``section
7203(8)'' and inserting ``section 7203(9)'';
(7) by striking ``opioid trafficking'' each place it
appears and inserting ``illicit drug trafficking'';
(8) by striking ``illicit opioids'' each place it appears
and inserting ``illicit drugs'';
(9) by striking ``foreign opioid traffickers'' each place
it appears and inserting ``foreign illicit drug traffickers'';
and
(10) by striking ``foreign opioid trafficker'' each place
it appears and inserting ``foreign illicit drug trafficker''.
(b) International Narcotics Control Strategy Report.--Section
489(a)(9) of the Foreign Assistance Act of 1961 (22 U.S.C. 2291h(a)(9))
is amended--
(1) in subparagraph (A), by inserting ``(or a designee of
the Director)'' after ``Director of National Intelligence'';
and
(2) by striking ``illicit opioids'' each place it appears
and inserting ``illicit drugs''.
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