119 S3134 IS: Combating Counterfeit Pharmaceuticals Act of 2025
U.S. Senate
2025-11-06
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II
119th CONGRESS
1st Session
S. 3134
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.
1.

Short title
This Act may be cited as the “Combating Counterfeit Pharmaceuticals Act of 2025”.
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;”.
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).
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)”.
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”.