119 S3134 IS: Combating Counterfeit Pharmaceuticals Act of 2025 U.S. Senate 2025-11-06 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II119th CONGRESS1st SessionS. 3134IN THE SENATE OF THE UNITED STATESNovember 6, 2025Mr. Cotton (for himself and Mr. Ricketts) introduced the following bill; which was read twice and referred to the Committee on Banking, Housing, and Urban AffairsA BILLTo 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.