S. 3134

119 S3134 IS: Combating Counterfeit Pharmaceuticals Act of 2025
 U.S. Senate
 2025-11-06
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 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.
 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 .