Section 1 Short title
This Act may be cited as the “Combating Counterfeit Pharmaceuticals Act of 2025”.
Combating Counterfeit Pharmaceuticals Act of 2025
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.
Sec. 2 Definitions
Section 7203 of the Fentanyl Sanctions Act (21 U.S.C. 2302) is amended—
by redesignating paragraphs (4) through (10) as paragraphs (5) through (11), respectively;
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)).”
in paragraph (6), as redesignated by paragraph (1)—
in the paragraph heading, by striking “opioid” and inserting “illicit drug”; and
by striking “opioid” each place it appears and inserting “illicit drug”; and
by striking paragraph (9), as so redesignated—
in the paragraph heading, by striking “Opioid” and inserting “Illicit drug”;
in the matter preceding subparagraph (A), by striking “opioid” and inserting “illicit drug”; and
in subparagraph (A)—
in clause (i), by striking “; or” and inserting a semicolon; and
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
Authority To delegate—
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.
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”.
Program on use of intelligence resources— Section 7231 of the Fentanyl Sanctions Act (21 U.S.C. 2331) is amended—
in the section heading, by striking “opioid” and inserting “illicit drug”;
in subsection (a)—
in paragraph (1), by striking “, in consultation” and all that follows through “Policy,”; and
in paragraph (2)(A), by striking “narcotics” and inserting “illicit drug”;
by striking subsections (b) and (c); and
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
in section 7202(3) (21 U.S.C. 2301(3)), by inserting “and other illicit drugs” after “fentanyl”;
in the subtitle heading for subtitle A, by striking “opioid” and inserting “illicit drug”;
in section 7211 (21 U.S.C. 2311), in the section heading, by striking “opioid” and inserting “illicit drug”;
in section 7214 (21 U.S.C. 2314)—
in subsection (a)(2)(B)(ii), by striking “opioids” and inserting “illicit drugs”; and
in subsection (b)(2), by striking “illicit opioids” and inserting “illicit drugs”;
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”;
in section 7233 (21 U.S.C. 2333), by striking “section 7203(8)” and inserting “section 7203(9)”;
by striking “opioid trafficking” each place it appears and inserting “illicit drug trafficking”;
by striking “illicit opioids” each place it appears and inserting “illicit drugs”;
by striking “foreign opioid traffickers” each place it appears and inserting “foreign illicit drug traffickers”; and
by striking “foreign opioid trafficker” each place it appears and inserting “foreign illicit drug trafficker”.
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—
in subparagraph (A), by inserting “(or a designee of the Director)” after “Director of National Intelligence”; and
by striking “illicit opioids” each place it appears and inserting “illicit drugs”.