S3134-119

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— by redesignating paragraphs (4) through (10) as paragraphs (5) through (11), respectively; by inserting after paragraph (3) the following: 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— the ingredient is manufactured by a different process than specified for the drug substance in the approval or licensure of the drug; or the purity or quality of the ingredient falls below that of the drug substance that is a component of the approved or licensed 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: counterfeit drugs; or copy-cat ingredients; (4)Copy-cat ingredientThe 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 drugThe 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)).; (iii)counterfeit drugs; or(iv)copy-cat ingredients;.

3. Modification of requirements for Director of National Intelligence 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. 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. 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).

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 The Fentanyl Sanctions Act (21 U.S.C. 2301 et seq.) is amended— 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. 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.