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;.