; and (III) the drug or other substance does not meet the requirements of subparagraph (A)(i); or (ii) the drug or other substance is approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). . (b) Authority and criteria for classification of substances Section 201(j) of the Controlled Substances Act ( 21 U.S.C. 811(j) ) is amended— (1) in paragraph (1), by inserting a drug designated as a breakthrough therapy under section 506(a) of the Food Drug and Cosmetic Act ( 21 U.S.C. 356(a) ), or a drug authorized for expanded access under subsection (b) or (c) of section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) after subsection (f), ; (2) in paragraph (2)— (A) in subparagraph (A), by striking ; or and inserting a semicolon; (B) in subparagraph (B), by striking the period at the end and inserting a semicolon; and (C) by adding at the end the following: (C) the date on which the Attorney General receives notification from the Secretary of Health and Human Services that the Secretary has designated a drug as a breakthrough therapy under section 506(a) of the Food Drug and Cosmetic Act ( 21 U.S.C. 356(a) ) or authorized a drug for expanded access under subsection (b) or (c) of section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ); or (D) the date on which the Attorney General receives any written notification demonstrating that the Secretary, before the date of enactment of this subparagraph, designated a drug as a breakthrough therapy under section 506(a) of the Food Drug and Cosmetic Act ( 21 U.S.C. 356(a) ) or authorized a drug for expanded access under subsection (b) or (c) of section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ). ; (3) in paragraph (3), by inserting or paragraph (4) after paragraph (1)