; (II) there is no other investigational new drug containing the drug or other substance for which expanded access has been authorized under section 561(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb(a) ); 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 the drug as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a) ) or authorized the 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 )