1. Currently accepted medical use with severe restrictions (a) Definitions Section 102 of the Controlled Substances Act ( 21 U.S.C. 802 ) is amended— (1) by redesignating paragraph (58) (defining a serious violent felony) as paragraph (59); (2) by redesignating the second paragraph (57) (defining a serious drug felony) as paragraph (58); and (3) by adding at the end the following: (60) (A) Subject to subparagraph (B), the term currently accepted medical use with severe restrictions , with respect to a drug or other substance, includes a drug or other substance that is an active metabolite, moiety, or ingredient (whether in natural or synthetic form) of an investigational new drug for which a waiver is in effect under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351(a)(3) of the Public Health Service Act ( 42 U.S.C. 262(a)(3) ) and that the Secretary— (i) designates as a breakthrough therapy under section 506(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356(a) ); or (ii) authorizes for expanded access under subsection (b) or (c) of section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ), either alone or as part of a therapeutic protocol, to treat patients with serious or life-threatening diseases for which no comparable or satisfactory therapies are available. (B) A drug or other substance shall not be treated as meeting the criteria under subparagraph (A) for having a currently accepted medical use with severe restrictions if— (i) in the case of a drug or other substance described in subparagraph (A)(ii)— (I) the Secretary places the expanded access or protocol for such drug on clinical hold as described in section 312.42 of title 21, Code of Federal Regulations (or any successor regulations); (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) )