I 
118TH CONGRESS 
1ST SESSION H. R. 1393 
To amend the Controlled Substances Act to define currently accepted medical 
use with severe restrictions, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 7, 2023 
Ms. DEAN of Pennsylvania (for herself and Ms. MACE) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on the Judiciary, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To amend the Controlled Substances Act to define currently 
accepted medical use with severe restrictions, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 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); 
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(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 re-
strictions’, with respect to a drug or other sub-
stance, 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 Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb), either alone or as part of a thera-
peutic protocol, to treat patients with serious or 
life-threatening diseases for which no com-
parable or satisfactory therapies are available. 
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‘‘(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 sub-
stance described in subparagraph (A)(ii)— 
‘‘(I) the Secretary places the ex-
panded 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 sub-
stance 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 sub-
paragraph (A)(i); or 
‘‘(ii) the drug or other substance is ap-
proved 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).’’. 
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(b) AUTHORITY AND CRITERIA FOR CLASSIFICATION 
OF SUBSTANCES.—Section 201(j) of the Controlled Sub-
stances Act (21 U.S.C. 811(j)) is amended— 
(1) in paragraph (1), by inserting ‘‘a drug des-
ignated 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 Gen-
eral 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 ac-
cess under subsection (b) or (c) of section 561 
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of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb); or 
‘‘(D) the date on which the Attorney Gen-
eral receives any written notification dem-
onstrating that the Secretary, before the date of 
enactment of this subparagraph, designated the 
drug as a breakthrough therapy under section 
506(a) of the Federal Food, Drug, and Cos-
metic 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).’’; 
(3) in paragraph (3), by inserting ‘‘or para-
graph (4)’’ after ‘‘paragraph (1)’’; and 
(4) by adding at the end the following: 
‘‘(4) With respect to a drug moved from schedule I 
to schedule II pursuant to paragraph (1) and the expe-
dited procedures described under this subsection, if the 
drug no longer has a currently accepted medical use with 
severe restrictions and the Secretary of Health and 
Human Services recommends that the Attorney General 
control the drug in schedule I pursuant to subsections (a) 
and (b), the Attorney General shall, not later than 90 days 
after receiving written notification from the Secretary, 
issue an interim final rule controlling the drug in accord-
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