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 following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period 

to be subsequently determined by the Speaker, in each case for consideration 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. CURRENTLY ACCEPTED MEDICAL USE WITH 

4 SEVERE RESTRICTIONS. 

5 (a) DEFINITIONS.—Section 102 of the Controlled 

6 Substances Act (21 U.S.C. 802) is amended— 

7 (1) by redesignating paragraph (58) (defining a 

8 serious violent felony) as paragraph (59); 


pbinns on DSKJLVW7X2PROD with $$_JOB
2 

•HR 1393 IH

1 (2) by redesignating the second paragraph (57) 

2 (defining a serious drug felony) as paragraph (58); 

3 and 

4 (3) by adding at the end the following: 

5 ‘‘(60)(A) Subject to subparagraph (B), the 

6 term ‘currently accepted medical use with severe re7 strictions’, with respect to a drug or other sub8 stance, includes a drug or other substance that is an 

9 active metabolite, moiety, or ingredient (whether in 

10 natural or synthetic form) of an investigational new 

11 drug for which a waiver is in effect under section 

12 505(i) of the Federal Food, Drug, and Cosmetic Act 

13 (21 U.S.C. 355(i)) or section 351(a)(3) of the Public 

14 Health Service Act (42 U.S.C. 262(a)(3)) and that 

15 the Secretary— 

16 ‘‘(i) designates as a breakthrough therapy 

17 under section 506(a) of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 356(a)); or 

19 ‘‘(ii) authorizes for expanded access under 

20 subsection (b) or (c) of section 561 of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

22 360bbb), either alone or as part of a thera23 peutic protocol, to treat patients with serious or 

24 life-threatening diseases for which no com25 parable or satisfactory therapies are available. 


pbinns on DSKJLVW7X2PROD with $$_JOB
3 

•HR 1393 IH

1 ‘‘(B) A drug or other substance shall not be 

2 treated as meeting the criteria under subparagraph 

3 (A) for having a currently accepted medical use with 

4 severe restrictions if— 

5 ‘‘(i) in the case of a drug or other sub6 stance described in subparagraph (A)(ii)— 

7 ‘‘(I) the Secretary places the ex8 panded access or protocol for such drug on 

9 clinical hold as described in section 312.42 

10 of title 21, Code of Federal Regulations (or 

11 any successor regulations); 

12 ‘‘(II) there is no other investigational 

13 new drug containing the drug or other sub14 stance for which expanded access has been 

15 authorized under section 561(a) of the 

16 Federal Food, Drug, and Cosmetic Act (21 

17 U.S.C. 360bbb(a)); and 

18 ‘‘(III) the drug or other substance 

19 does not meet the requirements of sub20 paragraph (A)(i); or 

21 ‘‘(ii) the drug or other substance is ap22 proved under section 505 of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 355) or 

24 section 351 of the Public Health Service Act 

25 (42 U.S.C. 262).’’. 


pbinns on DSKJLVW7X2PROD with $$_JOB
4 

•HR 1393 IH

1 (b) AUTHORITY AND CRITERIA FOR CLASSIFICATION

2 OF SUBSTANCES.—Section 201(j) of the Controlled Sub3 stances Act (21 U.S.C. 811(j)) is amended— 

4 (1) in paragraph (1), by inserting ‘‘a drug des5 ignated as a breakthrough therapy under section 

6 506(a) of the Food Drug and Cosmetic Act (21 

7 U.S.C. 356(a)), or a drug authorized for expanded 

8 access under subsection (b) or (c) of section 561 of 

9 the Federal Food, Drug, and Cosmetic Act (21 

10 U.S.C. 360bbb),’’ after ‘‘subsection (f),’’; 

11 (2) in paragraph (2)— 

12 (A) in subparagraph (A), by striking ‘‘; 

13 or’’ and inserting a semicolon; 

14 (B) in subparagraph (B), by striking the 

15 period at the end and inserting a semicolon; 

16 and 

17 (C) by adding at the end the following: 

18 ‘‘(C) the date on which the Attorney Gen19 eral receives notification from the Secretary of 

20 Health and Human Services that the Secretary 

21 has designated the drug as a breakthrough 

22 therapy under section 506(a) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 

24 356(a)) or authorized the drug for expanded ac25 cess under subsection (b) or (c) of section 561 


pbinns on DSKJLVW7X2PROD with $$_JOB
5 

•HR 1393 IH

1 of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 360bbb); or 

3 ‘‘(D) the date on which the Attorney Gen4 eral receives any written notification dem5 onstrating that the Secretary, before the date of 

6 enactment of this subparagraph, designated the 

7 drug as a breakthrough therapy under section 

8 506(a) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 356(a)) or authorized the 

10 drug for expanded access under subsection (b) 

11 or (c) of section 561 of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 360bbb).’’; 

13 (3) in paragraph (3), by inserting ‘‘or para14 graph (4)’’ after ‘‘paragraph (1)’’; and 

15 (4) by adding at the end the following: 

16 ‘‘(4) With respect to a drug moved from schedule I 

17 to schedule II pursuant to paragraph (1) and the expe18 dited procedures described under this subsection, if the 

19 drug no longer has a currently accepted medical use with 

20 severe restrictions and the Secretary of Health and 

21 Human Services recommends that the Attorney General 

22 control the drug in schedule I pursuant to subsections (a) 

23 and (b), the Attorney General shall, not later than 90 days 

24 after receiving written notification from the Secretary, 

25 issue an interim final rule controlling the drug in accordVerDate Sep 11 2014 04:11 Mar 24, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1393.IH H1393

pbinns on DSKJLVW7X2PROD with $$_JOB
6 

•HR 1393 IH

1 ance with such subsections and section 202(b) using the 

2 procedures described in paragraph (3) of this subsection.’’. 

Æ 


pbinns on DSKJLVW7X2PROD with $$_JOB