II 

118TH CONGRESS 

1ST SESSION S. 689 

To amend the Controlled Substances Act to define currently accepted medical 

use with severe restrictions, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 7, 2023 

Mr. BOOKER (for himself and Mr. PAUL) introduced the following bill; which 

was read twice and referred to the Committee on the Judiciary 

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 by inserting 

7 after paragraph (7) the following: 

8 ‘‘(7)(A) Subject to subparagraph (B), the term 

9 ‘currently accepted medical use with severe restric10 tions’, with respect to a drug or other substance, inVerDate Sep 11 2014 03:04 Mar 16, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S689.IS S689

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1 cludes a drug or other substance that is an active 

2 metabolite, moiety, or ingredient (whether in natural 

3 or synthetic form) of an investigational new drug for 

4 which a waiver is in effect under section 505(i) of 

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

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

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

8 the Secretary— 

9 ‘‘(i) designates as a breakthrough therapy 

10 under section 506(a) of the Food Drug and 

11 Cosmetic Act (21 U.S.C. 356(a)); or 

12 ‘‘(ii) authorizes for expanded access under 

13 subsection (b) or (c) of section 561 of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

15 360bbb), either alone or as part of a thera16 peutic protocol, to treat patients with serious or 

17 life-threatening diseases for which no com18 parable or satisfactory therapies are available. 

19 ‘‘(B) A drug or other substance shall not meet 

20 the criteria under subparagraph (A) for having a 

21 currently accepted medical use with severe restric22 tions if— 

23 ‘‘(i) in the case of a drug or other sub24 stance described in subparagraph (A)(ii)— 


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1 ‘‘(I) the Secretary places the ex2 panded access or protocol for such drug on 

3 clinical hold as described in section 312.42 

4 of title 21, Code of Federal Regulations (or 

5 any successor regulations); 

6 ‘‘(II) there is no other investigational 

7 new drug containing the drug or other sub8 stance for which expanded access has been 

9 authorized under section 561(a) of the 

10 Federal Food, Drug, and Cosmetic Act (21 

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

12 ‘‘(III) the drug or other substance 

13 does not meet the requirements of sub14 paragraph (A)(i); or 

15 ‘‘(ii) the drug or other substance is ap16 proved under section 505 of the Federal Food, 

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

18 section 351 of the Public Health Service Act 

19 (42 U.S.C. 262).’’. 

20 (b) AUTHORITY AND CRITERIA FOR CLASSIFICATION

21 OF SUBSTANCES.—Section 201(j) of the Controlled Sub22 stances Act (21 U.S.C. 811(j)) is amended— 

23 (1) in paragraph (1), by inserting ‘‘a drug des24 ignated as a breakthrough therapy under section 

25 506(a) of the Food Drug and Cosmetic Act (21 


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

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

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

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

5 (2) in paragraph (2)— 

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

7 or’’ and inserting a semicolon; 

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

9 period at the end and inserting a semicolon; 

10 and 

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

12 ‘‘(C) the date on which the Attorney Gen13 eral receives notification from the Secretary of 

14 Health and Human Services that the Secretary 

15 has designated a drug as a breakthrough ther16 apy under section 506(a) of the Food Drug and 

17 Cosmetic Act (21 U.S.C. 356(a)) or authorized 

18 a drug for expanded access under subsection 

19 (b) or (c) of section 561 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360bbb); or 

21 ‘‘(D) the date on which the Attorney Gen22 eral receives any written notification dem23 onstrating that the Secretary, before the date of 

24 enactment of this subparagraph, designated a 

25 drug as a breakthrough therapy under section 


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1 506(a) of the Food Drug and Cosmetic Act (21 

2 U.S.C. 356(a)) or authorized a drug for ex3 panded access under subsection (b) or (c) of 

4 section 561 of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 360bbb).’’; 

6 (3) in paragraph (3), by inserting ‘‘or para7 graph (4)’’ after ‘‘paragraph (1)’’; and 

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

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

10 to schedule II pursuant to paragraph (1) and the expe11 dited procedures described under this subsection, if the 

12 drug no longer has a currently accepted medical use with 

13 severe restrictions and the Secretary of Health and 

14 Human Services recommends that the Attorney General 

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

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

17 after receiving written notification from the Secretary, 

18 issue an interim final rule controlling the drug in accord19 ance with such subsections and section 202(b) using the 

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

Æ 


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