II 

117TH CONGRESS 

2D SESSION S. 5123 

To amend the Controlled Substances Act to modify the registration 

requirements relating to research, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 17, 2022 

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 modify the registration requirements relating to research, 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. SHORT TITLE. 

4 This Act may be cited as the ‘‘Breakthrough Thera5 pies Act’’. 

6 SEC. 2. REGISTRATION REQUIREMENTS RELATED TO RE7 SEARCH. 

8 (a) ALTERNATIVE REGISTRATION PROCESS FOR

9 SCHEDULE I RESEARCH.—Section 303 of the Controlled 


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1 Substances Act (21 U.S.C. 823) is amended by adding at 

2 the end the following new subsection: 

3 ‘‘(l) SPECIAL PROVISIONS FOR THOSE CONDUCTING

4 CERTAIN RESEARCH WITH SCHEDULE I CONTROLLED

5 SUBSTANCES.— 

6 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

7 (f), a practitioner may conduct research that is de8 scribed by paragraph (2) and that is with 1 or more 

9 schedule I substances if one of the following condi10 tions is satisfied: 

11 ‘‘(A) RESEARCHER WITH A CURRENT

12 SCHEDULE I OR II RESEARCH REGISTRATION.— 

13 If the practitioner is registered to conduct re14 search with a controlled substance in schedule 

15 I or II, the practitioner may conduct research 

16 under this paragraph 30 days after the practi17 tioner has sent a notice to the Attorney General 

18 containing the following information, with re19 spect to each substance with which the research 

20 will be conducted: 

21 ‘‘(i) The chemical name of the sub22 stance. 

23 ‘‘(ii) The quantity of the substance to 

24 be used in such research. 


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1 ‘‘(iii) Demonstration that the research 

2 is in the category described by paragraph 

3 (2), which demonstration can be satis4 fied— 

5 ‘‘(I) in the case of a grant, con6 tract, cooperative agreement, or other 

7 transaction, or intramural research 

8 project, by identifying the sponsoring 

9 agency and supplying information re10 lated to the grant, contract, coopera11 tive agreement, other transaction, or 

12 project; or 

13 ‘‘(II) in the case of an applica14 tion under section 505(i) of the Fed15 eral Food, Drug, and Cosmetic Act, 

16 by supplying the application number 

17 and the sponsor of record on such ap18 plication. 

19 ‘‘(iv) Demonstration that the re20 searcher is authorized to conduct research 

21 with respect to the substance under the 

22 laws of the State in which the research will 

23 take place. 

24 ‘‘(B) RESEARCHER WITHOUT A CURRENT

25 SCHEDULE I OR II.— 


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1 ‘‘(i) RESEARCH REGISTRATION.—If 

2 the practitioner is not currently registered 

3 to conduct research with a controlled sub4 stance in schedule I or II, the practitioner 

5 may send a notice to the Attorney General 

6 containing the information listed in sub7 paragraph (A), with respect to each sub8 stance with which the research will be con9 ducted, and the Attorney General will treat 

10 such notice as a sufficient application for 

11 a research registration. Not later than 45 

12 days of receiving such a notice that con13 tains all information required by subpara14 graph (A), the Attorney General shall reg15 ister the applicant, or serve an order to 

16 show cause upon the applicant in accord17 ance with section 824(c) of this title. 

18 ‘‘(C) VERIFICATION OF INFORMATION.— 

19 On request from the Attorney General, the Sec20 retary of Health and Human Services or the 

21 Secretary of Veterans Affairs, as appropriate, 

22 shall verify information submitted by an appli23 cant under subparagraph (A)(iii). 


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1 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO2 CEDURE.—Research is described by this paragraph 

3 if— 

4 ‘‘(A) the research is the subject of an ap5 plication under section 505(i) of the Federal 

6 Food, Drug, and Cosmetic Act for the inves7 tigation of a drug which is in effect in accord8 ance with section 312.40 of title 21, Code of 

9 Federal Regulations; or 

10 ‘‘(B) the research is conducted by the De11 partment of Health and Human Services or the 

12 Department of Veterans Affairs or is funded 

13 partly or entirely by a grant, contract, coopera14 tive agreement, or other transaction from the 

15 Department of Health and Human Services, 

16 Department of Veterans Affairs, or a State 

17 health department. 

18 ‘‘(3) ELECTRONIC SUBMISSIONS.—The Attorney 

19 General shall provide a means to permit practi20 tioners to submit notifications under paragraph (1) 

21 electronically. 

22 ‘‘(4) LIMITATION ON AMOUNTS.—A practitioner 

23 conducting research with a schedule I substance pur24 suant to this subsection shall only be permitted to 


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1 possess the amounts of schedule I substance identi2 fied in— 

3 ‘‘(A) the notification to the Attorney Gen4 eral under paragraph (1); or 

5 ‘‘(B) a supplemental notification that the 

6 practitioner may send if the practitioner needs 

7 additional amounts for the research, which sup8 plemental notification shall include the reg9 istrant’s name, the additional quantity needed 

10 of the substance, and an attestation that the re11 search to be conducted with the substance is 

12 consistent with the scope of the research that 

13 was the subject of the notification under para14 graph (1). 

15 ‘‘(5) IMPORTATION AND EXPORTATION RE16 QUIREMENTS NOT AFFECTED.—Nothing in this sec17 tion alters the requirements of part A of title III, re18 garding the importation and exportation of con19 trolled substances.’’. 

20 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR

21 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec22 tion 302 of the Controlled Substances Act (21 U.S.C. 822) 

23 is amended in subsection (c), by adding the following para24 graph: 


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1 ‘‘(4) An agent or employee of a research insti2 tution that is conducting research with a controlled 

3 substance if— 

4 ‘‘(A) such agent or employee is acting 

5 within the scope of his or her professional prac6 tice; 

7 ‘‘(B) another agent or employee of such in8 stitution is registered to conduct research with 

9 a controlled substance in the same schedule; 

10 ‘‘(C) the researcher who is so registered— 

11 ‘‘(i) informs the Attorney General of 

12 the name, position title, and employing in13 stitution of the agent or employee who is 

14 not separately registered; 

15 ‘‘(ii) authorizes such agent or em16 ployee to perform research under the reg17 istered researcher’s registration; and 

18 ‘‘(iii) affirms that all acts taken by 

19 such agent or employee involving controlled 

20 substances shall be attributable to the reg21 istered researcher, as if the researcher had 

22 directly committed such acts, for purposes 

23 of any proceeding under section 304(a) (21 

24 U.S.C. 824(a)) to suspend or revoke the 


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1 registration of the registered researcher; 

2 and 

3 ‘‘(D) the Attorney General does not, within 

4 30 days of receiving the information, authoriza5 tion, and affirmation described in subparagraph 

6 (C), refuse, for a reason listed in section 304(a) 

7 (21 U.S.C. 824(a)), to allow such agent or em8 ployee to possess such substance without a sep9 arate registration.’’. 

10 (c) SINGLE REGISTRATION FOR RELATED RESEARCH

11 SITES.—Such section 302 is further amended in sub12 section (e) by adding at the end the following new para13 graph: 

14 ‘‘(3)(A) Notwithstanding paragraph (1), a per15 son registered to conduct research with a controlled 

16 substance under section 303(f) may conduct such re17 search under a single registration if— 

18 ‘‘(i) such research occurs exclusively on 

19 sites all of which are within the same city or 

20 county and are under the control of the same 

21 institution, organization, or agency; and 

22 ‘‘(ii) the researcher notifies the Attorney 

23 General of all sites where the research will be 

24 conducted or where the controlled substance 


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1 will be stored or administered prior to com2 mencing such research. 

3 ‘‘(B) A site described by subparagraph (A) shall 

4 be included in such registration only if the re5 searcher has notified the Attorney General of such 

6 site— 

7 ‘‘(i) in the application for such registra8 tion; or 

9 ‘‘(ii) before the research is conducted, or 

10 before the controlled substance is stored or ad11 ministered, at such site. 

12 ‘‘(C) The Attorney General may, in consultation 

13 with the Secretary of Health and Human Services, 

14 issue regulations addressing— 

15 ‘‘(i) the manner in which controlled sub16 stances may be delivered to the research sites 

17 described in subparagraph (A); 

18 ‘‘(ii) the storage and security of controlled 

19 substances at such research sites; 

20 ‘‘(iii) the maintenance of records for such 

21 research sites; and 

22 ‘‘(iv) any other matters necessary to en23 sure effective controls against diversion at such 

24 research sites.’’. 


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1 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

2 SITUATIONS.—Such section 302 is further amended in 

3 subsection (f)— 

4 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 

5 The’’; and 

6 (2) by adding a new paragraph, as follows: 

7 ‘‘(2)(A) If a person is registered to conduct re8 search with a controlled substance and applies for a 

9 registration, or for a modification of a registration, 

10 to conduct research with a second controlled sub11 stance that is in the same schedule as the first con12 trolled substance, or is in a schedule with a higher 

13 numerical designation than the schedule of the first 

14 controlled substance, a new inspection by the Attor15 ney General of the registered location is not re16 quired. 

17 ‘‘(B) Nothing in this paragraph shall prohibit 

18 the Attorney General from conducting any inspec19 tion if the Attorney General deems it necessary to 

20 ensure that the registrant maintains effective con21 trols against diversion.’’. 

22 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

23 NEWLY ADDED TO SCHEDULE I.—Such section 302 is 

24 further amended by adding at the end the following new 

25 subsection: 


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1 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES

2 NEWLY ADDED TO SCHEDULE I.—If a person is con3 ducting research on a substance at the time the substance 

4 is added to schedule I, and such person is already reg5 istered to conduct research with a controlled substance in 

6 schedule I, then— 

7 ‘‘(1) the person shall, not later than 90 days of 

8 the scheduling of the newly scheduled substance, 

9 submit a completed application for registration or 

10 modification of existing registration, to conduct re11 search on such substance, in accordance with the 

12 regulations issued by the Attorney General; 

13 ‘‘(2) the person may, notwithstanding sub14 sections (a) and (b), continue to conduct the re15 search on such substance until the person withdraws 

16 such application or until the Attorney General serves 

17 on the person an order to show cause proposing the 

18 denial of the application pursuant to section 304(c); 

19 ‘‘(3) if the Attorney General serves such an 

20 order to show cause and the person requests a hear21 ing, such hearing shall be held on an expedited basis 

22 and not later than 45 days after the request is 

23 made, except that the hearing may be held at a later 

24 time if so requested by the person; and 


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1 ‘‘(4) if the person sends a copy of the applica2 tion referred to in that paragraph to a manufacturer 

3 or distributor of such substance, receipt of such copy 

4 by such manufacturer or distributor shall constitute 

5 sufficient evidence that the person is authorized to 

6 receive such substance.’’. 

7 (f) TREATMENT OF CERTAIN MANUFACTURING AC8 TIVITIES AS COINCIDENT TO RESEARCH.—Such section 

9 302 (21 U.S.C. 822) is further amended by adding at the 

10 end the following new subsection: 

11 ‘‘(j) TREATMENT OF CERTAIN MANUFACTURING AC12 TIVITIES AS COINCIDENT TO RESEARCH.— 

13 ‘‘(1) IN GENERAL.—Except as specified in 

14 paragraph (3), a person who is registered to perform 

15 research on a controlled substance may perform 

16 manufacturing activities with small quantities of 

17 that substance, including activities listed in para18 graph (2), without being required to obtain a manu19 facturing registration, if such activities are per20 formed for the purpose of the research and if the ac21 tivities and the quantities of the substance involved 

22 in those activities are stated in— 

23 ‘‘(A) a notification submitted to the Attor24 ney General under section 303(l); 


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1 ‘‘(B) a protocol filed with an application 

2 for registration approval, under section 303(f); 

3 or 

4 ‘‘(C) a notification to the Attorney General 

5 that includes the registrant’s name and an at6 testation that the research to be conducted with 

7 the small quantities of manufactured substance 

8 is consistent with the scope of the research that 

9 is the basis for the registration. 

10 ‘‘(2) ACTIVITIES INCLUDED.—Activities per11 mitted under paragraph (1) include— 

12 ‘‘(A) processing the substance to create ex13 tracts, tinctures, oils, solutions, derivatives, or 

14 other forms of the substance consistent the in15 formation provided as part of a notification 

16 submitted to the Attorney General under sec17 tion 303(l) (21 U.S.C. 823(l)) or a research 

18 protocol filed with the application for registra19 tion approval; and 

20 ‘‘(B) dosage form development studies per21 formed for the purpose of satisfying FDA regu22 latory requirements for submitting an investiga23 tional new drug application. 

24 ‘‘(3) EXCEPTION REGARDING MARIHUANA.— 

25 The authority under paragraph (1) to manufacture 


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1 substances does not include authority to grow mari2 huana.’’. 

3 (g) TRANSPARENCY REGARDING SPECIAL PROCE4 DURES.—Section 303 of such Act (21 U.S.C. 823) is fur5 ther amended by adding at the end the following new sub6 section: 

7 ‘‘(m) TRANSPARENCY REGARDING SPECIAL PROCE8 DURES.— 

9 ‘‘(1) IN GENERAL.—If the Attorney General de10 termines, with respect to a controlled substance, that 

11 an application by a practitioner to conduct research 

12 with such substance should be considered under a 

13 process, or subject to criteria, different from the 

14 process or criteria applicable to applications to con15 duct research with other controlled substances in the 

16 same schedule, the Attorney General shall make 

17 public, including by posting on the website of the 

18 Drug Enforcement Administration— 

19 ‘‘(A) the identities of all substances for 

20 which such determinations have been made; 

21 ‘‘(B) the process and criteria that shall be 

22 applied to applications to conduct research with 

23 such substances; and 

24 ‘‘(C) how such process and criteria differ 

25 from those applicable to applications to conduct 


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1 research with other controlled substances in the 

2 same schedule. 

3 ‘‘(2) TIMING OF POSTING.—The Attorney Gen4 eral shall make such information public upon mak5 ing such determination, regardless of whether a 

6 practitioner has submitted such an application at 

7 that time.’’. 

8 SEC. 3. CURRENTLY ACCEPTED MEDICAL USE WITH SE9 VERE RESTRICTIONS. 

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

11 Substances Act (21 U.S.C. 802) is amended by inserting 

12 after paragraph (7) the following: 

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

14 ‘currently accepted medical use with severe restric15 tions’, with respect to a drug or other substance, in16 cludes a drug or other substance that is an active 

17 moiety or active ingredient (whether in natural or 

18 synthetic form) of an investigational new drug for 

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

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

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

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

23 the Secretary— 


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1 ‘‘(i) designates as a breakthrough therapy 

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

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

4 ‘‘(ii) authorizes for expanded access under 

5 subsection (b) or (c) of section 561 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

7 360bbb), either alone or as part of a thera8 peutic protocol, to treat patients with serious or 

9 life-threatening diseases for which no com10 parable or satisfactory therapies are available. 

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

12 the criteria under subparagraph (A) for having a 

13 currently accepted medical use with severe restric14 tions if— 

15 ‘‘(i) in the case of a drug or other sub16 stance described in subparagraph (A)(ii)— 

17 ‘‘(I) the Secretary places the ex18 panded access or protocol for such drug on 

19 clinical hold as described in section 312.42 

20 of title 21, Code of Federal Regulations (or 

21 any successor regulations); 

22 ‘‘(II) there is no other investigational 

23 new drug containing the drug or other sub24 stance for which expanded access has been 

25 authorized under section 561(a) of the 


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1 Federal Food, Drug, and Cosmetic Act (21 

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

3 ‘‘(III) the drug or other substance 

4 does not meet the requirements of sub5 paragraph (A)(i); or 

6 ‘‘(ii) the drug or other substance is an ac7 tive moiety or active ingredient (whether nat8 ural or synthetic) of an application approved 

9 under section 505 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355) or section 

11 351 of the Public Health Service Act (42 

12 U.S.C. 262).’’. 

13 (b) AUTHORITY AND CRITERIA FOR CLASSIFICATION

14 OF SUBSTANCES.—Section 201(j) of the Controlled Sub15 stances Act (21 U.S.C. 811(j)) is amended— 

16 (1) in paragraph (1), by inserting ‘‘a drug des17 ignated as a breakthrough therapy under section 

18 506(a) of the Federal Food, Drug, and Cosmetic Act 

19 (21 U.S.C. 356(a)), or a drug authorized for ex20 panded access under subsection (b) or (c) of section 

21 561 of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 360bbb)’’ after ‘‘subsection (f),’’; and 

23 (2) in paragraph (2)— 

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

25 or’’ and inserting a semicolon; 


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

2 period at the end and inserting a semicolon; 

3 and 

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

5 ‘‘(C) the date on which the Attorney Gen6 eral receives notification from the Secretary of 

7 Health and Human Services that the Secretary 

8 has designated a drug as a breakthrough ther9 apy under section 506(a) of the Federal Food, 

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

11 authorized a drug for expanded access under 

12 subsection (b) or (c) of section 561 of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

14 360bbb); or 

15 ‘‘(D) the date on which the Attorney Gen16 eral receives any written notification dem17 onstrating that the Secretary, before the date of 

18 enactment of this subparagraph, designated a 

19 drug as a breakthrough therapy under section 

20 506(a) of the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 356(a)) or authorized a 

22 drug for expanded access under subsection (b) 

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

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

Æ 


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