II 

118TH CONGRESS 

1ST SESSION S. 1141 

To amend the Controlled Substances Act with respect to the scheduling 

of fentanyl-related substances, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 30, 2023 

Mr. CASSIDY (for himself, Mr. MARSHALL, and Mr. YOUNG) introduced the 

following bill; which was read twice and referred to the Committee on the 

Judiciary 

A BILL 

To amend the Controlled Substances Act with respect to 

the scheduling of fentanyl-related substances, 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 ‘‘Halt All Lethal Traf5 ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 


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1 SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB2 STANCES. 

3 Section 202(c) of the Controlled Substances Act (21 

4 U.S.C. 812(c)) is amended by adding at the end of sched5 ule I the following: 

6 ‘‘(e)(1) Unless specifically exempted or unless listed 

7 in another schedule, any material, compound, mixture, or 

8 preparation which contains any quantity of a fentanyl-re9 lated substance, or which contains the salts, isomers, and 

10 salts of isomers of a fentanyl-related substance whenever 

11 the existence of such salts, isomers, and salts of isomers 

12 is possible within the specific chemical designation. 

13 ‘‘(2) For purposes of paragraph (1), except as pro14 vided in paragraph (3), the term ‘fentanyl-related sub15 stance’ means any substance that is structurally related 

16 to fentanyl by 1 or more of the following modifications: 

17 ‘‘(A) By replacement of the phenyl portion of 

18 the phenethyl group by any monocycle, whether or 

19 not further substituted in or on the monocycle. 

20 ‘‘(B) By substitution in or on the phenethyl 

21 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 

22 haloalkyl, amino, or nitro groups. 

23 ‘‘(C) By substitution in or on the piperidine 

24 ring with alkyl, alkenyl, alkoxyl, ester, ether, 

25 hydroxyl, halo, haloalkyl, amino, or nitro groups. 


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1 ‘‘(D) By replacement of the aniline ring with 

2 any aromatic monocycle whether or not further sub3 stituted in or on the aromatic monocycle. 

4 ‘‘(E) By replacement of the N–propionyl group 

5 with another acyl group. 

6 ‘‘(3) A substance that satisfies the definition of the 

7 term ‘fentanyl-related substance’ in paragraph (2) shall 

8 nonetheless not be treated as a fentanyl-related substance 

9 subject to this schedule if the substance— 

10 ‘‘(A) is controlled by action of the Attorney 

11 General under section 201; or 

12 ‘‘(B) is otherwise expressly listed in a schedule 

13 other than this schedule. 

14 ‘‘(4)(A) The Attorney General may by order publish 

15 in the Federal Register a list of substances that satisfy 

16 the definition of the term ‘fentanyl-related substance’ in 

17 paragraph (2). 

18 ‘‘(B) The absence of a substance from a list published 

19 under subparagraph (A) does not negate the control status 

20 of the substance under this schedule if the substance satis21 fies the definition of the term ‘fentanyl-related substance’ 

22 in paragraph (2).’’. 


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1 SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE2 SEARCH. 

3 (a) ALTERNATIVE REGISTRATION PROCESS FOR

4 SCHEDULE I RESEARCH.—Section 303 of the Controlled 

5 Substances Act (21 U.S.C. 823) is amended— 

6 (1) by redesignating the second subsection (l) 

7 (relating to required training for prescribers) as sub8 section (m); and 

9 (2) by adding at the end the following: 

10 ‘‘(n) SPECIAL PROVISIONS FOR PRACTITIONERS

11 CONDUCTING CERTAIN RESEARCH WITH SCHEDULE I 

12 CONTROLLED SUBSTANCES.— 

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

14 (f), a practitioner may conduct research described in 

15 paragraph (2) of this subsection with 1 or more 

16 schedule I substances in accordance with subpara17 graph (A) or (B) of paragraph (3) of this sub18 section. 

19 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO20 CEDURES.—Research described in this paragraph is 

21 research that— 

22 ‘‘(A) is with respect to a drug that is the 

23 subject of an investigational use exemption 

24 under section 505(i) of the Federal Food, Drug, 

25 and Cosmetic Act (21 U.S.C. 355(i)); or 

26 ‘‘(B) is— 


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1 ‘‘(i) conducted by the Department of 

2 Health and Human Services or the De3 partment of Veterans Affairs; or 

4 ‘‘(ii) funded partly or entirely by a 

5 grant, contract, cooperative agreement, or 

6 other transaction from the Department of 

7 Health and Human Services or the De8 partment of Veterans Affairs. 

9 ‘‘(3) EXPEDITED PROCEDURES.— 

10 ‘‘(A) RESEARCHER WITH A CURRENT

11 SCHEDULE I OR II RESEARCH REGISTRATION.— 

12 ‘‘(i) IN GENERAL.—If a practitioner is 

13 registered to conduct research with a con14 trolled substance in schedule I or II, the 

15 practitioner may conduct research under 

16 this subsection on and after the date that 

17 is 30 days after the date on which the 

18 practitioner sends a notice to the Attorney 

19 General containing the following informa20 tion, with respect to each substance with 

21 which the practitioner will conduct the re22 search: 

23 ‘‘(I) The chemical name of the 

24 substance. 


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1 ‘‘(II) The quantity of the sub2 stance to be used in the research. 

3 ‘‘(III) Demonstration that the re4 search is in the category described in 

5 paragraph (2), which demonstration 

6 may be satisfied— 

7 ‘‘(aa) in the case of a grant, 

8 contract, cooperative agreement, 

9 or other transaction, or intra10 mural research project, by identi11 fying the sponsoring agency and 

12 supplying the number of the 

13 grant, contract, cooperative 

14 agreement, other transaction, or 

15 project; or 

16 ‘‘(bb) in the case of an ap17 plication under section 505(i) of 

18 the Federal Food, Drug, and 

19 Cosmetic Act (21 U.S.C. 355(i)), 

20 by supplying the application 

21 number and the sponsor of 

22 record on the application. 

23 ‘‘(IV) Demonstration that the re24 searcher is authorized to conduct re25 search with respect to the substance 


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1 under the laws of the State in which 

2 the research will take place. 

3 ‘‘(ii) VERIFICATION OF INFORMATION

4 BY HHS OR VA.—Upon request from the 

5 Attorney General, the Secretary of Health 

6 and Human Services or the Secretary of 

7 Veterans Affairs, as appropriate, shall 

8 verify information submitted by an appli9 cant under clause (i)(III). 

10 ‘‘(B) RESEARCHER WITHOUT A CURRENT

11 SCHEDULE I OR II RESEARCH REGISTRATION.— 

12 ‘‘(i) IN GENERAL.—If a practitioner is 

13 not registered to conduct research with a 

14 controlled substance in schedule I or II, 

15 the practitioner may send a notice to the 

16 Attorney General containing the informa17 tion listed in subparagraph (A)(i), with re18 spect to each substance with which the 

19 practitioner will conduct the research. 

20 ‘‘(ii) ATTORNEY GENERAL ACTION.— 

21 The Attorney General shall— 

22 ‘‘(I) treat notice received under 

23 clause (i) as a sufficient application 

24 for a research registration; and 


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1 ‘‘(II) not later than 45 days of 

2 receiving such a notice that contains 

3 all information required under sub4 paragraph (A)(i)— 

5 ‘‘(aa) register the applicant; 

6 or 

7 ‘‘(bb) serve an order to show 

8 cause upon the applicant in ac9 cordance with section 304(c). 

10 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 

11 General shall provide a means to permit a practi12 tioner to submit a notification under paragraph (3) 

13 electronically. 

14 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner 

15 conducting research with a schedule I substance 

16 under this subsection may only possess the amounts 

17 of schedule I substance identified in— 

18 ‘‘(A) the notification to the Attorney Gen19 eral under paragraph (3); or 

20 ‘‘(B) a supplemental notification that the 

21 practitioner may send if the practitioner needs 

22 additional amounts for the research, which sup23 plemental notification shall include— 

24 ‘‘(i) the name of the practitioner; 


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1 ‘‘(ii) the additional quantity needed of 

2 the substance; and 

3 ‘‘(iii) an attestation that the research 

4 to be conducted with the substance is con5 sistent with the scope of the research that 

6 was the subject of the notification under 

7 paragraph (3). 

8 ‘‘(6) IMPORTATION AND EXPORTATION RE9 QUIREMENTS NOT AFFECTED.—Nothing in this sub10 section alters the requirements of part A of title III, 

11 regarding the importation and exportation of con12 trolled substances.’’. 

13 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR

14 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec15 tion 302(c) of the Controlled Substances Act (21 U.S.C. 

16 822(c)) is amended by adding at the end the following: 

17 ‘‘(4) An agent or employee of a research insti18 tution that is conducting research with a controlled 

19 substance if— 

20 ‘‘(A) the agent or employee is acting with21 in the scope of the professional practice of the 

22 agent or employee; 

23 ‘‘(B) another agent or employee of the in24 stitution is registered to conduct research with 

25 a controlled substance in the same schedule; 


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

2 ‘‘(i) informs the Attorney General of 

3 the name, position title, and employing in4 stitution of the agent or employee who is 

5 not separately registered; 

6 ‘‘(ii) authorizes that agent or em7 ployee to perform research under the reg8 istration of the registered researcher; and 

9 ‘‘(iii) affirms that any act taken by 

10 that agent or employee involving a con11 trolled substance shall be attributable to 

12 the registered researcher, as if the re13 searcher had directly committed the act, 

14 for purposes of any proceeding under sec15 tion 304(a) to suspend or revoke the reg16 istration of the registered researcher; and 

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

18 30 days of receiving the information, authoriza19 tion, and affirmation described in subparagraph 

20 (C), refuse, for a reason listed in section 

21 304(a), to allow the agent or employee to pos22 sess the substance without a separate registra23 tion.’’. 

24 (c) SINGLE REGISTRATION FOR RELATED RESEARCH

25 SITES.—Section 302(e) of the Controlled Substances Act 


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1 (21 U.S.C. 822(e)) is amended by adding at the end the 

2 following: 

3 ‘‘(3)(A) Notwithstanding paragraph (1), a person 

4 registered to conduct research with a controlled substance 

5 under section 303(f) may conduct the research under a 

6 single registration if— 

7 ‘‘(i) the research occurs exclusively on sites all 

8 of which are— 

9 ‘‘(I) within the same city or county; and 

10 ‘‘(II) under the control of the same institu11 tion, organization, or agency; and 

12 ‘‘(ii) before commencing the research, the re13 searcher notifies the Attorney General of each site 

14 where— 

15 ‘‘(I) the research will be conducted; or 

16 ‘‘(II) the controlled substance will be 

17 stored or administered. 

18 ‘‘(B) A site described in subparagraph (A) shall be 

19 included in a registration described in that subparagraph 

20 only if the researcher has notified the Attorney General 

21 of the site— 

22 ‘‘(i) in the application for the registration; or 

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

24 the controlled substance is stored or administered, at 

25 the site. 


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1 ‘‘(C) The Attorney General may, in consultation with 

2 the Secretary, issue regulations addressing, with respect 

3 to research sites described in subparagraph (A)— 

4 ‘‘(i) the manner in which controlled substances 

5 may be delivered to the research sites; 

6 ‘‘(ii) the storage and security of controlled sub7 stances at the research sites; 

8 ‘‘(iii) the maintenance of records for the re9 search sites; and 

10 ‘‘(iv) any other matters necessary to ensure ef11 fective controls against diversion at the research 

12 sites.’’. 

13 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

14 SITUATIONS.—Section 302(f) of the Controlled Sub15 stances Act (21 U.S.C. 822(f)) is amended— 

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

17 The’’; and 

18 (2) by adding at the end the following: 

19 ‘‘(2)(A) If a person is registered to conduct research 

20 with a controlled substance and applies for a registration, 

21 or for a modification of a registration, to conduct research 

22 with a second controlled substance that is in the same 

23 schedule as the first controlled substance, or is in a sched24 ule with a higher numerical designation than the schedule 


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1 of the first controlled substance, a new inspection by the 

2 Attorney General of the registered location is not required. 

3 ‘‘(B) Nothing in subparagraph (A) shall prohibit the 

4 Attorney General from conducting an inspection that the 

5 Attorney General determines necessary to ensure that a 

6 registrant maintains effective controls against diversion.’’. 

7 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

8 NEWLY ADDED TO SCHEDULE I.—Section 302 of the 

9 Controlled Substances Act (21 U.S.C. 822) is amended 

10 by adding at the end the following: 

11 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES

12 NEWLY ADDED TO SCHEDULE I.—If a person is con13 ducting research on a substance when the substance is 

14 added to schedule I, and the person is already registered 

15 to conduct research with a controlled substance in sched16 ule I— 

17 ‘‘(1) not later than 90 days after the scheduling 

18 of the newly scheduled substance, the person shall 

19 submit a completed application for registration or 

20 modification of existing registration, to conduct re21 search on the substance, in accordance with regula22 tions issued by the Attorney General for purposes of 

23 this paragraph; 


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1 ‘‘(2) the person may, notwithstanding sub2 sections (a) and (b), continue to conduct the re3 search on the substance until— 

4 ‘‘(A) the person withdraws the application 

5 described in paragraph (1) of this subsection; 

6 or 

7 ‘‘(B) the Attorney General serves on the 

8 person an order to show cause proposing the 

9 denial of the application under section 304(c); 

10 ‘‘(3) if the Attorney General serves an order to 

11 show cause as described in paragraph (2)(B) and 

12 the person requests a hearing, the hearing shall be 

13 held on an expedited basis and not later than 45 

14 days after the request is made, except that the hear15 ing may be held at a later time if so requested by 

16 the person; and 

17 ‘‘(4) if the person sends a copy of the applica18 tion described in paragraph (1) to a manufacturer or 

19 distributor of the substance, receipt of the copy by 

20 the manufacturer or distributor shall constitute suf21 ficient evidence that the person is authorized to re22 ceive the substance.’’. 

23 (f) TREATMENT OF CERTAIN MANUFACTURING AC24 TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 

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1 ed by subsection (e), is amended by adding at the end 

2 the following: 

3 ‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC4 TIVITIES AS COINCIDENT TO RESEARCH.— 

5 ‘‘(1) IN GENERAL.—Except as provided in para6 graph (3), a person who is registered to perform re7 search on a controlled substance may perform manu8 facturing activities with small quantities of that sub9 stance, including activities described in paragraph 

10 (2), without being required to obtain a manufac11 turing registration, if— 

12 ‘‘(A) the activities are performed for the 

13 purpose of the research; and 

14 ‘‘(B) the activities and the quantities of 

15 the substance involved in the activities are stat16 ed in— 

17 ‘‘(i) a notification submitted to the 

18 Attorney General under section 303(l); 

19 ‘‘(ii) a research protocol filed with an 

20 application for registration approval under 

21 section 303(f); or 

22 ‘‘(iii) a notification to the Attorney 

23 General that includes— 

24 ‘‘(I) the name of the registrant; 

25 and 


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1 ‘‘(II) an attestation that the re2 search to be conducted with the small 

3 quantities of manufactured substance 

4 is consistent with the scope of the re5 search that is the basis for the reg6 istration. 

7 ‘‘(2) ACTIVITIES INCLUDED.—Activities per8 mitted under paragraph (1) include— 

9 ‘‘(A) processing the substance to create ex10 tracts, tinctures, oils, solutions, derivatives, or 

11 other forms of the substance consistent with— 

12 ‘‘(i) the information provided as part 

13 of a notification submitted to the Attorney 

14 General under section 303(l); or 

15 ‘‘(ii) a research protocol filed with an 

16 application for registration approval under 

17 section 303(f); and 

18 ‘‘(B) dosage form development studies per19 formed for the purpose of requesting an inves20 tigational new drug exemption under section 

21 505(i) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 355(i)). 

23 ‘‘(3) EXCEPTION REGARDING MARIJUANA.—The 

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1 stances does not include the authority to grow mari2 juana.’’. 

3 (g) TRANSPARENCY REGARDING SPECIAL PROCE4 DURES.—Section 303 of the Controlled Substances Act 

5 (21 U.S.C. 823), as amended by subsection (a), is amend6 ed by adding at the end the following: 

7 ‘‘(o) 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 the 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 those substances; and 

24 ‘‘(C) how the process and criteria described 

25 in subparagraph (B) differ from the process 


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1 and criteria applicable to applications to con2 duct research with other controlled substances 

3 in the same schedule. 

4 ‘‘(2) TIMING OF POSTING.—The Attorney Gen5 eral shall make information described in paragraph 

6 (1) public upon making a determination described in 

7 that paragraph, regardless of whether a practitioner 

8 has submitted such an application at that time.’’. 

9 SEC. 4. RULEMAKING. 

10 (a) INTERIM FINAL RULES.—The Attorney Gen11 eral— 

12 (1) shall, not later than 1 year of the date of 

13 enactment of this Act, issue rules to implement this 

14 Act and the amendments made by this Act; and 

15 (2) may issue the rules under paragraph (1) as 

16 interim final rules. 

17 (b) PROCEDURE FOR FINAL RULE.— 

18 (1) EFFECTIVENESS OF INTERIM FINAL

19 RULES.—A rule issued by the Attorney General as 

20 an interim final rule under subsection (a) shall be21 come immediately effective as an interim final rule 

22 without requiring the Attorney General to dem23 onstrate good cause therefor, notwithstanding sub24 paragraph (B) of section 553(b) of title 5, United 

25 States Code. 


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1 (2) OPPORTUNITY FOR COMMENT AND HEAR2 ING.—An interim final rule issued under subsection 

3 (a) shall give interested persons the opportunity to 

4 comment and to request a hearing. 

5 (3) FINAL RULE.—After the conclusion of such 

6 proceedings, the Attorney General shall issue a final 

7 rule to implement this Act and the amendments 

8 made by this Act in accordance with section 553 of 

9 title 5, United States Code. 

Æ 


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