II 

117TH CONGRESS 

1ST SESSION S. 3336 

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 

DECEMBER 8, 2021 

Mr. CASSIDY (for himself and Mr. BURR) 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’’. 

6 SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB7 STANCES. 

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

9 U.S.C. 812(c)) is amended by adding at the end of sched10 ule I the following: 


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

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

3 preparation which contains any quantity of a fentanyl-re4 lated substance, or which contains the salts, isomers, and 

5 salts of isomers of a fentanyl-related substance whenever 

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

7 is possible within the specific chemical designation. 

8 ‘‘(2) For purposes of paragraph (1), except as pro9 vided in paragraph (3), the term ‘fentanyl-related sub10 stance’ means any substance that is structurally related 

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

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

13 the phenethyl group by any monocycle, whether or 

14 not further substituted in or on the monocycle. 

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

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

17 haloalkyl, amino, or nitro groups. 

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

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

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

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

22 any aromatic monocycle whether or not further sub23 stituted in or on the aromatic monocycle. 

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

25 with another acyl group. 


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

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

3 nonetheless not be treated as a fentanyl-related substance 

4 subject to this schedule if the substance— 

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

6 General under section 201; or 

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

8 other than this schedule. 

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

10 in the Federal Register a list of substances that satisfy 

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

12 paragraph (2). 

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

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

15 of the substance under this schedule if the substance satis16 fies the definition of the term ‘fentanyl-related substance’ 

17 in paragraph (2).’’. 

18 SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE19 SEARCH. 

20 (a) ALTERNATIVE REGISTRATION PROCESS FOR

21 SCHEDULE I RESEARCH.—Section 303 of the Controlled 

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

23 the end the following: 


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1 ‘‘(l) SPECIAL PROVISIONS FOR PRACTITIONERS CON2 DUCTING CERTAIN RESEARCH WITH SCHEDULE I CON3 TROLLED SUBSTANCES.— 

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

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

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

7 schedule I substances in accordance with subpara8 graph (A) or (B) of paragraph (3) of this sub9 section. 

10 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO11 CEDURES.—Research described in this paragraph is 

12 research that— 

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

14 subject of an investigational use exemption 

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

16 and Cosmetic Act; or 

17 ‘‘(B) is— 

18 ‘‘(i) conducted by the Department of 

19 Health and Human Services or the De20 partment of Veterans Affairs; or 

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

22 grant, contract, cooperative agreement, or 

23 other transaction from the Department of 

24 Health and Human Services or the De25 partment of Veterans Affairs. 


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1 ‘‘(3) EXPEDITED PROCEDURES.— 

2 ‘‘(A) RESEARCHER WITH A CURRENT

3 SCHEDULE I OR II RESEARCH REGISTRATION.— 

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

5 registered to conduct research with a con6 trolled substance in schedule I or II, the 

7 practitioner may conduct research under 

8 this subsection on and after the date that 

9 is 30 days after the date on which the 

10 practitioner sends a notice to the Attorney 

11 General containing the following informa12 tion, with respect to each substance with 

13 which the practitioner will conduct the re14 search: 

15 ‘‘(I) The chemical name of the 

16 substance. 

17 ‘‘(II) The quantity of the sub18 stance to be used in the research. 

19 ‘‘(III) Demonstration that the re20 search is in the category described in 

21 paragraph (2), which demonstration 

22 may be satisfied— 

23 ‘‘(aa) in the case of a grant, 

24 contract, cooperative agreement, 

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1 mural research project, by identi2 fying the sponsoring agency and 

3 supplying the number of the 

4 grant, contract, cooperative 

5 agreement, other transaction, or 

6 project; or 

7 ‘‘(bb) in the case of an ap8 plication under section 505(i) of 

9 the Federal Food, Drug, and 

10 Cosmetic Act, by supplying the 

11 application number and the spon12 sor of record on the application. 

13 ‘‘(IV) Demonstration that the re14 searcher is authorized to conduct re15 search with respect to the substance 

16 under the laws of the State in which 

17 the research will take place. 

18 ‘‘(ii) VERIFICATION OF INFORMATION

19 BY HHS OR VA.—Upon request from the 

20 Attorney General, the Secretary of Health 

21 and Human Services or the Secretary of 

22 Veterans Affairs, as appropriate, shall 

23 verify information submitted by an appli24 cant under clause (i)(III). 


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1 ‘‘(B) RESEARCHER WITHOUT A CURRENT

2 SCHEDULE I OR II RESEARCH REGISTRATION.— 

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

4 not registered to conduct research with a 

5 controlled substance in schedule I or II, 

6 the practitioner may send a notice to the 

7 Attorney General containing the informa8 tion listed in subparagraph (A)(i), with re9 spect to each substance with which the 

10 practitioner will conduct the research. 

11 ‘‘(ii) ATTORNEY GENERAL ACTION.— 

12 The Attorney General shall— 

13 ‘‘(I) treat notice received under 

14 clause (i) as a sufficient application 

15 for a research registration; and 

16 ‘‘(II) not later than 45 days of 

17 receiving such a notice that contains 

18 all information required under sub19 paragraph (A)(i)— 

20 ‘‘(aa) register the applicant; 

21 or 

22 ‘‘(bb) serve an order to show 

23 cause upon the applicant in ac24 cordance with section 304(c). 


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

2 General shall provide a means to permit a practi3 tioner to submit a notification under paragraph (3) 

4 electronically. 

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

6 conducting research with a schedule I substance 

7 under this subsection may only possess the amounts 

8 of schedule I substance identified in— 

9 ‘‘(A) the notification to the Attorney Gen10 eral under paragraph (3); or 

11 ‘‘(B) a supplemental notification that the 

12 practitioner may send if the practitioner needs 

13 additional amounts for the research, which sup14 plemental notification shall include— 

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

16 ‘‘(ii) the additional quantity needed of 

17 the substance; and 

18 ‘‘(iii) an attestation that the research 

19 to be conducted with the substance is con20 sistent with the scope of the research that 

21 was the subject of the notification under 

22 paragraph (3). 

23 ‘‘(6) IMPORTATION AND EXPORTATION RE24 QUIREMENTS NOT AFFECTED.—Nothing in this sub25 section alters the requirements of part A of title III, 


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1 regarding the importation and exportation of con2 trolled substances.’’. 

3 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR

4 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec5 tion 302(c) of the Controlled Substances Act (21 U.S.C. 

6 822(c)) is amended by adding at the end the following: 

7 ‘‘(4) An agent or employee of a research insti8 tution that is conducting research with a controlled 

9 substance if— 

10 ‘‘(A) the agent or employee is acting with11 in the scope of the professional practice of the 

12 agent or employee; 

13 ‘‘(B) another agent or employee of the in14 stitution is registered to conduct research with 

15 a controlled substance in the same schedule; 

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

17 ‘‘(i) informs the Attorney General of 

18 the name, position title, and employing in19 stitution of the agent or employee who is 

20 not separately registered; 

21 ‘‘(ii) authorizes that agent or em22 ployee to perform research under the reg23 istration of the registered researcher; and 

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

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1 trolled substance shall be attributable to 

2 the registered researcher, as if the re3 searcher had directly committed the act, 

4 for purposes of any proceeding under sec5 tion 304(a) to suspend or revoke the reg6 istration of the registered researcher; and 

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

8 30 days of receiving the information, authoriza9 tion, and affirmation described in subparagraph 

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

11 304(a), to allow the agent or employee to pos12 sess the substance without a separate registra13 tion.’’. 

14 (c) SINGLE REGISTRATION FOR RELATED RESEARCH

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

16 (21 U.S.C. 822(e)) is amended by adding at the end the 

17 following: 

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

19 registered to conduct research with a controlled substance 

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

21 single registration if— 

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

23 of which are— 

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


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1 ‘‘(II) under the control of the same institu2 tion, organization, or agency; and 

3 ‘‘(ii) before commencing the research, the re4 searcher notifies the Attorney General of each site 

5 where— 

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

7 ‘‘(II) the controlled substance will be 

8 stored or administered. 

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

10 included in a registration described in that subparagraph 

11 only if the researcher has notified the Attorney General 

12 of the site— 

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

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

15 the controlled substance is stored or administered, at 

16 the site. 

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

18 the Secretary, issue regulations addressing, with respect 

19 to research sites described in subparagraph (A)— 

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

21 may be delivered to the research sites; 

22 ‘‘(ii) the storage and security of controlled sub23 stances at the research sites; 

24 ‘‘(iii) the maintenance of records for the re25 search sites; and 


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1 ‘‘(iv) any other matters necessary to ensure ef2 fective controls against diversion at the research 

3 sites.’’. 

4 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

5 SITUATIONS.—Section 302(f) of the Controlled Sub6 stances Act (21 U.S.C. 822(f)) is amended— 

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

8 The’’; and 

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

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

11 with a controlled substance and applies for a registration, 

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

13 with a second controlled substance that is in the same 

14 schedule as the first controlled substance, or is in a sched15 ule with a higher numerical designation than the schedule 

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

17 Attorney General of the registered location is not required. 

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

19 Attorney General from conducting an inspection that the 

20 Attorney General determines necessary to ensure that a 

21 registrant maintains effective controls against diversion.’’. 

22 (e) CONTINUATION OF RESEARCH ON SUBSTANCES

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

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

25 by adding at the end the following: 


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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 when the substance is 

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

5 to conduct research with a controlled substance in sched6 ule I— 

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

8 of the newly scheduled substance, the person shall 

9 submit a completed application for registration or 

10 modification of existing registration, to conduct re11 search on the substance, in accordance with regula12 tions issued by the Attorney General for purposes of 

13 this paragraph; 

14 ‘‘(2) the person may, notwithstanding sub15 sections (a) and (b), continue to conduct the re16 search on the substance until— 

17 ‘‘(A) the person withdraws the application 

18 described in paragraph (1) of this subsection; 

19 or 

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

21 person an order to show cause proposing the 

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

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

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

25 the person requests a hearing, the hearing shall be 


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1 held on an expedited basis and not later than 45 

2 days after the request is made, except that the hear3 ing may be held at a later time if so requested by 

4 the person; and 

5 ‘‘(4) if the person sends a copy of the applica6 tion described in paragraph (1) to a manufacturer or 

7 distributor of the substance, receipt of the copy by 

8 the manufacturer or distributor shall constitute suf9 ficient evidence that the person is authorized to re10 ceive the substance.’’. 

11 (f) TREATMENT OF CERTAIN MANUFACTURING AC12 TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 

13 the Controlled Substances Act (21 U.S.C. 822), as amend14 ed by subsection (e), is amended by adding at the end 

15 the following: 

16 ‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC17 TIVITIES AS COINCIDENT TO RESEARCH.— 

18 ‘‘(1) IN GENERAL.—Except as provided in para19 graph (3), a person who is registered to perform re20 search on a controlled substance may perform manu21 facturing activities with small quantities of that sub22 stance, including activities described in paragraph 

23 (2), without being required to obtain a manufac24 turing registration, if— 


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

2 purpose of the research; and 

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

4 the substance involved in the activities are stat5 ed in— 

6 ‘‘(i) a notification submitted to the 

7 Attorney General under section 303(l); 

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

9 application for registration approval under 

10 section 303(f); or 

11 ‘‘(iii) a notification to the Attorney 

12 General that includes— 

13 ‘‘(I) the name of the registrant; 

14 and 

15 ‘‘(II) an attestation that the re16 search to be conducted with the small 

17 quantities of manufactured substance 

18 is consistent with the scope of the re19 search that is the basis for the reg20 istration. 

21 ‘‘(2) ACTIVITIES INCLUDED.—Activities per22 mitted under paragraph (1) include— 

23 ‘‘(A) processing the substance to create ex24 tracts, tinctures, oils, solutions, derivatives, or 

25 other forms of the substance consistent with— 


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1 ‘‘(i) the information provided as part 

2 of a notification submitted to the Attorney 

3 General under section 303(l); or 

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

5 application for registration approval under 

6 section 303(f); and 

7 ‘‘(B) dosage form development studies per8 formed for the purpose of requesting an inves9 tigational new drug exemption under section 

10 505(i) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355(i)). 

12 ‘‘(3) EXCEPTION REGARDING MARIHUANA.— 

13 The authority under paragraph (1) to manufacture 

14 substances does not include the authority to grow 

15 marihuana.’’. 

16 (g) TRANSPARENCY REGARDING SPECIAL PROCE17 DURES.—Section 303 of the Controlled Substances Act 

18 (21 U.S.C. 823), as amended by subsection (a), is amend19 ed by adding at the end the following: 

20 ‘‘(m) TRANSPARENCY REGARDING SPECIAL PROCE21 DURES.— 

22 ‘‘(1) IN GENERAL.—If the Attorney General de23 termines, with respect to a controlled substance, that 

24 an application by a practitioner to conduct research 

25 with the substance should be considered under a 


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1 process, or subject to criteria, different from the 

2 process or criteria applicable to applications to con3 duct research with other controlled substances in the 

4 same schedule, the Attorney General shall make 

5 public, including by posting on the website of the 

6 Drug Enforcement Administration— 

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

8 which such determinations have been made; 

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

10 applied to applications to conduct research with 

11 those substances; and 

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

13 in subparagraph (B) differ from the process 

14 and criteria applicable to applications to con15 duct research with other controlled substances 

16 in the same schedule. 

17 ‘‘(2) TIMING OF POSTING.—The Attorney Gen18 eral shall make information described in paragraph 

19 (1) public upon making a determination described in 

20 that paragraph, regardless of whether a practitioner 

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

22 SEC. 4. RULEMAKING. 

23 (a) INTERIM FINAL RULES.—The Attorney Gen24 eral— 


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

2 enactment of this Act, issue rules to implement this 

3 Act and the amendments made by this Act; and 

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

5 interim final rules. 

6 (b) PROCEDURE FOR FINAL RULE.— 

7 (1) EFFECTIVENESS OF INTERIM FINAL

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

9 an interim final rule under subsection (a) shall be10 come immediately effective as an interim final rule 

11 without requiring the Attorney General to dem12 onstrate good cause therefor, notwithstanding sub13 paragraph (B) of section 553(b) of title 5, United 

14 States Code. 

15 (2) OPPORTUNITY FOR COMMENT AND HEAR16 ING.—An interim final rule issued under subsection 

17 (a) shall give interested persons the opportunity to 

18 comment and to request a hearing. 

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

20 proceedings, the Attorney General shall issue a final 

21 rule to implement this Act and the amendments 

22 made by this Act in accordance with section 553 of 

23 title 5, United States Code. 

Æ 


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