I 

117TH CONGRESS 

1ST SESSION H. R. 2041 

To amend the Controlled Substances Act to list fentanyl-related substances 

as schedule I controlled substances. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 18, 2021 

Mr. LUETKEMEYER (for himself, Mr. LONG, Mr. SMITH of Missouri, Mrs. 

HARTZLER, Mr. GRAVES of Missouri, Mr. SESSIONS, Mr. JACKSON, Mr. 

BABIN, Mr. CRAWFORD, Mr. ALLEN, Mr. RODNEY DAVIS of Illinois, Mr. 

BAIRD, Mr. RESCHENTHALER, and Mr. TIFFANY) 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 list fentanylrelated substances as schedule I controlled substances. 

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 ‘‘Stopping Illicit Traf5 ficking Act of 2021’’ or the ‘‘SIFT Act of 2021’’. 


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1 SEC. 2. FENTANYL-RELATED SUBSTANCES. 

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

3 U.S.C. 812) is amended— 

4 (1) by adding at the end of subsection (b) of 

5 Schedule I the following: 

6 ‘‘(23) Isobutyryl fentanyl. 

7 ‘‘(24) Para-Methoxybutyrylfentanyl. 

8 ‘‘(25) Valeryl fentanyl. 

9 ‘‘(26) Cyclopentyl fentanyl. 

10 ‘‘(27) Para-Chloroisobutyryl fentanyl.’’; and 

11 (2) by adding at the end of Schedule I the fol12 lowing: 

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

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

15 preparation which contains any quantity of fentanyl-re16 lated substances, or which contains their salts, isomers, 

17 and salts of isomers whenever the existence of such salts, 

18 isomers, and salts of isomers is possible within the specific 

19 chemical designation. 

20 ‘‘(2) In paragraph (1), the term ‘fentanyl-related sub21 stances’ includes the following: 

22 ‘‘(A) Any substance that is structurally related 

23 to fentanyl by one or more of the following modifica24 tions: 

25 ‘‘(i) By replacement of the phenyl portion 

26 of the phenethyl group by any monocycle, 


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1 whether or not further substituted in or on the 

2 monocycle. 

3 ‘‘(ii) By substitution in or on the phenethyl 

4 group with alkyl, alkenyl, alkoxy, hydroxy, halo, 

5 haloalkyl, amino or nitro groups. 

6 ‘‘(iii) By substitution in or on the piper7 idine ring with alkyl, alkenyl, alkoxy, ester, 

8 ether, hydroxy, halo, haloalkyl, amino or nitro 

9 groups. 

10 ‘‘(iv) By replacement of the aniline ring 

11 with any aromatic monocycle whether or not 

12 further substituted in or on the aromatic mono13 cycle. 

14 ‘‘(v) By replacement of the N-propionyl 

15 group by another acyl group. 

16 ‘‘(B) 4′-Methyl acetyl fentanyl. 

17 ‘‘(C) Crotonyl fentanyl. 

18 ‘‘(D) 2′-Fluoro ortho-fluorofentanyl. 

19 ‘‘(E) Ortho-Methyl acetylfentanyl. 

20 ‘‘(F) Thiofuranyl fentanyl. 

21 ‘‘(G) Ortho-Fluorobutyryl fentanyl. 

22 ‘‘(H) Ortho-Fluoroacryl fentanyl. 

23 ‘‘(I) Beta-Methyl fentanyl. 

24 ‘‘(J) Phenyl fentanyl. 

25 ‘‘(K) Para-Methylfentanyl. 


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1 ‘‘(L) Beta′-Phenyl fentanyl. 

2 ‘‘(M) Benzodioxole fentanyl.’’. 

3 SEC. 3. REMOVAL FROM SCHEDULE I(e) OF FENTANYL-RE4 LATED SUBSTANCES. 

5 Section 201 of the Controlled Substances Act (21 

6 U.S.C. 811) is amended by adding at the end the following 

7 new subsection: 

8 ‘‘(k)(1) If the Secretary finds, based on the factors 

9 specified in paragraph (4), that a substance listed in 

10 schedule I(e) has no potential for abuse, the Secretary 

11 shall— 

12 ‘‘(A) notify the Attorney General at least 90 

13 days prior to submitting an evaluation scientific and 

14 medical evaluation of that substance supporting that 

15 conclusion; and 

16 ‘‘(B) submit to the Attorney General such eval17 uation and conclusion that— 

18 ‘‘(i) is in writing; and 

19 ‘‘(ii) includes the bases for such conclu20 sion. 

21 ‘‘(2) Not later than 90 days after the receipt of such 

22 evaluation and conclusion, the Attorney General shall 

23 issue an order removing such substance from the schedule. 

24 ‘‘(3)(A) If the Secretary finds, based on the factors 

25 specified in paragraph (4), that a substance listed in 


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1 schedule I(e) does not meet the requirements for inclusion 

2 in that schedule, and that the substance has a low poten3 tial for abuse, the Secretary shall submit to the Attorney 

4 General a scientific and medical evaluation of that sub5 stance supporting those conclusions that is in writing and 

6 that includes the bases for that conclusion. 

7 ‘‘(B) Within 180 days of receipt of such evaluation 

8 and conclusion, the Attorney General shall— 

9 ‘‘(i) issue an order removing such substance 

10 from scheduling for research purposes only, or 

11 ‘‘(ii) notify the Secretary in writing that the At12 torney General declines to issue such an order. 

13 ‘‘(4) In making the evaluation and conclusion de14 scribed in paragraph (1) or (3), the Secretary— 

15 ‘‘(A) shall consider the factors specified in 

16 paragraphs (1), (2), (3), and (6) of subsection (c) 

17 and any information submitted to the Attorney Gen18 eral under paragraph (1) of this subsection; and 

19 ‘‘(B) may also consider factors specified in 

20 paragraphs (4), (5), and (7) of subsection (c) if the 

21 Secretary finds that reliable evidence exists with re22 spect to such factors. 

23 ‘‘(5) Nothing in this subsection shall preclude the At24 torney General from transferring a substance listed in 

25 schedule I to another schedule, or removing such subVerDate Sep 11 2014 06:23 May 18, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2041.IH H2041

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1 stance entirely from the schedules, pursuant to other pro2 visions of this section or section 202. 

3 ‘‘(6) A substance removed from schedule I(e) pursu4 ant to paragraph (1) or (3) may, at any time, be controlled 

5 pursuant to the other provisions of this section or section 

6 202 without regard to that removal.’’. 

7 SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION RE8 QUIREMENTS RELATED TO RESEARCH. 

9 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF

10 REGISTERED RESEARCHERS.—Section 302(c)(1) of the 

11 Controlled Substances Act (21 U.S.C. 822(c)(1)) is 

12 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis13 penser, or researcher’’. 

14 (b) CONFORMING AMENDMENT.—Section 102(3) of 

15 the Controlled Substances Act (21 U.S.C. 802(3)) is 

16 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis17 penser, or researcher.’’ 

18 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE19 SEARCH SITES.—Section 302(e) of the Controlled Sub20 stances Act (21 U.S.C. 822(e)) is amended by adding at 

21 the end the following new paragraph: 

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

23 registered to conduct research with a controlled sub24 stance under section 303(f) may conduct such re25 search under a single registration if such research 


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1 occurs exclusively on a single, contiguous campus 

2 and the registrant notifies the Attorney General in 

3 writing of all sites on the campus where the research 

4 will be conducted or where the controlled substance 

5 will be stored or administered. If the registrant 

6 seeks to conduct such research at additional sites, 

7 the registrant shall submit a new notification before 

8 conducting such research at any such additional 

9 sites.’’. 

10 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

11 SITUATIONS.—Section 303(f) of the Controlled Sub12 stances Act (21 U.S.C. 823(f)) is amended— 

13 (1) by redesignating paragraphs (1) through 

14 (5) as subparagraphs (A) through (E), respectively, 

15 and by moving the margins of such subparagraphs 

16 (as so redesignated) two ems to the right; 

17 (2) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 

18 The’’; and 

19 (3) by adding at the end the following new 

20 paragraph: 

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

22 with a controlled substance and applies to be registered, 

23 or to modify a registration to conduct research with a sec24 ond controlled substance that is in the same schedule or 

25 in a schedule with a higher numerical designation, a new 


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1 inspection by the Attorney General of the registered loca2 tion is not required. 

3 ‘‘(B) Nothing in this paragraph shall prohibit the At4 torney General from conducting any inspection if the At5 torney General determines such an inspection is nec6 essary.’’. 

7 (e) CONTINUATION OF RESEARCH ON NEWLY ADDED

8 SUBSTANCES; AUTHORITY TO CONDUCT RESEARCH WITH

9 OTHER SUBSTANCES.—Section 302 of the Controlled 

10 Substances Act (21 U.S.C. 822), as amended by sub11 sections (a) and (c), is further amended by adding at the 

12 end the following new subsection: 

13 ‘‘(h)(1) In the case of a person who is conducting 

14 research on a substance at the time the substance is added 

15 to schedule I and who is already registered to conduct re16 search with another controlled substance in schedule I or 

17 II, the person— 

18 ‘‘(A) within 30 days of the scheduling of such 

19 substance, shall submit a completed application for 

20 registration or modification of the existing registra21 tion of such person, to conduct research on such 

22 substance, in accordance with the regulations issued 

23 by the Attorney General; and 


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1 ‘‘(B) notwithstanding subsections (a) and (b), 

2 may continue to conduct the research on such sub3 stance until the date on which— 

4 ‘‘(i) the application referred to in subpara5 graph (A) is withdrawn by the applicant; or 

6 ‘‘(ii) the Attorney General serves on the 

7 applicant an order to show cause proposing the 

8 denial of the application pursuant to section 

9 304(c). 

10 ‘‘(2) If the Attorney General serves an order to show 

11 cause under paragraph (1)(B) and the applicant requests 

12 a hearing, such hearing shall be held— 

13 ‘‘(A) on an expedited basis; and 

14 ‘‘(B) not later than 45 days after the request 

15 is made, or such a later time as requested by the ap16 plicant. 

17 ‘‘(3)(A) A person who is registered to conduct re18 search with a controlled substance in schedule I may, not19 withstanding subsections (a) and (b), conduct research 

20 with another controlled substance in schedule I, if each 

21 of following conditions are met: 

22 ‘‘(i) The person has applied for a modification 

23 of the person’s registration to authorize research 

24 with such other controlled substance in accordance 

25 with the regulations issued by the Attorney General. 


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1 ‘‘(ii) The Attorney General has obtained 

2 verification from the Secretary that the research 

3 protocol submitted with the application is meri4 torious. 

5 ‘‘(iii) The Attorney General has determined 

6 under subparagraph (B) that the conduct of such re7 search is consistent with United States obligations 

8 under the Single Convention on Narcotic Drugs, 

9 1961. 

10 ‘‘(B) Not later than 30 days after receiving an appli11 cation under clause (i), the Attorney General shall deter12 mine whether the conduct of research that is the subject 

13 of the application is consistent with United States obliga14 tions under the Single Convention on Narcotic Drugs, 

15 1961. 

16 ‘‘(C) Nothing in this section shall be construed to 

17 alter the authority of the Attorney General to initiate pro18 ceedings to deny, suspend, or revoke any registration in 

19 accordance with sections 303 and 304.’’. 

20 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI21 DENT TO RESEARCH.—Section 302 of the Controlled Sub22 stances Act (21 U.S.C. 822), as amended by subsections 

23 (a), (c), and (e), is further amended by adding at the end 

24 the following new subsection: 


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1 ‘‘(i) A person who is registered to perform research 

2 with a controlled substance (other than marihuana) under 

3 this title may, without being required to registered to man4 ufacture such substance, using small quantities of such 

5 substance, perform the following activities: 

6 ‘‘(1) Processing the substance to create ex7 tracts, tinctures, oils, solutions, derivatives, or other 

8 forms of the substance consistent with the approved 

9 research protocol. 

10 ‘‘(2) Dosage form development for the purpose 

11 of satisfying requirements with respect to the sub12 mission of an investigational new drug application 

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

14 Cosmetic Act.’’. 

15 SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS. 

16 (a) REVIEW.—Not later than one year after the date 

17 of the enactment of this section, the Attorney General and 

18 the Secretary of Health and Human Services shall jointly 

19 conduct a review of the processes used to register or mod20 ify a registration to conduct research with controlled sub21 stances under the Controlled Substances Act (21 U.S.C. 

22 801 et seq.), including— 

23 (1) an evaluation of the impacts of the amend24 ments made by this Act on the risk of the diversion 


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1 of controlled substances used in research and related 

2 public safety considerations; and 

3 (2) an identification of opportunities to reduce 

4 any unnecessary burden on persons seeking registra5 tion, potential redundancies, and inefficiencies in 

6 such processes, including— 

7 (A) the process for obtaining a registration 

8 under section 303 of the Controlled Substances 

9 Act (21 U.S.C. 823); and 

10 (B) the process by which the Secretary re11 views research protocols submitted with respect 

12 to such registration. 

13 (b) GUIDANCE.—Not later than 60 days after con14 cluding the review described in subsection (a), the Attor15 ney General and the Secretary shall, as appropriate, joint16 ly issue guidance to registrants and potential registrants 

17 clarifying the process for registration. 

Æ 


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