I 

116TH CONGRESS 

1ST SESSION H. R. 5421 

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

as schedule I controlled substances. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 12, 2019 

Mr. LUETKEMEYER (for himself, Mrs. WAGNER, Mr. CLAY, Mr. SMITH of Missouri, Mr. LONG, Mr. GRAVES of Missouri, and Mr. CLEAVER) 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 2019’’ or the ‘‘SIFT Act of 2019’’. 

6 SEC. 2. FENTANYL-RELATED SUBSTANCES. 

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

8 U.S.C. 812) is amended— 


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

2 Schedule I the following: 

3 ‘‘(23) Isobutyryl fentanyl. 

4 ‘‘(24) Para-Methoxybutyrylfentanyl. 

5 ‘‘(25) Valeryl fentanyl. 

6 ‘‘(26) Cyclopentyl fentanyl. 

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

8 (2) by adding at the end of Schedule I the fol9 lowing: 

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

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

12 preparation which contains any quantity of fentanyl-re13 lated substances, or which contains their salts, isomers, 

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

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

16 chemical designation. 

17 ‘‘(2) In paragraph (1), the term ‘fentanyl-related sub18 stances’ includes the following: 

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

20 to fentanyl by one or more of the following modifica21 tions: 

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

23 of the phenethyl group by any monocycle, 

24 whether or not further substituted in or on the 

25 monocycle. 


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

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

3 haloalkyl, amino or nitro groups. 

4 ‘‘(iii) By substitution in or on the piper5 idine ring with alkyl, alkenyl, alkoxy, ester, 

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

7 groups. 

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

9 with any aromatic monocycle whether or not 

10 further substituted in or on the aromatic mono11 cycle. 

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

13 group by another acyl group. 

14 ‘‘(B) 4′-Methyl acetyl fentanyl. 

15 ‘‘(C) Crotonyl fentanyl. 

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

17 ‘‘(E) Ortho-Methyl acetylfentanyl. 

18 ‘‘(F) Thiofuranyl fentanyl. 

19 ‘‘(G) Ortho-Fluorobutyryl fentanyl. 

20 ‘‘(H) Ortho-Fluoroacryl fentanyl. 

21 ‘‘(I) Beta-Methyl fentanyl. 

22 ‘‘(J) Phenyl fentanyl. 

23 ‘‘(K) Para-Methylfentanyl. 

24 ‘‘(L) Beta′-Phenyl fentanyl. 

25 ‘‘(M) Benzodioxole fentanyl.’’. 


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1 SEC. 3. REMOVAL FROM SCHEDULE I(e) OF FENTANYL-RE2 LATED SUBSTANCES. 

3 Section 201 of the Controlled Substances Act (21 

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

5 new subsection: 

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

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

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

9 shall— 

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

11 days prior to submitting an evaluation scientific and 

12 medical evaluation of that substance supporting that 

13 conclusion; and 

14 ‘‘(B) submit to the Attorney General such eval15 uation and conclusion that— 

16 ‘‘(i) is in writing; and 

17 ‘‘(ii) includes the bases for such conclu18 sion. 

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

20 evaluation and conclusion, the Attorney General shall 

21 issue an order removing such substance from the schedule. 

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

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

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

25 in that schedule, and that the substance has a low poten26 tial for abuse, the Secretary shall submit to the Attorney 


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1 General a scientific and medical evaluation of that sub2 stance supporting those conclusions that is in writing and 

3 that includes the bases for that conclusion. 

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

5 and conclusion, the Attorney General shall— 

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

7 from scheduling for research purposes only, or 

8 ‘‘(ii) notify the Secretary in writing that the At9 torney General declines to issue such an order. 

10 ‘‘(4) In making the evaluation and conclusion de11 scribed in paragraph (1) or (3), the Secretary— 

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

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

14 and any information submitted to the Attorney Gen15 eral under paragraph (1) of this subsection; and 

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

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

18 Secretary finds that reliable evidence exists with re19 spect to such factors. 

20 ‘‘(5) Nothing in this subsection shall preclude the At21 torney General from transferring a substance listed in 

22 schedule I to another schedule, or removing such sub23 stance entirely from the schedules, pursuant to other pro24 visions of this section or section 202. 


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1 ‘‘(6) A substance removed from schedule I(e) pursu2 ant to paragraph (1) or (3) may, at any time, be controlled 

3 pursuant to the other provisions of this section or section 

4 202 without regard to that removal.’’. 

5 SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION RE6 QUIREMENTS RELATED TO RESEARCH. 

7 (a) EXCEPTION FOR AGENTS OR EMPLOYEES OF

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

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

10 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis11 penser, or researcher’’. 

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

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

14 amended by striking ‘‘or dispenser’’ and inserting ‘‘dis15 penser, or researcher.’’ 

16 (c) SINGLE REGISTRATION FOR CONTIGUOUS RE17 SEARCH SITES.—Section 302(e) of the Controlled Sub18 stances Act (21 U.S.C. 822(e)) is amended by adding at 

19 the end the following new paragraph: 

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

21 registered to conduct research with a controlled sub22 stance under section 303(f) may conduct such re23 search under a single registration if such research 

24 occurs exclusively on a single, contiguous campus 

25 and the registrant notifies the Attorney General in 


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1 writing of all sites on the campus where the research 

2 will be conducted or where the controlled substance 

3 will be stored or administered. If the registrant 

4 seeks to conduct such research at additional sites, 

5 the registrant shall submit a new notification before 

6 conducting such research at any such additional 

7 sites.’’. 

8 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN

9 SITUATIONS.—Section 303(f) of the Controlled Sub10 stances Act (21 U.S.C. 823(f)) is amended— 

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

12 The’’; and 

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

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

15 with a controlled substance and applies to be registered, 

16 or to modify a registration to conduct research with a sec17 ond controlled substance that is in the same schedule or 

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

19 inspection by the Attorney General of the registered loca20 tion is not required. 

21 ‘‘(B) Nothing in this paragraph shall prohibit the At22 torney General from conducting any inspection if the At23 torney General determines such an inspection is nec24 essary.’’. 


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1 (e) CONTINUATION OF RESEARCH ON NEWLY ADDED

2 SUBSTANCES; AUTHORITY TO CONDUCT RESEARCH WITH

3 OTHER SUBSTANCES.—Section 302 of the Controlled 

4 Substances Act (21 U.S.C. 822), as amended by sub5 sections (a) and (c), is further amended by adding at the 

6 end the following new subsection: 

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

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

9 to schedule I and who is already registered to conduct re10 search with another controlled substance in schedule I or 

11 II, the person— 

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

13 substance, shall submit a completed application for 

14 registration or modification of the existing registra15 tion of such person, to conduct research on such 

16 substance, in accordance with the regulations issued 

17 by the Attorney General; and 

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

19 may continue to conduct the research on such sub20 stance until the date on which— 

21 ‘‘(i) the application referred to in subpara22 graph (A) is withdrawn by the applicant; or 

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

24 applicant an order to show cause proposing the 


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1 denial of the application pursuant to section 

2 304(c). 

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

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

5 a hearing, such hearing shall be held— 

6 ‘‘(A) on an expedited basis; and 

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

8 is made, or such a later time as requested by the ap9 plicant. 

10 ‘‘(3)(A) A person who is registered to conduct re11 search with a controlled substance in schedule I may, not12 withstanding subsections (a) and (b), conduct research 

13 with another controlled substance in schedule I, if each 

14 of following conditions are met: 

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

16 of the person’s registration to authorize research 

17 with such other controlled substance in accordance 

18 with the regulations issued by the Attorney General. 

19 ‘‘(ii) The Attorney General has obtained 

20 verification from the Secretary that the research 

21 protocol submitted with the application is meri22 torious. 

23 ‘‘(iii) The Attorney General has determined 

24 under subparagraph (B) that the conduct of such re25 search is consistent with United States obligations 


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1 under the Single Convention on Narcotic Drugs, 

2 1961. 

3 ‘‘(B) Not later than 30 days after receiving an appli4 cation under clause (i), the Attorney General shall deter5 mine whether the conduct of research that is the subject 

6 of the application is consistent with United States obliga7 tions under the Single Convention on Narcotic Drugs, 

8 1961. 

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

10 alter the authority of the Attorney General to initiate pro11 ceedings to deny, suspend, or revoke any registration in 

12 accordance with sections 303 and 304.’’. 

13 (f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI14 DENT TO RESEARCH.—Section 302 of the Controlled Sub15 stances Act (21 U.S.C. 822), as amended by subsections 

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

17 the following new subsection: 

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

19 with a controlled substance (other than marihuana) under 

20 this title may, without being required to registered to man21 ufacture such substance, using small quantities of such 

22 substance, perform the following activities: 

23 ‘‘(1) Processing the substance to create ex24 tracts, tinctures, oils, solutions, derivatives, or other 


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1 forms of the substance consistent with the approved 

2 research protocol. 

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

4 of satisfying requirements with respect to the sub5 mission of an investigational new drug application 

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

7 Cosmetic Act.’’. 

8 SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS. 

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

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

11 the Secretary of Health and Human Services shall jointly 

12 conduct a review of the processes used to register or mod13 ify a registration to conduct research with controlled sub14 stances under the Controlled Substances Act (21 U.S.C. 

15 801 et seq.), including— 

16 (1) an evaluation of the impacts of the amend17 ments made by this Act on the risk of the diversion 

18 of controlled substances used in research and related 

19 public safety considerations; and 

20 (2) an identification of opportunities to reduce 

21 any unnecessary burden on persons seeking registra22 tion, potential redundancies, and inefficiencies in 

23 such processes, including— 


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1 (A) the process for obtaining a registration 

2 under section 303 of the Controlled Substances 

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

4 (B) the process by which the Secretary re5 views research protocols submitted with respect 

6 to such registration. 

7 (b) GUIDANCE.—Not later than 60 days after con8 cluding the review described in subsection (a), the Attor9 ney General and the Secretary shall, as appropriate, joint10 ly issue guidance to registrants and potential registrants 

11 clarifying the process for registration. 

Æ 


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