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 Mis-
souri, 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 pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend the Controlled Substances Act to list fentanyl- 
related substances as schedule I controlled substances. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Stopping Illicit Traf-
ficking Act of 2019’’ or the ‘‘SIFT Act of 2019’’. 
SEC. 2. FENTANYL-RELATED SUBSTANCES. 
Section 202(c) of the Controlled Substances Act (21 
U.S.C. 812) is amended— 
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(1) by adding at the end of subsection (b) of 
Schedule I the following: 
‘‘(23) Isobutyryl fentanyl. 
‘‘(24) Para-Methoxybutyrylfentanyl. 
‘‘(25) Valeryl fentanyl. 
‘‘(26) Cyclopentyl fentanyl. 
‘‘(27) Para-Chloroisobutyryl fentanyl.’’; and 
(2) by adding at the end of Schedule I the fol-
lowing: 
‘‘(e)(1) Unless specifically exempted or unless listed 
in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of fentanyl-re-
lated substances, or which contains their salts, isomers, 
and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific 
chemical designation. 
‘‘(2) In paragraph (1), the term ‘fentanyl-related sub-
stances’ includes the following: 
‘‘(A) Any substance that is structurally related 
to fentanyl by one or more of the following modifica-
tions: 
‘‘(i) By replacement of the phenyl portion 
of the phenethyl group by any monocycle, 
whether or not further substituted in or on the 
monocycle. 
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‘‘(ii) By substitution in or on the phenethyl 
group with alkyl, alkenyl, alkoxy, hydroxy, halo, 
haloalkyl, amino or nitro groups. 
‘‘(iii) By substitution in or on the piper-
idine ring with alkyl, alkenyl, alkoxy, ester, 
ether, hydroxy, halo, haloalkyl, amino or nitro 
groups. 
‘‘(iv) By replacement of the aniline ring 
with any aromatic monocycle whether or not 
further substituted in or on the aromatic mono-
cycle. 
‘‘(v) By replacement of the N-propionyl 
group by another acyl group. 
‘‘(B) 4′-Methyl acetyl fentanyl. 
‘‘(C) Crotonyl fentanyl. 
‘‘(D) 2′-Fluoro ortho-fluorofentanyl. 
‘‘(E) Ortho-Methyl acetylfentanyl. 
‘‘(F) Thiofuranyl fentanyl. 
‘‘(G) Ortho-Fluorobutyryl fentanyl. 
‘‘(H) Ortho-Fluoroacryl fentanyl. 
‘‘(I) Beta-Methyl fentanyl. 
‘‘(J) Phenyl fentanyl. 
‘‘(K) Para-Methylfentanyl. 
‘‘(L) Beta′-Phenyl fentanyl. 
‘‘(M) Benzodioxole fentanyl.’’. 
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SEC. 3. REMOVAL FROM SCHEDULE I(e) OF FENTANYL-RE-
LATED SUBSTANCES. 
Section 201 of the Controlled Substances Act (21 
U.S.C. 811) is amended by adding at the end the following 
new subsection: 
‘‘(k)(1) If the Secretary finds, based on the factors 
specified in paragraph (4), that a substance listed in 
schedule I(e) has no potential for abuse, the Secretary 
shall— 
‘‘(A) notify the Attorney General at least 90 
days prior to submitting an evaluation scientific and 
medical evaluation of that substance supporting that 
conclusion; and 
‘‘(B) submit to the Attorney General such eval-
uation and conclusion that— 
‘‘(i) is in writing; and 
‘‘(ii) includes the bases for such conclu-
sion. 
‘‘(2) Not later than 90 days after the receipt of such 
evaluation and conclusion, the Attorney General shall 
issue an order removing such substance from the schedule. 
‘‘(3)(A) If the Secretary finds, based on the factors 
specified in paragraph (4), that a substance listed in 
schedule I(e) does not meet the requirements for inclusion 
in that schedule, and that the substance has a low poten-
tial for abuse, the Secretary shall submit to the Attorney 
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‘‘(6) A substance removed from schedule I(e) pursu-
ant to paragraph (1) or (3) may, at any time, be controlled 
pursuant to the other provisions of this section or section 
202 without regard to that removal.’’. 
SEC. 4. CLARIFICATION OF CERTAIN REGISTRATION RE-
QUIREMENTS RELATED TO RESEARCH. 
(a) EXCEPTION FOR AGENTS OR EMPLOYEES OF 
REGISTERED RESEARCHERS.—Section 302(c)(1) of the 
Controlled Substances Act (21 U.S.C. 822(c)(1)) is 
amended by striking ‘‘or dispenser’’ and inserting ‘‘dis-
penser, or researcher’’. 
(b) CONFORMING AMENDMENT.—Section 102(3) of 
the Controlled Substances Act (21 U.S.C. 802(3)) is 
amended by striking ‘‘or dispenser’’ and inserting ‘‘dis-
penser, or researcher.’’ 
(c) SINGLE REGISTRATION FOR CONTIGUOUS RE-
SEARCH SITES.—Section 302(e) of the Controlled Sub-
stances Act (21 U.S.C. 822(e)) is amended by adding at 
the end the following new paragraph: 
‘‘(3) Notwithstanding paragraph (1), a person 
registered to conduct research with a controlled sub-
stance under section 303(f) may conduct such re-
search under a single registration if such research 
occurs exclusively on a single, contiguous campus 
and the registrant notifies the Attorney General in 
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writing of all sites on the campus where the research 
will be conducted or where the controlled substance 
will be stored or administered. If the registrant 
seeks to conduct such research at additional sites, 
the registrant shall submit a new notification before 
conducting such research at any such additional 
sites.’’. 
(d) NEW INSPECTION NOT REQUIRED IN CERTAIN 
SITUATIONS.—Section 303(f) of the Controlled Sub-
stances Act (21 U.S.C. 823(f)) is amended— 
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 
The’’; and 
(2) by adding a new paragraph, as follows: 
‘‘(2)(A) If a person is registered to conduct research 
with a controlled substance and applies to be registered, 
or to modify a registration to conduct research with a sec-
ond controlled substance that is in the same schedule or 
in a schedule with a higher numerical designation, a new 
inspection by the Attorney General of the registered loca-
tion is not required. 
‘‘(B) Nothing in this paragraph shall prohibit the At-
torney General from conducting any inspection if the At-
torney General determines such an inspection is nec-
essary.’’. 
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(e) CONTINUATION OF RESEARCH ON NEWLY ADDED 
SUBSTANCES; AUTHORITY TO CONDUCT RESEARCH WITH 
OTHER SUBSTANCES.—Section 302 of the Controlled 
Substances Act (21 U.S.C. 822), as amended by sub-
sections (a) and (c), is further amended by adding at the 
end the following new subsection: 
‘‘(h)(1) In the case of a person who is conducting 
research on a substance at the time the substance is added 
to schedule I and who is already registered to conduct re-
search with another controlled substance in schedule I or 
II, the person— 
‘‘(A) within 30 days of the scheduling of such 
substance, shall submit a completed application for 
registration or modification of the existing registra-
tion of such person, to conduct research on such 
substance, in accordance with the regulations issued 
by the Attorney General; and 
‘‘(B) notwithstanding subsections (a) and (b), 
may continue to conduct the research on such sub-
stance until the date on which— 
‘‘(i) the application referred to in subpara-
graph (A) is withdrawn by the applicant; or 
‘‘(ii) the Attorney General serves on the 
applicant an order to show cause proposing the 
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denial of the application pursuant to section 
304(c). 
‘‘(2) If the Attorney General serves an order to show 
cause under paragraph (1)(B) and the applicant requests 
a hearing, such hearing shall be held— 
‘‘(A) on an expedited basis; and 
‘‘(B) not later than 45 days after the request 
is made, or such a later time as requested by the ap-
plicant. 
‘‘(3)(A) A person who is registered to conduct re-
search with a controlled substance in schedule I may, not-
withstanding subsections (a) and (b), conduct research 
with another controlled substance in schedule I, if each 
of following conditions are met: 
‘‘(i) The person has applied for a modification 
of the person’s registration to authorize research 
with such other controlled substance in accordance 
with the regulations issued by the Attorney General. 
‘‘(ii) The Attorney General has obtained 
verification from the Secretary that the research 
protocol submitted with the application is meri-
torious. 
‘‘(iii) The Attorney General has determined 
under subparagraph (B) that the conduct of such re-
search is consistent with United States obligations 
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under the Single Convention on Narcotic Drugs, 
1961. 
‘‘(B) Not later than 30 days after receiving an appli-
cation under clause (i), the Attorney General shall deter-
mine whether the conduct of research that is the subject 
of the application is consistent with United States obliga-
tions under the Single Convention on Narcotic Drugs, 
1961. 
‘‘(C) Nothing in this section shall be construed to 
alter the authority of the Attorney General to initiate pro-
ceedings to deny, suspend, or revoke any registration in 
accordance with sections 303 and 304.’’. 
(f) TREATMENT OF CERTAIN ACTIVITIES AS COINCI-
DENT TO RESEARCH.—Section 302 of the Controlled Sub-
stances Act (21 U.S.C. 822), as amended by subsections 
(a), (c), and (e), is further amended by adding at the end 
the following new subsection: 
‘‘(i) A person who is registered to perform research 
with a controlled substance (other than marihuana) under 
this title may, without being required to registered to man-
ufacture such substance, using small quantities of such 
substance, perform the following activities: 
‘‘(1) Processing the substance to create ex-
tracts, tinctures, oils, solutions, derivatives, or other 
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forms of the substance consistent with the approved 
research protocol. 
‘‘(2) Dosage form development for the purpose 
of satisfying requirements with respect to the sub-
mission of an investigational new drug application 
under section 505(i) of the Federal Food, Drug, and 
Cosmetic Act.’’. 
SEC. 5. REVIEW OF RESEARCH REGISTRATION PROCESS. 
(a) REVIEW.—Not later than one year after the date 
of the enactment of this section, the Attorney General and 
the Secretary of Health and Human Services shall jointly 
conduct a review of the processes used to register or mod-
ify a registration to conduct research with controlled sub-
stances under the Controlled Substances Act (21 U.S.C. 
801 et seq.), including— 
(1) an evaluation of the impacts of the amend-
ments made by this Act on the risk of the diversion 
of controlled substances used in research and related 
public safety considerations; and 
(2) an identification of opportunities to reduce 
any unnecessary burden on persons seeking registra-
tion, potential redundancies, and inefficiencies in 
such processes, including— 
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(A) the process for obtaining a registration 
under section 303 of the Controlled Substances 
Act (21 U.S.C. 823); and 
(B) the process by which the Secretary re-
views research protocols submitted with respect 
to such registration. 
(b) GUIDANCE.—Not later than 60 days after con-
cluding the review described in subsection (a), the Attor-
ney General and the Secretary shall, as appropriate, joint-
ly issue guidance to registrants and potential registrants 
clarifying the process for registration. 
Æ 
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