I 
117TH CONGRESS 
1ST SESSION H. R. 6184 
To amend the Controlled Substances Act with respect to the scheduling 
of fentanyl-related substances, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 8, 2021 
Mr. GRIFFITH (for himself, Mr. LATTA, Mr. BILIRAKIS, Mr. BURGESS, Mr. 
CARTER of Georgia, Mr. CLINE, Mr. CURTIS, Mr. FITZPATRICK, Mr. 
GUTHRIE, Mr. HARRIS, Mr. HUDSON, Mr. JACKSON, Mr. JOYCE of Penn-
sylvania, Mr. KELLER, Mrs. LESKO, Mr. LONG, Mr. MCKINLEY, Mrs. 
RODGERS of Washington, Mrs. MILLER of West Virginia, Mrs. MILLER- 
MEEKS, Mr. MULLIN, Mr. ARMSTRONG, Mr. MURPHY of North Carolina, 
Mr. PALAZZO, Mr. AUSTIN
SCOTT
of Georgia, Mr. UPTON, Mr. 
WALBERG, and Ms. HERRELL) 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 deter-
mined 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 with respect to 
the scheduling of fentanyl-related substances, and for 
other purposes. 
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 ‘‘Halt All Lethal Traf-
ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 
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SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-
STANCES. 
Section 202(c) of the Controlled Substances Act (21 
U.S.C. 812(c)) is amended by adding at the end of sched-
ule I the following: 
‘‘(e)(1) Unless specifically exempted or unless listed 
in another schedule, any material, compound, mixture, or 
preparation which contains any quantity of a fentanyl-re-
lated substance, or which contains the salts, isomers, and 
salts of isomers of a fentanyl-related substance whenever 
the existence of such salts, isomers, and salts of isomers 
is possible within the specific chemical designation. 
‘‘(2) For purposes of paragraph (1), except as pro-
vided in paragraph (3), the term ‘fentanyl-related sub-
stance’ means any substance that is structurally related 
to fentanyl by 1 or more of the following modifications: 
‘‘(A) By replacement of the phenyl portion of 
the phenethyl group by any monocycle, whether or 
not further substituted in or on the monocycle. 
‘‘(B) By substitution in or on the phenethyl 
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 
haloalkyl, amino, or nitro groups. 
‘‘(C) By substitution in or on the piperidine 
ring with alkyl, alkenyl, alkoxyl, ester, ether, 
hydroxyl, halo, haloalkyl, amino, or nitro groups. 
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‘‘(D) By replacement of the aniline ring with 
any aromatic monocycle whether or not further sub-
stituted in or on the aromatic monocycle. 
‘‘(E) By replacement of the N–propionyl group 
with another acyl group. 
‘‘(3) A substance that satisfies the definition of the 
term ‘fentanyl-related substance’ in paragraph (2) shall 
nonetheless not be treated as a fentanyl-related substance 
subject to this schedule if the substance— 
‘‘(A) is controlled by action of the Attorney 
General under section 201; or 
‘‘(B) is otherwise expressly listed in a schedule 
other than this schedule. 
‘‘(4)(A) The Attorney General may by order publish 
in the Federal Register a list of substances that satisfy 
the definition of the term ‘fentanyl-related substance’ in 
paragraph (2). 
‘‘(B) The absence of a substance from a list published 
under subparagraph (A) does not negate the control status 
of the substance under this schedule if the substance satis-
fies the definition of the term ‘fentanyl-related substance’ 
in paragraph (2).’’. 
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SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-
SEARCH. 
(a) ALTERNATIVE
REGISTRATION
PROCESS
FOR 
SCHEDULE I RESEARCH.—Section 303 of the Controlled 
Substances Act (21 U.S.C. 823) is amended by adding at 
the end the following: 
‘‘(l) SPECIAL PROVISIONS FOR PRACTITIONERS CON-
DUCTING CERTAIN RESEARCH WITH SCHEDULE I CON-
TROLLED SUBSTANCES.— 
‘‘(1) IN GENERAL.—Notwithstanding subsection 
(f), a practitioner may conduct research described in 
paragraph (2) of this subsection with 1 or more 
schedule I substances in accordance with subpara-
graph (A) or (B) of paragraph (3) of this sub-
section. 
‘‘(2) RESEARCH SUBJECT TO EXPEDITED PRO-
CEDURES.—Research described in this paragraph is 
research that— 
‘‘(A) is with respect to a drug that is the 
subject of an investigational use exemption 
under section 505(i) of the Federal Food, Drug, 
and Cosmetic Act; or 
‘‘(B) is— 
‘‘(i) conducted by the Department of 
Health and Human Services or the De-
partment of Veterans Affairs; or 
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‘‘(ii) funded partly or entirely by a 
grant, contract, cooperative agreement, or 
other transaction from the Department of 
Health and Human Services or the De-
partment of Veterans Affairs. 
‘‘(3) EXPEDITED PROCEDURES.— 
‘‘(A) RESEARCHER
WITH
A
CURRENT 
SCHEDULE I OR II RESEARCH REGISTRATION.— 
‘‘(i) IN GENERAL.—If a practitioner is 
registered to conduct research with a con-
trolled substance in schedule I or II, the 
practitioner may conduct research under 
this subsection on and after the date that 
is 30 days after the date on which the 
practitioner sends a notice to the Attorney 
General containing the following informa-
tion, with respect to each substance with 
which the practitioner will conduct the re-
search: 
‘‘(I) The chemical name of the 
substance. 
‘‘(II) The quantity of the sub-
stance to be used in the research. 
‘‘(III) Demonstration that the re-
search is in the category described in 
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paragraph (2), which demonstration 
may be satisfied— 
‘‘(aa) in the case of a grant, 
contract, cooperative agreement, 
or other transaction, or intra-
mural research project, by identi-
fying the sponsoring agency and 
supplying the number of the 
grant, 
contract, 
cooperative 
agreement, other transaction, or 
project; or 
‘‘(bb) in the case of an ap-
plication under section 505(i) of 
the Federal Food, Drug, and 
Cosmetic Act, by supplying the 
application number and the spon-
sor of record on the application. 
‘‘(IV) Demonstration that the re-
searcher is authorized to conduct re-
search with respect to the substance 
under the laws of the State in which 
the research will take place. 
‘‘(ii) VERIFICATION OF INFORMATION 
BY HHS OR VA.—Upon request from the 
Attorney General, the Secretary of Health 
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and Human Services or the Secretary of 
Veterans Affairs, as appropriate, shall 
verify information submitted by an appli-
cant under clause (i)(III). 
‘‘(B) RESEARCHER WITHOUT A CURRENT 
SCHEDULE I OR II RESEARCH REGISTRATION.— 
‘‘(i) IN GENERAL.—If a practitioner is 
not registered to conduct research with a 
controlled substance in schedule I or II, 
the practitioner may send a notice to the 
Attorney General containing the informa-
tion listed in subparagraph (A)(i), with re-
spect to each substance with which the 
practitioner will conduct the research. 
‘‘(ii) ATTORNEY GENERAL ACTION.— 
The Attorney General shall— 
‘‘(I) treat notice received under 
clause (i) as a sufficient application 
for a research registration; and 
‘‘(II) not later than 45 days of 
receiving such a notice that contains 
all information required under sub-
paragraph (A)(i)— 
‘‘(aa) register the applicant; 
or 
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‘‘(bb) serve an order to show 
cause upon the applicant in ac-
cordance with section 304(c). 
‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney 
General shall provide a means to permit a practi-
tioner to submit a notification under paragraph (3) 
electronically. 
‘‘(5) LIMITATION ON AMOUNTS.—A practitioner 
conducting research with a schedule I substance 
under this subsection may only possess the amounts 
of schedule I substance identified in— 
‘‘(A) the notification to the Attorney Gen-
eral under paragraph (3); or 
‘‘(B) a supplemental notification that the 
practitioner may send if the practitioner needs 
additional amounts for the research, which sup-
plemental notification shall include— 
‘‘(i) the name of the practitioner; 
‘‘(ii) the additional quantity needed of 
the substance; and 
‘‘(iii) an attestation that the research 
to be conducted with the substance is con-
sistent with the scope of the research that 
was the subject of the notification under 
paragraph (3). 
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‘‘(6) IMPORTATION
AND
EXPORTATION
RE-
QUIREMENTS NOT AFFECTED.—Nothing in this sub-
section alters the requirements of part A of title III, 
regarding the importation and exportation of con-
trolled substances.’’. 
(b) SEPARATE REGISTRATIONS NOT REQUIRED FOR 
ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec-
tion 302(c) of the Controlled Substances Act (21 U.S.C. 
822(c)) is amended by adding at the end the following: 
‘‘(4) An agent or employee of a research insti-
tution that is conducting research with a controlled 
substance if— 
‘‘(A) the agent or employee is acting with-
in the scope of the professional practice of the 
agent or employee; 
‘‘(B) another agent or employee of the in-
stitution is registered to conduct research with 
a controlled substance in the same schedule; 
‘‘(C) the researcher who is so registered— 
‘‘(i) informs the Attorney General of 
the name, position title, and employing in-
stitution of the agent or employee who is 
not separately registered; 
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‘‘(ii) authorizes that agent or em-
ployee to perform research under the reg-
istration of the registered researcher; and 
‘‘(iii) affirms that any act taken by 
that agent or employee involving a con-
trolled substance shall be attributable to 
the registered researcher, as if the re-
searcher had directly committed the act, 
for purposes of any proceeding under sec-
tion 304(a) to suspend or revoke the reg-
istration of the registered researcher; and 
‘‘(D) the Attorney General does not, within 
30 days of receiving the information, authoriza-
tion, and affirmation described in subparagraph 
(C), refuse, for a reason listed in section 
304(a), to allow the agent or employee to pos-
sess the substance without a separate registra-
tion.’’. 
(c) SINGLE REGISTRATION FOR RELATED RESEARCH 
SITES.—Section 302(e) of the Controlled Substances Act 
(21 U.S.C. 822(e)) is amended by adding at the end the 
following: 
‘‘(3)(A) Notwithstanding paragraph (1), a person 
registered to conduct research with a controlled substance 
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under section 303(f) may conduct the research under a 
single registration if— 
‘‘(i) the research occurs exclusively on sites all 
of which are— 
‘‘(I) within the same city or county; and 
‘‘(II) under the control of the same institu-
tion, organization, or agency; and 
‘‘(ii) before commencing the research, the re-
searcher notifies the Attorney General of each site 
where— 
‘‘(I) the research will be conducted; or 
‘‘(II) the controlled substance will be 
stored or administered. 
‘‘(B) A site described in subparagraph (A) shall be 
included in a registration described in that subparagraph 
only if the researcher has notified the Attorney General 
of the site— 
‘‘(i) in the application for the registration; or 
‘‘(ii) before the research is conducted, or before 
the controlled substance is stored or administered, at 
the site. 
‘‘(C) The Attorney General may, in consultation with 
the Secretary, issue regulations addressing, with respect 
to research sites described in subparagraph (A)— 
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‘‘(i) the manner in which controlled substances 
may be delivered to the research sites; 
‘‘(ii) the storage and security of controlled sub-
stances at the research sites; 
‘‘(iii) the maintenance of records for the re-
search sites; and 
‘‘(iv) any other matters necessary to ensure ef-
fective controls against diversion at the research 
sites.’’. 
(d) NEW INSPECTION NOT REQUIRED IN CERTAIN 
SITUATIONS.—Section 302(f) of the Controlled Sub-
stances Act (21 U.S.C. 822(f)) is amended— 
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 
The’’; and 
(2) by adding at the end the following: 
‘‘(2)(A) If a person is registered to conduct research 
with a controlled substance and applies for a registration, 
or for a modification of a registration, to conduct research 
with a second controlled substance that is in the same 
schedule as the first controlled substance, or is in a sched-
ule with a higher numerical designation than the schedule 
of the first controlled substance, a new inspection by the 
Attorney General of the registered location is not required. 
‘‘(B) Nothing in subparagraph (A) shall prohibit the 
Attorney General from conducting an inspection that the 
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rule to implement this Act and the amendments 
made by this Act in accordance with section 553 of 
title 5, United States Code. 
Æ 
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