IIB 
118TH CONGRESS 
1ST SESSION 
H. R. 467 
IN THE SENATE OF THE UNITED STATES 
MAY 30, 2023 
Received; read twice and referred to the Committee on the Judiciary 
AN ACT 
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, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Halt All Lethal Traf-
ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 
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. 
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‘‘(C) By substitution in or on the piperidine 
ring with alkyl, alkenyl, alkoxyl, ester, ether, 
hydroxyl, halo, haloalkyl, amino, or nitro groups. 
‘‘(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— 
(1) by redesignating the second subsection (l) 
(relating to required training for prescribers) as sub-
section (m); and 
(2) by adding at the end the following: 
‘‘(n) SPECIAL
PROVISIONS
FOR
PRACTITIONERS 
CONDUCTING CERTAIN RESEARCH WITH SCHEDULE I 
CONTROLLED 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— 
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‘‘(i) conducted by the Department of 
Health and Human Services, the Depart-
ment of Defense, or the Department of 
Veterans Affairs; or 
‘‘(ii) funded partly or entirely by a 
grant, contract, cooperative agreement, or 
other transaction from the Department of 
Health and Human Services, the Depart-
ment of Defense, or the Department 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: 
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‘‘(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 
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-
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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 
and Human Services, the Department of 
Defense, or the Secretary of Veterans Af-
fairs, as appropriate, shall verify informa-
tion submitted by an applicant 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— 
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‘‘(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 
‘‘(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 
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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). 
‘‘(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. 
‘‘(7) INSPECTOR GENERAL REPORT.—Not later 
than 1 year after the date of enactment of this Act, 
the Inspector General of the Department of Justice 
shall complete a study, and submit a report thereon, 
about research described in paragraph (2) of this 
subsection with fentanyl.’’. 
(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: 
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‘‘(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; 
‘‘(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 
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‘‘(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: 
‘‘(4)(A) Notwithstanding paragraph (1), a person 
registered to conduct research with a controlled substance 
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 
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‘‘(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)— 
‘‘(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— 
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(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 
Attorney General determines necessary to ensure that a 
registrant maintains effective controls against diversion.’’. 
(e) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I.—Section 302 of the 
Controlled Substances Act (21 U.S.C. 822) is amended 
by adding at the end the following: 
‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES 
NEWLY ADDED TO SCHEDULE I.—If a person is con-
ducting research on a substance when the substance is 
added to schedule I, and the person is already registered 
to conduct research with a controlled substance in sched-
ule I— 
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‘‘(1) not later than 90 days after the scheduling 
of the newly scheduled substance, the person shall 
submit a completed application for registration or 
modification of existing registration, to conduct re-
search on the substance, in accordance with regula-
tions issued by the Attorney General for purposes of 
this paragraph; 
‘‘(2) the person may, notwithstanding sub-
sections (a) and (b), continue to conduct the re-
search on the substance until— 
‘‘(A) the person withdraws the application 
described in paragraph (1) of this subsection; 
or 
‘‘(B) the Attorney General serves on the 
person an order to show cause proposing the 
denial of the application under section 304(c); 
‘‘(3) if the Attorney General serves an order to 
show cause as described in paragraph (2)(B) and 
the person requests a hearing, the hearing shall be 
held on an expedited basis and not later than 45 
days after the request is made, except that the hear-
ing may be held at a later time if so requested by 
the person; and 
‘‘(4) if the person sends a copy of the applica-
tion described in paragraph (1) to a manufacturer or 
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distributor of the substance, receipt of the copy by 
the manufacturer or distributor shall constitute suf-
ficient evidence that the person is authorized to re-
ceive the substance.’’. 
(f) TREATMENT OF CERTAIN MANUFACTURING AC-
TIVITIES AS COINCIDENT TO RESEARCH.—Section 302 of 
the Controlled Substances Act (21 U.S.C. 822), as amend-
ed by subsection (e), is amended by adding at the end 
the following: 
‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC-
TIVITIES AS COINCIDENT TO RESEARCH.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (3), a person who is registered to perform re-
search on a controlled substance may perform manu-
facturing activities with small quantities of that sub-
stance, including activities described in paragraph 
(2), without being required to obtain a manufac-
turing registration, if— 
‘‘(A) the activities are performed for the 
purpose of the research; and 
‘‘(B) the activities and the quantities of 
the substance involved in the activities are stat-
ed in— 
‘‘(i) a notification submitted to the 
Attorney General under section 303(l); 
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‘‘(ii) a research protocol filed with an 
application for registration approval under 
section 303(f); or 
‘‘(iii) a notification to the Attorney 
General that includes— 
‘‘(I) the name of the registrant; 
and 
‘‘(II) an attestation that the re-
search to be conducted with the small 
quantities of manufactured substance 
is consistent with the scope of the re-
search that is the basis for the reg-
istration. 
‘‘(2) ACTIVITIES
INCLUDED.—Activities per-
mitted under paragraph (1) include— 
‘‘(A) processing the substance to create ex-
tracts, tinctures, oils, solutions, derivatives, or 
other forms of the substance consistent with— 
‘‘(i) the information provided as part 
of a notification submitted to the Attorney 
General under section 303(l); or 
‘‘(ii) a research protocol filed with an 
application for registration approval under 
section 303(f); and 
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‘‘(B) dosage form development studies per-
formed for the purpose of requesting an inves-
tigational new drug exemption under section 
505(i) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(i)). 
‘‘(3) EXCEPTION
REGARDING
MARIHUANA.— 
The authority under paragraph (1) to manufacture 
substances does not include the authority to grow 
marihuana.’’. 
(g) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.—Section 303 of the Controlled Substances Act 
(21 U.S.C. 823), as amended by subsection (a), is amend-
ed by adding at the end the following: 
‘‘(o) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.— 
‘‘(1) IN GENERAL.—If the Attorney General de-
termines, with respect to a controlled substance, that 
an application by a practitioner to conduct research 
with the substance should be considered under a 
process, or subject to criteria, different from the 
process or criteria applicable to applications to con-
duct research with other controlled substances in the 
same schedule, the Attorney General shall make 
public, including by posting on the website of the 
Drug Enforcement Administration— 
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‘‘(A) the identities of all substances for 
which such determinations have been made; 
‘‘(B) the process and criteria that shall be 
applied to applications to conduct research with 
those substances; and 
‘‘(C) how the process and criteria described 
in subparagraph (B) differ from the process 
and criteria applicable to applications to con-
duct research with other controlled substances 
in the same schedule. 
‘‘(2) TIMING OF POSTING.—The Attorney Gen-
eral shall make information described in paragraph 
(1) public upon making a determination described in 
that paragraph, regardless of whether a practitioner 
has submitted such an application at that time.’’. 
SEC. 4. RULEMAKING. 
(a) INTERIM FINAL RULES.—The Attorney Gen-
eral— 
(1) shall, not later than 6 months after the date 
of enactment of this Act, issue rules to implement 
this Act and the amendments made by this Act; and 
(2) may issue the rules under paragraph (1) as 
interim final rules. 
(b) PROCEDURE FOR FINAL RULE.— 
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(1) 
EFFECTIVENESS
OF
INTERIM
FINAL 
RULES.—A rule issued by the Attorney General as 
an interim final rule under subsection (a) shall be-
come immediately effective as an interim final rule 
without requiring the Attorney General to dem-
onstrate good cause therefor, notwithstanding sub-
paragraph (B) of section 553(b) of title 5, United 
States Code. 
(2) OPPORTUNITY FOR COMMENT AND HEAR-
ING.—An interim final rule issued under subsection 
(a) shall give interested persons the opportunity to 
comment and to request a hearing. 
(3) FINAL RULE.—After the conclusion of such 
proceedings, the Attorney General shall issue a final 
rule to implement this Act and the amendments 
made by this Act in accordance with section 553 of 
title 5, United States Code. 
SEC. 5. PENALTIES. 
(a) IN GENERAL.—Section 401(b)(1) of the Con-
trolled Substances Act (21 U.S.C. 841(b)(1)) is amend-
ed— 
(1) in subparagraph (A)(vi), by inserting ‘‘or a 
fentanyl-related substance’’ after ‘‘any analogue of 
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 
propanamide’’; and 
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(2) in subparagraph (B)(vi), by inserting ‘‘or a 
fentanyl-related substance’’ after ‘‘any analogue of 
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 
propanamide’’. 
(b) IMPORTATION
AND
EXPORTATION.—Section 
1010(b) of the Controlled Substances Import and Export 
Act (21 U.S.C. 960(b)) is amended— 
(1) in paragraph (1)(F), by inserting ‘‘or a 
fentanyl-related substance’’ after ‘‘any analogue of 
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 
propanamide’’; and 
(2) in paragraph (2)(F), by inserting ‘‘or a 
fentanyl-related substance’’ after ‘‘any analogue of 
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 
propanamide’’. 
SEC. 6. APPLICABILITY; OTHER MATTERS. 
(a) IN GENERAL.—Irrespective of the date on which 
the rules required by section 4 are finalized, the amend-
ments made by this Act apply beginning as of the enact-
ment of this Act. 
(b) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this Act may be construed as evi-
dence that, in applying sections 401(b)(1) and 1010(b) of 
the Controlled Substances Act (21 U.S.C. 841(b)(1) and 
960(b)) with respect to conduct occurring before the date 
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of the enactment of this Act, a fentanyl-related substance 
(as defined by such amendments) is not an analogue of 
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 
propanamide. 
(c) SENSE OF CONGRESS.—The Congress agrees with 
the interpretation of the Controlled Substances Act (21 
U.S.C. 801 et seq.) in United States v. McCray, 346 F. 
Supp. 3d 363 (2018). 
Passed the House of Representatives May 25, 2023. 
Attest: 
CHERYL L. JOHNSON, 
Clerk. 
By LISA P. GRANT 
Deputy Clerk. 
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