118THCONGRESS
1
STSESSION H. R. 467
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-1
tives of the United States of America in Congress assembled, 2 2
•HR 467 EH
SECTION 1. SHORT TITLE. 1
This Act may be cited as the ‘‘Halt All Lethal Traf-2
ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 3
SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-4
STANCES. 5
Section 202(c) of the Controlled Substances Act (21 6
U.S.C. 812(c)) is amended by adding at the end of sched-7
ule I the following: 8
‘‘(e)(1) Unless specifically exempted or unless listed 9
in another schedule, any material, compound, mixture, or 10
preparation which contains any quantity of a fentanyl-re-11
lated substance, or which contains the salts, isomers, and 12
salts of isomers of a fentanyl-related substance whenever 13
the existence of such salts, isomers, and salts of isomers 14
is possible within the specific chemical designation. 15
‘‘(2) For purposes of paragraph (1), except as pro-16
vided in paragraph (3), the term ‘fentanyl-related sub-17
stance’ means any substance that is structurally related 18
to fentanyl by 1 or more of the following modifications: 19
‘‘(A) By replacement of the phenyl portion of 20
the phenethyl group by any monocycle, whether or 21
not further substituted in or on the monocycle. 22
‘‘(B) By substitution in or on the phenethyl 23
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 24
haloalkyl, amino, or nitro groups. 25 3
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‘‘(C) By substitution in or on the piperidine 1
ring with alkyl, alkenyl, alkoxyl, ester, ether, 2
hydroxyl, halo, haloalkyl, amino, or nitro groups. 3
‘‘(D) By replacement of the aniline ring with 4
any aromatic monocycle whether or not further sub-5
stituted in or on the aromatic monocycle. 6
‘‘(E) By replacement of the N–propionyl group 7
with another acyl group. 8
‘‘(3) A substance that satisfies the definition of the 9
term ‘fentanyl-related substance’ in paragraph (2) shall 10
nonetheless not be treated as a fentanyl-related substance 11
subject to this schedule if the substance— 12
‘‘(A) is controlled by action of the Attorney 13
General under section 201; or 14
‘‘(B) is otherwise expressly listed in a schedule 15
other than this schedule. 16
‘‘(4)(A) The Attorney General may by order publish 17
in the Federal Register a list of substances that satisfy 18
the definition of the term ‘fentanyl-related substance’ in 19
paragraph (2). 20
‘‘(B) The absence of a substance from a list published 21
under subparagraph (A) does not negate the control status 22
of the substance under this schedule if the substance satis-23
fies the definition of the term ‘fentanyl-related substance’ 24
in paragraph (2).’’. 25 4
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SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-1
SEARCH. 2
(a) A
LTERNATIVE REGISTRATIONPROCESS FOR 3
S
CHEDULEI RESEARCH.—Section 303 of the Controlled 4
Substances Act (21 U.S.C. 823) is amended— 5
(1) by redesignating the second subsection (l) 6
(relating to required training for prescribers) as sub-7
section (m); and 8
(2) by adding at the end the following: 9
‘‘(n) S
PECIALPROVISIONS FOR PRACTITIONERS 10
C
ONDUCTINGCERTAINRESEARCHWITHSCHEDULEI 11
C
ONTROLLEDSUBSTANCES.— 12
‘‘(1) I
N GENERAL.—Notwithstanding subsection 13
(f), a practitioner may conduct research described in 14
paragraph (2) of this subsection with 1 or more 15
schedule I substances in accordance with subpara-16
graph (A) or (B) of paragraph (3) of this sub-17
section. 18
‘‘(2) R
ESEARCH SUBJECT TO EXPEDITED PRO -19
CEDURES.—Research described in this paragraph is 20
research that— 21
‘‘(A) is with respect to a drug that is the 22
subject of an investigational use exemption 23
under section 505(i) of the Federal Food, Drug, 24
and Cosmetic Act; or 25
‘‘(B) is— 26 5
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‘‘(i) conducted by the Department of 1
Health and Human Services, the Depart-2
ment of Defense, or the Department of 3
Veterans Affairs; or 4
‘‘(ii) funded partly or entirely by a 5
grant, contract, cooperative agreement, or 6
other transaction from the Department of 7
Health and Human Services, the Depart-8
ment of Defense, or the Department of 9
Veterans Affairs. 10
‘‘(3) E
XPEDITED PROCEDURES .— 11
‘‘(A) R
ESEARCHER WITH A CURRENT 12
SCHEDULE I OR II RESEARCH REGISTRATION .— 13
‘‘(i) I
N GENERAL.—If a practitioner is 14
registered to conduct research with a con-15
trolled substance in schedule I or II, the 16
practitioner may conduct research under 17
this subsection on and after the date that 18
is 30 days after the date on which the 19
practitioner sends a notice to the Attorney 20
General containing the following informa-21
tion, with respect to each substance with 22
which the practitioner will conduct the re-23
search: 24 6
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‘‘(I) The chemical name of the 1
substance. 2
‘‘(II) The quantity of the sub-3
stance to be used in the research. 4
‘‘(III) Demonstration that the re-5
search is in the category described in 6
paragraph (2), which demonstration 7
may be satisfied— 8
‘‘(aa) in the case of a grant, 9
contract, cooperative agreement, 10
or other transaction, or intra-11
mural research project, by identi-12
fying the sponsoring agency and 13
supplying the number of the 14
grant, contract, cooperative 15
agreement, other transaction, or 16
project; or 17
‘‘(bb) in the case of an ap-18
plication under section 505(i) of 19
the Federal Food, Drug, and 20
Cosmetic Act, by supplying the 21
application number and the spon-22
sor of record on the application. 23
‘‘(IV) Demonstration that the re-24
searcher is authorized to conduct re-25 7
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search with respect to the substance 1
under the laws of the State in which 2
the research will take place. 3
‘‘(ii) V
ERIFICATION OF INFORMATION 4
BY HHS OR VA.—Upon request from the 5
Attorney General, the Secretary of Health 6
and Human Services, the Department of 7
Defense, or the Secretary of Veterans Af-8
fairs, as appropriate, shall verify informa-9
tion submitted by an applicant under 10
clause (i)(III). 11
‘‘(B) R
ESEARCHER WITHOUT A CURRENT 12
SCHEDULE I OR II RESEARCH REGISTRATION .— 13
‘‘(i) I
N GENERAL.—If a practitioner is 14
not registered to conduct research with a 15
controlled substance in schedule I or II, 16
the practitioner may send a notice to the 17
Attorney General containing the informa-18
tion listed in subparagraph (A)(i), with re-19
spect to each substance with which the 20
practitioner will conduct the research. 21
‘‘(ii) A
TTORNEY GENERAL ACTION .— 22
The Attorney General shall— 23 8
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‘‘(I) treat notice received under 1
clause (i) as a sufficient application 2
for a research registration; and 3
‘‘(II) not later than 45 days of 4
receiving such a notice that contains 5
all information required under sub-6
paragraph (A)(i)— 7
‘‘(aa) register the applicant; 8
or 9
‘‘(bb) serve an order to show 10
cause upon the applicant in ac-11
cordance with section 304(c). 12
‘‘(4) E
LECTRONIC SUBMISSIONS .—The Attorney 13
General shall provide a means to permit a practi-14
tioner to submit a notification under paragraph (3) 15
electronically. 16
‘‘(5) L
IMITATION ON AMOUNTS .—A practitioner 17
conducting research with a schedule I substance 18
under this subsection may only possess the amounts 19
of schedule I substance identified in— 20
‘‘(A) the notification to the Attorney Gen-21
eral under paragraph (3); or 22
‘‘(B) a supplemental notification that the 23
practitioner may send if the practitioner needs 24 9
•HR 467 EH
additional amounts for the research, which sup-1
plemental notification shall include— 2
‘‘(i) the name of the practitioner; 3
‘‘(ii) the additional quantity needed of 4
the substance; and 5
‘‘(iii) an attestation that the research 6
to be conducted with the substance is con-7
sistent with the scope of the research that 8
was the subject of the notification under 9
paragraph (3). 10
‘‘(6) I
MPORTATION AND EXPORTATION RE -11
QUIREMENTS NOT AFFECTED .—Nothing in this sub-12
section alters the requirements of part A of title III, 13
regarding the importation and exportation of con-14
trolled substances. 15
‘‘(7) I
NSPECTOR GENERAL REPORT .—Not later 16
than 1 year after the date of enactment of this Act, 17
the Inspector General of the Department of Justice 18
shall complete a study, and submit a report thereon, 19
about research described in paragraph (2) of this 20
subsection with fentanyl.’’. 21
(b) S
EPARATEREGISTRATIONSNOTREQUIRED FOR 22
A
DDITIONALRESEARCHER INSAMEINSTITUTION.—Sec-23
tion 302(c) of the Controlled Substances Act (21 U.S.C. 24
822(c)) is amended by adding at the end the following: 25 10
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‘‘(4) An agent or employee of a research insti-1
tution that is conducting research with a controlled 2
substance if— 3
‘‘(A) the agent or employee is acting with-4
in the scope of the professional practice of the 5
agent or employee; 6
‘‘(B) another agent or employee of the in-7
stitution is registered to conduct research with 8
a controlled substance in the same schedule; 9
‘‘(C) the researcher who is so registered— 10
‘‘(i) informs the Attorney General of 11
the name, position title, and employing in-12
stitution of the agent or employee who is 13
not separately registered; 14
‘‘(ii) authorizes that agent or em-15
ployee to perform research under the reg-16
istration of the registered researcher; and 17
‘‘(iii) affirms that any act taken by 18
that agent or employee involving a con-19
trolled substance shall be attributable to 20
the registered researcher, as if the re-21
searcher had directly committed the act, 22
for purposes of any proceeding under sec-23
tion 304(a) to suspend or revoke the reg-24
istration of the registered researcher; and 25 11
•HR 467 EH
‘‘(D) the Attorney General does not, within 1
30 days of receiving the information, authoriza-2
tion, and affirmation described in subparagraph 3
(C), refuse, for a reason listed in section 4
304(a), to allow the agent or employee to pos-5
sess the substance without a separate registra-6
tion.’’. 7
(c) S
INGLEREGISTRATION FORRELATEDRESEARCH 8
S
ITES.—Section 302(e) of the Controlled Substances Act 9
(21 U.S.C. 822(e)) is amended by adding at the end the 10
following: 11
‘‘(4)(A) Notwithstanding paragraph (1), a person 12
registered to conduct research with a controlled substance 13
under section 303(f) may conduct the research under a 14
single registration if— 15
‘‘(i) the research occurs exclusively on sites all 16
of which are— 17
‘‘(I) within the same city or county; and 18
‘‘(II) under the control of the same institu-19
tion, organization, or agency; and 20
‘‘(ii) before commencing the research, the re-21
searcher notifies the Attorney General of each site 22
where— 23
‘‘(I) the research will be conducted; or 24 12
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‘‘(II) the controlled substance will be 1
stored or administered. 2
‘‘(B) A site described in subparagraph (A) shall be 3
included in a registration described in that subparagraph 4
only if the researcher has notified the Attorney General 5
of the site— 6
‘‘(i) in the application for the registration; or 7
‘‘(ii) before the research is conducted, or before 8
the controlled substance is stored or administered, at 9
the site. 10
‘‘(C) The Attorney General may, in consultation with 11
the Secretary, issue regulations addressing, with respect 12
to research sites described in subparagraph (A)— 13
‘‘(i) the manner in which controlled substances 14
may be delivered to the research sites; 15
‘‘(ii) the storage and security of controlled sub-16
stances at the research sites; 17
‘‘(iii) the maintenance of records for the re-18
search sites; and 19
‘‘(iv) any other matters necessary to ensure ef-20
fective controls against diversion at the research 21
sites.’’. 22
(d) N
EWINSPECTIONNOTREQUIRED INCERTAIN 23
S
ITUATIONS.—Section 302(f) of the Controlled Sub-24
stances Act (21 U.S.C. 822(f)) is amended— 25 13
•HR 467 EH
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 1
The’’; and 2
(2) by adding at the end the following: 3
‘‘(2)(A) If a person is registered to conduct research 4
with a controlled substance and applies for a registration, 5
or for a modification of a registration, to conduct research 6
with a second controlled substance that is in the same 7
schedule as the first controlled substance, or is in a sched-8
ule with a higher numerical designation than the schedule 9
of the first controlled substance, a new inspection by the 10
Attorney General of the registered location is not required. 11
‘‘(B) Nothing in subparagraph (A) shall prohibit the 12
Attorney General from conducting an inspection that the 13
Attorney General determines necessary to ensure that a 14
registrant maintains effective controls against diversion.’’. 15
(e) C
ONTINUATION OF RESEARCH ONSUBSTANCES 16
N
EWLYADDED TOSCHEDULEI.—Section 302 of the 17
Controlled Substances Act (21 U.S.C. 822) is amended 18
by adding at the end the following: 19
‘‘(h) C
ONTINUATION OFRESEARCH ONSUBSTANCES 20
N
EWLYADDED TOSCHEDULEI.—If a person is con-21
ducting research on a substance when the substance is 22
added to schedule I, and the person is already registered 23
to conduct research with a controlled substance in sched-24
ule I— 25 14
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‘‘(1) not later than 90 days after the scheduling 1
of the newly scheduled substance, the person shall 2
submit a completed application for registration or 3
modification of existing registration, to conduct re-4
search on the substance, in accordance with regula-5
tions issued by the Attorney General for purposes of 6
this paragraph; 7
‘‘(2) the person may, notwithstanding sub-8
sections (a) and (b), continue to conduct the re-9
search on the substance until— 10
‘‘(A) the person withdraws the application 11
described in paragraph (1) of this subsection; 12
or 13
‘‘(B) the Attorney General serves on the 14
person an order to show cause proposing the 15
denial of the application under section 304(c); 16
‘‘(3) if the Attorney General serves an order to 17
show cause as described in paragraph (2)(B) and 18
the person requests a hearing, the hearing shall be 19
held on an expedited basis and not later than 45 20
days after the request is made, except that the hear-21
ing may be held at a later time if so requested by 22
the person; and 23
‘‘(4) if the person sends a copy of the applica-24
tion described in paragraph (1) to a manufacturer or 25 15
•HR 467 EH
distributor of the substance, receipt of the copy by 1
the manufacturer or distributor shall constitute suf-2
ficient evidence that the person is authorized to re-3
ceive the substance.’’. 4
(f) T
REATMENT OF CERTAINMANUFACTURING AC-5
TIVITIES ASCOINCIDENT TORESEARCH.—Section 302 of 6
the Controlled Substances Act (21 U.S.C. 822), as amend-7
ed by subsection (e), is amended by adding at the end 8
the following: 9
‘‘(i) T
REATMENT OFCERTAINMANUFACTURINGAC-10
TIVITIES ASCOINCIDENT TORESEARCH.— 11
‘‘(1) I
N GENERAL.—Except as provided in para-12
graph (3), a person who is registered to perform re-13
search on a controlled substance may perform manu-14
facturing activities with small quantities of that sub-15
stance, including activities described in paragraph 16
(2), without being required to obtain a manufac-17
turing registration, if— 18
‘‘(A) the activities are performed for the 19
purpose of the research; and 20
‘‘(B) the activities and the quantities of 21
the substance involved in the activities are stat-22
ed in— 23
‘‘(i) a notification submitted to the 24
Attorney General under section 303(l); 25 16
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‘‘(ii) a research protocol filed with an 1
application for registration approval under 2
section 303(f); or 3
‘‘(iii) a notification to the Attorney 4
General that includes— 5
‘‘(I) the name of the registrant; 6
and 7
‘‘(II) an attestation that the re-8
search to be conducted with the small 9
quantities of manufactured substance 10
is consistent with the scope of the re-11
search that is the basis for the reg-12
istration. 13
‘‘(2) A
CTIVITIES INCLUDED.—Activities per-14
mitted under paragraph (1) include— 15
‘‘(A) processing the substance to create ex-16
tracts, tinctures, oils, solutions, derivatives, or 17
other forms of the substance consistent with— 18
‘‘(i) the information provided as part 19
of a notification submitted to the Attorney 20
General under section 303(l); or 21
‘‘(ii) a research protocol filed with an 22
application for registration approval under 23
section 303(f); and 24 17
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‘‘(B) dosage form development studies per-1
formed for the purpose of requesting an inves-2
tigational new drug exemption under section 3
505(i) of the Federal Food, Drug, and Cos-4
metic Act (21 U.S.C. 355(i)). 5
‘‘(3) E
XCEPTION REGARDING MARIHUANA .— 6
The authority under paragraph (1) to manufacture 7
substances does not include the authority to grow 8
marihuana.’’. 9
(g) T
RANSPARENCY REGARDINGSPECIALPROCE-10
DURES.—Section 303 of the Controlled Substances Act 11
(21 U.S.C. 823), as amended by subsection (a), is amend-12
ed by adding at the end the following: 13
‘‘(o) T
RANSPARENCY REGARDINGSPECIALPROCE-14
DURES.— 15
‘‘(1) I
N GENERAL.—If the Attorney General de-16
termines, with respect to a controlled substance, that 17
an application by a practitioner to conduct research 18
with the substance should be considered under a 19
process, or subject to criteria, different from the 20
process or criteria applicable to applications to con-21
duct research with other controlled substances in the 22
same schedule, the Attorney General shall make 23
public, including by posting on the website of the 24
Drug Enforcement Administration— 25 18
•HR 467 EH
‘‘(A) the identities of all substances for 1
which such determinations have been made; 2
‘‘(B) the process and criteria that shall be 3
applied to applications to conduct research with 4
those substances; and 5
‘‘(C) how the process and criteria described 6
in subparagraph (B) differ from the process 7
and criteria applicable to applications to con-8
duct research with other controlled substances 9
in the same schedule. 10
‘‘(2) T
IMING OF POSTING.—The Attorney Gen-11
eral shall make information described in paragraph 12
(1) public upon making a determination described in 13
that paragraph, regardless of whether a practitioner 14
has submitted such an application at that time.’’. 15
SEC. 4. RULEMAKING. 16
(a) I
NTERIMFINALRULES.—The Attorney Gen-17
eral— 18
(1) shall, not later than 6 months after the date 19
of enactment of this Act, issue rules to implement 20
this Act and the amendments made by this Act; and 21
(2) may issue the rules under paragraph (1) as 22
interim final rules. 23
(b) P
ROCEDURE FORFINALRULE.— 24 19
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(1) EFFECTIVENESS OF INTERIM FINAL 1
RULES.—A rule issued by the Attorney General as 2
an interim final rule under subsection (a) shall be-3
come immediately effective as an interim final rule 4
without requiring the Attorney General to dem-5
onstrate good cause therefor, notwithstanding sub-6
paragraph (B) of section 553(b) of title 5, United 7
States Code. 8
(2) O
PPORTUNITY FOR COMMENT AND HEAR -9
ING.—An interim final rule issued under subsection 10
(a) shall give interested persons the opportunity to 11
comment and to request a hearing. 12
(3) F
INAL RULE.—After the conclusion of such 13
proceedings, the Attorney General shall issue a final 14
rule to implement this Act and the amendments 15
made by this Act in accordance with section 553 of 16
title 5, United States Code. 17
SEC. 5. PENALTIES. 18
(a) I
NGENERAL.—Section 401(b)(1) of the Con-19
trolled Substances Act (21 U.S.C. 841(b)(1)) is amend-20
ed— 21
(1) in subparagraph (A)(vi), by inserting ‘‘or a 22
fentanyl-related substance’’ after ‘‘any analogue of 23
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 24
propanamide’’; and 25 20
•HR 467 EH
(2) in subparagraph (B)(vi), by inserting ‘‘or a 1
fentanyl-related substance’’ after ‘‘any analogue of 2
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 3
propanamide’’. 4
(b) I
MPORTATION AND EXPORTATION.—Section 5
1010(b) of the Controlled Substances Import and Export 6
Act (21 U.S.C. 960(b)) is amended— 7
(1) in paragraph (1)(F), by inserting ‘‘or a 8
fentanyl-related substance’’ after ‘‘any analogue of 9
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 10
propanamide’’; and 11
(2) in paragraph (2)(F), by inserting ‘‘or a 12
fentanyl-related substance’’ after ‘‘any analogue of 13
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 14
propanamide’’. 15
SEC. 6. APPLICABILITY; OTHER MATTERS. 16
(a) I
NGENERAL.—Irrespective of the date on which 17
the rules required by section 4 are finalized, the amend-18
ments made by this Act apply beginning as of the enact-19
ment of this Act. 20
(b) R
ULE OF CONSTRUCTION.—Nothing in the 21
amendments made by this Act may be construed as evi-22
dence that, in applying sections 401(b)(1) and 1010(b) of 23
the Controlled Substances Act (21 U.S.C. 841(b)(1) and 24
960(b)) with respect to conduct occurring before the date 25 21
•HR 467 EH
of the enactment of this Act, a fentanyl-related substance 1
(as defined by such amendments) is not an analogue of 2
N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 3
propanamide. 4
(c) S
ENSE OFCONGRESS.—The Congress agrees with 5
the interpretation of the Controlled Substances Act (21 6
U.S.C. 801 et seq.) in United States v. McCray, 346 F. 7
Supp. 3d 363 (2018). 8
Passed the House of Representatives May 25, 2023.
Attest:
Clerk. 118
TH
CONGRESS
1
ST
S
ESSION
H. R. 467
AN ACT
To amend the Controlled Substances Act with re-
spect to the scheduling of fentanyl-related sub-
stances, and for other purposes.