IB
Union Calendar No. 47
118THCONGRESS
1
STSESSION H. R. 467
[Report No. 118–67, Part I]
To amend the Controlled Substances Act with respect to the scheduling
of fentanyl-related substances, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY24, 2023
Mr. G
RIFFITH(for himself, Mr. LATTA, Mrs. RODGERSof Washington, Mr.
G
UTHRIE, Mr. BILIRAKIS, Mr. BUCSHON, Mr. HUDSON, Mr. BURGESS,
Mr. C
ARTERof Georgia, Mr. DUNCAN, Mr. DUNNof Florida, Mr. CREN-
SHAW, Mr. JOYCEof Pennsylvania, Mr. BALDERSON, Mrs.
H
ARSHBARGER, Mrs. MILLER-MEEKS, Mrs. CAMMACK, Mr. ALLEN, Mr.
W
ALBERG, Mr. CURTIS, Mr. PALMER, Mr. BUCHANAN, Mr. BANKS, Mr.
F
ITZGERALD, and Mr. MOONEY) 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
M
AY17, 2023
Additional sponsors: Mr. P
FLUGER, Mr. ARMSTRONG, Mr. PENCE, Mr. AUS-
TINSCOTTof Georgia, Mr. OBERNOLTE, Mr. WOMACK, Mr. EDWARDS,
Mr. F
INSTAD, Mr. CARL, Mrs. LESKO, Mr. MIKEGARCIAof California,
Mr. C
ISCOMANI, Mr. CLINE, Mrs. BICE, Mr. CARTERof Texas, Mr.
M
OOLENAAR, Mr. ROGERSof Kentucky, Mr. BEANof Florida, Mr.
M
EUSER, Mr. BOST, Mr. BARR, Mr. VANDREW, Mr. D’ESPOSITO, Mrs.
M
ILLERof West Virginia, Mrs. CHAVEZ-DEREMER, Mr. WESTERMAN,
Mr. L
ANGWORTHY, and Mr. BURCHETT
M
AY17, 2023
Reported from the Committee on Energy and Commerce with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
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MAY17, 2023
Committee on the Judiciary discharged; committed to the Committee of the
Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on January 24, 2023]
A BILL
To amend the Controlled Substances Act with respect to
the scheduling of fentanyl-related substances, and for
other purposes.
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Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Halt All Lethal Traf-4
ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’. 5
SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-6
STANCES. 7
Section 202(c) of the Controlled Substances Act (21 8
U.S.C. 812(c)) is amended by adding at the end of schedule 9
I the following: 10
‘‘(e)(1) Unless specifically exempted or unless listed in 11
another schedule, any material, compound, mixture, or 12
preparation which contains any quantity of a fentanyl-re-13
lated substance, or which contains the salts, isomers, and 14
salts of isomers of a fentanyl-related substance whenever the 15
existence of such salts, isomers, and salts of isomers is pos-16
sible within the specific chemical designation. 17
‘‘(2) For purposes of paragraph (1), except as provided 18
in paragraph (3), the term ‘fentanyl-related substance’ 19
means any substance that is structurally related to fentanyl 20
by 1 or more of the following modifications: 21
‘‘(A) By replacement of the phenyl portion of the 22
phenethyl group by any monocycle, whether or not 23
further substituted in or on the monocycle. 24
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‘‘(B) By substitution in or on the phenethyl 1
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 2
haloalkyl, amino, or nitro groups. 3
‘‘(C) By substitution in or on the piperidine 4
ring with alkyl, alkenyl, alkoxyl, ester, ether, 5
hydroxyl, halo, haloalkyl, amino, or nitro groups. 6
‘‘(D) By replacement of the aniline ring with 7
any aromatic monocycle whether or not further sub-8
stituted in or on the aromatic monocycle. 9
‘‘(E) By replacement of the N–propionyl group 10
with another acyl group. 11
‘‘(3) A substance that satisfies the definition of the 12
term ‘fentanyl-related substance’ in paragraph (2) shall 13
nonetheless not be treated as a fentanyl-related substance 14
subject to this schedule if the substance— 15
‘‘(A) is controlled by action of the Attorney Gen-16
eral under section 201; or 17
‘‘(B) is otherwise expressly listed in a schedule 18
other than this schedule. 19
‘‘(4)(A) The Attorney General may by order publish 20
in the Federal Register a list of substances that satisfy the 21
definition of the term ‘fentanyl-related substance’ in para-22
graph (2). 23
‘‘(B) The absence of a substance from a list published 24
under subparagraph (A) does not negate the control status 25
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of the substance under this schedule if the substance satisfies 1
the definition of the term ‘fentanyl-related substance’ in 2
paragraph (2).’’. 3
SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-4
SEARCH. 5
(a) A
LTERNATIVEREGISTRATIONPROCESS FOR 6
S
CHEDULEI RESEARCH.—Section 303 of the Controlled 7
Substances Act (21 U.S.C. 823) is amended— 8
(1) by redesignating the second subsection (l) (re-9
lating to required training for prescribers) as sub-10
section (m); and 11
(2) by adding at the end the following: 12
‘‘(n) S
PECIALPROVISIONS FORPRACTITIONERSCON-13
DUCTINGCERTAINRESEARCHWITHSCHEDULEI CON-14
TROLLEDSUBSTANCES.— 15
‘‘(1) I
N GENERAL.—Notwithstanding subsection 16
(f), a practitioner may conduct research described in 17
paragraph (2) of this subsection with 1 or more 18
schedule I substances in accordance with subpara-19
graph (A) or (B) of paragraph (3) of this subsection. 20
‘‘(2) R
ESEARCH SUBJECT TO EXPEDITED PROCE -21
DURES.—Research described in this paragraph is re-22
search that— 23
‘‘(A) is with respect to a drug that is the 24
subject of an investigational use exemption under 25
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section 505(i) of the Federal Food, Drug, and 1
Cosmetic Act; or 2
‘‘(B) is— 3
‘‘(i) conducted by the Department of 4
Health and Human Services or the Depart-5
ment of Veterans Affairs; or 6
‘‘(ii) funded partly or entirely by a 7
grant, contract, cooperative agreement, or 8
other transaction from the Department of 9
Health and Human Services or the Depart-10
ment of Veterans Affairs. 11
‘‘(3) E
XPEDITED PROCEDURES .— 12
‘‘(A) R
ESEARCHER WITH A CURRENT 13
SCHEDULE I OR II RESEARCH REGISTRATION .— 14
‘‘(i) I
N GENERAL.—If a practitioner is 15
registered to conduct research with a con-16
trolled substance in schedule I or II, the 17
practitioner may conduct research under 18
this subsection on and after the date that is 19
30 days after the date on which the practi-20
tioner sends a notice to the Attorney Gen-21
eral containing the following information, 22
with respect to each substance with which 23
the practitioner will conduct the research: 24
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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 agree-15
ment, other transaction, or 16
project; or 17
‘‘(bb) in the case of an appli-18
cation under section 505(i) of the 19
Federal Food, Drug, and Cosmetic 20
Act, by supplying the application 21
number and the sponsor of record 22
on the application. 23
‘‘(IV) Demonstration that the re-24
searcher is authorized to conduct re-25
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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 At-5
torney General, the Secretary of Health and 6
Human Services or the Secretary of Vet-7
erans Affairs, as appropriate, shall verify 8
information submitted by an applicant 9
under clause (i)(III). 10
‘‘(B) R
ESEARCHER WITHOUT A CURRENT 11
SCHEDULE I OR II RESEARCH REGISTRATION .— 12
‘‘(i) I
N GENERAL.—If a practitioner is 13
not registered to conduct research with a 14
controlled substance in schedule I or II, the 15
practitioner may send a notice to the Attor-16
ney General containing the information 17
listed in subparagraph (A)(i), with respect 18
to each substance with which the practi-19
tioner will conduct the research. 20
‘‘(ii) A
TTORNEY GENERAL ACTION .— 21
The Attorney General shall— 22
‘‘(I) treat notice received under 23
clause (i) as a sufficient application 24
for a research registration; and 25
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‘‘(II) not later than 45 days of re-1
ceiving such a notice that contains all 2
information required under subpara-3
graph (A)(i)— 4
‘‘(aa) register the applicant; 5
or 6
‘‘(bb) serve an order to show 7
cause upon the applicant in ac-8
cordance with section 304(c). 9
‘‘(4) E
LECTRONIC SUBMISSIONS.—The Attorney 10
General shall provide a means to permit a practi-11
tioner to submit a notification under paragraph (3) 12
electronically. 13
‘‘(5) L
IMITATION ON AMOUNTS .—A practitioner 14
conducting research with a schedule I substance under 15
this subsection may only possess the amounts of 16
schedule I substance identified in— 17
‘‘(A) the notification to the Attorney Gen-18
eral under paragraph (3); or 19
‘‘(B) a supplemental notification that the 20
practitioner may send if the practitioner needs 21
additional amounts for the research, which sup-22
plemental notification shall include— 23
‘‘(i) the name of the practitioner; 24
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‘‘(ii) the additional quantity needed of 1
the substance; and 2
‘‘(iii) an attestation that the research 3
to be conducted with the substance is con-4
sistent with the scope of the research that 5
was the subject of the notification under 6
paragraph (3). 7
‘‘(6) I
MPORTATION AND EXPORTATION REQUIRE -8
MENTS NOT AFFECTED .—Nothing in this subsection 9
alters the requirements of part A of title III, regard-10
ing the importation and exportation of controlled sub-11
stances.’’. 12
(b) S
EPARATEREGISTRATIONSNOTREQUIRED FOR 13
A
DDITIONALRESEARCHER IN SAMEINSTITUTION.—Sec-14
tion 302(c) of the Controlled Substances Act (21 U.S.C. 15
822(c)) is amended by adding at the end the following: 16
‘‘(4) An agent or employee of a research institu-17
tion that is conducting research with a controlled sub-18
stance if— 19
‘‘(A) the agent or employee is acting within 20
the scope of the professional practice of the agent 21
or employee; 22
‘‘(B) another agent or employee of the insti-23
tution is registered to conduct research with a 24
controlled substance in the same schedule; 25
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‘‘(C) the researcher who is so registered— 1
‘‘(i) informs the Attorney General of 2
the name, position title, and employing in-3
stitution of the agent or employee who is 4
not separately registered; 5
‘‘(ii) authorizes that agent or employee 6
to perform research under the registration of 7
the registered researcher; and 8
‘‘(iii) affirms that any act taken by 9
that agent or employee involving a con-10
trolled substance shall be attributable to the 11
registered researcher, as if the researcher 12
had directly committed the act, for purposes 13
of any proceeding under section 304(a) to 14
suspend or revoke the registration of the reg-15
istered researcher; and 16
‘‘(D) the Attorney General does not, within 17
30 days of receiving the information, authoriza-18
tion, and affirmation described in subparagraph 19
(C), refuse, for a reason listed in section 304(a), 20
to allow the agent or employee to possess the sub-21
stance without a separate registration.’’. 22
(c) S
INGLEREGISTRATION FORRELATEDRESEARCH 23
S
ITES.—Section 302(e) of the Controlled Substances Act (21 24
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U.S.C. 822(e)) is amended by adding at the end the fol-1
lowing: 2
‘‘(4)(A) Notwithstanding paragraph (1), a person reg-3
istered to conduct research with a controlled substance 4
under section 303(f) may conduct the research under a sin-5
gle registration if— 6
‘‘(i) the research occurs exclusively on sites all of 7
which are— 8
‘‘(I) within the same city or county; and 9
‘‘(II) under the control of the same institu-10
tion, organization, or agency; and 11
‘‘(ii) before commencing the research, the re-12
searcher notifies the Attorney General of each site 13
where— 14
‘‘(I) the research will be conducted; or 15
‘‘(II) the controlled substance will be stored 16
or administered. 17
‘‘(B) A site described in subparagraph (A) shall be in-18
cluded in a registration described in that subparagraph 19
only if the researcher has notified the Attorney General of 20
the site— 21
‘‘(i) in the application for the registration; or 22
‘‘(ii) before the research is conducted, or before 23
the controlled substance is stored or administered, at 24
the site. 25
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‘‘(C) The Attorney General may, in consultation with 1
the Secretary, issue regulations addressing, with respect to 2
research sites described in subparagraph (A)— 3
‘‘(i) the manner in which controlled substances 4
may be delivered to the research sites; 5
‘‘(ii) the storage and security of controlled sub-6
stances at the research sites; 7
‘‘(iii) the maintenance of records for the research 8
sites; and 9
‘‘(iv) any other matters necessary to ensure effec-10
tive controls against diversion at the research sites.’’. 11
(d) N
EWINSPECTIONNOTREQUIRED INCERTAINSIT-12
UATIONS.—Section 302(f) of the Controlled Substances Act 13
(21 U.S.C. 822(f)) is amended— 14
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 15
The’’; and 16
(2) by adding at the end the following: 17
‘‘(2)(A) If a person is registered to conduct research 18
with a controlled substance and applies for a registration, 19
or for a modification of a registration, to conduct research 20
with a second controlled substance that is in the same sched-21
ule as the first controlled substance, or is in a schedule with 22
a higher numerical designation than the schedule of the first 23
controlled substance, a new inspection by the Attorney Gen-24
eral of the registered location is not required. 25
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‘‘(B) Nothing in subparagraph (A) shall prohibit the 1
Attorney General from conducting an inspection that the 2
Attorney General determines necessary to ensure that a reg-3
istrant maintains effective controls against diversion.’’. 4
(e) C
ONTINUATION OF RESEARCH ON SUBSTANCES 5
N
EWLYADDED TOSCHEDULEI.—Section 302 of the Con-6
trolled Substances Act (21 U.S.C. 822) is amended by add-7
ing at the end the following: 8
‘‘(h) C
ONTINUATION OFRESEARCH ONSUBSTANCES 9
N
EWLYADDED TOSCHEDULEI.—If a person is conducting 10
research on a substance when the substance is added to 11
schedule I, and the person is already registered to conduct 12
research with a controlled substance in schedule I— 13
‘‘(1) not later than 90 days after the scheduling 14
of the newly scheduled substance, the person shall sub-15
mit a completed application for registration or modi-16
fication of existing registration, to conduct research 17
on the substance, in accordance with regulations 18
issued by the Attorney General for purposes of this 19
paragraph; 20
‘‘(2) the person may, notwithstanding sub-21
sections (a) and (b), continue to conduct the research 22
on the substance until— 23
‘‘(A) the person withdraws the application 24
described in paragraph (1) of this subsection; or 25
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‘‘(B) the Attorney General serves on the per-1
son an order to show cause proposing the denial 2
of the application under section 304(c); 3
‘‘(3) if the Attorney General serves an order to 4
show cause as described in paragraph (2)(B) and the 5
person requests a hearing, the hearing shall be held on 6
an expedited basis and not later than 45 days after 7
the request is made, except that the hearing may be 8
held at a later time if so requested by the person; and 9
‘‘(4) if the person sends a copy of the application 10
described in paragraph (1) to a manufacturer or dis-11
tributor of the substance, receipt of the copy by the 12
manufacturer or distributor shall constitute sufficient 13
evidence that the person is authorized to receive the 14
substance.’’. 15
(f) T
REATMENT OFCERTAINMANUFACTURINGACTIVI-16
TIES ASCOINCIDENT TORESEARCH.—Section 302 of the 17
Controlled Substances Act (21 U.S.C. 822), as amended by 18
subsection (e), is amended by adding at the end the fol-19
lowing: 20
‘‘(i) T
REATMENT OFCERTAINMANUFACTURINGAC-21
TIVITIES ASCOINCIDENT TORESEARCH.— 22
‘‘(1) I
N GENERAL.—Except as provided in para-23
graph (3), a person who is registered to perform re-24
search on a controlled substance may perform manu-25
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facturing activities with small quantities of that sub-1
stance, including activities described in paragraph 2
(2), without being required to obtain a manufac-3
turing registration, if— 4
‘‘(A) the activities are performed for the 5
purpose of the research; and 6
‘‘(B) the activities and the quantities of the 7
substance involved in the activities are stated 8
in— 9
‘‘(i) a notification submitted to the At-10
torney General under section 303(l); 11
‘‘(ii) a research protocol filed with an 12
application for registration approval under 13
section 303(f); or 14
‘‘(iii) a notification to the Attorney 15
General that includes— 16
‘‘(I) the name of the registrant; 17
and 18
‘‘(II) an attestation that the re-19
search to be conducted with the small 20
quantities of manufactured substance 21
is consistent with the scope of the re-22
search that is the basis for the registra-23
tion. 24
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‘‘(2) ACTIVITIES INCLUDED.—Activities per-1
mitted under paragraph (1) include— 2
‘‘(A) processing the substance to create ex-3
tracts, tinctures, oils, solutions, derivatives, or 4
other forms of the substance consistent with— 5
‘‘(i) the information provided as part 6
of a notification submitted to the Attorney 7
General under section 303(l); or 8
‘‘(ii) a research protocol filed with an 9
application for registration approval under 10
section 303(f); and 11
‘‘(B) dosage form development studies per-12
formed for the purpose of requesting an inves-13
tigational new drug exemption under section 14
505(i) of the Federal Food, Drug, and Cosmetic 15
Act (21 U.S.C. 355(i)). 16
‘‘(3) E
XCEPTION REGARDING MARIHUANA .—The 17
authority under paragraph (1) to manufacture sub-18
stances does not include the authority to grow mari-19
huana.’’. 20
(g) T
RANSPARENCY REGARDINGSPECIALPROCE-21
DURES.—Section 303 of the Controlled Substances Act (21 22
U.S.C. 823), as amended by subsection (a), is amended by 23
adding at the end the following: 24
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‘‘(o) TRANSPARENCYREGARDINGSPECIALPROCE-1
DURES.— 2
‘‘(1) I
N GENERAL.—If the Attorney General de-3
termines, with respect to a controlled substance, that 4
an application by a practitioner to conduct research 5
with the substance should be considered under a proc-6
ess, or subject to criteria, different from the process or 7
criteria applicable to applications to conduct research 8
with other controlled substances in the same schedule, 9
the Attorney General shall make public, including by 10
posting on the website of the Drug Enforcement Ad-11
ministration— 12
‘‘(A) the identities of all substances for 13
which such determinations have been made; 14
‘‘(B) the process and criteria that shall be 15
applied to applications to conduct research with 16
those substances; and 17
‘‘(C) how the process and criteria described 18
in subparagraph (B) differ from the process and 19
criteria applicable to applications to conduct re-20
search with other controlled substances in the 21
same schedule. 22
‘‘(2) T
IMING OF POSTING.—The Attorney General 23
shall make information described in paragraph (1) 24
public upon making a determination described in 25
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that paragraph, regardless of whether a practitioner 1
has submitted such an application at that time.’’. 2
SEC. 4. RULEMAKING. 3
(a) I
NTERIMFINALRULES.—The Attorney General— 4
(1) shall, not later than 1 year of the date of en-5
actment of this Act, issue rules to implement this Act 6
and the amendments made by this Act; and 7
(2) may issue the rules under paragraph (1) as 8
interim final rules. 9
(b) P
ROCEDURE FORFINALRULE.— 10
(1) E
FFECTIVENESS OF INTERIM FINAL RULES .— 11
A rule issued by the Attorney General as an interim 12
final rule under subsection (a) shall become imme-13
diately effective as an interim final rule without re-14
quiring the Attorney General to demonstrate good 15
cause therefor, notwithstanding subparagraph (B) of 16
section 553(b) of title 5, United States Code. 17
(2) O
PPORTUNITY FOR COMMENT AND HEAR -18
ING.—An interim final rule issued under subsection 19
(a) shall give interested persons the opportunity to 20
comment and to request a hearing. 21
(3) F
INAL RULE.—After the conclusion of such 22
proceedings, the Attorney General shall issue a final 23
rule to implement this Act and the amendments made 24
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by this Act in accordance with section 553 of title 5, 1
United States Code. 2
SEC. 5. PENALTIES. 3
(a) I
NGENERAL.—Section 401(b)(1) of the Controlled 4
Substances Act (21 U.S.C. 841(b)(1)) is amended— 5
(1) in subparagraph (A)(vi), by inserting ‘‘or a 6
fentanyl-related substance’’ after ‘‘any analogue of N- 7
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 8
propanamide’’; and 9
(2) in subparagraph (B)(vi), by inserting ‘‘or a 10
fentanyl-related substance’’ after ‘‘any analogue of N- 11
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 12
propanamide’’. 13
(b) I
MPORTATION AND EXPORTATION.—Section 14
1010(b) of the Controlled Substances Import and Export 15
Act (21 U.S.C. 960(b)) is amended— 16
(1) in paragraph (1)(F), by inserting ‘‘or a 17
fentanyl-related substance’’ after ‘‘any analogue of N- 18
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 19
propanamide’’; and 20
(2) in paragraph (2)(F), by inserting ‘‘or a 21
fentanyl-related substance’’ after ‘‘any analogue of N- 22
phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] 23
propanamide’’. 24
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•HR 467 RH
SEC. 6. APPLICABILITY; OTHER MATTERS. 1
(a) I
NGENERAL.—Irrespective of the date on which 2
the rules required by section 4 are finalized, the amend-3
ments made by this Act apply beginning as of the enact-4
ment of this Act. 5
(b) R
ULE OFCONSTRUCTION.—Nothing in the amend-6
ments made by this Act may be construed as evidence that, 7
in applying sections 401(b)(1) and 1010(b) of the Con-8
trolled Substances Act (21 U.S.C. 841(b)(1) and 960(b)) 9
with respect to conduct occurring before the date of the en-10
actment of this Act, a fentanyl-related substance (as defined 11
by such amendments) is not an analogue of N-phenyl-N- 12
[1-(2-phenylethyl)-4-piperidinyl] propanamide. 13
(c) S
ENSE OFCONGRESS.—The Congress agrees with 14
the interpretation of the Controlled Substances Act (21 15
U.S.C. 801 et seq.) in United States v. McCray, 346 F. 16
Supp. 3d 363 (2018). 17
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kjohnson on DSK79L0C42PROD with BILLS Union Calendar No.
47
118
TH
CONGRESS
1
ST
S
ESSION
H. R. 467
[Report No. 118–67, Part I]
A BILL
To amend the Controlled Substances Act with re-
spect to the scheduling of fentanyl-related sub-
stances, and for other purposes.
M
AY
17, 2023
Reported from the Committee on Energy and Commerce
with an amendment
M
AY
17, 2023
Committee on the Judiciary discharged; committed to the
Committee of the Whole House on the State of the
Union and ordered to be printed
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