II
118THCONGRESS
1
STSESSION S. 1141
To amend the Controlled Substances Act with respect to the scheduling
of fentanyl-related substances, and for other purposes.
IN THE SENATE OF THE UNITED STATES
MARCH30, 2023
Mr. C
ASSIDY(for himself, Mr. MARSHALL, and Mr. YOUNG) introduced the
following bill; which was read twice and referred to the Committee on the
Judiciary
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-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
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SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-1
STANCES. 2
Section 202(c) of the Controlled Substances Act (21 3
U.S.C. 812(c)) is amended by adding at the end of sched-4
ule I the following: 5
‘‘(e)(1) Unless specifically exempted or unless listed 6
in another schedule, any material, compound, mixture, or 7
preparation which contains any quantity of a fentanyl-re-8
lated substance, or which contains the salts, isomers, and 9
salts of isomers of a fentanyl-related substance whenever 10
the existence of such salts, isomers, and salts of isomers 11
is possible within the specific chemical designation. 12
‘‘(2) For purposes of paragraph (1), except as pro-13
vided in paragraph (3), the term ‘fentanyl-related sub-14
stance’ means any substance that is structurally related 15
to fentanyl by 1 or more of the following modifications: 16
‘‘(A) By replacement of the phenyl portion of 17
the phenethyl group by any monocycle, whether or 18
not further substituted in or on the monocycle. 19
‘‘(B) By substitution in or on the phenethyl 20
group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 21
haloalkyl, amino, or nitro groups. 22
‘‘(C) By substitution in or on the piperidine 23
ring with alkyl, alkenyl, alkoxyl, ester, ether, 24
hydroxyl, halo, haloalkyl, amino, or nitro groups. 25
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‘‘(D) By replacement of the aniline ring with 1
any aromatic monocycle whether or not further sub-2
stituted in or on the aromatic monocycle. 3
‘‘(E) By replacement of the N–propionyl group 4
with another acyl group. 5
‘‘(3) A substance that satisfies the definition of the 6
term ‘fentanyl-related substance’ in paragraph (2) shall 7
nonetheless not be treated as a fentanyl-related substance 8
subject to this schedule if the substance— 9
‘‘(A) is controlled by action of the Attorney 10
General under section 201; or 11
‘‘(B) is otherwise expressly listed in a schedule 12
other than this schedule. 13
‘‘(4)(A) The Attorney General may by order publish 14
in the Federal Register a list of substances that satisfy 15
the definition of the term ‘fentanyl-related substance’ in 16
paragraph (2). 17
‘‘(B) The absence of a substance from a list published 18
under subparagraph (A) does not negate the control status 19
of the substance under this schedule if the substance satis-20
fies the definition of the term ‘fentanyl-related substance’ 21
in paragraph (2).’’. 22
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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 (21 U.S.C. 355(i)); or 25
‘‘(B) is— 26
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‘‘(i) conducted by the Department of 1
Health and Human Services or the De-2
partment of Veterans Affairs; or 3
‘‘(ii) funded partly or entirely by a 4
grant, contract, cooperative agreement, or 5
other transaction from the Department of 6
Health and Human Services or the De-7
partment of Veterans Affairs. 8
‘‘(3) E
XPEDITED PROCEDURES .— 9
‘‘(A) R
ESEARCHER WITH A CURRENT 10
SCHEDULE I OR II RESEARCH REGISTRATION .— 11
‘‘(i) I
N GENERAL.—If a practitioner is 12
registered to conduct research with a con-13
trolled substance in schedule I or II, the 14
practitioner may conduct research under 15
this subsection on and after the date that 16
is 30 days after the date on which the 17
practitioner sends a notice to the Attorney 18
General containing the following informa-19
tion, with respect to each substance with 20
which the practitioner will conduct the re-21
search: 22
‘‘(I) The chemical name of the 23
substance. 24
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‘‘(II) The quantity of the sub-1
stance to be used in the research. 2
‘‘(III) Demonstration that the re-3
search is in the category described in 4
paragraph (2), which demonstration 5
may be satisfied— 6
‘‘(aa) in the case of a grant, 7
contract, cooperative agreement, 8
or other transaction, or intra-9
mural research project, by identi-10
fying the sponsoring agency and 11
supplying the number of the 12
grant, contract, cooperative 13
agreement, other transaction, or 14
project; or 15
‘‘(bb) in the case of an ap-16
plication under section 505(i) of 17
the Federal Food, Drug, and 18
Cosmetic Act (21 U.S.C. 355(i)), 19
by supplying the application 20
number and the sponsor of 21
record on the application. 22
‘‘(IV) Demonstration that the re-23
searcher is authorized to conduct re-24
search with respect to the substance 25
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under the laws of the State in which 1
the research will take place. 2
‘‘(ii) V
ERIFICATION OF INFORMATION 3
BY HHS OR VA.—Upon request from the 4
Attorney General, the Secretary of Health 5
and Human Services or the Secretary of 6
Veterans Affairs, as appropriate, shall 7
verify information submitted by an appli-8
cant under clause (i)(III). 9
‘‘(B) R
ESEARCHER WITHOUT A CURRENT 10
SCHEDULE I OR II RESEARCH REGISTRATION .— 11
‘‘(i) I
N GENERAL.—If a practitioner is 12
not registered to conduct research with a 13
controlled substance in schedule I or II, 14
the practitioner may send a notice to the 15
Attorney General containing the informa-16
tion listed in subparagraph (A)(i), with re-17
spect to each substance with which the 18
practitioner will conduct the research. 19
‘‘(ii) A
TTORNEY GENERAL ACTION .— 20
The Attorney General shall— 21
‘‘(I) treat notice received under 22
clause (i) as a sufficient application 23
for a research registration; and 24
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‘‘(II) not later than 45 days of 1
receiving such a notice that contains 2
all information required under sub-3
paragraph (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 15
under this subsection may only possess the amounts 16
of 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 RE -8
QUIREMENTS NOT AFFECTED .—Nothing in this sub-9
section alters the requirements of part A of title III, 10
regarding the importation and exportation of con-11
trolled substances.’’. 12
(b) S
EPARATEREGISTRATIONSNOTREQUIRED FOR 13
A
DDITIONALRESEARCHER INSAMEINSTITUTION.—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 insti-17
tution that is conducting research with a controlled 18
substance if— 19
‘‘(A) the agent or employee is acting with-20
in the scope of the professional practice of the 21
agent or employee; 22
‘‘(B) another agent or employee of the in-23
stitution is registered to conduct research with 24
a 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 em-6
ployee to perform research under the reg-7
istration of 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 11
the registered researcher, as if the re-12
searcher had directly committed the act, 13
for purposes of any proceeding under sec-14
tion 304(a) to suspend or revoke the reg-15
istration of the registered 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 20
304(a), to allow the agent or employee to pos-21
sess the substance without a separate registra-22
tion.’’. 23
(c) S
INGLEREGISTRATION FORRELATEDRESEARCH 24
S
ITES.—Section 302(e) of the Controlled Substances Act 25
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(21 U.S.C. 822(e)) is amended by adding at the end the 1
following: 2
‘‘(3)(A) Notwithstanding paragraph (1), a person 3
registered to conduct research with a controlled substance 4
under section 303(f) may conduct the research under a 5
single registration if— 6
‘‘(i) the research occurs exclusively on sites all 7
of 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 16
stored or administered. 17
‘‘(B) A site described in subparagraph (A) shall be 18
included in a registration described in that subparagraph 19
only if the researcher has notified the Attorney General 20
of 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 2
to 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 re-8
search sites; and 9
‘‘(iv) any other matters necessary to ensure ef-10
fective controls against diversion at the research 11
sites.’’. 12
(d) N
EWINSPECTIONNOTREQUIRED INCERTAIN 13
S
ITUATIONS.—Section 302(f) of the Controlled Sub-14
stances Act (21 U.S.C. 822(f)) is amended— 15
(1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1) 16
The’’; and 17
(2) by adding at the end the following: 18
‘‘(2)(A) If a person is registered to conduct research 19
with a controlled substance and applies for a registration, 20
or for a modification of a registration, to conduct research 21
with a second controlled substance that is in the same 22
schedule as the first controlled substance, or is in a sched-23
ule with a higher numerical designation than the schedule 24
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of the first controlled substance, a new inspection by the 1
Attorney General of the registered location is not required. 2
‘‘(B) Nothing in subparagraph (A) shall prohibit the 3
Attorney General from conducting an inspection that the 4
Attorney General determines necessary to ensure that a 5
registrant maintains effective controls against diversion.’’. 6
(e) C
ONTINUATION OF RESEARCH ONSUBSTANCES 7
N
EWLYADDED TOSCHEDULEI.—Section 302 of the 8
Controlled Substances Act (21 U.S.C. 822) is amended 9
by adding at the end the following: 10
‘‘(h) C
ONTINUATION OFRESEARCH ONSUBSTANCES 11
N
EWLYADDED TOSCHEDULEI.—If a person is con-12
ducting research on a substance when the substance is 13
added to schedule I, and the person is already registered 14
to conduct research with a controlled substance in sched-15
ule I— 16
‘‘(1) not later than 90 days after the scheduling 17
of the newly scheduled substance, the person shall 18
submit a completed application for registration or 19
modification of existing registration, to conduct re-20
search on the substance, in accordance with regula-21
tions issued by the Attorney General for purposes of 22
this paragraph; 23
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‘‘(2) the person may, notwithstanding sub-1
sections (a) and (b), continue to conduct the re-2
search on the substance until— 3
‘‘(A) the person withdraws the application 4
described in paragraph (1) of this subsection; 5
or 6
‘‘(B) the Attorney General serves on the 7
person an order to show cause proposing the 8
denial of the application under section 304(c); 9
‘‘(3) if the Attorney General serves an order to 10
show cause as described in paragraph (2)(B) and 11
the person requests a hearing, the hearing shall be 12
held on an expedited basis and not later than 45 13
days after the request is made, except that the hear-14
ing may be held at a later time if so requested by 15
the person; and 16
‘‘(4) if the person sends a copy of the applica-17
tion described in paragraph (1) to a manufacturer or 18
distributor of the substance, receipt of the copy by 19
the manufacturer or distributor shall constitute suf-20
ficient evidence that the person is authorized to re-21
ceive the substance.’’. 22
(f) T
REATMENT OF CERTAINMANUFACTURING AC-23
TIVITIES ASCOINCIDENT TORESEARCH.—Section 302 of 24
the Controlled Substances Act (21 U.S.C. 822), as amend-25
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ed by subsection (e), is amended by adding at the end 1
the following: 2
‘‘(i) T
REATMENT OFCERTAINMANUFACTURINGAC-3
TIVITIES ASCOINCIDENT TORESEARCH.— 4
‘‘(1) I
N GENERAL.—Except as provided in para-5
graph (3), a person who is registered to perform re-6
search on a controlled substance may perform manu-7
facturing activities with small quantities of that sub-8
stance, including activities described in paragraph 9
(2), without being required to obtain a manufac-10
turing registration, if— 11
‘‘(A) the activities are performed for the 12
purpose of the research; and 13
‘‘(B) the activities and the quantities of 14
the substance involved in the activities are stat-15
ed in— 16
‘‘(i) a notification submitted to the 17
Attorney General under section 303(l); 18
‘‘(ii) a research protocol filed with an 19
application for registration approval under 20
section 303(f); or 21
‘‘(iii) a notification to the Attorney 22
General that includes— 23
‘‘(I) the name of the registrant; 24
and 25
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‘‘(II) an attestation that the re-1
search to be conducted with the small 2
quantities of manufactured substance 3
is consistent with the scope of the re-4
search that is the basis for the reg-5
istration. 6
‘‘(2) A
CTIVITIES INCLUDED.—Activities per-7
mitted under paragraph (1) include— 8
‘‘(A) processing the substance to create ex-9
tracts, tinctures, oils, solutions, derivatives, or 10
other forms of the substance consistent with— 11
‘‘(i) the information provided as part 12
of a notification submitted to the Attorney 13
General under section 303(l); or 14
‘‘(ii) a research protocol filed with an 15
application for registration approval under 16
section 303(f); and 17
‘‘(B) dosage form development studies per-18
formed for the purpose of requesting an inves-19
tigational new drug exemption under section 20
505(i) of the Federal Food, Drug, and Cos-21
metic Act (21 U.S.C. 355(i)). 22
‘‘(3) E
XCEPTION REGARDING MARIJUANA .—The 23
authority under paragraph (1) to manufacture sub-24
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stances does not include the authority to grow mari-1
juana.’’. 2
(g) T
RANSPARENCY REGARDINGSPECIALPROCE-3
DURES.—Section 303 of the Controlled Substances Act 4
(21 U.S.C. 823), as amended by subsection (a), is amend-5
ed by adding at the end the following: 6
‘‘(o) T
RANSPARENCY REGARDINGSPECIALPROCE-7
DURES.— 8
‘‘(1) I
N GENERAL.—If the Attorney General de-9
termines, with respect to a controlled substance, that 10
an application by a practitioner to conduct research 11
with the substance should be considered under a 12
process, or subject to criteria, different from the 13
process or criteria applicable to applications to con-14
duct research with other controlled substances in the 15
same schedule, the Attorney General shall make 16
public, including by posting on the website of the 17
Drug Enforcement Administration— 18
‘‘(A) the identities of all substances for 19
which such determinations have been made; 20
‘‘(B) the process and criteria that shall be 21
applied to applications to conduct research with 22
those substances; and 23
‘‘(C) how the process and criteria described 24
in subparagraph (B) differ from the process 25
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and criteria applicable to applications to con-1
duct research with other controlled substances 2
in the same schedule. 3
‘‘(2) T
IMING OF POSTING.—The Attorney Gen-4
eral shall make information described in paragraph 5
(1) public upon making a determination described in 6
that paragraph, regardless of whether a practitioner 7
has submitted such an application at that time.’’. 8
SEC. 4. RULEMAKING. 9
(a) I
NTERIMFINALRULES.—The Attorney Gen-10
eral— 11
(1) shall, not later than 1 year of the date of 12
enactment of this Act, issue rules to implement this 13
Act and the amendments made by this Act; and 14
(2) may issue the rules under paragraph (1) as 15
interim final rules. 16
(b) P
ROCEDURE FORFINALRULE.— 17
(1) E
FFECTIVENESS OF INTERIM FINAL 18
RULES.—A rule issued by the Attorney General as 19
an interim final rule under subsection (a) shall be-20
come immediately effective as an interim final rule 21
without requiring the Attorney General to dem-22
onstrate good cause therefor, notwithstanding sub-23
paragraph (B) of section 553(b) of title 5, United 24
States Code. 25
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(2) OPPORTUNITY FOR COMMENT AND HEAR -1
ING.—An interim final rule issued under subsection 2
(a) shall give interested persons the opportunity to 3
comment and to request a hearing. 4
(3) F
INAL RULE.—After the conclusion of such 5
proceedings, the Attorney General shall issue a final 6
rule to implement this Act and the amendments 7
made by this Act in accordance with section 553 of 8
title 5, United States Code. 9
Æ
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