H.R. 27

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 27 Referred in Senate (RFS)]

<DOC>
119th CONGRESS
1st Session
H. R. 27

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

February 10, 2025

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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Halt All Lethal Trafficking of 
Fentanyl Act'' or the ``HALT Fentanyl Act''.

SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUBSTANCES.

Section 202(c) of the Controlled Substances Act (21 U.S.C. 812(c)) 
is amended by adding at the end of schedule 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-related 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 provided in 
paragraph (3), the term `fentanyl-related substance' 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.
``(D) By replacement of the aniline ring with any 
aromatic monocycle whether or not further substituted 
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 satisfies the definition of the term 
`fentanyl-related substance' in paragraph (2).''.

SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RESEARCH.

(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 subsection (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 (g), a 
practitioner may conduct research described in paragraph (2) of 
this subsection with 1 or more schedule I substances in 
accordance with subparagraph (A) or (B) of paragraph (3) of 
this subsection.
``(2) Research subject to expedited procedures.--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, the Department 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 Department 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 
controlled 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 information, with 
respect to each substance with which the 
practitioner will conduct the research:
``(I) The chemical name of the 
substance.
``(II) The quantity of the 
substance to be used in the research.
``(III) Demonstration that the 
research 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 intramural 
research project, by 
identifying the sponsoring 
agency and supplying the number 
of the grant, contract, 
cooperative agreement, other 
transaction, or project; or
``(bb) in the case of an 
application under section 
505(i) of the Federal Food, 
Drug, and Cosmetic Act, by 
supplying the application 
number and the sponsor of 
record on the application.
``(IV) Demonstration that the 
researcher is authorized to conduct 
research 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 Affairs, as appropriate, shall verify 
information 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 information listed in 
subparagraph (A)(i), with respect 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 
subparagraph (A)(i)--
``(aa) register the 
applicant; or
``(bb) serve an order to 
show cause upon the applicant 
in accordance with section 
304(c).
``(4) Electronic submissions.--The Attorney General shall 
provide a means to permit a practitioner 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 General 
under paragraph (3); or
``(B) a supplemental notification that the 
practitioner may send if the practitioner needs 
additional amounts for the research, which supplemental 
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 consistent 
with the scope of the research that was the 
subject of the notification under paragraph 
(3).
``(6) Importation and exportation requirements not 
affected.--Nothing in this subsection alters the requirements 
of part A of title III, regarding the importation and 
exportation of controlled 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.--
(1) In general.--Section 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 institution that 
is conducting research with a controlled substance if--
``(A) the agent or employee is acting within the 
scope of the professional practice of the agent or 
employee;
``(B) another agent or employee of the institution 
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 institution 
of the agent or employee who is not separately 
registered;
``(ii) authorizes that agent or employee to 
perform research under the registration of the 
registered researcher; and
``(iii) affirms that any act taken by that 
agent or employee involving a controlled 
substance shall be attributable to the 
registered researcher, as if the researcher had 
directly committed the act, for purposes of any 
proceeding under section 304(a) to suspend or 
revoke the registration of the registered 
researcher; and
``(D) the Attorney General does not, within 30 days 
of receiving the information, authorization, and 
affirmation described in subparagraph (C), refuse, for 
a reason listed in section 304(a), to allow the agent 
or employee to possess the substance without a separate 
registration.''.
(2) Technical correction.--Section 302(c)(3) of the 
Controlled Substances Act (21 U.S.C. 822(c)(3)) is amended by 
striking ``(25)'' and inserting ``(27)''.
(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(g) 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 institution, organization, or 
agency; and
``(ii) before commencing the research, the 
researcher 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)--
``(i) the manner in which controlled 
substances may be delivered to the research 
sites;
``(ii) the storage and security of 
controlled substances at the research sites;
``(iii) the maintenance of records for the 
research sites; and
``(iv) any other matters necessary to 
ensure effective controls against diversion at 
the research sites.''.
(d) New Inspection Not Required in Certain Situations.--Section 
302(f) of the Controlled Substances 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 schedule 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 conducting 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 schedule I--
``(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 research on the substance, in 
accordance with regulations issued by the Attorney General for 
purposes of this paragraph;
``(2) the person may, notwithstanding subsections (a) and 
(b), continue to conduct the research 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 hearing may be held at a later time if so requested by the 
person; and
``(4) if the person sends a copy of the application 
described in paragraph (1) to a manufacturer or distributor of 
the substance, receipt of the copy by the manufacturer or 
distributor shall constitute sufficient evidence that the 
person is authorized to receive the substance.''.
(f) Treatment of Certain Manufacturing Activities as Coincident to 
Research.--Section 302 of the Controlled Substances Act (21 U.S.C. 
822), as amended by subsection (e), is amended by adding at the end the 
following:
``(i) Treatment of Certain Manufacturing Activities as Coincident 
to Research.--
``(1) In general.--Except as provided in paragraph (3), a 
person who is registered to perform research on a controlled 
substance may perform manufacturing activities with small 
quantities of that substance, including activities described in 
paragraph (2), without being required to obtain a manufacturing 
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 stated in--
``(i) a notification submitted to the 
Attorney General under section 303(n);
``(ii) a research protocol filed with an 
application for registration approval under 
section 303(g); or
``(iii) a notification to the Attorney 
General that includes--
``(I) the name of the registrant; 
and
``(II) an attestation that the 
research to be conducted with the small 
quantities of manufactured substance is 
consistent with the scope of the 
research that is the basis for the 
registration.
``(2) Activities included.--Activities permitted under 
paragraph (1) include--
``(A) processing the substance to create extracts, 
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(n); or
``(ii) a research protocol filed with an 
application for registration approval under 
section 303(g); and
``(B) dosage form development studies performed for 
the purpose of requesting an investigational new drug 
exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic 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 Procedures.--Section 303 of the 
Controlled Substances Act (21 U.S.C. 823), as amended by subsection 
(a), is amended by adding at the end the following:
``(o) Transparency Regarding Special Procedures.--
``(1) In general.--If the Attorney General determines, 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 
conduct 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--
``(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 conduct research with 
other controlled substances in the same schedule.
``(2) Timing of posting.--The Attorney General 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. TECHNICAL CORRECTION ON CONTROLLED SUBSTANCES DISPENSING.

Effective as if included in the enactment of Public Law 117-328--
(1) section 1252(a) of division FF of Public Law 117-328 
(136 Stat. 5681) is amended, in the matter being inserted into 
section 302(e) of the Controlled Substances Act, by striking 
``303(g)'' and inserting ``303(h)'';
(2) section 1262 of division FF of Public Law 117-328 (136 
Stat. 5681) is amended--
(A) in subsection (a)--
(i) in the matter preceding paragraph (1), 
by striking ``303(g)'' and inserting 
``303(h)'';
(ii) in the matter being stricken by 
subsection (a)(2), by striking ``(g)(1)'' and 
inserting ``(h)(1)''; and
(iii) in the matter being inserted by 
subsection (a)(2), by striking ``(g) 
Practitioners'' and inserting ``(h) 
Practitioners''; and
(B) in subsection (b)--
(i) in the matter being stricken by 
paragraph (1), by striking ``303(g)(1)'' and 
inserting ``303(h)(1)'';
(ii) in the matter being inserted by 
paragraph (1), by striking ``303(g)'' and 
inserting ``303(h)'';
(iii) in the matter being stricken by 
paragraph (2)(A), by striking ``303(g)(2)'' and 
inserting ``303(h)(2)'';
(iv) in the matter being stricken by 
paragraph (3), by striking ``303(g)(2)(B)'' and 
inserting ``303(h)(2)(B)'';
(v) in the matter being stricken by 
paragraph (5), by striking ``303(g)'' and 
inserting ``303(h)''; and
(vi) in the matter being stricken by 
paragraph (6), by striking ``303(g)'' and 
inserting ``303(h)''; and
(3) section 1263(b) of division FF of Public Law 117-328 
(136 Stat. 5685) is amended--
(A) by striking ``303(g)(2)'' and inserting 
``303(h)(2)''; and
(B) by striking ``(21 U.S.C. 823(g)(2))'' and 
inserting ``(21 U.S.C. 823(h)(2))''.

SEC. 5. RULEMAKING.

(a) Interim Final Rules.--The Attorney General--
(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.--
(1) Effectiveness of interim final rules.--A rule issued by 
the Attorney General as an interim final rule under subsection 
(a) shall become immediately effective as an interim final rule 
without requiring the Attorney General to demonstrate good 
cause therefor, notwithstanding subparagraph (B) of section 
553(b) of title 5, United States Code.
(2) Opportunity for comment and hearing.--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. 6. PENALTIES.

(a) In General.--Section 401(b)(1) of the Controlled Substances Act 
(21 U.S.C. 841(b)(1)) is amended--
(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
(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''.
(c) Definition of Fentanyl-related Substance.--Section 102 of the 
Controlled Substances Act (21 U.S.C. 802) is amended by adding at the 
end the following:
``(60) The term `fentanyl-related substance' has the 
meaning given the term in subsection (e)(2) of schedule I of 
section 202(c).''.

SEC. 7. APPLICABILITY; OTHER MATTERS.

(a) In General.--Irrespective of the date on which the rules 
required by section 5 are finalized, the amendments made by this Act 
apply beginning as of the enactment of this Act.
(b) Rule of Construction.--Nothing in the amendments made by this 
Act may be construed as evidence 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 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 February 6, 2025.

Attest:

KEVIN F. MCCUMBER,

Clerk.