Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act
This act permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act.
Under the act, offenses involving fentanyl-related substances are triggered by the same quantity thresholds and subject to the same penalties as offenses involving fentanyl analogues (e.g., offenses involving 100 grams or more trigger a 10-year mandatory minimum prison term).
Additionally, the act establishes a new, alternative registration process for certain schedule I research.
The act also makes several other changes to registration requirements for conducting research with controlled substances, including
Finally, the act expresses the sense that Congress agrees with the interpretation of the Controlled Substances Act in United States v. McCray, a 2018 case decided by the U.S. District Court for the Western District of New York. In that case, the court held that butyryl fentanyl, a controlled substance, can be considered an analogue of fentanyl even though, under the Controlled Substances Act, the term controlled substance analogue specifically excludes a controlled substance.
[119th Congress Public Law 26]
[From the U.S. Government Publishing Office]
[[Page 409]]
HALT ALL LETHAL TRAFFICKING OF FENTANYL ACT
[[Page 139 STAT. 410]]
Public Law 119-26
119th Congress
An Act
To amend the Controlled Substances Act with respect to the scheduling of
fentanyl-related substances, and for other purposes. <<NOTE: July 16,
2025 - [S. 331]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Halt All Lethal
Trafficking of Fentanyl Act.>>
SECTION 1. <<NOTE: 21 USC 801 note.>> 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) <<NOTE: Definition.>> 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
[[Page 139 STAT. 411]]
``(B) is otherwise expressly listed in a schedule other than
this schedule.
``(4)(A) <<NOTE: Federal Register, publication. List.>> 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 (21 U.S.C.
355(i)); 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) <<NOTE: Notices.>> Expedited procedures.--
``(A) Researcher with a current schedule i or ii
research registration.--
``(i) <<NOTE: Time period.>> 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,
[[Page 139 STAT. 412]]
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 (21 U.S.C. 355(i)),
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) <<NOTE: Deadline.>> 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) <<NOTE: Notification.>> 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
[[Page 139 STAT. 413]]
``(iii) <<NOTE: Attestation.>> 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) <<NOTE: Study.>> Inspector general report.--Not later
than 1 year after the date of enactment of the Halt All Lethal
Trafficking of Fentanyl Act, the Inspector General of the
Department of Justice shall complete a study, and submit to
Congress 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) <<NOTE: Notification.>> 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) <<NOTE: Deadline.>> 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
[[Page 139 STAT. 414]]
``(II) under the control of the same institution,
organization, or agency; and
``(ii) <<NOTE: Notification.>> 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) <<NOTE: Regulations.>> 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) <<NOTE: Records.>> 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) <<NOTE: Deadline.>> 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--
[[Page 139 STAT. 415]]
``(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) <<NOTE: Hearing. Deadline.>> 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) <<NOTE: Records.>> 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) <<NOTE: Notification.>> a
notification to the Attorney General that
includes--
``(I) the name of the registrant;
and
``(II) <<NOTE: Attestation.>> 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)).
[[Page 139 STAT. 416]]
``(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) <<NOTE: Determination. Public information. Web
posting.>> 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) <<NOTE: Process. Criteria. Applicability.>>
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. <<NOTE: Effective date. 21 USC 822 note.>> 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) <<NOTE: 21 USC 822.>> 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) <<NOTE: 21 USC 823.>> 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) <<NOTE: 21 USC 824.>> 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) <<NOTE: 21 USC 829a.>> in the matter
being stricken by paragraph (2)(A), by striking
``303(g)(2)'' and inserting ``303(h)(2)'';
[[Page 139 STAT. 417]]
(iv) in the matter being stricken by paragraph
(3) <<NOTE: 42 USC 290bb-36d.>> , by striking
``303(g)(2)(B)'' and inserting ``303(h)(2)(B)'';
(v) <<NOTE: 42 USC 1395l.>> in the matter
being stricken by paragraph (5), by striking
``303(g)'' and inserting ``303(h)''; and
(vi) <<NOTE: 42 USC 1395m.>> 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. <<NOTE: 21 USC 812 note.>> RULEMAKING.
(a) Interim Final Rules.--The Attorney General--
(1) <<NOTE: Deadline.>> 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 the undesignated
matter following paragraph (4) 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:
[[Page 139 STAT. 418]]
``(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) <<NOTE: Effective date. 21 USC 812 note.>> 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
date of enactment of this Act.
(b) <<NOTE: 21 USC 841 note.>> Rule of Construction.--Nothing in
the amendments made by this Act may be construed as evidence that, in
applying sections 401(b)(1) of the Controlled Substances Act (21 U.S.C.
841(b)(1)) and 1010(b) of the Controlled Substances Import and Export
Act (21 U.S.C. 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.--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 (W.D.N.Y. 2018).
Approved July 16, 2025.
LEGISLATIVE HISTORY--S. 331:
---------------------------------------------------------------------------
CONGRESSIONAL RECORD, Vol. 171 (2025):
Mar. 10, 11, 13, 14, considered and passed Senate.
June 11, 12, considered and passed House.
DAILY COMPILATION OF PRESIDENTIAL DOCUMENTS (2025):
July 16, Presidential remarks.
<all>
Message on Senate action sent to the House.
Received in the House.
Held at the desk.
Rules Committee Resolution H. Res. 489 Reported to House. Rule provides for consideration of H.R. 884, H.R. 2056, H.R. 2096 and S. 331. The resolution provides for consideration of H.R. 884, H.R. 2056, H.R. 2096, and S. 331 under a closed rule with one hour of general debate for each bill. The resolution provides for one motion to recommit on H.R. 884, H.R. 2056, and H.R. 2096, and one motion to commit on S. 331.
Rule H. Res. 489 passed House.
Considered under the provisions of rule H. Res. 489. (consideration: CR H2625-2633)
Rule provides for consideration of H.R. 884, H.R. 2056, H.R. 2096 and S. 331. The resolution provides for consideration of H.R. 884, H.R. 2056, H.R. 2096, and S. 331 under a closed rule with one hour of general debate for each bill. The resolution provides for one motion to recommit on H.R. 884, H.R. 2056, and H.R. 2096, and one motion to commit on S. 331.
DEBATE - The House proceeded with one hour of debate on S. 331.
The previous question was ordered pursuant to the rule.
POSTPONED PROCEEDINGS - At the conclusion of debate on S. 331, the Chair put the question on passage of the bill and by voice vote, announced that the ayes had prevailed. Mr. Pallone demanded the yeas and nays and the Chair postponed further proceedings until a time to be announced.
Enacted as Public Law 119-26
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Considered as unfinished business. (consideration: CR H2806)
Passed/agreed to in House: On passage Passed by the Yeas and Nays: 321 - 104 (Roll no. 166). (text: 6/11/2025 CR H2625-2627)
Roll Call #166 (House)On passage Passed by the Yeas and Nays: 321 - 104 (Roll no. 166). (text: 6/11/2025 CR H2625-2627)
Roll Call #166 (House)Motion to reconsider laid on the table Agreed to without objection.
Presented to President.
Presented to President.
Signed by President.
Signed by President.
Became Public Law No: 119-26.
Became Public Law No: 119-26.