S. 331

[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>