[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 331 Engrossed in Senate (ES)]
<DOC>
119th CONGRESS
1st Session
S. 331
_______________________________________________________________________
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 (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) 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 (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) 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 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) 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 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:
``(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 date of 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)
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).
Passed the Senate March 14, 2025.
Attest:
Secretary.
119th CONGRESS
1st Session
S. 331
_______________________________________________________________________
AN ACT
To amend the Controlled Substances Act with respect to the scheduling
of fentanyl-related substances, and for other purposes.