[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 331 Enrolled Bill (ENR)]
S.331
One Hundred Nineteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Friday,
the third day of January, two thousand and twenty five
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).
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.