119-hr27

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

    (RFS) ]

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

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 February 10, 2025

 Received; read twice and referred to the Committee on the Judiciary

_______________________________________________________________________

 AN ACT

 To amend the Controlled Substances Act with respect to the scheduling 
 of fentanyl-related substances, and for other purposes.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

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

 

Section 202
            (c) of the Controlled Substances Act (21 U.S.C. 812
            (c) ) 
is amended by adding at the end of schedule I the following:
 ``

    (e)

    (1) Unless specifically exempted or unless listed in another 
schedule, any material, compound, mixture, or preparation which 
contains any quantity of a fentanyl-related substance, or which 
contains the salts, isomers, and salts of isomers of a fentanyl-related 
substance whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation.
 ``

    (2) For purposes of paragraph

    (1) , except as provided in 
 paragraph

    (3) , the term `fentanyl-related substance' means any 
 substance that is structurally related to fentanyl by 1 or more 
 of the following modifications:
 ``
        (A) By replacement of the phenyl portion of the 
 phenethyl group by any monocycle, whether or not 
 further substituted in or on the monocycle.
 ``
        (B) By substitution in or on the phenethyl group 
 with alkyl, alkenyl, alkoxyl, hydroxyl, halo, 
 haloalkyl, amino, or nitro groups.
 ``
            (C) By substitution in or on the piperidine ring 
 with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, 
 halo, haloalkyl, amino, or nitro groups.
 ``
            (D) By replacement of the aniline ring with any 
 aromatic monocycle whether or not further substituted 
 in or on the aromatic monocycle.
 ``
        (E) By replacement of the N-propionyl group with 
 another acyl group.
 ``

    (3) A substance that satisfies the definition of the term 
 `fentanyl-related substance' in paragraph

    (2) shall nonetheless 
 not be treated as a fentanyl-related substance subject to this 
 schedule if the substance--
 ``
        (A) is controlled by action of the Attorney 
 General under 

section 201; or
 ``
        (B) is otherwise expressly listed in a schedule 
 other than this schedule.
 ``

    (4)
        (A) The Attorney General may by order publish in the 
 Federal Register a list of substances that satisfy the 
 definition of the term `fentanyl-related substance' in 
 paragraph

    (2) .
 ``
        (B) The absence of a substance from a list 
 published under subparagraph
        (A) does not negate the 
 control status of the substance under this schedule if 
 the substance satisfies the definition of the term 
 `fentanyl-related substance' in paragraph

    (2) .''.

SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RESEARCH.

    (a) Alternative Registration Process for Schedule I Research.--

Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended--

    (1) by redesignating the second subsection
            (l) (relating to 
 required training for prescribers) as subsection
            (m) ; and

    (2) by adding at the end the following:
 ``

    (n) Special Provisions for Practitioners Conducting Certain 
Research With Schedule I Controlled Substances.--
 ``

    (1) In general.--Notwithstanding subsection

    (g) , a 
 practitioner may conduct research described in paragraph

    (2) of 
 this subsection with 1 or more schedule I substances in 
 accordance with subparagraph
        (A) or
        (B) of paragraph

    (3) of 
 this subsection.
 ``

    (2) Research subject to expedited procedures.--Research 
 described in this paragraph is research that--
 ``
        (A) is with respect to a drug that is the subject 
 of an investigational use exemption under 

section 505
            (i) of the Federal Food, Drug, and Cosmetic Act; or
 ``
        (B) is--
 ``
            (i) conducted by the Department of Health 
 and Human Services, the Department of Defense, 
 or the Department of Veterans Affairs; or
 ``
            (ii) funded partly or entirely by a 
 grant, contract, cooperative agreement, or 
 other transaction from the Department of Health 
 and Human Services, the Department of Defense, 
 or the Department of Veterans Affairs.
 ``

    (3) Expedited procedures.--
 ``
        (A) Researcher with a current schedule i or ii 
 research registration.--
 ``
            (i) In general.--If a practitioner is 
 registered to conduct research with a 
 controlled substance in schedule I or II, the 
 practitioner may conduct research under this 
 subsection on and after the date that is 30 
 days after the date on which the practitioner 
 sends a notice to the Attorney General 
 containing the following information, with 
 respect to each substance with which the 
 practitioner will conduct the research:
 ``
            (I) The chemical name of the 
 substance.
 ``
            (II) The quantity of the 
 substance to be used in the research.
 ``
            (III) Demonstration that the 
 research is in the category described 
 in paragraph

    (2) , which demonstration 
 may be satisfied--
 ``

    (aa) in the case of a 
 grant, contract, cooperative 
 agreement, or other 
 transaction, or intramural 
 research project, by 
 identifying the sponsoring 
 agency and supplying the number 
 of the grant, contract, 
 cooperative agreement, other 
 transaction, or project; or
 ``

    (bb) in the case of an 
 application under 

section 505
            (i) of the Federal Food, 
 Drug, and Cosmetic Act, by 
 supplying the application 
 number and the sponsor of 
 record on the application.
 ``
            (IV) Demonstration that the 
 researcher is authorized to conduct 
 research with respect to the substance 
 under the laws of the State in which 
 the research will take place.
 ``
            (ii) Verification of information by hhs 
 or va.--Upon request from the Attorney General, 
 the Secretary of Health and Human Services, the 
 Department of Defense, or the Secretary of 
 Veterans Affairs, as appropriate, shall verify 
 information submitted by an applicant under 
 clause
            (i) 
            (III) .
 ``
        (B) Researcher without a current schedule i or ii 
 research registration.--
 ``
            (i) In general.--If a practitioner is not 
 registered to conduct research with a 
 controlled substance in schedule I or II, the 
 practitioner may send a notice to the Attorney 
 General containing the information listed in 
 subparagraph
        (A)
            (i) , with respect to each 
 substance with which the practitioner will 
 conduct the research.
 ``
            (ii) Attorney general action.--The 
 Attorney General shall--
 ``
            (I) treat notice received under 
 clause
            (i) as a sufficient application 
 for a research registration; and
 ``
            (II) not later than 45 days of 
 receiving such a notice that contains 
 all information required under 
 subparagraph
        (A)
            (i) --
 ``

    (aa) register the 
 applicant; or
 ``

    (bb) serve an order to 
 show cause upon the applicant 
 in accordance with 

section 304
            (c) .
 ``

    (4) Electronic submissions.--The Attorney General shall 
 provide a means to permit a practitioner to submit a 
 notification under paragraph

    (3) electronically.
 ``

    (5) Limitation on amounts.--A practitioner conducting 
 research with a schedule I substance under this subsection may 
 only possess the amounts of schedule I substance identified 
 in--
 ``
        (A) the notification to the Attorney General 
 under paragraph

    (3) ; or
 ``
        (B) a supplemental notification that the 
 practitioner may send if the practitioner needs 
 additional amounts for the research, which supplemental 
 notification shall include--
 ``
            (i) the name of the practitioner;
 ``
            (ii) the additional quantity needed of 
 the substance; and
 ``
            (iii) an attestation that the research to 
 be conducted with the substance is consistent 
 with the scope of the research that was the 
 subject of the notification under paragraph

    (3) .
 ``

    (6) Importation and exportation requirements not 
 affected.--Nothing in this subsection alters the requirements 
 of part A of title III, regarding the importation and 
 exportation of controlled substances.
 ``

    (7) Inspector general report.--Not later than 1 year 
 after the date of enactment of this Act, the Inspector General 
 of the Department of Justice shall complete a study, and submit 
 a report thereon, about research described in paragraph

    (2) of 
 this subsection with fentanyl.''.

    (b) Separate Registrations Not Required for Additional Researcher 
in Same Institution.--

    (1) In general.--

Section 302
            (c) of the Controlled 
 Substances Act (21 U.S.C. 822
            (c) ) is amended by adding at the 
 end the following:
 ``

    (4) An agent or employee of a research institution that 
 is conducting research with a controlled substance if--
 ``
        (A) the agent or employee is acting within the 
 scope of the professional practice of the agent or 
 employee;
 ``
        (B) another agent or employee of the institution 
 is registered to conduct research with a controlled 
 substance in the same schedule;
 ``
            (C) the researcher who is so registered--
 ``
            (i) informs the Attorney General of the 
 name, position title, and employing institution 
 of the agent or employee who is not separately 
 registered;
 ``
            (ii) authorizes that agent or employee to 
 perform research under the registration of the 
 registered researcher; and
 ``
            (iii) affirms that any act taken by that 
 agent or employee involving a controlled 
 substance shall be attributable to the 
 registered researcher, as if the researcher had 
 directly committed the act, for purposes of any 
 proceeding under 

section 304

    (a) to suspend or 
 revoke the registration of the registered 
 researcher; and
 ``
            (D) the Attorney General does not, within 30 days 
 of receiving the information, authorization, and 
 affirmation described in subparagraph
            (C) , refuse, for 
 a reason listed in 

section 304

    (a) , to allow the agent 
 or employee to possess the substance without a separate 
 registration.''.

    (2) Technical correction.--

Section 302
            (c) (3) of the 
 Controlled Substances Act (21 U.S.C. 822
            (c) (3) ) is amended by 
 striking ``

    (25) '' and inserting ``

    (27) ''.
            (c) Single Registration for Related Research Sites.--

Section 302

    (e) of the Controlled Substances Act (21 U.S.C. 822

    (e) ) is amended by 
adding at the end the following:
 ``

    (4)
        (A) Notwithstanding paragraph

    (1) , a person registered 
 to conduct research with a controlled substance under 

section 303

    (g) may conduct the research under a single registration 
 if--
 ``
            (i) the research occurs exclusively on 
 sites all of which are--
 ``
            (I) within the same city or 
 county; and
 ``
            (II) under the control of the 
 same institution, organization, or 
 agency; and
 ``
            (ii) before commencing the research, the 
 researcher notifies the Attorney General of 
 each site where--
 ``
            (I) the research will be 
 conducted; or
 ``
            (II) the controlled substance 
 will be stored or administered.
 ``
        (B) A site described in subparagraph
        (A) shall be 
 included in a registration described in that 
 subparagraph only if the researcher has notified the 
 Attorney General of the site--
 ``
            (i) in the application for the 
 registration; or
 ``
            (ii) before the research is conducted, or 
 before the controlled substance is stored or 
 administered, at the site.
 ``
            (C) The Attorney General may, in consultation 
 with the Secretary, issue regulations addressing, with 
 respect to research sites described in subparagraph
        (A) --
 ``
            (i) the manner in which controlled 
 substances may be delivered to the research 
 sites;
 ``
            (ii) the storage and security of 
 controlled substances at the research sites;
 ``
            (iii) the maintenance of records for the 
 research sites; and
 ``
            (iv) any other matters necessary to 
 ensure effective controls against diversion at 
 the research sites.''.
            (d) New Inspection Not Required in Certain Situations.--

Section 302

    (f) of the Controlled Substances Act (21 U.S.C. 822

    (f) ) is amended--

    (1) by striking ``

    (f) The'' and inserting ``

    (f)

    (1) The''; 
 and

    (2) by adding at the end the following:
 ``

    (2)
        (A) If a person is registered to conduct research with 
 a controlled substance and applies for a registration, or for a 
 modification of a registration, to conduct research with a 
 second controlled substance that is in the same schedule as the 
 first controlled substance, or is in a schedule with a higher 
 numerical designation than the schedule of the first controlled 
 substance, a new inspection by the Attorney General of the 
 registered location is not required.
 ``
        (B) Nothing in subparagraph
        (A) shall prohibit the 
 Attorney General from conducting an inspection that the 
 Attorney General determines necessary to ensure that a 
 registrant maintains effective controls against diversion.''.

    (e) Continuation of Research on Substances Newly Added to Schedule 
I.--

Section 302 of the Controlled Substances Act (21 U.S.C. 822) is 
amended by adding at the end the following:
 ``

    (h) Continuation of Research on Substances Newly Added to 
Schedule I.--If a person is conducting research on a substance when the 
substance is added to schedule I, and the person is already registered 
to conduct research with a controlled substance in schedule I--
 ``

    (1) not later than 90 days after the scheduling of the 
 newly scheduled substance, the person shall submit a completed 
 application for registration or modification of existing 
 registration, to conduct research on the substance, in 
 accordance with regulations issued by the Attorney General for 
 purposes of this paragraph;
 ``

    (2) the person may, notwithstanding subsections

    (a) and

    (b) , continue to conduct the research on the substance until--
 ``
        (A) the person withdraws the application 
 described in paragraph

    (1) of this subsection; or
 ``
        (B) the Attorney General serves on the person an 
 order to show cause proposing the denial of the 
 application under 

section 304
            (c) ;
 ``

    (3) if the Attorney General serves an order to show cause 
 as described in paragraph

    (2)
        (B) and the person requests a 
 hearing, the hearing shall be held on an expedited basis and 
 not later than 45 days after the request is made, except that 
 the hearing may be held at a later time if so requested by the 
 person; and
 ``

    (4) if the person sends a copy of the application 
 described in paragraph

    (1) to a manufacturer or distributor of 
 the substance, receipt of the copy by the manufacturer or 
 distributor shall constitute sufficient evidence that the 
 person is authorized to receive the substance.''.

    (f) Treatment of Certain Manufacturing Activities as Coincident to 
Research.--

Section 302 of the Controlled Substances Act (21 U.S.C. 
822), as amended by subsection

    (e) , is amended by adding at the end the 
following:
 ``
            (i) Treatment of Certain Manufacturing Activities as Coincident 
to Research.--
 ``

    (1) In general.--Except as provided in paragraph

    (3) , a 
 person who is registered to perform research on a controlled 
 substance may perform manufacturing activities with small 
 quantities of that substance, including activities described in 
 paragraph

    (2) , without being required to obtain a manufacturing 
 registration, if--
 ``
        (A) the activities are performed for the purpose 
 of the research; and
 ``
        (B) the activities and the quantities of the 
 substance involved in the activities are stated in--
 ``
            (i) a notification submitted to the 
 Attorney General under 

section 303

    (n) ;
 ``
            (ii) a research protocol filed with an 
 application for registration approval under 
 

section 303

    (g) ; or
 ``
            (iii) a notification to the Attorney 
 General that includes--
 ``
            (I) the name of the registrant; 
 and
 ``
            (II) an attestation that the 
 research to be conducted with the small 
 quantities of manufactured substance is 
 consistent with the scope of the 
 research that is the basis for the 
 registration.
 ``

    (2) Activities included.--Activities permitted under 
 paragraph

    (1) include--
 ``
        (A) processing the substance to create extracts, 
 tinctures, oils, solutions, derivatives, or other forms 
 of the substance consistent with--
 ``
            (i) the information provided as part of a 
 notification submitted to the Attorney General 
 under 

section 303

    (n) ; or
 ``
            (ii) a research protocol filed with an 
 application for registration approval under 
 

section 303

    (g) ; and
 ``
        (B) dosage form development studies performed for 
 the purpose of requesting an investigational new drug 
 exemption under 

section 505
            (i) of the Federal Food, 
 Drug, and Cosmetic Act (21 U.S.C. 355
            (i) ).
 ``

    (3) Exception regarding marihuana.--The authority under 
 paragraph

    (1) to manufacture substances does not include the 
 authority to grow marihuana.''.

    (g) Transparency Regarding Special Procedures.--

Section 303 of the 
Controlled Substances Act (21 U.S.C. 823), as amended by subsection

    (a) , is amended by adding at the end the following:
 ``

    (o) Transparency Regarding Special Procedures.--
 ``

    (1) In general.--If the Attorney General determines, with 
 respect to a controlled substance, that an application by a 
 practitioner to conduct research with the substance should be 
 considered under a process, or subject to criteria, different 
 from the process or criteria applicable to applications to 
 conduct research with other controlled substances in the same 
 schedule, the Attorney General shall make public, including by 
 posting on the website of the Drug Enforcement Administration--
 ``
        (A) the identities of all substances for which 
 such determinations have been made;
 ``
        (B) the process and criteria that shall be 
 applied to applications to conduct research with those 
 substances; and
 ``
            (C) how the process and criteria described in 
 subparagraph
        (B) differ from the process and criteria 
 applicable to applications to conduct research with 
 other controlled substances in the same schedule.
 ``

    (2) Timing of posting.--The Attorney General shall make 
 information described in paragraph

    (1) public upon making a 
 determination described in that paragraph, regardless of 
 whether a practitioner has submitted such an application at 
 that time.''.

SEC. 4. TECHNICAL CORRECTION ON CONTROLLED SUBSTANCES DISPENSING.

 Effective as if included in the enactment of Public Law 117-328--

    (1) section 1252

    (a) of division FF of Public Law 117-328 
 (136 Stat. 5681) is amended, in the matter being inserted into 
 

section 302

    (e) of the Controlled Substances Act, by striking 
 ``303

    (g) '' and inserting ``303

    (h) '';

    (2) section 1262 of division FF of Public Law 117-328 (136 
 Stat. 5681) is amended--
        (A) in subsection

    (a) --
            (i) in the matter preceding paragraph

    (1) , 
 by striking ``303

    (g) '' and inserting 
 ``303

    (h) '';
            (ii) in the matter being stricken by 
 subsection

    (a)

    (2) , by striking ``

    (g)

    (1) '' and 
 inserting ``

    (h)

    (1) ''; and
            (iii) in the matter being inserted by 
 subsection

    (a)

    (2) , by striking ``

    (g) Practitioners'' and inserting ``

    (h) Practitioners''; and
        (B) in subsection

    (b) --
            (i) in the matter being stricken by 
 paragraph

    (1) , by striking ``303

    (g)

    (1) '' and 
 inserting ``303

    (h)

    (1) '';
            (ii) in the matter being inserted by 
 paragraph

    (1) , by striking ``303

    (g) '' and 
 inserting ``303

    (h) '';
            (iii) in the matter being stricken by 
 paragraph

    (2)
        (A) , by striking ``303

    (g)

    (2) '' and 
 inserting ``303

    (h)

    (2) '';
            (iv) in the matter being stricken by 
 paragraph

    (3) , by striking ``303

    (g)

    (2)
        (B) '' and 
 inserting ``303

    (h)

    (2)
        (B) '';
            (v) in the matter being stricken by 
 paragraph

    (5) , by striking ``303

    (g) '' and 
 inserting ``303

    (h) ''; and
            (vi) in the matter being stricken by 
 paragraph

    (6) , by striking ``303

    (g) '' and 
 inserting ``303

    (h) ''; and

    (3) section 1263

    (b) of division FF of Public Law 117-328 
 (136 Stat. 5685) is amended--
        (A) by striking ``303

    (g)

    (2) '' and inserting 
 ``303

    (h)

    (2) ''; and
        (B) by striking ``(21 U.S.C. 823

    (g)

    (2) )'' and 
 inserting ``(21 U.S.C. 823

    (h)

    (2) )''.

SEC. 5. RULEMAKING.

    (a) Interim Final Rules.--The Attorney General--

    (1) shall, not later than 6 months after the date of 
 enactment of this Act, issue rules to implement this Act and 
 the amendments made by this Act; and

    (2) may issue the rules under paragraph

    (1) as interim 
 final rules.

    (b) Procedure for Final Rule.--

    (1) Effectiveness of interim final rules.--A rule issued by 
 the Attorney General as an interim final rule under subsection

    (a) shall become immediately effective as an interim final rule 
 without requiring the Attorney General to demonstrate good 
 cause therefor, notwithstanding subparagraph
        (B) of 

section 553

    (b) of title 5, United States Code.

    (2) Opportunity for comment and hearing.--An interim final 
 rule issued under subsection

    (a) shall give interested persons 
 the opportunity to comment and to request a hearing.

    (3) Final rule.--After the conclusion of such proceedings, 
 the Attorney General shall issue a final rule to implement this 
 Act and the amendments made by this Act in accordance with 
 

section 553 of title 5, United States Code.

SEC. 6. PENALTIES.

    (a) In General.--

Section 401

    (b)

    (1) of the Controlled Substances Act 
(21 U.S.C. 841

    (b)

    (1) ) is amended--

    (1) in subparagraph
        (A)
            (vi) , by inserting ``or a fentanyl-
 related substance'' after ``any analogue of N-phenyl-N-[1-(2-
 phenylethyl)-4-piperidinyl] propanamide''; and

    (2) in subparagraph
        (B)
            (vi) , by inserting ``or a fentanyl-
 related substance'' after ``any analogue of N-phenyl-N-[1-(2-
 phenylethyl)-4-piperidinyl] propanamide''.

    (b) Importation and Exportation.--

Section 1010

    (b) of the Controlled 
Substances Import and Export Act (21 U.S.C. 960

    (b) ) is amended--

    (1) in paragraph

    (1)
        (F) , by inserting ``or a fentanyl-
 related substance'' after ``any analogue of N-phenyl-N-[1-(2-
 phenylethyl)-4-piperidinyl] propanamide''; and

    (2) in paragraph

    (2)
        (F) , by inserting ``or a fentanyl-
 related substance'' after ``any analogue of N-phenyl-N-[1-(2-
 phenylethyl)-4-piperidinyl] propanamide''.
            (c) Definition of Fentanyl-related Substance.--

Section 102 of the 
Controlled Substances Act (21 U.S.C. 802) is amended by adding at the 
end the following:
 ``

    (60) The term `fentanyl-related substance' has the 
 meaning given the term in subsection

    (e)

    (2) of schedule I of 
 

section 202
            (c) .''.

SEC. 7. APPLICABILITY; OTHER MATTERS.

    (a) In General.--Irrespective of the date on which the rules 
required by 

section 5 are finalized, the amendments made by this Act 
apply beginning as of the enactment of this Act.

    (b) Rule of Construction.--Nothing in the amendments made by this 
Act may be construed as evidence that, in applying sections 401

    (b)

    (1) and 1010

    (b) of the Controlled Substances Act (21 U.S.C. 841

    (b)

    (1) and 
960

    (b) ) with respect to conduct occurring before the date of the 
enactment of this Act, a fentanyl-related substance (as defined by such 
amendments) is not an analogue of N-phenyl-N-[1-(2-phenylethyl)-4-
piperidinyl] propanamide.
            (c) Sense of Congress.--The Congress agrees with the interpretation 
of the Controlled Substances Act (21 U.S.C. 801 et seq.) in United 
States v. McCray, 346 F. Supp. 3d 363

    (2018) .

 Passed the House of Representatives February 6, 2025.

 Attest:

 KEVIN F. MCCUMBER,

 Clerk.