119-s331

[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.