S 331 · 119th Congress · Crime and Law Enforcement

HALT Fentanyl Act

Introduced January 30, 2025 Latest action July 16, 2025 31 cosponsors

Sponsor

Latest action

Became Public Law No: 119-26.

Action timeline

Every recorded action on this bill, newest first. Stage badges color-code the legislative path.

Jul 16, 2025

signed Signed by President.

Jul 16, 2025

signed Became Public Law No: 119-26.

Jul 08, 2025

sent Presented to President.

Jun 12, 2025

floor Considered as unfinished business. (consideration: CR H2806)

Jun 12, 2025

passed Passed/agreed to in House: On passage Passed by the Yeas and Nays: 321 - 104 (Roll no. 166). (text: 6/11/2025 CR H2625-2627)

Text versions

Each stage of the bill — official text published by GPO. Click any format to read on congress.gov / govinfo.

Jul 16, 2025 Public Law

United States Legislative Markup

Mar 14, 2025 Engrossed in Senate

XML

Mar 03, 2025 Reported to Senate

XML

Jan 30, 2025 Introduced in Senate

XML

— Enrolled Bill

XML

CRS summaries

Plain-English summaries written by the Congressional Research Service — neutral, nonpartisan staff who summarize bills as they advance through stages. The authoritative description of what each version of the bill does.

49 Public Law Jul 17, 2025

Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act This act permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Under the act, offenses involving fentanyl-related substances are triggered by the same quantity thresholds and subject to the same penalties as offenses involving fentanyl analogues (e.g., offenses involving 100 grams or more trigger a 10-year mandatory minimum prison term). Additionally, the act establishes a new, alternative registration process for certain schedule I research. The act also makes several other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration. Finally, the act expresses the sense that Congress agrees with the interpretation of the Controlled Substances Act in United States v. McCray, a 2018 case decided by the U.S. District Court for the Western District of New York. In that case, the court held that butyryl fentanyl, a controlled substance, can be considered an analogue of fentanyl even though, under the Controlled Substances Act, the term controlled substance analogue specifically excludes a controlled substance.

Show 1 earlier CRS summary

00 Introduced in Senate Jan 30, 2025

Halt All Lethal Trafficking of Fentanyl Act or the HALT Fentanyl Act This bill permanently places fentanyl-related substances as a class into schedule I of the Controlled Substances Act. A schedule I controlled substance is a drug, substance, or chemical that has a high potential for abuse; has no currently accepted medical value; and is subject to regulatory controls and administrative, civil, and criminal penalties under the Controlled Substances Act. Under the bill, offenses involving fentanyl-related substances are triggered by the same quantity thresholds and subject to the same penalties as offenses involving fentanyl analogues (e.g., offenses involving 100 grams or more trigger a 10-year mandatory minimum prison term). Additionally, the bill establishes a new, alternative registration process for certain schedule I research. The bill also makes several other changes to registration requirements for conducting research with controlled substances, including permitting a single registration for related research sites in certain circumstances, waiving the requirement for a new inspection in certain situations, and allowing a registered researcher to perform certain manufacturing activities with small quantities of a substance without obtaining a manufacturing registration. Finally, the bill expresses the sense that Congress agrees with the interpretation of the Controlled Substances Act in United States v. McCray, a 2018 case decided by the U.S. District Court for the Western District of New York. In that case, the court held that butyryl fentanyl, a controlled substance, can be considered an analogue of fentanyl even though, under the Controlled Substances Act, the term controlled substance analogue specifically excludes a controlled substance.

via Congressional Research Service · published through congress.gov

Changelog

ⓘ

How a bill moves through Congress. Each stage produces a new official text. The diff between them shows what changed at that step.

`ih` / `is` — Introduced in House / Senate. First filed version.

`rfh` / `rfs` — Referred to a committee for review.

`rh` / `rs` — Reported back by the committee to the floor (often with amendments — this is where most language changes happen).

`pcs` / `pch` — Placed on Calendar for floor consideration.

`eh` / `es` — Engrossed. Passed by the originating chamber. Text is now what was actually voted on.

`rdh` / `rds` — Received by the other chamber.

`eah` / `eas` — Engrossed Amendment. The other chamber passed an amended version.

`ath` / `ats` — Agreed to. Both chambers settled on the same text.

`enr` — Enrolled. Final reconciled text, sent to the President.

`pl` — Public Law. Signed by the President. It's now law.

`pp` — Public Print. Official printing post-enactment.

Most bills die before `eh`/`es`. Going from `pcs` → `enr` is the full path through both chambers.

Line-level diff between text versions of this bill — what actually changed at each legislative stage.

+283 −347 119 unchanged

Generating AI summary
Reading both versions of the bill and writing a plain-English summary. Typical bills take 5–15 seconds; large reconciliation bills can take a minute. This summary will be cached after generation.

--- Engrossed (Senate)

+++ Enrolled

@@ -1,29 +1,30 @@

[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.

+[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

@@ -37,27 +38,27 @@

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.

+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.

+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.

+``(B) is otherwise expressly listed in a schedule other than

+this schedule.

``(4)(A) The Attorney General may by order publish in the Federal

`fentanyl-related substance' in paragraph (2).

@@ -65,9 +66,7 @@

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--

@@ -78,169 +77,144 @@

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.

+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

+``(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.

+``(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

+``(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

+``(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).

+``(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

+``(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).

+``(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.

+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--

+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.''.

+``(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;

+(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

+``(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

-``(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)''.

+``(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)''.

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

adding at the end the following:

@@ -252,8 +226,8 @@

``(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--

+``(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.

@@ -268,16 +242,14 @@

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.''.

+``(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

+(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

@@ -298,30 +270,29 @@

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

+``(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.''.

+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

@@ -334,40 +305,37 @@

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.

+``(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--

+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)).

+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.''.

@@ -378,98 +346,81 @@

``(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

+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.

+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.''.

+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)'';

+(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

+(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))''.

+(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.

+(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.

+(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-

@@ -480,20 +431,18 @@

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''.

+(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''.

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.

@@ -509,20 +458,7 @@

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.

+Speaker of the House of Representatives.

+Vice President of the United States and

+President of the Senate.

Lobbying activity

Organizations whose LDA filings reference this bill, ranked by filing count. Position not disclosed — LDA does not require lobbyists to report support / oppose / monitor. Bill-number references can be stale (lobbyists sometimes copy text year-over-year), so verify against the filing description.

NATIONAL FRATERNAL ORDER OF POLICE

LAW

filings · 2026 Q3

DUE PROCESS INSTITUTE

LAW

filings · 2025 Q3

PEACE OFFICERS RESEARCH ASSOCIATION OF CALIFORNIA

LAW

filings · 2025 Q3

LEADERSHIP CONFERENCE ON CIVIL AND HUMAN RIGHTS

LAW

filings · 2025 Q2

NATIONAL COUNCIL FOR BEHAVIORAL HEALTH

LAW

filings · 2025 Q2

THE SENTENCING PROJECT

LAW

filings · 2025 Q2

DRUG POLICY ALLIANCE

LAW

filings · 2025 Q2

NATIONAL ASSOCIATION OF CRIMINAL DEFENSE LAWYERS (NACDL)

LAW

filings · 2025 Q2

SERGEANTS BENEVOLENT ASSOCIATION OF NEW YORK CITY

LAW

filings · 2025 Q2

STUDENTS FOR SENSIBLE DRUG POLICY

ALCCIVEDUHCRLAWSCI

filings · 2025 Q2

via Senate LDA · self-reported quarterly. Filing count = filings mentioning this bill (no position required), not money spent on it. Click a client to see all bills they've filed on.

Cosponsors (31)

Members who signed on to support this bill.