H.R. 467House118th Congress (2023-2025)Passed House

HALT Fentanyl Act

Introduced January 24, 2023

AI-Generated Summary

Updated January 20, 2026 at 2:26 AM UTC

The HALT Fentanyl Act amends the Controlled Substances Act to automatically place any fentanyl‑related substance in Schedule I, defining those substances by specific chemical modifications. It gives the Attorney General authority to publish a list of such substances and updates penalties to cover them. The bill also streamlines research registration for Schedule I drugs, especially for federally funded or investigational studies, and eases registration and inspection requirements for researchers at the same institution or nearby sites.

Key Provisions

  • Adds a new category to Schedule I covering any material that contains a fentanyl‑related substance, with a detailed definition of what counts as fentanyl‑related.
  • Allows the Attorney General to publish a list of fentanyl‑related substances in the Federal Register, and clarifies that absence from the list does not exempt a substance from scheduling.
  • Creates an expedited registration process for researchers conducting Schedule I fentanyl research, including electronic notice, limited quantity limits, and faster approval for federally funded or investigational‑use projects.
  • Permits researchers at the same institution or within the same city/county to use a single registration and eliminates the need for a new DEA inspection when adding substances in the same or higher schedule.
  • Extends criminal penalties and import/export prohibitions to include fentanyl‑related substances.
  • Requires the Attorney General to issue interim final rules within six months to implement these changes.

Legislative Activity

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36 earlier actions
SenateIntro Referral Latest Action

Received in the Senate and Read twice and referred to the Committee on the Judiciary.

May 30, 2023

View full timeline
HouseIntro Referral

Introduced in House

January 24, 2023

HouseIntro Referral

Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

January 24, 2023

HouseCommittee

Referred to the Subcommittee on Health.

January 24, 2023

HouseCommittee

Subcommittee Consideration and Mark-up Session Held.

March 8, 2023

HouseCommittee

Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 17 - 10 .

March 8, 2023

HouseCommittee

Subcommittee Consideration and Mark-up Session Held.

March 23, 2023

HouseCommittee

Committee Consideration and Mark-up Session Held.

March 24, 2023

HouseCommittee

Ordered to be Reported (Amended) by the Yeas and Nays: 27 - 19.

March 24, 2023

HouseCommittee

Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-67, Part I.

May 17, 2023

HouseCommittee

Committee on the Judiciary discharged.

May 17, 2023

HouseCalendars

Placed on the Union Calendar, Calendar No. 47.

May 17, 2023

HouseFloor

Rules Committee Resolution H. Res. 429 Reported to House. Rule provides for consideration of H.R. 467, S.J. Res. 11 and H.J. Res. 45. The resolution provides for consideration of H.R. 467 under a structured rule with one of hour of general debate. S.J. Res. 11 and H.J. Res. 45 are considered under closed rules with one hour of general debate. Motion to recommit provided on H.R. 467 and H.J. Res. 45, and one motion to commit on S.J. Res. 11.

May 22, 2023 • 8:30 PM

HouseFloor

Considered under the provisions of rule H. Res. 429. (consideration: CR H2579-2587)

May 24, 2023 • 5:33 PM

HouseFloor

Rule provides for consideration of H.R. 467, S.J. Res. 11 and H.J. Res. 45. The resolution provides for consideration of H.R. 467 under a structured rule with one of hour of general debate. S.J. Res. 11 and H.J. Res. 45 are considered under closed rules with one hour of general debate. Motion to recommit provided on H.R. 467 and H.J. Res. 45, and one motion to commit on S.J. Res. 11.

May 24, 2023 • 5:33 PM

HouseFloor

House resolved itself into the Committee of the Whole House on the state of the Union pursuant to H. Res. 429 and Rule XVIII.

May 24, 2023 • 5:34 PM

HouseFloor

The Speaker designated the Honorable Marjorie Taylor Greene to act as Chairwoman of the Committee.

May 24, 2023 • 5:34 PM

HouseFloor

GENERAL DEBATE - The Committee of the Whole proceeded with one hour of general debate on H.R. 467.

May 24, 2023 • 5:35 PM

HouseFloor

Mr. Guthrie moved that the committee rise.

May 24, 2023 • 6:44 PM

HouseFloor

On motion that the committee rise Agreed to by voice vote.

May 24, 2023 • 6:44 PM

HouseFloor

Committee of the Whole House on the state of the Union rises leaving H.R. 467 as unfinished business.

May 24, 2023 • 6:45 PM

HouseFloor

Considered as unfinished business. (consideration: CR H2602-2605)

May 25, 2023 • 9:14 AM

HouseFloor

The House resolved into Committee of the Whole House on the state of the Union for further consideration.

May 25, 2023 • 9:14 AM

HouseFloor

DEBATE - Pursuant to the provisions of H. Res. 429, the Committee of the Whole proceeded with 10 minutes of debate on the Miller (OH) amendment No. 1.

May 25, 2023 • 9:17 AM

HouseFloor

DEBATE - Pursuant to the provisions of H. Res. 429, the Committee of the Whole proceeded with 10 minutes of debate on the Mills amendment No. 2.

May 25, 2023 • 9:21 AM

HouseFloor

DEBATE - Pursuant to the provisions of H. Res. 429, the Committee of the Whole proceeded with 10 minutes of debate on the Pettersen amendment No. 3.

May 25, 2023 • 9:27 AM

HouseFloor

POSTPONED PROCEEDINGS - At the conclusion of debate on the Pettersen amendment No. 3, the Chair put the question on adoption of the amendment and by voice vote, announced that the noes had prevailed. Mr. Pallone demanded a recorded vote and the Chair postponed further proceedings until a time to be announced.

May 25, 2023 • 9:34 AM

HouseFloor

Mr. Bucshon moved that the committee rise.

May 25, 2023 • 9:35 AM

HouseFloor

On motion that the committee rise Agreed to by voice vote.

May 25, 2023 • 9:35 AM

HouseFloor

Committee of the Whole House on the state of the Union rises leaving H.R. 467 as unfinished business.

May 25, 2023 • 9:36 AM

HouseFloor

Considered as unfinished business. (consideration: CR H2605-2607)

May 25, 2023 • 9:45 AM

HouseFloor

The House rose from the Committee of the Whole House on the state of the Union to report H.R. 467.

May 25, 2023 • 10:19 AM

HouseFloor

The previous question was ordered pursuant to the rule.

May 25, 2023 • 10:20 AM

HouseFloor

The House adopted the amendment in the nature of a substitute as agreed to by the Committee of the Whole House on the state of the Union.

May 25, 2023 • 10:20 AM

HouseFloor

Passed/agreed to in House: On passage Passed by the Yeas and Nays: 289 - 133 (Roll no. 237).

May 25, 2023 • 10:32 AM

HouseFloor

On passage Passed by the Yeas and Nays: 289 - 133 (Roll no. 237).

May 25, 2023 • 10:32 AM

HouseFloor

Motion to reconsider laid on the table Agreed to without objection.

May 25, 2023 • 10:32 AM

SenateIntro Referral

Received in the Senate and Read twice and referred to the Committee on the Judiciary.

May 30, 2023

Floor Debate

24 members

What members said about H.R. 467 on the floor

13 Republicans11 Democrats
Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · May 24, 2023

Madam Chair, I yield myself such time as I may consume. Madam Chair, I rise in opposition to H.R. 467. I have deep concerns with the partisan approach my Republican colleagues have taken on this bill…

Teresa Leger Fernandez
Rep. Teresa Leger FernandezD-NM-3 · May 23, 2023

Madam Speaker, I thank Mr. Burgess for yielding me the customary 30 minutes, and I yield myself such time as I may consume. Madam Speaker, today while we stand here debating this rule, the…

Michael C. Burgess
Rep. Michael C. BurgessR-TX-26 · May 23, 2023

Madam Speaker, by direction of the Committee on Rules, I call up House Resolution 429 and ask for its immediate consideration. Madam Speaker, for the purpose of debate only, I yield the customary 30…

Brett Guthrie
Rep. Brett GuthrieR-KY-2 · May 24, 2023

Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days to revise and extend their remarks on the legislation and to insert extraneous material on H.R. 467. Madam Chair, I yield…

Bill Cassidy
Sen. Bill CassidyR-LA · May 15, 2024

Mr. President, everyone here--everyone here--everybody in the audience, everybody watching on C-SPAN has a loved one or knows of someone whom they have loved who has either overdosed or died,…

Show 8 more
Brittany Pettersen
Rep. Brittany PettersenD-CO-7 · May 25, 2023

Mr. Chair, I have an amendment at the desk. Mr. Chair, I rise today in support of my amendment, which would require a certification from the Secretary of the Department of Health and Human Services…

Larry Bucshon
Rep. Larry BucshonR-IN-8 · May 25, 2023

Mr. Chair, I support Mr. Miller's amendment, which would require the Attorney General to issue interim final rules to implement this act 6 months after the date of enactment. Fentanyl-related…

Cory Mills
Rep. Cory MillsR-FL-7 · May 25, 2023

Mr. Chair, I have an amendment made in order by the rule. Mr. Chair, today I stand before you to emphasize the critical need for the Department of Defense's involvement in fentanyl research. My…

Val T. Hoyle
Rep. Val T. HoyleD-OR-4 · May 25, 2023

Mr. Chair, today I will vote in support of H.R. 467, the Halt All Lethal Trafficking of (HALT) Fentanyl Act. This legislation permanently classifies all fentanyl-related substances as Schedule I…

Chip Roy
Rep. Chip RoyR-TX-21 · May 23, 2023

Madam Speaker, I thank my friend from Texas for yielding. A lot of conservatives believe in conservation. For example, the Governor of Florida, Ron DeSantis, has expanded the Everglades more than any…

Sheila Jackson Lee
Rep. Sheila Jackson LeeD-TX-18 · May 23, 2023

Mr. Speaker, I give the compliment back to the distinguished gentlewoman from New Mexico. We are alums, and we will leave that for all to find out from where, but I am very proud to stand with her…

H. Morgan Griffith
Rep. H. Morgan GriffithR-VA-9 · May 24, 2023

Madam Chair, everyone in this body knows someone who has been affected by the drug overdose epidemic. According to the Centers for Disease Control and Prevention, in 2022, there were more than…

Edward J. Markey
Sen. Edward J. MarkeyD-MA · May 15, 2024

Mr. President, reserving the right to object, the HALT Fentanyl Act would permanently classify fentanyl-related substances as schedule I substances under the Controlled Substances Act. The fentanyl…

Show 11 more
Summer L. Lee
Rep. Summer L. LeeD-PA-12 · May 24, 2023

Madam Chair, I stand today in solidarity with the millions of Black and Brown folks who have been locked up over the failed war on drugs. I stand before you today some 50 years from the war on drugs…

Maxwell Frost
Rep. Maxwell FrostD-FL-10 · May 23, 2023

Madam Speaker, I thank the gentlewoman for yielding. Madam Speaker, seniors in America deserve to retire with dignity. They have earned Social Security and Medicare benefits through a lifetime of…

Lloyd Doggett
Rep. Lloyd DoggettD-TX-37 · May 23, 2023

Madam Speaker, it reminds me of Texas--in fact, it reminds me of someone with whom I served in the Texas Legislature. He was asked what he did there, and he said: ``Oh, I am not here to do anything,…

Sydney Kamlager-Dove
Rep. Sydney Kamlager-DoveD-CA-37 · May 24, 2023

Madam Chair, I rise today to strongly oppose the Republicans' HALT Fentanyl Act. Republicans want to ban American history so that they can repeat the bad parts. Did we learn nothing from the war on…

Donald M. Payne, Jr.
Rep. Donald M. Payne, Jr.D-NJ-10 · May 24, 2023

Madam Chair, I thank the gentleman from New Jersey for yielding to me. Madam Chair, I will follow up with the last two colleagues of mine, the gentlewoman from California and the previous speaker. We…

Max L. Miller
Rep. Max L. MillerR-OH-7 · May 25, 2023

Mr. Chair, I have an amendment made in order by the rule. Mr. Chair, the HALT Fentanyl Act is one of the most important pieces of legislation this body could possibly address. We all understand…

Robert E. Latta
Rep. Robert E. LattaR-OH-5 · May 24, 2023

Madam Chair, I thank the gentleman for yielding. Madam Chair, for over 2 years, I have worked with my colleague from Virginia's Ninth District to pass the HALT Fentanyl Act. During this time, our…

Nicholas A. Langworthy
Rep. Nicholas A. LangworthyR-NY-23 · May 23, 2023

Madam Speaker, I thank the gentleman from Texas that I am proud to serve with on the House Committee on Rules for yielding. Madam Speaker, I rise today in support of the rule which provides for…

Bill Johnson
Rep. Bill JohnsonR-OH-6 · May 23, 2023

Mr. Speaker, I rise today to speak in strong support of H.R. 467 to make class-wide scheduling of fentanyl-related substances permanent. This hits close to home for me. I represent the men and women…

Gus M. Bilirakis
Rep. Gus M. BilirakisR-FL-12 · May 24, 2023

Madam Chair, I thank the chairman of the Health Subcommittee for his leadership and for yielding me time. Madam Chair, I rise today in support of the HALT Fentanyl Act. The American people are in the…

Mariannette Miller-Meeks
Rep. Mariannette Miller-MeeksR-IA-1 · May 24, 2023

Madam Chair, I thank my colleague for yielding time. Madam Chair, I rise today in support of HALT Fentanyl Act introduced by my friends and colleagues, Morgan Griffith and Bob Latta. The fentanyl…

Bill Text

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Referred in SenateIssued May 30, 2023

IIB

118th CONGRESS

1st Session

H. R. 467

IN THE SENATE OF THE UNITED STATES

May 30, 2023

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.


1.

Short title

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

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).

.

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 (f), 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

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.

.

(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(f) 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(l);

(ii)

a research protocol filed with an application for registration approval under section 303(f); 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(l); or

(ii)

a research protocol filed with an application for registration approval under section 303(f); 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.

.

4.

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.

5.

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.

6.

Applicability; other matters

(a)

In general

Irrespective of the date on which the rules required by section 4 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 May 25, 2023.

Cheryl L. Johnson,

Clerk.

Lisa P. Grant

Deputy Clerk