S. 331Senate119th Congress (2025-2027)Enacted

HALT Fentanyl Act

Introduced January 30, 2025

AI-Generated Summary

Updated November 24, 2025 at 3:11 AM UTC

The HALT Fentanyl Act expands Schedule I of the Controlled Substances Act to automatically cover any fentanyl‑related chemicals, tightening control and penalties for those substances. It also streamlines the process for researchers to obtain registrations and conduct studies on these drugs, allows single registrations for multiple research sites, and permits limited manufacturing for research without extra licensing. The law requires new rulemaking and transparency from the Attorney General and adds specific penalties for fentanyl‑related substances.

Key Provisions

  • Adds a new category to Schedule I that automatically includes any material containing a fentanyl‑related substance, defined by specific chemical modifications to the fentanyl molecule.
  • Allows the Attorney General to publish a list of substances that meet this definition, but any substance that fits the definition is controlled even if not on the list.
  • Creates exemptions so a fentanyl‑related substance already controlled under another schedule or by a specific Attorney General action is not double‑scheduled.
  • Amends research registration rules to let qualified researchers start fentanyl‑related Schedule I studies after a 30‑day notice to the Attorney General, with expedited review for federally funded or FDA‑investigational‑use projects.
  • Permits institutions to have a single registration for research at multiple sites within the same city/county and to authorize employees under that registration without separate applications.
  • Allows limited manufacturing of small quantities for research purposes without a separate manufacturing registration, provided it is documented to the Attorney General.
  • Requires the Attorney General to publicly disclose any special procedures or criteria applied to particular fentanyl‑related substances.
  • Updates criminal and import/export penalties to explicitly include fentanyl‑related substances.
  • Mandates the Attorney General to issue interim final rules within six months of enactment and to complete a DOJ Inspector General report on fentanyl research within one year.

Legislative Activity

Stay on top of the latest movement without scrolling through every action

36 earlier actions
Became Law Latest Action

Became Public Law No: 119-26.

July 16, 2025

View full timeline
SenateIntro Referral

Introduced in Senate

January 30, 2025

SenateIntro Referral

Read twice and referred to the Committee on the Judiciary.

January 30, 2025

SenateCommittee

Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.

February 27, 2025

SenateCommittee

Committee on the Judiciary. Reported by Senator Grassley with an amendment in the nature of a substitute. Without written report.

March 3, 2025

SenateCalendars

Placed on Senate Legislative Calendar under General Orders. Calendar No. 18.

March 3, 2025

SenateFloor

Motion to proceed to consideration of measure made in Senate. (CR S1488)

March 4, 2025

SenateFloor

Cloture motion on the motion to proceed to the measure presented in Senate. (CR S1488)

March 4, 2025

SenateFloor

Motion to proceed to measure considered in Senate. (CR S1521)

March 5, 2025

SenateFloor

Motion to proceed to measure considered in Senate. (CR S1596)

March 6, 2025

SenateFloor

Cloture on the motion to proceed to the measure invoked in Senate by Yea-Nay Vote. 82 - 12. Record Vote Number: 110. (CR S1596)

March 6, 2025

SenateFloor

Motion to proceed to measure considered in Senate. (CR S1623)

March 10, 2025

SenateFloor

Motion to proceed to consideration of measure agreed to in Senate by Voice Vote. (consideration: CR S1623)

March 10, 2025

SenateFloor

Measure laid before Senate by motion.

March 10, 2025

SenateFloor

Considered by Senate. (consideration: CR S1659)

March 11, 2025

SenateFloor

Cloture motion on the measure presented in Senate. (CR S1659)

March 11, 2025

SenateFloor

Cloture on the measure invoked in Senate by Yea-Nay Vote. 84 - 15. Record Vote Number: 124. (CR S1735)

March 13, 2025

SenateFloor

Considered by Senate. (consideration: CR S1735)

March 13, 2025

SenateFloor

Considered by Senate. (consideration: CR S1762-1765)

March 14, 2025

SenateFloor

The committee substitute agreed to by Unanimous Consent.

March 14, 2025

SenateFloor

Passed Senate with an amendment by Yea-Nay Vote. 84 - 16. Record Vote Number: 127.

March 14, 2025

SenateFloor

Message on Senate action sent to the House.

March 14, 2025

HouseFloor

Received in the House.

March 18, 2025 • 12:02 PM

HouseFloor

Held at the desk.

March 18, 2025 • 12:03 PM

HouseFloor

Rules Committee Resolution H. Res. 489 Reported to House. Rule provides for consideration of H.R. 884, H.R. 2056, H.R. 2096 and S. 331. The resolution provides for consideration of H.R. 884, H.R. 2056, H.R. 2096, and S. 331 under a closed rule with one hour of general debate for each bill. The resolution provides for one motion to recommit on H.R. 884, H.R. 2056, and H.R. 2096, and one motion to commit on S. 331.

June 9, 2025 • 6:43 PM

HouseFloor

Rule H. Res. 489 passed House.

June 10, 2025 • 2:16 PM

HouseFloor

Considered under the provisions of rule H. Res. 489. (consideration: CR H2625-2633)

June 11, 2025 • 1:31 PM

HouseFloor

Rule provides for consideration of H.R. 884, H.R. 2056, H.R. 2096 and S. 331. The resolution provides for consideration of H.R. 884, H.R. 2056, H.R. 2096, and S. 331 under a closed rule with one hour of general debate for each bill. The resolution provides for one motion to recommit on H.R. 884, H.R. 2056, and H.R. 2096, and one motion to commit on S. 331.

June 11, 2025 • 1:32 PM

HouseFloor

DEBATE - The House proceeded with one hour of debate on S. 331.

June 11, 2025 • 1:32 PM

HouseFloor

The previous question was ordered pursuant to the rule.

June 11, 2025 • 2:23 PM

HouseFloor

POSTPONED PROCEEDINGS - At the conclusion of debate on S. 331, the Chair put the question on passage of the bill and by voice vote, announced that the ayes had prevailed. Mr. Pallone demanded the yeas and nays and the Chair postponed further proceedings until a time to be announced.

June 11, 2025 • 2:23 PM

HouseFloor

Considered as unfinished business. (consideration: CR H2806)

June 12, 2025 • 3:02 PM

SenateFloor

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)

June 12, 2025 • 3:36 PM

HouseFloor

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

June 12, 2025 • 3:36 PM

HouseFloor

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

June 12, 2025 • 3:36 PM

President

Presented to President.

July 8, 2025

Became Law

Signed by President.

July 16, 2025

Became Law

Became Public Law No: 119-26.

July 16, 2025

Floor Debate

20 members

What members said about S. 331 on the floor

8 Republicans11 Democrats1 Independent
Kathy Castor
Rep. Kathy CastorD-FL-14 · Feb 6, 2025

Mr. Speaker, I thank Ranking Member Pallone for yielding me time. Mr. Speaker, I rise today in opposition to H.R. 27. I am here to say this is not business as usual right now in Washington, D.C., or…

Christopher Murphy
Sen. Christopher MurphyD-CT · Mar 6, 2025

Mr. President, I am a big Boston Red Sox fan, and one of the most famous players in Red Sox recent history is Manny Ramirez. Manny Ramirez was a good baseball player, but he had a habit of doing some…

James P. McGovern
Rep. James P. McGovernD-MA-2 · Jun 10, 2025

Mr. Speaker, I thank the gentlewoman from Indiana (Mrs. Houchin) for yielding me the customary 30 minutes, and I yield myself such time as I may consume. Mr. Speaker, the bills in this rule today are…

Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Jun 11, 2025

Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise in opposition to S. 331, the HALT Fentanyl Act. The House approved this bill in February, and since that time, the Trump…

Erin Houchin
Rep. Erin HouchinR-IN-9 · Jun 10, 2025

Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 489 and ask for its immediate consideration. Mr. Speaker, for the purpose of debate only, I yield the customary 30…

Show 8 more
Frank Pallone, Jr.
Rep. Frank Pallone, Jr.D-NJ-6 · Feb 6, 2025

Mr. Speaker, I yield myself such time as I may consume. I rise in opposition to H.R. 27, the HALT Fentanyl Act. Mr. Speaker, throughout this debate today, House Republicans will claim that they are…

Rand Paul
Sen. Rand PaulR-KY · Mar 14, 2025

Mr. President, President Trump has pledged to balance the budget. I want to help him. I want to help him with this task. But to balance the budget requires much less spending than this current bill…

H. Morgan Griffith
Rep. H. Morgan GriffithR-VA-9 · Jun 11, 2025

Mr. Speaker, pursuant to House Resolution 489, I call up the bill (S. 331) to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other…

Brett Guthrie
Rep. Brett GuthrieR-KY-2 · Feb 6, 2025

Mr. Speaker, pursuant to House Resolution 93, I call up the bill (H.R. 27) to amend the Controlled Substances Act with respect to the scheduling of fentanyl-related substances, and for other…

Charles E. Schumer
Sen. Charles E. SchumerD-NY · Mar 13, 2025

Mr. President, over the last 2 months, the United States has confronted a bitter--a very bitter truth: The Federal Government has been taken over by a nihilist. Donald Trump, in 2 months, has taken a…

Bill Cassidy
Sen. Bill CassidyR-LA · Mar 13, 2025

Mr. President, 74,000 people died of fentanyl and fentanyl analogs in 2023. Everyone in this Chamber and everyone watching from home knows of someone who has died of a fentanyl overdose. If you…

Bernard Sanders
Sen. Bernard SandersI-VT · Mar 14, 2025

Mr. President, let me thank Senator Wyden for his outstanding work as the former chairman of the Finance Committee and now as the ranking member. I get around Vermont a bit. I get around the country…

Katie Boyd Britt
Sen. Katie Boyd BrittR-AL · Mar 13, 2025

Mr. President, today I rise to celebrate the birthday of someone very special: my grandmother Lyra Baker Boyd, who I call MaMa. Today, she turns 100 years old. She is such an incredible woman. I…

Show 11 more
Ron Wyden
Sen. Ron WydenD-OR · Mar 14, 2025

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, notwithstanding rule XXII, I ask unanimous consent that Senator Wyden, Senator Sanders, and…

Maxine Dexter
Rep. Maxine DexterD-OR-3 · Feb 6, 2025

Mr. Speaker, I rise today in strong opposition to this bill because it is abundantly clear it is not a serious effort to address the drug overdose epidemic in this country. It is, in fact, partisan.…

Lori Trahan
Rep. Lori TrahanD-MA-3 · Feb 6, 2025

Mr. Speaker, as the designee of Congresswoman Pettersen, I have an amendment at the desk. Mr. Speaker, I rise to offer amendment 2 on behalf of my colleague, Congresswoman Brittany Pettersen, who…

Joe Neguse
Rep. Joe NeguseD-CO-2 · Jun 11, 2025

Mr. Speaker, I thank the gentleman for yielding me time. First, I thank the ranking member for his leadership in addressing the scourge of fentanyl overdoses across our country. I serve as one of the…

John Thune
Sen. John ThuneR-SD · Mar 14, 2025

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded. Mr. President, I ask unanimous consent that the cloture motion with respect to the motion to proceed to H.R.…

Brett Guthrie
Rep. Brett GuthrieR-KY-2 · Jun 11, 2025

Mr. Speaker, I thank the gentleman for yielding me the time. Mr. Speaker, this is not the answer to the problem. This problem is not going to be solved by only putting people in jail and throwing…

Jahana Hayes
Rep. Jahana HayesD-CT-5 · Feb 6, 2025

Mr. Speaker, the HALT Fentanyl Act would put us on a pathway to adopting the ill-informed practices of the past. The 1994 crime bill decimated generations by expanding harsh criminal punishment that…

Robert E. Latta
Rep. Robert E. LattaR-OH-5 · Feb 6, 2025

Mr. Speaker, I thank the chairman of the full committee for yielding to me. For 4 years, I have worked tirelessly with my colleague and friend, the gentleman from the Ninth Congressional District of…

Melanie A. Stansbury
Rep. Melanie A. StansburyD-NM-1 · Feb 6, 2025

Mr. Speaker, I want to be honest. This legislation is literally breaking my heart because I am a New Mexican, born and raised, and there is not a single family in the State of New Mexico who has not…

Robert E. Latta
Rep. Robert E. LattaR-OH-5 · Jun 11, 2025

Mr. Speaker, I thank my good friend for yielding me time. Mr. Speaker, for 4 years I have worked tirelessly with my colleague from Virginia's Ninth District to pass the HALT Fentanyl Act. In 2023, we…

H. Morgan Griffith
Rep. H. Morgan GriffithR-VA-9 · Feb 6, 2025

Mr. Speaker, I thank the chairman of the committee for yielding me time. My colleagues on the other side cry: Action, action. However, in February of 2025, there will be no action unless we pass H.R.…

Bill Text

5 versions available

Reading Mode
Latest
Enrolled BillPublication date not provided

One Hundred Nineteenth Congress of the United States of America

1st Session

Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty five

S. 331

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 (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.

.

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)).

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.

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).

.

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