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H.R. 467, HALT Fentanyl Act

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Union Calendar No. 47


118TH CONGRESS
1ST SESSION
H. R. 467
[Report No. 118–67, Part I]

To amend the Controlled Substances Act with respect to the scheduling


of fentanyl-related substances, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES


JANUARY 24, 2023
Mr. GRIFFITH (for himself, Mr. LATTA, Mrs. RODGERS of Washington, Mr.
GUTHRIE, Mr. BILIRAKIS, Mr. BUCSHON, Mr. HUDSON, Mr. BURGESS,
Mr. CARTER of Georgia, Mr. DUNCAN, Mr. DUNN of Florida, Mr. CREN-
SHAW, Mr. JOYCE of Pennsylvania, Mr. BALDERSON, Mrs.
HARSHBARGER, Mrs. MILLER-MEEKS, Mrs. CAMMACK, Mr. ALLEN, Mr.
WALBERG, Mr. CURTIS, Mr. PALMER, Mr. BUCHANAN, Mr. BANKS, Mr.
FITZGERALD, and Mr. MOONEY) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committee on the Judiciary, for a period to be subsequently deter-
mined by the Speaker, in each case for consideration of such provisions
as fall within the jurisdiction of the committee concerned

MAY 17, 2023


Additional sponsors: Mr. PFLUGER, Mr. ARMSTRONG, Mr. PENCE, Mr. AUS-
TIN SCOTT of Georgia, Mr. OBERNOLTE, Mr. WOMACK, Mr. EDWARDS,
Mr. FINSTAD, Mr. CARL, Mrs. LESKO, Mr. MIKE GARCIA of California,
Mr. CISCOMANI, Mr. CLINE, Mrs. BICE, Mr. CARTER of Texas, Mr.
MOOLENAAR, Mr. ROGERS of Kentucky, Mr. BEAN of Florida, Mr.
MEUSER, Mr. BOST, Mr. BARR, Mr. VAN DREW, Mr. D’ESPOSITO, Mrs.
MILLER of West Virginia, Mrs. CHAVEZ-DEREMER, Mr. WESTERMAN,
Mr. LANGWORTHY, and Mr. BURCHETT

MAY 17, 2023


Reported from the Committee on Energy and Commerce with an amendment
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[Strike out all after the enacting clause and insert the part printed in italic]

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MAY 17, 2023
Committee on the Judiciary discharged; committed to the Committee of the
Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on January 24, 2023]

A BILL
To amend the Controlled Substances Act with respect to
the scheduling of fentanyl-related substances, and for
other purposes.
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1 Be it enacted by the Senate and House of Representa-
2 tives of the United States of America in Congress assembled,
3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Halt All Lethal Traf-


5 ficking of Fentanyl Act’’ or the ‘‘HALT Fentanyl Act’’.
6 SEC. 2. CLASS SCHEDULING OF FENTANYL-RELATED SUB-

7 STANCES.

8 Section 202(c) of the Controlled Substances Act (21


9 U.S.C. 812(c)) is amended by adding at the end of schedule
10 I the following:
11 ‘‘(e)(1) Unless specifically exempted or unless listed in
12 another schedule, any material, compound, mixture, or
13 preparation which contains any quantity of a fentanyl-re-
14 lated substance, or which contains the salts, isomers, and
15 salts of isomers of a fentanyl-related substance whenever the
16 existence of such salts, isomers, and salts of isomers is pos-
17 sible within the specific chemical designation.
18 ‘‘(2) For purposes of paragraph (1), except as provided
19 in paragraph (3), the term ‘fentanyl-related substance’
20 means any substance that is structurally related to fentanyl
21 by 1 or more of the following modifications:
22 ‘‘(A) By replacement of the phenyl portion of the
23 phenethyl group by any monocycle, whether or not
24 further substituted in or on the monocycle.
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1 ‘‘(B) By substitution in or on the phenethyl
2 group with alkyl, alkenyl, alkoxyl, hydroxyl, halo,
3 haloalkyl, amino, or nitro groups.
4 ‘‘(C) By substitution in or on the piperidine
5 ring with alkyl, alkenyl, alkoxyl, ester, ether,
6 hydroxyl, halo, haloalkyl, amino, or nitro groups.
7 ‘‘(D) By replacement of the aniline ring with
8 any aromatic monocycle whether or not further sub-
9 stituted in or on the aromatic monocycle.
10 ‘‘(E) By replacement of the N–propionyl group
11 with another acyl group.
12 ‘‘(3) A substance that satisfies the definition of the
13 term ‘fentanyl-related substance’ in paragraph (2) shall
14 nonetheless not be treated as a fentanyl-related substance
15 subject to this schedule if the substance—
16 ‘‘(A) is controlled by action of the Attorney Gen-
17 eral under section 201; or
18 ‘‘(B) is otherwise expressly listed in a schedule
19 other than this schedule.
20 ‘‘(4)(A) The Attorney General may by order publish
21 in the Federal Register a list of substances that satisfy the
22 definition of the term ‘fentanyl-related substance’ in para-
23 graph (2).
24 ‘‘(B) The absence of a substance from a list published
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25 under subparagraph (A) does not negate the control status

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1 of the substance under this schedule if the substance satisfies
2 the definition of the term ‘fentanyl-related substance’ in
3 paragraph (2).’’.
4 SEC. 3. REGISTRATION REQUIREMENTS RELATED TO RE-

5 SEARCH.

6 (a) ALTERNATIVE REGISTRATION PROCESS FOR

7 SCHEDULE I RESEARCH.—Section 303 of the Controlled


8 Substances Act (21 U.S.C. 823) is amended—
9 (1) by redesignating the second subsection (l) (re-
10 lating to required training for prescribers) as sub-
11 section (m); and
12 (2) by adding at the end the following:
13 ‘‘(n) SPECIAL PROVISIONS FOR PRACTITIONERS CON-
14 DUCTING CERTAIN RESEARCH WITH SCHEDULE I CON-
15 TROLLED SUBSTANCES.—
16 ‘‘(1) IN GENERAL.—Notwithstanding subsection
17 (f), a practitioner may conduct research described in
18 paragraph (2) of this subsection with 1 or more
19 schedule I substances in accordance with subpara-
20 graph (A) or (B) of paragraph (3) of this subsection.
21 ‘‘(2) RESEARCH SUBJECT TO EXPEDITED PROCE-

22 DURES.—Research described in this paragraph is re-


23 search that—
24 ‘‘(A) is with respect to a drug that is the
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25 subject of an investigational use exemption under

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1 section 505(i) of the Federal Food, Drug, and
2 Cosmetic Act; or
3 ‘‘(B) is—
4 ‘‘(i) conducted by the Department of
5 Health and Human Services or the Depart-
6 ment of Veterans Affairs; or
7 ‘‘(ii) funded partly or entirely by a
8 grant, contract, cooperative agreement, or
9 other transaction from the Department of
10 Health and Human Services or the Depart-
11 ment of Veterans Affairs.
12 ‘‘(3) EXPEDITED PROCEDURES.—

13 ‘‘(A) RESEARCHER WITH A CURRENT

14 SCHEDULE I OR II RESEARCH REGISTRATION.—

15 ‘‘(i) IN GENERAL.—If a practitioner is


16 registered to conduct research with a con-
17 trolled substance in schedule I or II, the
18 practitioner may conduct research under
19 this subsection on and after the date that is
20 30 days after the date on which the practi-
21 tioner sends a notice to the Attorney Gen-
22 eral containing the following information,
23 with respect to each substance with which
24 the practitioner will conduct the research:
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1 ‘‘(I) The chemical name of the
2 substance.
3 ‘‘(II) The quantity of the sub-
4 stance to be used in the research.
5 ‘‘(III) Demonstration that the re-
6 search is in the category described in
7 paragraph (2), which demonstration
8 may be satisfied—
9 ‘‘(aa) in the case of a grant,
10 contract, cooperative agreement,
11 or other transaction, or intra-
12 mural research project, by identi-
13 fying the sponsoring agency and
14 supplying the number of the
15 grant, contract, cooperative agree-
16 ment, other transaction, or
17 project; or
18 ‘‘(bb) in the case of an appli-
19 cation under section 505(i) of the
20 Federal Food, Drug, and Cosmetic
21 Act, by supplying the application
22 number and the sponsor of record
23 on the application.
24 ‘‘(IV) Demonstration that the re-
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25 searcher is authorized to conduct re-

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1 search with respect to the substance
2 under the laws of the State in which
3 the research will take place.
4 ‘‘(ii) VERIFICATION OF INFORMATION

5 BY HHS OR VA.—Upon request from the At-


6 torney General, the Secretary of Health and
7 Human Services or the Secretary of Vet-
8 erans Affairs, as appropriate, shall verify
9 information submitted by an applicant
10 under clause (i)(III).
11 ‘‘(B) RESEARCHER WITHOUT A CURRENT

12 SCHEDULE I OR II RESEARCH REGISTRATION.—

13 ‘‘(i) IN GENERAL.—If a practitioner is


14 not registered to conduct research with a
15 controlled substance in schedule I or II, the
16 practitioner may send a notice to the Attor-
17 ney General containing the information
18 listed in subparagraph (A)(i), with respect
19 to each substance with which the practi-
20 tioner will conduct the research.
21 ‘‘(ii) ATTORNEY GENERAL ACTION.—

22 The Attorney General shall—


23 ‘‘(I) treat notice received under
24 clause (i) as a sufficient application
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25 for a research registration; and

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1 ‘‘(II) not later than 45 days of re-
2 ceiving such a notice that contains all
3 information required under subpara-
4 graph (A)(i)—
5 ‘‘(aa) register the applicant;
6 or
7 ‘‘(bb) serve an order to show
8 cause upon the applicant in ac-
9 cordance with section 304(c).
10 ‘‘(4) ELECTRONIC SUBMISSIONS.—The Attorney
11 General shall provide a means to permit a practi-
12 tioner to submit a notification under paragraph (3)
13 electronically.
14 ‘‘(5) LIMITATION ON AMOUNTS.—A practitioner
15 conducting research with a schedule I substance under
16 this subsection may only possess the amounts of
17 schedule I substance identified in—
18 ‘‘(A) the notification to the Attorney Gen-
19 eral under paragraph (3); or
20 ‘‘(B) a supplemental notification that the
21 practitioner may send if the practitioner needs
22 additional amounts for the research, which sup-
23 plemental notification shall include—
24 ‘‘(i) the name of the practitioner;
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1 ‘‘(ii) the additional quantity needed of
2 the substance; and
3 ‘‘(iii) an attestation that the research
4 to be conducted with the substance is con-
5 sistent with the scope of the research that
6 was the subject of the notification under
7 paragraph (3).
8 ‘‘(6) IMPORTATION AND EXPORTATION REQUIRE-

9 MENTS NOT AFFECTED.—Nothing in this subsection


10 alters the requirements of part A of title III, regard-
11 ing the importation and exportation of controlled sub-
12 stances.’’.
13 (b) SEPARATE REGISTRATIONS NOT REQUIRED FOR

14 ADDITIONAL RESEARCHER IN SAME INSTITUTION.—Sec-


15 tion 302(c) of the Controlled Substances Act (21 U.S.C.
16 822(c)) is amended by adding at the end the following:
17 ‘‘(4) An agent or employee of a research institu-
18 tion that is conducting research with a controlled sub-
19 stance if—
20 ‘‘(A) the agent or employee is acting within
21 the scope of the professional practice of the agent
22 or employee;
23 ‘‘(B) another agent or employee of the insti-
24 tution is registered to conduct research with a
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25 controlled substance in the same schedule;

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1 ‘‘(C) the researcher who is so registered—
2 ‘‘(i) informs the Attorney General of
3 the name, position title, and employing in-
4 stitution of the agent or employee who is
5 not separately registered;
6 ‘‘(ii) authorizes that agent or employee
7 to perform research under the registration of
8 the registered researcher; and
9 ‘‘(iii) affirms that any act taken by
10 that agent or employee involving a con-
11 trolled substance shall be attributable to the
12 registered researcher, as if the researcher
13 had directly committed the act, for purposes
14 of any proceeding under section 304(a) to
15 suspend or revoke the registration of the reg-
16 istered researcher; and
17 ‘‘(D) the Attorney General does not, within
18 30 days of receiving the information, authoriza-
19 tion, and affirmation described in subparagraph
20 (C), refuse, for a reason listed in section 304(a),
21 to allow the agent or employee to possess the sub-
22 stance without a separate registration.’’.
23 (c) SINGLE REGISTRATION FOR RELATED RESEARCH
24 SITES.—Section 302(e) of the Controlled Substances Act (21
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1 U.S.C. 822(e)) is amended by adding at the end the fol-
2 lowing:
3 ‘‘(4)(A) Notwithstanding paragraph (1), a person reg-
4 istered to conduct research with a controlled substance
5 under section 303(f) may conduct the research under a sin-
6 gle registration if—
7 ‘‘(i) the research occurs exclusively on sites all of
8 which are—
9 ‘‘(I) within the same city or county; and
10 ‘‘(II) under the control of the same institu-
11 tion, organization, or agency; and
12 ‘‘(ii) before commencing the research, the re-
13 searcher notifies the Attorney General of each site
14 where—
15 ‘‘(I) the research will be conducted; or
16 ‘‘(II) the controlled substance will be stored
17 or administered.
18 ‘‘(B) A site described in subparagraph (A) shall be in-
19 cluded in a registration described in that subparagraph
20 only if the researcher has notified the Attorney General of
21 the site—
22 ‘‘(i) in the application for the registration; or
23 ‘‘(ii) before the research is conducted, or before
24 the controlled substance is stored or administered, at
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25 the site.

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1 ‘‘(C) The Attorney General may, in consultation with
2 the Secretary, issue regulations addressing, with respect to
3 research sites described in subparagraph (A)—
4 ‘‘(i) the manner in which controlled substances
5 may be delivered to the research sites;
6 ‘‘(ii) the storage and security of controlled sub-
7 stances at the research sites;
8 ‘‘(iii) the maintenance of records for the research
9 sites; and
10 ‘‘(iv) any other matters necessary to ensure effec-
11 tive controls against diversion at the research sites.’’.
12 (d) NEW INSPECTION NOT REQUIRED IN CERTAIN SIT-
13 UATIONS.—Section 302(f) of the Controlled Substances Act
14 (21 U.S.C. 822(f)) is amended—
15 (1) by striking ‘‘(f) The’’ and inserting ‘‘(f)(1)
16 The’’; and
17 (2) by adding at the end the following:
18 ‘‘(2)(A) If a person is registered to conduct research
19 with a controlled substance and applies for a registration,
20 or for a modification of a registration, to conduct research
21 with a second controlled substance that is in the same sched-
22 ule as the first controlled substance, or is in a schedule with
23 a higher numerical designation than the schedule of the first
24 controlled substance, a new inspection by the Attorney Gen-
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25 eral of the registered location is not required.

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1 ‘‘(B) Nothing in subparagraph (A) shall prohibit the
2 Attorney General from conducting an inspection that the
3 Attorney General determines necessary to ensure that a reg-
4 istrant maintains effective controls against diversion.’’.
5 (e) CONTINUATION OF RESEARCH ON SUBSTANCES
6 NEWLY ADDED TO SCHEDULE I.—Section 302 of the Con-
7 trolled Substances Act (21 U.S.C. 822) is amended by add-
8 ing at the end the following:
9 ‘‘(h) CONTINUATION OF RESEARCH ON SUBSTANCES
10 NEWLY ADDED TO SCHEDULE I.—If a person is conducting
11 research on a substance when the substance is added to
12 schedule I, and the person is already registered to conduct
13 research with a controlled substance in schedule I—
14 ‘‘(1) not later than 90 days after the scheduling
15 of the newly scheduled substance, the person shall sub-
16 mit a completed application for registration or modi-
17 fication of existing registration, to conduct research
18 on the substance, in accordance with regulations
19 issued by the Attorney General for purposes of this
20 paragraph;
21 ‘‘(2) the person may, notwithstanding sub-
22 sections (a) and (b), continue to conduct the research
23 on the substance until—
24 ‘‘(A) the person withdraws the application
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25 described in paragraph (1) of this subsection; or

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1 ‘‘(B) the Attorney General serves on the per-
2 son an order to show cause proposing the denial
3 of the application under section 304(c);
4 ‘‘(3) if the Attorney General serves an order to
5 show cause as described in paragraph (2)(B) and the
6 person requests a hearing, the hearing shall be held on
7 an expedited basis and not later than 45 days after
8 the request is made, except that the hearing may be
9 held at a later time if so requested by the person; and
10 ‘‘(4) if the person sends a copy of the application
11 described in paragraph (1) to a manufacturer or dis-
12 tributor of the substance, receipt of the copy by the
13 manufacturer or distributor shall constitute sufficient
14 evidence that the person is authorized to receive the
15 substance.’’.
16 (f) TREATMENT OF CERTAIN MANUFACTURING ACTIVI-
17 TIES AS COINCIDENT TO RESEARCH.—Section 302 of the
18 Controlled Substances Act (21 U.S.C. 822), as amended by
19 subsection (e), is amended by adding at the end the fol-
20 lowing:
21 ‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC-
22 TIVITIES AS COINCIDENT TO RESEARCH.—
23 ‘‘(1) IN GENERAL.—Except as provided in para-
24 graph (3), a person who is registered to perform re-
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25 search on a controlled substance may perform manu-

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1 facturing activities with small quantities of that sub-
2 stance, including activities described in paragraph
3 (2), without being required to obtain a manufac-
4 turing registration, if—
5 ‘‘(A) the activities are performed for the
6 purpose of the research; and
7 ‘‘(B) the activities and the quantities of the
8 substance involved in the activities are stated
9 in—
10 ‘‘(i) a notification submitted to the At-
11 torney General under section 303(l);
12 ‘‘(ii) a research protocol filed with an
13 application for registration approval under
14 section 303(f); or
15 ‘‘(iii) a notification to the Attorney
16 General that includes—
17 ‘‘(I) the name of the registrant;
18 and
19 ‘‘(II) an attestation that the re-
20 search to be conducted with the small
21 quantities of manufactured substance
22 is consistent with the scope of the re-
23 search that is the basis for the registra-
24 tion.
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1 ‘‘(2) ACTIVITIES INCLUDED.—Activities per-
2 mitted under paragraph (1) include—
3 ‘‘(A) processing the substance to create ex-
4 tracts, tinctures, oils, solutions, derivatives, or
5 other forms of the substance consistent with—
6 ‘‘(i) the information provided as part
7 of a notification submitted to the Attorney
8 General under section 303(l); or
9 ‘‘(ii) a research protocol filed with an
10 application for registration approval under
11 section 303(f); and
12 ‘‘(B) dosage form development studies per-
13 formed for the purpose of requesting an inves-
14 tigational new drug exemption under section
15 505(i) of the Federal Food, Drug, and Cosmetic
16 Act (21 U.S.C. 355(i)).
17 ‘‘(3) EXCEPTION REGARDING MARIHUANA.—The

18 authority under paragraph (1) to manufacture sub-


19 stances does not include the authority to grow mari-
20 huana.’’.
21 (g) TRANSPARENCY REGARDING SPECIAL PROCE-
22 DURES.—Section 303 of the Controlled Substances Act (21
23 U.S.C. 823), as amended by subsection (a), is amended by
24 adding at the end the following:
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1 ‘‘(o) TRANSPARENCY REGARDING SPECIAL PROCE-
2 DURES.—

3 ‘‘(1) IN GENERAL.—If the Attorney General de-


4 termines, with respect to a controlled substance, that
5 an application by a practitioner to conduct research
6 with the substance should be considered under a proc-
7 ess, or subject to criteria, different from the process or
8 criteria applicable to applications to conduct research
9 with other controlled substances in the same schedule,
10 the Attorney General shall make public, including by
11 posting on the website of the Drug Enforcement Ad-
12 ministration—
13 ‘‘(A) the identities of all substances for
14 which such determinations have been made;
15 ‘‘(B) the process and criteria that shall be
16 applied to applications to conduct research with
17 those substances; and
18 ‘‘(C) how the process and criteria described
19 in subparagraph (B) differ from the process and
20 criteria applicable to applications to conduct re-
21 search with other controlled substances in the
22 same schedule.
23 ‘‘(2) TIMING OF POSTING.—The Attorney General
24 shall make information described in paragraph (1)
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25 public upon making a determination described in

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1 that paragraph, regardless of whether a practitioner
2 has submitted such an application at that time.’’.
3 SEC. 4. RULEMAKING.

4 (a) INTERIM FINAL RULES.—The Attorney General—


5 (1) shall, not later than 1 year of the date of en-
6 actment of this Act, issue rules to implement this Act
7 and the amendments made by this Act; and
8 (2) may issue the rules under paragraph (1) as
9 interim final rules.
10 (b) PROCEDURE FOR FINAL RULE.—
11 (1) EFFECTIVENESS OF INTERIM FINAL RULES.—

12 A rule issued by the Attorney General as an interim


13 final rule under subsection (a) shall become imme-
14 diately effective as an interim final rule without re-
15 quiring the Attorney General to demonstrate good
16 cause therefor, notwithstanding subparagraph (B) of
17 section 553(b) of title 5, United States Code.
18 (2) OPPORTUNITY FOR COMMENT AND HEAR-

19 ING.—An interim final rule issued under subsection


20 (a) shall give interested persons the opportunity to
21 comment and to request a hearing.
22 (3) FINAL RULE.—After the conclusion of such
23 proceedings, the Attorney General shall issue a final
24 rule to implement this Act and the amendments made
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1 by this Act in accordance with section 553 of title 5,
2 United States Code.
3 SEC. 5. PENALTIES.

4 (a) IN GENERAL.—Section 401(b)(1) of the Controlled


5 Substances Act (21 U.S.C. 841(b)(1)) is amended—
6 (1) in subparagraph (A)(vi), by inserting ‘‘or a
7 fentanyl-related substance’’ after ‘‘any analogue of N-
8 phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]
9 propanamide’’; and
10 (2) in subparagraph (B)(vi), by inserting ‘‘or a
11 fentanyl-related substance’’ after ‘‘any analogue of N-
12 phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]
13 propanamide’’.
14 (b) IMPORTATION AND EXPORTATION.—Section
15 1010(b) of the Controlled Substances Import and Export
16 Act (21 U.S.C. 960(b)) is amended—
17 (1) in paragraph (1)(F), by inserting ‘‘or a
18 fentanyl-related substance’’ after ‘‘any analogue of N-
19 phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]
20 propanamide’’; and
21 (2) in paragraph (2)(F), by inserting ‘‘or a
22 fentanyl-related substance’’ after ‘‘any analogue of N-
23 phenyl-N-[1-(2-phenylethyl)-4-piperidinyl]
24 propanamide’’.
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21
1 SEC. 6. APPLICABILITY; OTHER MATTERS.

2 (a) IN GENERAL.—Irrespective of the date on which


3 the rules required by section 4 are finalized, the amend-
4 ments made by this Act apply beginning as of the enact-
5 ment of this Act.
6 (b) RULE OF CONSTRUCTION.—Nothing in the amend-
7 ments made by this Act may be construed as evidence that,
8 in applying sections 401(b)(1) and 1010(b) of the Con-
9 trolled Substances Act (21 U.S.C. 841(b)(1) and 960(b))
10 with respect to conduct occurring before the date of the en-
11 actment of this Act, a fentanyl-related substance (as defined
12 by such amendments) is not an analogue of N-phenyl-N-
13 [1-(2-phenylethyl)-4-piperidinyl] propanamide.
14 (c) SENSE OF CONGRESS.—The Congress agrees with
15 the interpretation of the Controlled Substances Act (21
16 U.S.C. 801 et seq.) in United States v. McCray, 346 F.
17 Supp. 3d 363 (2018).
kjohnson on DSK79L0C42PROD with BILLS

•HR 467 RH

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Union Calendar No. 47
118TH CONGRESS
1ST SESSION H. R. 467
[Report No. 118–67, Part I]

H467
A BILL

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To amend the Controlled Substances Act with re-
spect to the scheduling of fentanyl-related sub-
stances, and for other purposes.

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MAY 17, 2023
Reported from the Committee on Energy and Commerce
with an amendment

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MAY 17, 2023
Committee on the Judiciary discharged; committed to the

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Committee of the Whole House on the State of the
Union and ordered to be printed

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kjohnson on DSK79L0C42PROD with BILLS

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