‘‘(B) the Attorney General serves on the per-
son 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 dis-
tributor 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 ACTIVI-
TIES 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 fol-
lowing: 
‘‘(i) TREATMENT OF CERTAIN MANUFACTURING AC-
TIVITIES AS COINCIDENT TO RESEARCH.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (3), a person who is registered to perform re-
search on a controlled substance may perform manu-
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
facturing activities with small quantities of that sub-
stance, including activities described in paragraph 
(2), without being required to obtain a manufac-
turing 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 At-
torney 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 re-
search to be conducted with the small 
quantities of manufactured substance 
is consistent with the scope of the re-
search that is the basis for the registra-
tion. 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
‘‘(2) ACTIVITIES
INCLUDED.—Activities per-
mitted under paragraph (1) include— 
‘‘(A) processing the substance to create ex-
tracts, 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 per-
formed for the purpose of requesting an inves-
tigational 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 sub-
stances does not include the authority to grow mari-
huana.’’. 
(g) TRANSPARENCY
REGARDING
SPECIAL
PROCE-
DURES.—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: 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
‘‘(o) TRANSPARENCY REGARDING SPECIAL PROCE-
DURES.— 
‘‘(1) IN GENERAL.—If the Attorney General de-
termines, with respect to a controlled substance, that 
an application by a practitioner to conduct research 
with the substance should be considered under a proc-
ess, 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 Ad-
ministration— 
‘‘(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 re-
search 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 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00018
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
that paragraph, regardless of whether a practitioner 
has submitted such an application at that time.’’. 
SEC. 4. RULEMAKING. 
(a) INTERIM FINAL RULES.—The Attorney General— 
(1) shall, not later than 1 year of the date of en-
actment 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 imme-
diately effective as an interim final rule without re-
quiring 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
HEAR-
ING.—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 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
by this Act in accordance with section 553 of title 5, 
United States Code. 
SEC. 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’’. 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
SEC. 6. APPLICABILITY; OTHER MATTERS. 
(a) IN GENERAL.—Irrespective of the date on which 
the rules required by section 4 are finalized, the amend-
ments made by this Act apply beginning as of the enact-
ment of this Act. 
(b) RULE OF CONSTRUCTION.—Nothing in the amend-
ments made by this Act may be construed as evidence that, 
in applying sections 401(b)(1) and 1010(b) of the Con-
trolled Substances Act (21 U.S.C. 841(b)(1) and 960(b)) 
with respect to conduct occurring before the date of the en-
actment 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). 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6203
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS
Union Calendar No. 47 
118TH CONGRESS 
1ST SESSION 
H. R. 467 
[Report No. 118–67, Part I] 
A BILL 
To amend the Controlled Substances Act with re-
spect to the scheduling of fentanyl-related sub-
stances, and for other purposes. 
MAY 17, 2023 
Reported from the Committee on Energy and Commerce 
with an amendment 
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 
VerDate Sep 11 2014 
00:56 May 18, 2023
Jkt 039200
PO 00000
Frm 00022
Fmt 6651
Sfmt 6651
E:\BILLS\H467.RH
H467
kjohnson on DSK79L0C42PROD with BILLS