Notice2023-23931
Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 31, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) proposes to adjust the 2023 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemical phenylpropanolamine.
Full Text
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<title>Federal Register, Volume 88 Issue 209 (Tuesday, October 31, 2023)</title>
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[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Notices]
[Pages 74512-74520]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-23931]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1051A]
Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual Needs
for the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2023
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust
the 2023 aggregate production quotas for several controlled substances
in schedules I and II of the Controlled Substances Act (CSA) and the
assessment of annual needs for the list I chemical phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before November 30, 2023. Commenters should be aware that the
electronic Federal Docket Management System will not accept comments
after 11:59 p.m. Eastern Time on the last day of the comment period.
[[Page 74513]]
Based on comments received in response to this notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in her sole discretion to hold
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments or
objections, or after a hearing, if one is held, the Administrator will
publish in the Federal Register a final order establishing the 2023
adjusted aggregate production quotas for schedule I and II controlled
substances, and an adjusted assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as
relevant.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1051A'' on all correspondence, including any
attachments. DEA encourages that all comments be submitted
electronically through the Federal eRulemaking Portal, which provides
the ability to type short comments directly into the comment field on
the web page or attach a file for lengthier comments. Please go to
<a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online instructions at that
site for submitting comments. Upon completion of your submission, you
will receive a Comment Tracking Number for your comment. Please be
aware that submitted comments are not instantaneously available for
public view on <a href="http://Regulations.gov">Regulations.gov</a>. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment. Paper comments that duplicate
electronic submissions are not necessary and are discouraged. Should
you wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone: 571-776-3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. The Drug Enforcement
Administration (DEA) will make comments available for public inspection
online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Such information includes
personal or business identifiers (such as name, address, state or
Federal identifiers, etc.) voluntarily submitted by the commenter.
Generally, all information voluntarily submitted by the commenter,
unless clearly marked as Confidential Information in the method
described below, will be publicly posted. Comments may be submitted
anonymously. The Freedom of Information Act applies to all comments
received.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all claimed confidential PII and
business information already redacted. DEA will post only the redacted
comment on <a href="http://www.regulations.gov">http://www.regulations.gov</a> for public inspection.
For easy reference, an electronic copy of this document is
available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
Legal Authority and Background
Section 306 of the CSA (21 U.S.C. 826) requires the Attorney
General to establish aggregate production quotas (APQ) for each basic
class of controlled substance listed in schedules I and II and for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
The Attorney General has delegated this function to the Administrator
of DEA.\1\
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\1\ 28 CFR 0.100(b).
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DEA established the 2023 APQ for substances in schedules I and II
and the assessment of annual needs (AAN) for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine on December 2,
2022.\2\ That order stipulated that, in accordance with 21 CFR 1303.13
and 1315.13, all APQ and AAN are subject to adjustment.
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\2\ Established Aggregate Production Quotas for Schedule I and
II Controlled Substances and Assessment of Annual Needs for the List
I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2023, 87 FR 74168 (December 2, 2022).
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Analysis for Proposed Adjusted 2023 Aggregate Production Quotas and
Assessment of Annual Needs
DEA proposes to adjust the established 2023 APQ for certain
schedule I and II controlled substances and the AAN for certain list I
chemicals to be manufactured in the United States (U.S.) in 2023 to
provide for the estimated medical, scientific, research, and industrial
needs of the U.S., for lawful export requirements, and for the
establishment and maintenance of reserve stocks. These quotas do not
include imports of controlled substances for use in industrial
processes.
Factors for Determining the Proposed Adjustments
In determining the proposed adjustments, the Administrator has
taken into account the factors in 21 CFR 1303.13 (adjustment of APQ for
controlled substances) and 21 CFR 1315.13 (adjustment of the AAN for
ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator
is authorized to increase or reduce the APQ and the AAN at any time.\3\
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\3\ 21 CFR 1303.13(a) and 1315.13(a).
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DEA determined whether to propose an adjustment of the APQ for 2023
by considering the factors found at 21 CFR 1303.13(b): \4\
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\4\ DEA recently adopted revisions to its regulations for
setting quotas, but that rule has not yet taken effect and does not
affect this notice proposing some adjustments to the 2023 APQs.
Management of Quotas for Controlled Substances and List I Chemicals,
88 FR 60117 (Aug. 31, 2023) (effective Nov. 29, 2023).
(1) Changes in the demand for that class, changes in the
national rate of net disposal of the class, changes in the rate of
net disposal of the class by registrants holding individual
manufacturing quotas for that class, and changes in the extent of
any diversion in the class;
(2) Whether any increased demand for that class, the national
and/or individual rates of net disposal of that class are temporary,
short term, or long term;
(3) Whether any increased demand for that class can be met
through existing inventories, increased individual manufacturing
quotas, or increased importation, without increasing the aggregate
production quota, taking into account production delays and the
probability that other individual manufacturing quotas may be
suspended pursuant to Sec. 1303.24(b);
(4) Whether any decreased demand for that class will result in
excessive inventory accumulation by all persons registered to handle
that class (including manufacturers, distributors, practitioners,
importers, and
[[Page 74514]]
exporters), notwithstanding the possibility that individual
manufacturing quotas may be suspended pursuant to Sec. 1303.24(b) or
abandoned pursuant to Sec. 1303.27;
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export
requirements, as the Administrator finds relevant, including changes
in the currently accepted medical use in treatment with the class or
the substances which are manufactured from it, the economic and
physical availability of raw materials for use in manufacturing and
for inventory purposes, yield and stability problems, potential
disruptions to production (including possible labor strikes), and
recent unforeseen emergencies such as floods and fires.
DEA also considered updated information obtained from 2022 year-end
inventories, 2022 disposition data submitted by quota applicants,
changes in estimates of the medical needs of the U.S., export
requirements, and other information made available to DEA after the
initial APQ and AAN had been established. Additional factors the
Administrator considered in calculating the APQ, but not the AAN,
include product development requirements of both bulk and finished
dosage form manufacturers.
After considering the changes in the extent of diversion of all
controlled substances, as required by 21 CFR 1303.13(b)(1), DEA has
determined that any changes from the initial calculations are slight
and not statistically significant from the estimates of diversion that
DEA applied to the initial APQ valuations.
DEA determined whether to propose an adjustment of the AAN for 2023
by considering the factors found at 21 CFR 1315.13(b) and summarized
below:
(1) Changes in the demand for that chemical, changes in the
national rate of net disposal of the chemical, and changes in the
rate of net disposal of the chemical by registrants holding
individual manufacturing or import quotas for that chemical;
(2) Whether any increased demand for that chemical, the national
and/or changes in individual rates of net disposal of that chemical
are temporary, short term, or long term;
(3) Whether any increased demand for that chemical can be met
through existing inventories, increased individual manufacturing
quotas, or increased importation, without increasing the assessment
of annual needs, taking into account production delays and the
probability that other individual manufacturing quotas may be
suspended pursuant to Sec. 1315.24(b);
(4) Whether any decreased demand for that chemical will result
in excessive inventory accumulation by all persons registered to
handle that chemical (including manufacturers, distributors,
importers, and exporters), notwithstanding the possibility that
individual manufacturing quotas may be suspended pursuant to Sec.
1315.24(b) or abandoned pursuant to Sec. 1315.27;
(5) Other factors affecting medical, scientific, research,
industrial, and importation needs in the United States, lawful
export requirements, and reserve stocks, as the Administrator finds
relevant, including changes in the currently accepted medical use in
treatment with the chemical or the substances that are manufactured
from it, the economic and physical availability of raw materials for
use in manufacturing and for inventory purposes, yield and stability
problems, potential disruptions to production (including possible
labor strikes), and recent unforeseen emergencies such as floods and
fires.
In evaluating whether there is a need for adjustment of the 2023
AAN for list I chemicals, DEA used the calculation methodology
previously described in the 2010 and 2011 assessment of annual
needs.\5\ DEA considered the total net disposals of the list I
chemicals for the current and preceding two years, actual and estimated
inventories, projected demand, industrial use, and export requirements
from data provided by DEA registered manufacturers and importers on the
relevant quota application forms.\6\
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\5\ 74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20, 2010).
\6\ Id.
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Additional Considerations Applicable to Covered Controlled Substances
When setting APQ, the Administrator must estimate the amount of
diversion of any substance that is considered a ``covered controlled
substance.'' \7\ The covered controlled substances are fentanyl,
oxycodone, hydrocodone, oxymorphone, and hydromorphone.\8\ DEA is
required to ``make appropriate quota reductions, as determined by the
[Administrator], from the quota the [Administrator] would have
otherwise established had such diversion not been considered.'' \9\
When estimating diversion, the Administrator ``shall consider
information,'' in consultation with the Secretary of Health and Human
Services, the Administrator ``determines reliable on rates of overdose
deaths and abuse and overall public health impact related to the
covered controlled substance in the United States;'' and ``may take
into consideration'' whatever other sources of information they
determine reliable.\10\
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\7\ 21 U.S.C. 826(i)(1)(A).
\8\ 21 U.S.C. 826(i)(1)(A).
\9\ All functions vested in the Attorney General by the CSA have
been delegated to the Administrator of DEA. 28 CFR 0.100(b); 21
U.S.C. 826(i)(1)(C).
\10\ 21 U.S.C. 826(i)(1)(B).
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DEA sent letters to the Centers for Disease Control and Prevention
(CDC), and the states in February, April, and May 2023 requesting
overdose death and overprescribing data that could be considered in
estimating diversion. DEA received information from the CDC in April
2023 and received Prescription Data Monitoring Program (PDMP) data from
the states in May and June 2023. DEA considered this information in
developing the estimates of diversion for the five covered controlled
substances for this proposed adjustment.
To determine the estimates of diversion, DEA also aggregated data
for each covered controlled substance from the Drug Theft and Loss
Reports. DEA gathered data involving employee theft, break-ins, armed
robberies, and material lost in transit. DEA calculated the metric
weight in grams of each active pharmaceutical ingredient (API) of the
controlled substances being diverted as identified in these reports. In
calculating the estimates of diversion, DEA utilized the same
methodology as published in the Proposed APQ for Schedule I and II
Controlled Substances and AAN for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2023.\11\ Below, DEA
provides an updated chart showing estimations of diversion for each of
the covered controlled substances.
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\11\ 87 FR 63091 (October 18, 2022).
Diversion Estimates for 2023 (g)
------------------------------------------------------------------------
Fentanyl 59
------------------------------------------------------------------------
Hydrocodone................................................... 133,004
Hydromorphone................................................. 595
Oxycodone..................................................... 174,797
Oxymorphone................................................... 109
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Proposed Adjustments for the 2023 Aggregate Production Quotas and
Assessment of Annual Needs
DEA is proposing increases to the APQ for the following schedule I
substances: all other tetrahydrocannabinol, delta-9-
tetrahydrocannabinol, ibogaine, psilocybin, and psilocyn. These
proposed increases are to support research and clinical trials by DEA-
registered schedule I researchers. These proposed increases demonstrate
DEA's support for research with schedule I controlled substances.
DEA established the 2023 APQs for substances in schedules I and II
on December 2, 2022.\12\ Subsequent to that publication, DEA published
in the Federal Register final rules to permanently schedule four
synthetic
[[Page 74515]]
drugs under the CSA.\13\ The specific synthetic substances are
eutylone, mesocarb, methiopropamine, and zipeprol. As a result, these
substances will continue to be subject to the CSA schedule I controls
and DEA is proposing to assign individual APQ for each substance
pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
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\12\ 87 FR 74168.
\13\ 87 FR 70717 (November 21, 2022), 87 FR 71247 (November 22,
2022), 87 FR 20318 (April, 7 2022), and 87 FR 32996 (June 1, 2022).
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DEA previously adjusted the established 2023 aggregate production
quota for the schedule II-controlled substance methylphenidate (for
sale) to be manufactured in the United States to provide for the
estimated needs of the United States and export requirements in
accordance with 21 U.S.C. 826(h).\14\ This adjustment was necessary to
ensure that the United States has an adequate and uninterrupted supply
of methylphenidate (for sale) to meet legitimate patient needs both
domestically and globally.
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\14\ Adjustment to the Aggregate Production Quota for
Methylphenidate (for Sale) for 2023, 88 FR 68147 (October 3, 2023).
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The Administrator, therefore, proposes to adjust the 2023 APQ for
the schedule I controlled substances of all other tetrahydrocannabinol,
delta-9-tetrahydrocannabinol, eutylone, ibogaine, mesocarb,
methiopropamine, psilocybin, psilocyn, and zipeprol. The proposed
adjusted APQ and AAN, as expressed in grams of anhydrous acid or base,
are as follows:
------------------------------------------------------------------------
Established 2023 Proposed revised
Basic class quotas (g) 2023 quotas (g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-[1-(2- 20 no change.
Thienyl)cyclohexyl]pyrrolidine...
1-(1-Phenylcyclohexyl)pyrrolidine. 30 no change.
1-(2-Phenylethyl)-4-phenyl-4- 10 no change.
acetoxypiperidine................
1-(5-Fluoropentyl)-3-(1- 30 no change.
naphthoyl)indole (AM2201)........
1-(5-Fluoropentyl)-3-(2- 30 no change.
iodobenzoyl)indole (AM694).......
1-[1-(2- 15 no change.
Thienyl)cyclohexyl]piperidine....
2'-fluoro 2-fluorofentanyl........ 30 no change.
1-Benzylpiperazine................ 25 no change.
1-Methyl-4-phenyl-4- 10 no change.
propionoxypiperidine.............
2-(2,5-Dimethoxy-4- 30 no change.
ethylphenyl)ethanamine (2C-E)....
2-(2,5-Dimethoxy-4- 30 no change.
methylphenyl)ethanamine (2C-D)...
2-(2,5-Dimethoxy-4-nitro- 30 no change.
phenyl)ethanamine (2C-N).........
2-(2,5-Dimethoxy-4-n- 30 no change.
propylphenyl)ethanamine (2C-P)...
2-(2,5-Dimethoxyphenyl)ethanamine 100 no change.
(2C-H)...........................
2-(4-Bromo-2,5-dimethoxyphenyl)-N- 30 no change.
(2-methoxybenzyl)ethanamine (25B-
NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
2-(4-Chloro-2,5- 30 no change.
dimethoxyphenyl)ethanamine (2C-C)
2-(4-Chloro-2,5-dimethoxyphenyl)-N- 25 no change.
(2-methoxybenzyl)ethanamine (25C-
NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
2-(4-Iodo-2,5- 30 no change.
dimethoxyphenyl)ethanamine (2C-I)
2-(4-Iodo-2,5-dimethoxyphenyl)-N- 30 no change.
(2-methoxybenzyl)ethanamine (25I-
NBOMe; 2C-I-NBOMe; 25I; Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine 25 no change.
(DOET)...........................
2,5-Dimethoxy-4-n- 25 no change.
propylthiophenethylamine.........
2,5-Dimethoxyamphetamine.......... 25 no change.
2-[4-(Ethylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-T-
2)...............................
2-[4-(Isopropylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-T-
4)...............................
3,4,5-Trimethoxyamphetamine....... 30 no change.
3,4-Methylenedioxyamphetamine 12,000 no change.
(MDA)............................
3,4-Methylenedioxymethamphetamine 12,000 no change.
(MDMA)...........................
3,4-Methylenedioxy-N- 40 no change.
ethylamphetamine (MDEA)..........
3,4-Methylenedioxy-N- 5,200 no change.
methylcathinone (methylone)......
3,4-Methylenedioxypyrovalerone 35 no change.
(MDPV)...........................
3-FMC; 3-Fluoro-N-methylcathinone. 25 no change.
3-Methylfentanyl.................. 30 no change.
3-Methylthiofentanyl.............. 30 no change.
4-Bromo-2,5-dimethoxyamphetamine 5,100 no change.
(DOB)............................
4-Bromo-2,5- 25 no change.
dimethoxyphenethylamine (2-CB)...
4-Chloro-alpha- 25 no change.
pyrrolidinovalerophenone (4-
chloro-alpha-PVP)................
4-CN-Cumyl-Butinaca............... 25 no change.
4,4'-Dimethylaminorex............. 30 no change.
4-Fluoroisobutyryl fentanyl....... 30 no change.
4F-MDMB-BINACA.................... 30 no change.
4-FMC; Flephedrone................ 25 no change.
4-MEC; 4-Methyl-N-ethylcathinone.. 25 no change.
4-Methoxyamphetamine.............. 150 no change.
4-Methyl-2,5-dimethoxyamphetamine 25 no change.
(DOM)............................
4-Methylaminorex.................. 25 no change.
4-Methyl-N-methylcathinone 45 no change.
(mephedrone).....................
4-Methyl-alpha- 25 no change.
ethylaminopentiophenone (4-MEAP).
4-Methyl-alpha- 25 no change.
pyrrolidinohexiophenone (MPHP)...
4'-Methyl acetyl fentanyl......... 30 no change.
[[Page 74516]]
4-Methyl-[alpha]- 25 no change.
pyrrolidinopropiophenone (4-
MePPP)...........................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)- 50 no change.
3-hydroxycyclohexyl]-phenol......
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3- 40 no change.
hydroxycyclohexyl]-phenol
(cannabicyclohexanol or CP-47,497
C8-homolog)......................
5F-AB-PINACA; (1-Amino-3-methyl-1- 25 no change.
oxobutan-2-yl)-1-(5-fluoropentyl)-
1H-indazole-3-carboxamide........
5F-ADB; 5F-MDMB-PINACA (methyl 2- 25 no change.
(1-(5-fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate)...............
5F-CUMYL-P7AICA; 1-(5- 25 no change.
Fluoropentyl)-N-(2-phenylpropan-2-
yl)-1H-pyrrolo[2,3-b]pyridine-
3carboximide.....................
5F-CUMYL-PINACA................... 25 no change.
5F-EDMB-PINACA.................... 25 no change.
5F-MDMB-PICA...................... 25 no change.
5F-AMB (methyl 2-(1-(5- 25 no change.
fluoropentyl)-1H-indazole-3-
carboxamido)-3-methylbutanoate)..
5F-APINACA; 5F-AKB48 (N-(adamantan- 25 no change.
1-yl)-1-(5-fluoropentyl)-1H-
indazole-3-carboxamide)..........
5-Fluoro-PB-22; 5F-PB-22.......... 25 no change.
5-Fluoro-UR144, XLR11 ([1-(5- 25 no change.
fluoro-pentyl)-1Hindol-3-
yl](2,2,3,3-
tetramethylcyclopropyl)methanone.
5-Methoxy-3,4- 25 no change.
methylenedioxyamphetamine........
5-Methoxy-N,N- 25 no change.
diisopropyltryptamine............
5-Methoxy-N,N-dimethyltryptamine.. 11,000 no change.
AB-CHMINACA....................... 30 no change.
AB-FUBINACA....................... 50 no change.
AB-PINACA......................... 30 no change.
ADB-FUBINACA (N-(1-amino-3,3- 30 no change.
dimethyl-1-oxobutan-2-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-
carboxamide).....................
Acetorphine....................... 25 no change.
Acetyl Fentanyl................... 100 no change.
Acetyl-alpha-methylfentanyl....... 30 no change.
Acetyldihydrocodeine.............. 30 no change.
Acetylmethadol.................... 25 no change.
Acryl Fentanyl.................... 25 no change.
ADB-PINACA (N-(1-amino-3,3- 50 no change.
dimethyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-carboxamide)
AH-7921........................... 30 no change.
All other tetrahydrocannabinol.... 15,000 350,000.
Allylprodine...................... 25 no change.
Alphacetylmethadol................ 25 no change.
alpha-Ethyltryptamine............. 25 no change.
Alphameprodine.................... 25 no change.
Alphamethadol..................... 25 no change.
alpha-Methylfentanyl.............. 30 no change.
alpha-Methylthiofentanyl.......... 30 no change.
alpha-Methyltryptamine (AMT)...... 25 no change.
alpha-Pyrrolidinobutiophenone 25 no change.
([alpha]-PBP)....................
alpha-pyrrolidinoheptaphenone 25 no change.
(PV8)............................
alpha-pyrrolidinohexabophenone 25 no change.
([alpha] -PHP)...................
alpha-Pyrrolidinopentiophenone 25 no change.
([alpha]-PVP)....................
Amineptine........................ 30 no change.
Aminorex.......................... 25 no change.
Anileridine....................... 20 no change.
APINCA, AKB48 (N-(1-adamantyl)-1- 25 no change.
pentyl-1H-indazole-3-carboxamide)
Benzethidine...................... 25 no change.
Benzylmorphine.................... 30 no change.
Betacetylmethadol................. 25 no change.
beta-Hydroxy-3-methylfentanyl..... 30 no change.
beta-Hydroxyfentanyl.............. 30 no change.
beta-Hydroxythiofentanyl.......... 30 no change.
beta-Methyl fentanyl.............. 30 no change.
beta-Phenyl fentanyl.............. 30 no change.
Betameprodine..................... 25 no change.
Betamethadol...................... 4 no change.
Betaprodine....................... 25 no change.
Brorphine......................... 30 no change.
Bufotenine........................ 15 no change.
Butonitazene...................... 30 no change.
Butylone.......................... 25 no change.
Butyryl fentanyl.................. 30 no change.
Cathinone......................... 40 no change.
Clonitazene....................... 25 no change.
Codeine methylbromide............. 30 no change.
Codeine-N-oxide................... 192 no change.
Crotonyl Fentanyl................. 25 no change.
Cyclopentyl Fentanyl.............. 30 no change.
Cyclopropyl Fentanyl.............. 20 no change.
[[Page 74517]]
Cyprenorphine..................... 25 no change.
d-9-THC........................... 384,460 628,460.
Desomorphine...................... 25 no change.
Dextromoramide.................... 25 no change.
Diapromide........................ 20 no change.
Diethylthiambutene................ 20 no change.
Diethyltryptamine................. 25 no change.
Difenoxin......................... 9,300 no change.
Dihydromorphine................... 653,548 no change.
Dimenoxadol....................... 25 no change.
Dimepheptanol..................... 25 no change.
Dimethylthiambutene............... 20 no change.
Dimethyltryptamine................ 3,000 no change.
Dioxyaphetyl butyrate............. 25 no change.
Dipipanone........................ 25 no change.
Drotebanol........................ 25 no change.
Ethylmethylthiambutene............ 25 no change.
Ethylone.......................... 25 no change.
Etonitazene....................... 25 no change.
Etodesnitazene.................... 30 no change.
Etorphine......................... 30 no change.
Etoxeridine....................... 25 no change.
Eutylone.......................... N/A 30.
Fenethylline...................... 30 no change.
Fentanyl carbamate................ 30 no change.
Fentanyl related substances....... 600 no change.
FUB-144........................... 25 no change.
Flunitazene....................... 30 no change.
FUB-AKB48......................... 25 no change.
Fub-AMB, MMB-Fubinaca, AMB- 25 no change.
Fubinaca.........................
Furanyl fentanyl.................. 30 no change.
Furethidine....................... 25 no change.
gamma-Hydroxybutyric acid......... 29,417,000 no change.
Heroin............................ 150 no change.
Hydromorphinol.................... 40 no change.
Hydroxypethidine.................. 25 no change.
Ibogaine.......................... 30 150.
Isobutyryl Fentanyl............... 25 no change.
Isotonitazine..................... 25 no change.
JWH-018 and AM678 (1-Pentyl-3-(1- 35 no change.
naphthoyl)indole)................
JWH-019 (1-Hexyl-3-(1- 45 no change.
naphthoyl)indole)................
JWH-073 (1-Butyl-3-(1- 45 no change.
naphthoyl)indole)................
JWH-081 (1-Pentyl-3-[1-(4- 30 no change.
methoxynaphthoyl)]indole)........
JWH-122 (1-Pentyl-3-(4-methyl-1- 30 no change.
naphthoyl)indole)................
JWH-200 (1-[2-(4- 35 no change.
Morpholinyl)ethyl]-3-(1-
naphthoyl)indole)................
JWH-203 (1-Pentyl-3-(2- 30 no change.
chlorophenylacetyl)indole).......
JWH-250 (1-Pentyl-3-(2- 30 no change.
methoxyphenylacetyl)indole)......
JWH-398 (1-Pentyl-3-(4-chloro-1- 30 no change.
naphthoyl)indole)................
Ketobemidone...................... 30 no change.
Levomoramide...................... 25 no change.
Levophenyacylmorphan.............. 25 no change.
Lysergic acid diethylamide (LSD).. 1,200 no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1- 30 no change.
amino-3,3-dimethyl-1-oxobutan-2-
yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide)..........
MDMB-CHMICA; MMB-CHMINACA(methyl 2- 30 no change.
(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-
dimethylbutanoate)...............
MDMB-FUBINACA (methyl 2-(1-(4- 30 no change.
fluorobenzyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate)...............
MMB-CHMICA-(AMB-CHIMCA); Methyl-2- 25 no change.
(1-(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate...
Marijuana......................... 6,675,000 no change.
Marijuana extract................. 1,000,000 no change.
Mecloqualone...................... 30 no change.
Mescaline......................... 1,200 no change.
Mesocarb.......................... N/A 30.
Methaqualone...................... 60 no change.
Methcathinone..................... 25 no change.
Methiopropamine................... N/A 30.
Methoxetamine..................... 30 no change.
Methoxyacetyl fentanyl............ 30 no change.
Methyldesorphine.................. 5 no change.
Methyldihydromorphine............. 25 no change.
Metodesnitazene................... 30 no change.
[[Page 74518]]
Metonitazene...................... 30 no change.
Morpheridine...................... 25 no change.
Morphine methylbromide............ 5 no change.
Morphine methylsulfonate.......... 5 no change.
Morphine-N-oxide.................. 150 no change.
MT-45............................. 30 no change.
Myrophine......................... 25 no change.
NM2201: Naphthalen-1-yl 1-(5- 25 no change.
fluorpentyl)-1H-indole-3-
carboxylate......................
N,N-Dimethylamphetamine........... 25 no change.
Naphyrone......................... 25 no change.
N-Ethyl-1-phenylcyclohexylamine... 25 no change.
N-Ethyl-3-piperidyl benzilate..... 10 no change.
N-Ethylamphetamine................ 24 no change.
N-Ethylhexedrone.................. 25 no change.
N-Ethylpentylone, ephylone........ 30 no change.
N-Hydroxy-3,4- 24 no change.
methylenedioxyamphetamine........
Nicocodeine....................... 25 no change.
Nicomorphine...................... 25 no change.
N-methyl-3-piperidyl benzilate.... 30 no change.
Noracymethadol.................... 25 no change.
N-Pyrrolidino Etonitazene......... 30 no change.
Norlevorphanol.................... 2,550 no change.
Normethadone...................... 25 no change.
Normorphine....................... 40 no change.
Norpipanone....................... 25 no change.
Ocfentanil........................ 25 no change.
ortho-Fluoroacryl fentanyl........ 30 no change.
ortho-Fluorobutyryl fentanyl...... 30 no change.
ortho-Fluorofentanyl,2- 30 no change.
Fluorofentanyl...................
ortho-Fluoroisobutyryl fentanyl... 30 no change.
ortho-Methyl acetylfentanyl....... 30 no change.
ortho-Methyl methoxyacetyl 30 no change.
fentanyl.........................
Para-Chlorisobutyrl fentanyl...... 30 no change.
Para-flourobutyryl fentanyl....... 25 no change.
Para-fluorofentanyl............... 25 no change.
Para-Fluoro furanyl fentanyl...... 30 no change.
Para-Methoxybutyrl fentanyl....... 30 no change.
Para-methoxymethamphetamine....... 30 no change.
Para-Methylfentanyl............... 30 no change.
Parahexyl......................... 5 no change.
PB-22; QUPIC...................... 20 no change.
Pentedrone........................ 25 no change.
Pentylone......................... 25 no change.
Phenadoxone....................... 25 no change.
Phenampromide..................... 25 no change.
Phenomorphan...................... 25 no change.
Phenoperidine..................... 25 no change.
Phenyl fentanyl................... 30 no change.
Pholcodine........................ 5 no change.
Piritramide....................... 25 no change.
Proheptazine...................... 25 no change.
Properidine....................... 25 no change.
Propiram.......................... 25 no change.
Protonitazene..................... 30 no change.
Psilocybin........................ 8,000 15,000.
Psilocyn.......................... 12,000 24,000.
Racemoramide...................... 25 no change.
SR-18 and RCS-8 (1-Cyclohexylethyl- 45 no change.
3-(2-methoxyphenylacetyl)indole).
SR-19 and RCS-4 (1-Pentyl-3-[(4- 30 no change.
methoxy)-benzoyl]indole).........
Tetrahydrofuranyl fentanyl........ 15 no change.
Thebacon.......................... 25 no change.
Thiafentanil...................... 25 no change.
Thiofentanyl...................... 25 no change.
Thiofuranyl fentanyl.............. 30 no change.
THJ-2201 ([1-(5-fluoropentyl)-1H- 30 no change.
indazol-3-yl](naphthalen-1-
yl)methanone)....................
Tilidine.......................... 25 no change.
Trimeperidine..................... 25 no change.
UR-144 (1-pentyl-1H-indol-3- 25 no change.
yl)(2,2,3,3-
tetramethylcyclopropyl)methanone.
U-47700........................... 30 no change.
Valeryl fentanyl.................. 25 no change.
Zipeprol.......................... N/A 30.
------------------------------------------------------------------------
[[Page 74519]]
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine........... 15 no change.
1- 25 no change.
Piperidinocyclohexanecarbonitrile
4-Anilino-N-phenethyl-4-piperidine 937,874 no change.
(ANPP)...........................
Alfentanil........................ 5,000 no change.
Alphaprodine...................... 25 no change.
Amobarbital....................... 20,100 no change.
Amphetamine (for sale)(split)..... N/A no change.
Bezitramide....................... 25 no change.
Carfentanil....................... 20 no change.
Cocaine........................... 60,492 no change.
Codeine (for conversion).......... 1,085,024 no change.
Codeine (for sale)................ 21,003,397 no change.
D-amphetamine (for sale).......... 21,200,000 no change.
D,l-amphetamine................... 21,200,000 no change.
D-amphetamine (for conversion).... 20,000,000 no change.
Dexmethylphenidate (for sale)..... 6,200,000 no change.
Dexmethylphenidate (for 4,200,000 no change.
conversion)......................
Dextropropoxyphene................ 35 no change.
Dihydrocodeine.................... 132,658 no change.
Dihydroetorphine.................. 25 no change.
Diphenoxylate (for conversion).... 14,100 no change.
Diphenoxylate (for sale).......... 770,800 no change.
Ecgonine.......................... 60,492 no change.
Ethylmorphine..................... 30 no change.
Etorphine hydrochloride........... 32 no change.
Fentanyl.......................... 731,452 no change.
Glutethimide...................... 25 no change.
Hydrocodone (for conversion)...... 1,250 no change.
Hydrocodone (for sale)............ 27,239,822 no change.
Hydromorphone..................... 1,994,125 no change.
Isomethadone...................... 30 no change.
L-amphetamine..................... 30 no change.
Levo-alphacetylmethadol (LAAM).... 25 no change.
Levomethorphan.................... 30 no change.
Levorphanol....................... 23,010 no change.
Lisdexamfetamine.................. 26,500,000 no change.
Meperidine........................ 681,289 no change.
Meperidine Intermediate-A......... 30 no change.
Meperidine Intermediate-B......... 30 no change.
Meperidine Intermediate-C......... 30 no change.
Metazocine........................ 15 no change.
Methadone (for sale).............. 25,619,700 no change.
Methadone Intermediate............ 27,673,600 no change.
Methamphetamine................... 150 no change.
d-methamphetamine (for conversion) 485,020 no change.
d-methamphetamine (for sale)...... 47,000 no change.
l-methamphetamine................. 587,229 no change.
Methylphenidate (for sale)........ 53,283,000 no change.
Methylphenidate (for conversion).. 15,300,000 no change.
Metopon........................... 25 no change.
Moramide-intermediate............. 25 no change.
Morphine (for conversion)......... 2,458,460 no change.
Morphine (for sale)............... 21,747,625 no change.
Nabilone.......................... 62,000 no change.
Norfentanyl....................... 25 no change.
Noroxymorphone (for conversion)... 22,044,741 no change.
Noroxymorphone (for sale)......... 1,000 no change.
Oliceridine....................... 25,100 no change.
Opium (powder).................... 250,000 no change.
Opium (tincture).................. 530,837 no change.
Oripavine......................... 33,010,750 no change.
Oxycodone (for conversion)........ 437,827 no change.
Oxycodone (for sale).............. 53,840,608 no change.
Oxymorphone (for conversion)...... 28,204,371 no change.
Oxymorphone (for sale)............ 516,351 no change.
Pentobarbital..................... 33,843,337 no change.
Phenazocine....................... 25 no change.
Phencyclidine..................... 35 no change.
Phenmetrazine..................... 25 no change.
Phenylacetone..................... 100 no change.
[[Page 74520]]
Piminodine........................ 25 no change.
Racemethorphan.................... 5 no change.
Racemorphan....................... 5 no change.
Remifentanil...................... 3,000 no change.
Secobarbital...................... 172,100 no change.
Sufentanil........................ 4,000 no change.
Tapentadol........................ 11,941,416 no change.
Thebaine.......................... 57,137,944 no change.
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)........ 41,100 no change.
Ephedrine (for sale).............. 4,136,000 no change.
Phenylpropanolamine (for 14,878,320 no change.
conversion)......................
Phenylpropanolamine (for sale).... 7,990,000 no change.
Pseudoephedrine (for conversion).. 1,000 no change.
Pseudoephedrine (for sale)........ 174,246,000 no change.
------------------------------------------------------------------------
The Administrator further proposes that APQ for all other schedule
I and II controlled substances included in 21 CFR 1308.11 and 1308.12
remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13,
upon consideration of the relevant factors, the Administrator may
adjust the 2023 APQ and AAN as needed.
Conclusion
After consideration of any comments or objections, or after a
hearing, if one is held, the Administrator will issue and publish in
the Federal Register a final order establishing any adjustment of the
2023 APQ for each basic class of controlled substances in schedules I
and II and AAN for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.\15\
---------------------------------------------------------------------------
\15\ 21 CFR 1303.13(c) and 1315.13(c).
---------------------------------------------------------------------------
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 25, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-23931 Filed 10-30-23; 8:45 am]
BILLING CODE P
</pre></body>
</html>Indexed from Federal Register on October 31, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.