[Federal Register Volume 88, Number 209 (Tuesday, October 31, 2023)]
[Notices]
[Pages 74512-74520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23931]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
http://www.regulations.gov 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 Regulations.gov. 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 http://www.regulations.gov. 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 http://www.regulations.gov for public inspection.
    For easy reference, an electronic copy of this document is 
available at http://www.regulations.gov.

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\
---------------------------------------------------------------------------

    \1\ 28 CFR 0.100(b).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \3\ 21 CFR 1303.13(a) and 1315.13(a).
---------------------------------------------------------------------------

    DEA determined whether to propose an adjustment of the APQ for 2023 
by considering the factors found at 21 CFR 1303.13(b): \4\
---------------------------------------------------------------------------

    \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\
---------------------------------------------------------------------------

    \5\ 74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20, 2010).
    \6\ Id.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \11\ 87 FR 63091 (October 18, 2022).

                    Diversion Estimates for 2023 (g)
------------------------------------------------------------------------
                           Fentanyl                                59
------------------------------------------------------------------------
Hydrocodone...................................................   133,004
Hydromorphone.................................................       595
Oxycodone.....................................................   174,797
Oxymorphone...................................................       109
------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \14\ Adjustment to the Aggregate Production Quota for 
Methylphenidate (for Sale) for 2023, 88 FR 68147 (October 3, 2023).
---------------------------------------------------------------------------

    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