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 2024, 78764-78772 [2024-21960]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78764-78772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21960]



[[Page 78763]]

Vol. 89

Wednesday,

No. 186

September 25, 2024

Part VIII





Department of Justice





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Drug Enforcement Administration





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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 2024; Notices

Federal Register / Vol. 89 , No. 186 / Wednesday, September 25, 2024 
/ Notices

[[Page 78764]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1228A]


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 2024

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration proposes to adjust the 
2024 aggregate production quotas for several controlled substances in 
schedules I and II of the Controlled Substances Act. Additionally, as 
DEA announced in an April 29, 2024 letter to DEA-registered 
manufacturers, procurement quotas for commercial manufacturing of a 
schedule II controlled substance will be calculated on a semi-annual 
basis, except for injectable drug products containing schedule II 
controlled substances, which will be calculated on an annual basis.

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 October 25, 2024. 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.
    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 2024 
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-1228A'' 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 
https://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: Heather E. Achbach, 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. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at https://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    The Freedom of Information Act applies to all comments received. If 
you want to submit personal identifying information (such as your name, 
address, etc.) as part of your comment, but do not want it to be made 
publicly available, you must include the phrase ``PERSONAL IDENTIFYING 
INFORMATION'' in the first paragraph of your comment. You must also 
place all the personal identifying information you do not want made 
publicly available in the first paragraph of your comment and identify 
what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to https://www.regulations.gov may include any personal 
identifying information (such as name, address, and phone number) 
included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at https://www.regulations.gov for easy reference.

Legal Authority and Background

    Section 306 of the Controlled Substances Act (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 pursuant to 28 CFR 0.100.
    DEA established the 2024 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 January 3, 
2024.\1\ That order stipulated that, in accordance with 21 CFR 1303.13 
and 1315.13, all APQ and AAN are subject to adjustment. DEA published a 
Final Order revising the 2024 lisdexamfetamine and d-amphetamine (for 
conversion) APQ on September 5, 2024.\2\
---------------------------------------------------------------------------

    \1\ 89 FR 407.
    \2\ Adjustment to the Aggregate Production Quota for 
Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR 
72424 (Sept. 5, 2024).

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[[Page 78765]]

Analysis for Proposed Adjusted 2024 Aggregate Production Quotas and 
Assessment of Annual Needs

    DEA proposes to adjust the established 2024 APQ for certain 
schedule I and II controlled substances and the AAN for certain list I 
chemicals to be manufactured in the United States in 2024 to provide 
for the estimated medical, scientific, research, and industrial needs 
of the United States, 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), 1315.13(a).
---------------------------------------------------------------------------

    DEA determined whether to propose an adjustment of the APQ for 2024 
by considering the factors found at 21 CFR 1303.13(b):

    (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 [21 CFR] 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 exporters), notwithstanding the possibility that 
individual manufacturing quotas may be suspended pursuant to [21 
CFR] 1303.24(b) or abandoned pursuant to [21 CFR] 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 2023 year-end 
inventories, 2023 disposition data submitted by quota applicants, 
changes in estimates of the medical needs of the United States, 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 2024 
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 [21 CFR] 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 [21 
CFR] 1315.24(b) or abandoned pursuant to [21 CFR] 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 2024 
AAN for list I chemicals, DEA used the calculation methodology 
previously described in the 2010 and 2011 AAN.\4\ 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.\5\
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    \4\ 74 FR 60294 (Nov. 20, 2009); 75 FR 79407 (Dec. 20, 2010).
    \5\ 74 FR 60294 (Nov. 20, 2009); 75 FR 79407 (Dec. 20, 2010).
---------------------------------------------------------------------------

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.'' \6\ The covered controlled substances are fentanyl, 
oxycodone, hydrocodone, oxymorphone, and hydromorphone.\7\ 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.'' \8\ 
When estimating diversion, the Administrator ``shall consider 
information'' that she, in consultation with the Secretary of Health 
and Human Services, ``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 she determines 
reliable.\9\
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    \6\ 21 U.S.C. 826(i)(1)(A).
    \7\ 21 U.S.C. 826(i)(1).
    \8\ 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).
    \9\ 21 U.S.C. 826(i)(1)(B).
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    DEA sent letters to the Centers for Disease Control and Prevention 
(CDC), the Food and Drug Administration (FDA), and the states in March, 
April, and May 2024 requesting overdose death and overprescribing data 
that could be considered in estimating diversion. DEA received 
information from the CDC in May 2024, the FDA in June 2024, and has 
begun receiving Prescription Data Monitoring Program

[[Page 78766]]

(PDMP) data from the states. DEA considered this information in 
developing the estimates of diversion for the five covered controlled 
substances for this proposed adjustment.
    DEA also aggregated data for each covered controlled substance from 
Drug Theft and Loss Reports to determine the estimates of diversion. 
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 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 2024.\10\ Below, DEA provides an updated chart 
showing estimations of diversion for each of the covered controlled 
substances.
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    \10\ 88 FR 75312 (November 2, 2023).

                    Diversion Estimates for 2024 (g)
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Fentanyl.....................................................        112
Hydrocodone..................................................    124,170
Hydromorphone................................................      1,137
Oxycodone....................................................    263,236
Oxymorphone..................................................        165
------------------------------------------------------------------------

Implementation of Semi-Annual Quota Allotment

    For the 2024 quota year, DEA announced that it intended to allocate 
procurement quotas to DEA-registered manufacturers of schedule II 
controlled substances on a quarterly basis, in order to help DEA 
prevent shortages and be more nimble in its administration of the quota 
program. After the announcement, DEA met with several manufacturers to 
discuss the impact of that change. Numerous manufacturers asked DEA to 
consider allocating quotas semi-annually to assist with production 
planning and execution. DEA understands and appreciates the 
complexities of the supply chain. In light of the discussions with 
manufacturers, as well as meetings with FDA discussing their statutory 
obligations for drug availability to meet legitimate patients' needs, 
input from health associations in foreign countries, and consideration 
of the continuing issues with the supply chain in the aftermath of the 
COVID-19 pandemic, DEA determined that it would and will allocate 
procurement quotas for schedule II controlled substances on a semi-
annual basis, except that it would and will allocate procurement quotas 
for injectable drug products containing schedule II controlled 
substances on an annual basis. DEA announced this change in a letter to 
DEA-registered manufacturers on April 29, 2024. No further change is 
being implemented at this time. DEA remains committed to ensuring that 
all patients with legitimate medical need can access appropriately 
prescribed medications that are manufactured domestically.

Proposed Adjustments for the 2024 Aggregate Production Quotas and 
Assessment of Annual Needs

    DEA is proposing increases to the APQ for the following schedule I 
substances: 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. The proposed increases 
reflect research and development needs as part of the process for 
seeking the FDA approval of new drug products.
    DEA is proposing increases to the APQ for the following schedule II 
substances: noroxymorphone (for conversion), oripavine, and oxymorphone 
(for conversion). These proposed increases are necessary to meet 
manufacturing needs and increased consumption of naloxone products as 
standard treatment for opioid overdose. These substances are part of 
the synthesis pathway to manufacture naloxone products. On March 13, 
2024, the ``White House Challenge to Save Lives from Overdose'' was 
announced in support of the Administration's Unity Agenda efforts to 
address the opioid overdose crisis.\11\ The challenge is a nationwide 
initiative to increase training, awareness, and access to lifesaving 
opioid overdose reversal medications. The FDA has approved two over the 
counter (OTC) naloxone products for the emergency treatment of opioid 
overdose.\12\ As a result of the White House Challenge and efforts by 
the Department of Health and Human Services to help recipients of State 
and Tribal Opioid Response Grants increase distribution of opioid 
overdose reversal agents, DEA is expecting medical usage of naloxone to 
continue to rise in 2024. The proposed increase to the APQ of 
noroxymorphone (for conversion), oripavine and oxymorphone (for 
conversion) reflects this increasing medical usage of naloxone.
---------------------------------------------------------------------------

    \11\ https://www.whitehouse.gov/briefing-room/statements-releases/2024/03/13/fact-sheet-biden-harris-administration-launches-the-white-house-challenge-to-save-lives-from-overdose/.
    \12\ https://www.fda.gov/news-events/press-announcements/fda-approves-second-over-counter-naloxone-nasal-spray-product.
---------------------------------------------------------------------------

    DEA is proposing decreases to the following APQ: fentanyl, 
hydrocodone (for sale), hydromorphone, and oxycodone (for sale). These 
proposed decreases are based on adjustments to the diversion estimates 
for calendar year 2024.
    DEA established the 2024 APQ for substances in schedules I and II 
on January 3, 2024.\13\ Subsequent to that publication, DEA published 
in the Federal Register a final rule to permanently schedule 2-methyl 
AP-237 under the CSA.\14\ As a result, this substance is subject to CSA 
schedule I controls and DEA is proposing to assign an individual APQ 
for this substance pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
---------------------------------------------------------------------------

    \13\ 89 FR 407.
    \14\ 89 FR 18793 (March, 15, 2024).
---------------------------------------------------------------------------

    The Administrator, therefore, proposes to adjust the 2024 APQ for 
the schedule I and II controlled substances noroxymorphone (for 
conversion), oripavine, oxymorphone (for conversion), psilocybin, 
psilocyn, and 2-methyl AP-237. The proposed adjusted APQ and AAN, as 
expressed in grams of anhydrous acid or base, are as follows:

------------------------------------------------------------------------
                                            Established      Proposed
               Basic class                  2024 quotas    revised 2024
                                                (g)         quotas (g)
------------------------------------------------------------------------
             New Temporary Controlled Schedule I Substances
------------------------------------------------------------------------
4F-MDMB-BUTICA..........................              30       no change

[[Page 78767]]

 
5F-EDMB-PICA............................              30       no change
ADB-4en-PINACA..........................              30       no change
Clonazolam..............................              30       no change
CUMYL-PEGACLONE.........................              30       no change
Diclazepam..............................              30       no change
Etizolam................................              30       no change
Flualprazolam...........................              30       no change
Flubromazolam...........................              30       no change
MDMB-4en-PINACA.........................              30       no change
MMB-FUBICA..............................              30       no change
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
-[1-(2-Thienyl)cyclohexyl]pyrrolidine...              20       no change
1-(1-Phenylcyclohexyl)pyrrolidine.......              30       no change
1-(2-Phenylethyl)-4-phenyl-4-                         10       no change
 acetoxypiperidine......................
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole              30       no change
 (AM2201)...............................
1-(5-Fluoropentyl)-3-(2-                              30       no change
 iodobenzoyl)indole (AM694).............
1-[1-(2-Thienyl)cyclohexyl]piperidine...              15       no change
2'-fluoro 2-fluorofentanyl..............              30       no change
1-Benzylpiperazine......................              25       no change
1-Methyl-4-phenyl-4-propionoxypiperidine              10       no change
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 (2C-H)             100       no change
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                 30       no change
 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-(2-                25       no change
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-
 C-NBOMe; 25C; Cimbi-82)................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine              30       no change
 (2C-I).................................
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                  30       no change
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-
 I-NBOMe; 25I; Cimbi-5).................
2,5-Dimethoxy-4-ethylamphetamine (DOET).              25       no change
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)....
2-Methyl AP-237.........................               0              30
3,4,5-Trimethoxyamphetamine.............              30       no change
3,4-Methylenedioxyamphetamine (MDA).....          12,000       no change
3,4-Methylenedioxymethamphetamine (MDMA)          12,000       no change
3,4-Methylenedioxy-N-ethylamphetamine                 40       no change
 (MDEA).................................
3,4-Methylenedioxy-N-methylcathinone               5,200       no change
 (methylone)............................
3,4-Methylenedioxypyrovalerone (MDPV)...              35       no change
3-FMC; 3-Fluoro-N-methylcathinone.......              25       no change
3-Methylfentanyl........................              30       no change
3-Methylmethcathinone...................              30       no change
3-Methylthiofentanyl....................              30       no change
4,4'-Dimethylaminorex...................              30       no change
4-Bromo-2,5-dimethoxyamphetamine (DOB)..              30       no change
4-Bromo-2,5-dimethoxyphenethylamine (2-            5,100       no change
 CB)....................................
4-Chloro-alpha-pyrrolidinovalerophenone               25       no change
 (4-chloro-alpha-PVP)...................
4-CN-Cumyl-Butinaca.....................              25       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-1-phenyl-2-(pyrrolidin-1-                    30       no change
 yl)pentan-1-one (alpha-PiHP)...........
4-Methyl-2,5-dimethoxyamphetamine (DOM).              25       no change
4-Methylaminorex........................              25       no change
4-Methyl-N-methylcathinone (mephedrone).              45       no change
4-Methyl-alpha-ethylaminopentiophenone                25       no change
 (4-MEAP)...............................
4-Methyl-alpha-pyrrolidinohexiophenone                25       no change
 (MPHP).................................
4'-Methyl acetyl fentanyl...............              30       no change
4-Methyl-[alpha]-                                     25       no change
 pyrrolidinopropiophenone (4-MePPP).....
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                  50       no change
 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.................

[[Page 78768]]

 
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-               25       no change
 fluoropentyl)-1H-indazole-3-
 carboxamido)-3,3-dimethylbutanoate)....
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-             25       no change
 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-fluoropentyl)-1H-              25       no change
 indazole-3-carboxamido)-3-
 methylbutanoate).......................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-             25       no change
 1-(5-fluoropentyl)-1H-indazole-3-
 carboxamide)...........................
5-Fluoro-PB-22; 5F-PB-22................              25       no change
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-                  25       no change
 pentyl)-1Hindol-3-yl](2,2,3,3-
 tetramethylcyclopropyl)methanone.......
5-Methoxy-3,4-methylenedioxyamphetamine.              25       no change
5-Methoxy-N,N-diisopropyltryptamine.....              25       no change
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-BUTINACA............................              30       no change
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-              30       no change
 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-dimethyl-1-                50       no change
 oxobutan-2-yl)-1-pentyl-1H-indazole-3-
 carboxamide)...........................
AH-7921.................................              30       no change
All other tetrahydrocannabinol..........       1,166,130       no change
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 ([alpha]-               25       no change
 PBP)...................................
alpha-pyrrolidinoheptaphenone (PV8).....              25       no change
alpha-pyrrolidinohexabophenone (alpha-                25       no change
 PHP)...................................
alpha-Pyrrolidinopentiophenone ([alpha]-              25       no change
 PVP)...................................
Amineptine..............................              30       no change
Aminorex................................              25       no change
Anileridine.............................              20       no change
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-              25       no change
 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
Cyprenorphine...........................              25       no change
d-9-THC.................................       1,523,040       no change
Desomorphine............................              25       no change
Dextromoramide..........................              25       no change
Diapromide..............................              20       no change
Diethylthiambutene......................              20       no change

[[Page 78769]]

 
Diethyltryptamine.......................              25       no change
Difenoxin...............................           9,300       no change
Dihydromorphine.........................         639,954       no change
Dimenoxadol.............................              25       no change
Dimepheptanol...........................              25       no change
Dimethylthiambutene.....................              20       no change
Dimethyltryptamine......................          11,000       no change
Dioxyaphetyl butyrate...................              25       no change
Dipipanone..............................              25       no change
Drotebanol..............................              25       no change
Ethylmethylthiambutene..................              25       no change
Ethylone................................              25       no change
Etodesnitazene..........................              30       no change
Etonitazene.............................              25       no change
Etorphine...............................              30       no change
Etoxeridine.............................              25       no change
Eutylone................................              30       no change
Fenethylline............................              30       no change
Fentanyl carbamate......................              30       no change
Fentanyl related substances.............             600       no change
Flunitazene.............................              30       no change
FUB-144.................................              25       no change
FUB-AKB48...............................              25       no change
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca.....              25       no change
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................................             150       no change
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-naphthoyl)indole).              45       no change
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).              45       no change
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-Morpholinyl)ethyl]-3-(1-             35       no change
 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-amino-               30       no change
 3,3-dimethyl-1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide)...........................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-                30       no change
 (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-(1-                 25       no change
 (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................................              30       no change
Methaqualone............................              60       no change
Methcathinone...........................              25       no change
Methiopropamine.........................              30       no change
Methoxetamine...........................              30       no change
Methoxyacetyl fentanyl..................              30       no change
Methyldesorphine........................               5       no change
Methyldihydromorphine...................              25       no change
Metodesnitazene.........................              30       no change
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

[[Page 78770]]

 
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-methylenedioxyamphetamine.              24       no change
Nicocodeine.............................              25       no change
Nicomorphine............................              25       no change
N-methyl-3-piperidyl benzilate..........              30       no change
N-Pyrrolidino Etonitazene...............              30       no change
Noracymethadol..........................              25       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-Fluorofentanyl...              30       no change
ortho-Fluoroisobutyryl fentanyl.........              30       no change
ortho-Methyl acetylfentanyl.............              30       no change
ortho-Methyl methoxyacetyl fentanyl.....              30       no change
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..............................          20,000          30,000
Psilocyn................................          24,000          36,000
Racemoramide............................              25       no change
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-              45       no change
 methoxyphenylacetyl)indole)............
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-             30       no change
 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-indazol-             30       no change
 3-yl](naphthalen-1-yl)methanone).......
Tilidine................................              25       no change
Trimeperidine...........................              25       no change
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-              25       no change
 tetramethylcyclopropyl)methanone.......
U-47700.................................              30       no change
Valeryl fentanyl........................              25       no change
Zipeprol................................              30       no change
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................              15       no change
1-Piperidinocyclohexanecarbonitrile.....              25       no change
4-Anilino-N-phenethyl-4-piperidine               937,874       no change
 (ANPP).................................

[[Page 78771]]

 
Alfentanil..............................           5,000       no change
Alphaprodine............................              25       no change
Amobarbital.............................          20,100       no change
Bezitramide.............................              25       no change
Carfentanil.............................              20       no change
Cocaine.................................          60,492       no change
Codeine (for conversion)................         942,452       no change
Codeine (for sale)......................      19,262,957       no change
d-amphetamine (for sale)................      21,200,000       no change
d,l-amphetamine.........................      21,200,000       no change
d-amphetamine (for conversion)..........      23,688,235       no change
Dexmethylphenidate (for sale)...........       6,200,000       no change
Dexmethylphenidate (for conversion).....       5,374,683       no change
Dextropropoxyphene......................              35       no change
Dihydrocodeine..........................         115,227       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................................         731,360         731,341
Glutethimide............................              25       no change
Hydrocodone (for conversion)............           1,250       no change
Hydrocodone (for sale)..................      27,143,545      27,121,498
Hydromorphone...........................       1,951,801       1,951,508
Isomethadone............................              30       no change
L-amphetamine...........................              30       no change
Levo-alphacetylmethadol (LAAM)..........              25       no change
Levomethorphan..........................              30       no change
Levorphanol.............................          20,000       no change
Lisdexamfetamine........................      32,736,000       no change
Meperidine..............................         681,184       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
d,l-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)........      19,975,468       no change
Metopon.................................              25       no change
Moramide-intermediate...................              25       no change
Morphine (for conversion)...............       2,393,200       no change
Morphine (for sale).....................      20,805,957       no change
Nabilone................................          62,000       no change
Norfentanyl.............................              25       no change
Noroxymorphone (for conversion).........      22,044,741      24,756,979
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      37,721,950
Oxycodone (for conversion)..............         437,827       no change
Oxycodone (for sale)....................      53,658,226      53,584,449
Oxymorphone (for conversion)............      28,204,371      31,773,105
Oxymorphone (for sale)..................         464,464       no change
Pentobarbital...........................      40,000,000       no change
Phenazocine.............................              25       no change
Phencyclidine...........................              35       no change
Phenmetrazine...........................              25       no change
Phenylacetone...........................             100       no change
Piminodine..............................              25       no change
Racemethorphan..........................               5       no change
Racemorphan.............................               5       no change
Remifentanil............................           3,000       no change
Secobarbital............................         172,100       no change

[[Page 78772]]

 
Sufentanil..............................           4,000       no change
Tapentadol..............................      10,390,226       no change
Thebaine................................      57,137,944       no change
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............          41,100       no change
Ephedrine (for sale)....................       3,933,336       no change
Phenylpropanolamine (for conversion)....      14,878,320       no change
Phenylpropanolamine (for sale)..........       7,990,000       no change
Pseudoephedrine (for conversion)........           1,000       no change
Pseudoephedrine (for sale)..............     186,617,466       no change
------------------------------------------------------------------------

    The Administrator further proposes that the 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 2024 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 
2024 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 
September 20, 2024, 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.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-21960 Filed 9-20-24; 4:15 pm]
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