[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.
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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
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: 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 http://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 http://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 http://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\
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\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\
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\3\ 21 CFR 1303.13(a), 1315.13(a).
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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).
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Additional Considerations Applicable to Covered Controlled Substances
When setting APQ, the Administrator must estimate the amount of
diversion of any substance that is considered a ``covered controlled
substance.'' \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)
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------------------------------------------------------------------------
Fentanyl..................................................... 112
Hydrocodone.................................................. 124,170
Hydromorphone................................................ 1,137
Oxycodone.................................................... 263,236
Oxymorphone.................................................. 165
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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.
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\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.
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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.
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\13\ 89 FR 407.
\14\ 89 FR 18793 (March, 15, 2024).
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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]
BILLING CODE P