Notice2021-18935
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 2021
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 2, 2021
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration proposes to adjust the 2021 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Full Text
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<title>Federal Register, Volume 86 Issue 168 (Thursday, September 2, 2021)</title>
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[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49346-49354]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18935]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-688A]
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 2021
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
2021 aggregate production quotas for several controlled substances in
schedules I and II of the Controlled Substances Act and assessment of
annual needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before October 4, 2021. 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 2021
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.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-688A'' on all correspondence, including any
attachments. DEA encourages that all comments be submitted
electronically through the Federal eRulemaking Portal which provides
the ability to type short comments directly into the comment field on
the web page or attach a file for lengthier comments. Please go to
<a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online instructions at that
site for submitting comments. Upon completion of your submission, you
will receive a Comment Tracking Number for your comment. Please be
aware that submitted comments are not instantaneously available for
public view on <a href="http://Regulations.gov">Regulations.gov</a>. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment. Paper comments that duplicate
electronic submissions are not necessary and are discouraged. Should
you wish to mail a paper comment in lieu of an electronic comment, it
should be sent via regular or express mail to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone: (571) 776-2265.
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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
[[Page 49347]]
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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
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 2021 aggregate production quotas for substances
in schedules I and II and the assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on
November 30, 2020 (85 FR 76604). That order stipulated that, in
accordance with 21 CFR 1303.13 and 1315.13, all aggregate production
quotas and assessments of annual need are subject to adjustment.
Analysis for Proposed Adjusted 2021 Aggregate Production Quotas and
Assessment of Annual Needs
DEA proposes to adjust the established 2021 aggregate production
quotas to be manufactured in the United States in 2021 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. However, DEA's analysis does not suggest the need for
adjustment of the 2021 assessment of annual needs for the List I
chemicals.
Factors for Determining the Proposed Adjustments
In determining the proposed adjustments, the Administrator has
taken into account the criteria in accordance with 21 CFR 1303.13
(adjustment of aggregate production quotas for controlled substances)
and 21 CFR 1315.13 (adjustment of the assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator
is authorized to increase or reduce the aggregate production quota at
any time. 21 CFR 1303.13(a) and 1315.13(a). DEA regulations state that
there are five factors that shall be considered in determining to
adjust the aggregate production quota and the assessment of annual
needs. 21 CFR 1303.13(b) and 1315.13(b).
DEA determined whether to propose an adjustment of the aggregate
production quotas and assessment of annual needs for 2021 by
considering the factors summarized below:
(1) Changes in the demand for that class or chemical, changes in
the national rate of net disposal of the class or chemical, changes
in the national rate of net disposal of the class or chemical by
registrants holding individual manufacturing quotas for that class
or chemical, and changes in the extent of any diversion in the class
of controlled substance;
(2) whether any increased demand for that class or chemical, the
national and/or individual rates of net disposal of that class or
chemical are temporary, short term, or long term;
(3) whether any increased demand for that class or chemical can
be met through existing inventories, increased individual
manufacturing quotas, or increased importation, without increasing
the aggregate production quota or assessment of annual needs, taking
into account production delays and the probability that other
individual manufacturing quotas may be suspended pursuant to Sec.
1303.24(b) and 1315.24(b);
(4) whether any decreased demand for that class or chemical will
result in excessive inventory accumulation by all persons registered
to handle that class or chemical (including manufacturers,
distributors, practitioners, importers, and exporters),
notwithstanding the possibility that individual manufacturing quotas
may be suspended pursuant to Sec. 1303.24(b) and 1315.24(b) or
abandoned pursuant to Sec. 1303.27 and 1315.27; and
(5) other factors affecting medical, scientific, research, and
industrial needs in the United States, lawful export requirements,
and other factors affecting importation needs of listed chemicals in
the United States 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. 21 CFR
1303.13(b) and 1315(b).
DEA considered the change in the extent of diversion of all
controlled substances in proposing adjustments to the aggregate
production quotas as required by 21 CFR 1303.13(b)(1). Pursuant to
these factors, DEA has determined that any calculated changes from the
previously determined initial calculations are slight and not
statistically significant from the quantities originally calculated for
the extent of diversion that were applied to the initial aggregate
production quota valuations.
DEA also considered updated information obtained from 2020 year-end
inventories, 2020 disposition data submitted by quota applicants,
estimates of the medical needs of the United States, product
development, and other information made available to DEA after the
initial aggregate production quotas and assessment of annual needs had
been established. Other factors the Administrator considered in
calculating the aggregate production quotas, but not the assessment of
annual needs, include product development requirements of both bulk and
finished dosage form manufacturers, and other pertinent information.
In evaluating whether there is a need for adjustment of the 2021
assessment of annual needs for List I chemicals, DEA used the
calculation methodology previously described in the 2010 and 2011
assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR
79407, Dec. 20, 2010, respectively). However, DEA's analysis does not
suggest the need for adjustment of the 2021 assessment of annual needs.
Considerations Based Upon the Substance Use-Disorder Prevention That
Promotes Opioid Recovery and Treatment for Patients and Communities Act
Pursuant to 21 U.S.C. 826(a)(1), ``production quotas shall be
established in terms of quantities of each basic class of controlled
substance and not in terms of individual pharmaceutical dosage forms
prepared from or containing such a controlled substance.'' However, the
Substance Use-Disorder Prevention that Promotes Opioid Recovery
Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub.
L. 115-271), provides an exception to that general rule by now giving
DEA the authority to establish quotas in terms of pharmaceutical dosage
forms if the
[[Page 49348]]
agency determines that doing so will assist in avoiding the
overproduction, shortages, or diversion of a controlled substance.
DEA has stated before that while there is the authority to set
aggregate production quotas in terms of pharmaceutical dosage form, DEA
will not be using that authority at this time. Furthermore, when DEA
does utilize the authority, it will be doing so at the individual
dosage-form manufacturing level, as that is where it is most
appropriate to do so. As such, there are no adjustments to set any
controlled substances in terms of pharmaceutical dosage forms.
Under the SUPPORT Act, when setting the aggregate production quota,
DEA must estimate the amount of diversion of any substance that is
considered a ``covered controlled substance,'' as defined by the
SUPPORT Act. 21 U.S.C. 826(i)(1)(A). The covered controlled substances
are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.
The SUPPORT Act also requires DEA to ``make appropriate quota
reductions, as determined by the [Administrator],\1\ from the quota the
[Administrator] would have otherwise established had such diversion not
been considered.'' 21 U.S.C. 826(i)(1)(C). When estimating diversion,
the ``[Administrator]--(i) shall consider information the
[Administrator], 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 (ii) may take into consideration
whatever other sources of information the [Administrator] determines
reliable.'' 21 U.S.C. 826(i)(1)(B).
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\1\ All functions vested in the Attorney General by the CSA have
been delegated to the Administrator of DEA. 28 CFR 0.100(b).
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In February 2021, DEA sent letters to the Centers for Disease
Control and Prevention (CDC), Centers for Medicare and Medicaid
Services (CMS), and the states requesting overdose death and
overprescribing data that could be considered for estimating diversion.
DEA did not receive information from CMS. However, DEA did receive
information from the CDC in June 2021 and has started to receive
information from the states. DEA has begun to receive Prescription Drug
Monitoring Program (PDMP) data from the states in a format that will
allow the Agency to develop a more robust methodology to assist in the
determination of the diversion estimate in the future. This information
will be considered in determining the estimates of diversion for the
five covered controlled substances 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 2022.
To update the estimates of diversion, DEA used data from the Drug
Theft and Loss Report, Statistical Management Analysis & Reporting
Tools System (SMARTS), and System to Retrieve Information on Drug
Evidence (STRIDE) databases to aggregate the active pharmaceutical
ingredient (API) of each covered controlled substance by metric weight.
From the databases, DEA gathered data involving employee theft, break-
ins, armed robberies, and material lost in transit. DEA also used
seizure data obtained from reports submitted by law enforcement
agencies nationwide. This data was categorized by basic drug class and
the amount of API in the dosage form was delineated with an appropriate
metric for use in proposing the adjusted aggregate production quota
values. Using the data, DEA calculated the estimates for the amount of
diversion by multiplying the strength of the API listed for each
finished dosage form by the total amount of units reported to estimate
the metric weight in grams of the controlled substance being diverted.
Below, DEA has updated the chart to include estimations of diversion
for each of the covered controlled substances.
------------------------------------------------------------------------
------------------------------------------------------------------------
Diversion estimates for 2020 (g)
------------------------------------------------------------------------
Fentanyl..................................................... 184
Hydrocodone.................................................. 20,759
Hydromorphone................................................ 946
Oxycodone.................................................... 47,316
Oxymorphone.................................................. 534
------------------------------------------------------------------------
DEA considered the change in the extent of diversion of all
controlled substances in proposing adjustments to the aggregate
production quotas as required by 21 CFR 1303.13(b)(1). Pursuant to
these factors, DEA has determined that any calculated changes from the
previously determined initial calculations are slight and not
statistically significant from the quantities originally calculated for
the extent of diversion that were applied to the initial aggregate
production quota valuations.
Proposed Adjustments for the 2021 Aggregate Production Quotas and
Assessment of Annual Needs
DEA is proposing significant increases to the APQs of the schedule
I substances psilocybin, psilocin, marihuana, and marihuana extract,
which are directly related to increased interest by DEA registrants in
the use of hallucinogenic controlled substances for research and
clinical trial purposes. DEA firmly believes in supporting regulated
research of schedule I controlled substances. Therefore, the APQ
increases reflect the need to fulfill research and development
requirements in the production of new drug products, and the study of
marijuana effects in particular, as necessary steps toward potential
Food and Drug Administration (FDA) approval of new drug products.
The DEA established the 2021 aggregate production quotas for
substances in schedules I and II on November 30, 2020 (85 FR 76604).
Subsequent to that publication, DEA published in the Federal Register
two final rules to permanently schedule 14 specific fentanyl-related
substances under the CSA (86 FR 22113, April 27, 2021, and 86 FR 23602,
May 4, 2021). The specific fentanyl-related substances are 2'-fluoro 2-
fluorofentanyl, 4'-Methyl acetyl fentanyl, beta-Methyl fentanyl, beta-
Phenyl fentanyl, Fentanyl carbamate, ortho-Fluoroacryl fentanyl, ortho-
Fluorobutyryl fentanyl, ortho-Fluoroisobutyryl fentanyl, ortho-Methyl
acetylfentanyl, ortho-Methyl methoxyacetyl fentanyl, para-Fluoro
furanyl fentanyl, para-Methylfentanyl, Phenyl fentanyl, and Thiofuranyl
fentanyl. As a result, these substances will continue to be subject to
the CSA schedule I controls and are now being assigned individual
aggregate production quotas.
On March 1, 2021, DEA published a temporary scheduling order
placing Brorphine in schedule I of the CSA (86 FR 11862), making all
regulatory controls pertaining to schedule I controlled substances
applicable to the manufacture of these substances, including the
requirement to establish an aggregate production quota pursuant to 21
U.S.C. 826 and 21 CFR part 1303. This notice proposes to establish an
aggregate production quota for this substance.
On May 7, 2021, DEA published an interim final rule placing
serdexmethylphenidate, a component in a combination drug product
recently approved by FDA for the treatment of ADHD in patients six
years of age and older, in schedule IV of the CSA (86 FR 24487).
Serdexmethylphenidate is manufactured from methylphenidate, a schedule
II controlled substance. In order to more accurately estimate and
manage the quantity of methylphenidate necessary for direct formulation
into schedule II drug products versus the
[[Page 49349]]
quantity of methylphenidate necessary for the manufacturing of
serdexmethylphenidate or other substances, DEA has delineated
methylphenidate into methylphenidate (for sale) and methylphenidate
(for conversion). This notice proposes to establish an aggregate
production quota for methylphenidate (for conversion).
On June 20, 2021, DEA published the final rule to place
oliceridine, a medication recently approved by FDA for medical use as
an intravenous drug for the management of acute pain severe enough to
require an intravenous opioid analgesic and for patients for whom
alternative treatments are inadequate, in schedule II of the CSA
effective July 12, 2021 (86 FR 30772). The placement of oliceridine in
schedule II of the CSA, makes all regulatory controls pertaining to
schedule II controlled substances applicable to the manufacture of this
substance, including the requirement to establish an aggregate
production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303.
The Administrator, therefore, proposes to adjust the 2021 aggregate
production quotas for certain schedule I and II controlled substances.
The Administrator does not propose an adjustment to the assessments of
annual needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. The proposed adjusted APQs, as expressed in grams
of anhydrous acid or base, are as follows:
------------------------------------------------------------------------
Established Proposed revised
2021 quotas 2021 quotas
Basic class -----------------
-------------
(g) (g)
------------------------------------------------------------------------
Temporarily Scheduled
------------------------------------------------------------------------
Brorphine................................ N/A 30.
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Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine... 20 no change.
1-(1-Phenylcyclohexyl)pyrrolidine........ 15 30.
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-Benzylpiperazine....................... 25 no change.
1-Methyl-4-phenyl-4-propionoxypiperidine. 10 no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine.... 15 no change.
2'-fluoro 2-fluorofentanyl............... N/A 30.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine 30 no change.
(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 (DMA)........... 25 no change.
2-[4-(Ethylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-T-2).
2-[4-(Isopropylthio)-2,5- 30 no change.
dimethoxyphenyl]ethanamine (2C-T-4).
3,4,5-Trimethoxyamphetamine.............. 30 no change.
3,4-Methylenedioxyamphetamine (MDA)...... 55 no change.
3,4-Methylenedioxymethamphetamine (MDMA). 50 no change.
3,4-Methylenedioxy-N-ethylamphetamine 40 no change.
(MDEA).
3,4-Methylenedioxy-N-methylcathinone 40 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-Methylthiofentanyl..................... 30 no change.
4'-Methyl acetyl fentanyl................ N/A 30.
4-Bromo-2,5-dimethoxyamphetamine (DOB)... 30 no change.
4-Bromo-2,5-dimethoxyphenethylamine (2- 25 no change.
CB).
4-Chloro-[alpha]-pyrrolidinovalerophenone 25 no change.
(4-chloro-alpha-PVP).
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2- 25 no change.
phenylpropan-2-yl)-1H-indazole-3-
carboximide.
4-Fluoroisobutyryl fentanyl.............. 30 no change.
4-FMC; Flephedrone....................... 25 no change.
4-MEC; 4-Methyl-N-ethylcathinone......... 25 no change.
4-Methoxyamphetamine..................... 150 no change.
4-Methyl-2,5-dimethoxyamphetamine (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-[alpha]-pyrrolidinopropiophenone 25 no change.
(4-MePPP).
[[Page 49350]]
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-CUMYL-PINACA.......................... 25 no change.
5F-EDMB-PINACA........................... 25 no change.
5F-MDMB-PICA............................. 25 no change.
5F-AB-PINACA; N-(1-amino-3-methyl-1- 25 no change.
oxobutan-2-yl)-1-(5-fluoropentyl)-1H-
indazole-3-carboxamide.
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2- 25 no change.
phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboximide).
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5- 30 no change.
fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H- 30 no change.
indazole-3-carboxamido)-3-
methylbutanoate).
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)- 30 no change.
1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
5-Fluoro-PB-22; 5F-PB-22................. 20 no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro- 25 no change.
pentyl)-1H-indol-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......... 35 no change.
AB-CHMINACA.............................. 30 no change.
AB-FUBINACA.............................. 50 no change.
AB-PINACA................................ 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........... 1,000 no change.
Allylprodine............................. 25 no change.
Alphacetylmethadol....................... 25 no change.
alpha-Ethyltryptamine.................... 25 no change.
Alphameprodine........................... 25 no change.
Alphamethadol............................ 25 no change.
Alphaprodine............................. 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-Pyrrolidinohexanophenone ([alpha]- 25 no change.
PHP).
alpha-Pyrrolidinopentiophenone ([alpha]- 25 no change.
PVP).
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..................... N/A 30.
beta-Phenyl fentanyl..................... N/A 30.
Betameprodine............................ 25 no change.
Betamethadol............................. 4 no change.
Betaprodine.............................. 25 no change.
Bufotenine............................... 15 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.
Cyclopentyl Fentanyl..................... 30 no change.
Cyclopropyl Fentanyl..................... 20 no change.
Cyprenorphine............................ 25 no change.
d-9-THC.................................. 384,460 no change.
Desomorphine............................. 25 no change.
Dextromoramide........................... 25 no change.
Diapromide............................... 20 no change.
Diethylthiambutene....................... 20 no change.
[[Page 49351]]
Diethyltryptamine........................ 25 no change.
Difenoxin................................ 9,200 no change.
Dihydromorphine.......................... 753,500 no change.
Dimenoxadol.............................. 25 no change.
Dimepheptanol............................ 25 no change.
Dimethylthiambutene...................... 20 no change.
Dimethyltryptamine....................... 50 no change.
Dioxyaphetyl butyrate.................... 25 no change.
Dipipanone............................... 25 no change.
Drotebanol............................... 25 no change.
Ethylmethylthiambutene................... 25 no change.
Etorphine................................ 30 no change.
Etoxeridine.............................. 25 no change.
Fenethylline............................. 30 no change.
Fentanyl carbamate....................... N/A 30.
Fentanyl related substances.............. 600 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................................... 45 no change.
Hydromorphinol........................... 40 no change.
Hydroxypethidine......................... 25 no change.
Ibogaine................................. 30 no change.
Isobutyryl Fentanyl...................... 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.
Levophenacylmorphan...................... 25 no change.
Lysergic acid diethylamide (LSD)......... 40 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-CHMICA); Methyl-2-(1- 25 no change.
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate.
Marihuana................................ 1,500,000 2,000,000.
Marihuana extract........................ 200,000 500,000.
Mecloqualone............................. 30 no change.
Mescaline................................ 25 no change.
Methaqualone............................. 60 no change.
Methcathinone............................ 25 no change.
Methyoxyacetyl fentanyl.................. 30 no change.
Methyldesorphine......................... 5 no change.
Methyldihydromorphine.................... 25 no change.
Morpheridine............................. 25 no change.
Morphine methylbromide................... 5 no change.
Morphine methylsulfonate................. 5 no change.
Morphine-N-oxide......................... 150 no change.
MT-45.................................... 30 no change.
Myrophine................................ 25 no change.
NM2201; Naphthalen-1-yl 1-(5- 25 no change.
fluoropentyl)-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.
[[Page 49352]]
N-Methyl-3-Piperidyl Benzilate........... 30 no change.
Nicocodeine.............................. 25 no change.
Nicomorphine............................. 25 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-fluorofentanyl, 2-fluorofentanyl... 30 no change.
ortho-Fluoroacryl fentanyl............... N/A 30.
ortho-Fluorobutyryl fentanyl............. N/A 30.
ortho-Fluoroisobutyryl fentanyl.......... N/A 30.
ortho-Methyl acetylfentanyl.............. N/A 30.
ortho-Methyl methoxyacetyl fentanyl...... N/A 30.
Para-chloroisobutyryl fentanyl........... 30 no change.
Para-fluorofentanyl...................... 25 no change.
Para-fluorobutyryl fentanyl.............. 25 no change.
para-Fluoro furanyl fentanyl............. N/A 30.
para-Methylfentanyl...................... N/A 30.
Para-methoxybutyryl fentanyl............. 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.......................... N/A 30.
Pholcodine............................... 5 no change.
Piritramide.............................. 25 no change.
Proheptazine............................. 25 no change.
Properidine.............................. 25 no change.
Propiram................................. 25 no change.
Psilocybin............................... 30 1,500.
Psilocyn................................. 50 1,000.
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..................... N/A 30.
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.
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................. 15 no change.
1-Piperidinocyclohexanecarbonitrile...... 25 no change.
4-Anilino-N-phenethyl-4-piperidine (ANPP) 937,758 no change.
Alfentanil............................... 3,260 no change.
Alphaprodine............................. 25 no change.
Amobarbital.............................. 20,100 no change.
Bezitramide.............................. 25 no change.
Carfentanil.............................. 20 no change.
Cocaine.................................. 68,576 no change.
Codeine (for conversion)................. 1,612,500 no change.
Codeine (for sale)....................... 27,616,684 no change.
D-amphetamine (for sale)................. 21,200,000 no change.
D,l-amphetamine.......................... 21,200,000 no change.
D-amphetamine (for conversion)........... 14,137,578 16,068,789.
Dextropropoxyphene....................... 35 no change.
Dihydrocodeine........................... 156,713 no change.
[[Page 49353]]
Dihydroetorphine......................... 25 no change.
Diphenoxylate (for conversion)........... 14,100 no change.
Diphenoxylate (for sale)................. 770,800 no change.
Ecgonine................................. 68,576 no change.
Ethylmorphine............................ 30 no change.
Etorphine hydrochloride.................. 32 no change.
Fentanyl................................. 731,452 no change.
Glutethimide............................. 25 no change.
Hydrocodone (for conversion)............. 1,250 no change.
Hydrocodone (for sale)................... 30,821,224 no change.
Hydromorphone............................ 2,827,940 2,743,101.
Isomethadone............................. 30 no change.
L-amphetamine............................ 30 no change.
Levo-alphacetylmethadol (LAAM)........... 25 no change.
Levomethorphan........................... 30 no change.
Levorphanol.............................. 26,495 no change.
Lisdexamfetamine......................... 21,000,000 no change.
L-methamphetamine........................ 587,229 no change.
Meperidine............................... 856,695 no change.
Meperidine Intermediate-A................ 30 no change.
Meperidine Intermediate-B................ 30 no change.
Meperidine Intermediate-C................ 30 no change.
Metazocine............................... 15 no change.
Methadone (for sale)..................... 25,619,700 no change.
Methadone Intermediate................... 27,673,600 no change.
Methamphetamine.......................... 50 no change.
D-methamphetamine (for conversion)....... 485,020 no change.
D-methamphetamine (for sale)............. 40,000 no change.
Methylphenidate (for conversion)......... 0 15,300,000.
Methylphenidate (for sale)............... 57,438,334 no change.
Metopon.................................. 25 no change.
Moramide-intermediate.................... 25 no change.
Morphine (for conversion)................ 3,376,696 no change.
Morphine (for sale)...................... 27,784,062 26,505,995.
Nabilone................................. 62,000 no change.
Norfentanyl.............................. 25 no change.
Noroxymorphone (for conversion).......... 22,044,741 no change.
Noroxymorphone (for sale)................ 376,000 no change.
Oliceridine.............................. N/A 22,500.
Opium (powder)........................... 250,000 no change.
Opium (tincture)......................... 530,837 no change.
Oripavine................................ 33,010,750 no change.
Oxycodone (for conversion)............... 620,887 no change.
Oxycodone (for sale)..................... 57,110,032 no change.
Oxymorphone (for conversion)............. 28,204,371 no change.
Oxymorphone (for sale)................... 563,174 no change.
Pentobarbital............................ 25,850,000 30,766,670.
Phenazocine.............................. 25 no change.
Phencyclidine............................ 35 no change.
Phenmetrazine............................ 25 no change.
Phenylacetone............................ 40 no change.
Piminodine............................... 25 no change.
Racemethorphan........................... 5 no change.
Racemorphan.............................. 5 no change.
Remifentanil............................. 3,000 no change.
Secobarbital............................. 172,100 no change.
Sufentanil............................... 4,000 no change.
Tapentadol............................... 13,447,541 no change.
Thebaine................................. 57,137,944 no change.
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)............... 100 no change.
Ephedrine (for sale)..................... 4,136,000 no change.
Phenylpropanolamine (for conversion)..... 14,878,320 no change.
Phenylpropanolamine (for sale)........... 16,690,000 no change.
Pseudoephedrine (for conversion)......... 1,000 no change.
Pseudoephedrine (for sale)............... 174,246,000 no change.
------------------------------------------------------------------------
[[Page 49354]]
The Administrator further proposes that aggregate production quotas
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 2021 aggregate production quotas and
assessment of annual needs 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 2021
aggregate production quota for each basic class of controlled
substances in schedules I and II and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. 21 CFR 1303.13(c) and 1315.13(f).
Anne Milgram,
Administrator.
[FR Doc. 2021-18935 Filed 9-1-21; 8:45 am]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on September 2, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.