Final Adjusted 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 2020, 77243-77249 [2020-26443]
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Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
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[FR Doc. 2020–26453 Filed 11–30–20; 8:45 am]
BILLING CODE 4410–11–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–508F]
Final Adjusted 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 2020
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
This final order establishes
the final adjusted 2020 aggregate
production quotas for controlled
substances in schedules I and II of the
Controlled Substances Act and the
assessment of annual needs for the list
SUMMARY:
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77243
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
DATES: This order is effective December
1, 2020.
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, VA
22152, Telephone: (571) 362–3261.
SUPPLEMENTARY INFORMATION:
Legal Authority
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
substances 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 the Drug
Enforcement Administration (DEA)
pursuant to 28 CFR 0.100.
Background
DEA published the 2020 established
APQ for controlled substances in
schedules I and II and for the
assessment of annual needs (AAN) for
the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine in the Federal
Register on December 2, 2019. 84 FR
66014. DEA is committed to preventing
and limiting diversion by enforcing laws
and regulations regarding controlled
substances and the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine, while meeting
the legitimate medical, scientific, and
export needs of the United States. This
notice stated that the Administrator
would adjust, as needed, the established
APQ in 2020 in accordance with 21 CFR
1303.13 and 21 CFR 1315.13.
In response to the public health
emergency declared by the Secretary of
Health and Human Services (HHS) on
January 31, 2020, DEA published the
final order titled ‘‘Adjustments to
Aggregate Production Quotas for Certain
Schedule II Controlled Substances and
Assessment of Annual Needs for the List
I Chemicals Ephedrine and
Pseudoephedrine for 2020’’ on April 10,
2020. (85 FR 20302). While the
adjustments were effective immediately,
all interested persons were invited to
comment on or object to the adjustments
on or before May 11, 2020.
The 2020 proposed adjusted APQ for
controlled substances in schedules I and
II and AAN for the list I chemicals
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Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
ephedrine, pseudoephedrine, and
phenylpropanolamine were
subsequently published in the Federal
Register on September 1, 2020, (85 FR
54414), after consideration of the
criteria outlined in that notice. All
interested persons were invited to
comment on or object to the proposed
APQs and AANs on or before October 1,
2020.
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Comments Received
DEA received five timely comments
and one untimely comment in response
to the April Federal Register notice and
nine comments in response to the
September Federal Register notice from
patients, DEA-registered entities, and
non-DEA entities. The comments
included appreciation of DEA’s
response to the public health
emergency, concerns about potential
drug shortages, interference with doctorpatient relationships, and comments
outside the scope of this final order.
Issue: Commenters expressed
appreciation of DEA’s flexibility in
responding to the nationwide public
health emergency declared by the
Secretary of HHS on January 31, 2020,
by adjusting APQ for select schedule II
controlled substances and list I
chemicals.
DEA Response: DEA acknowledges
the expressions of appreciation to
changes in the APQ and AAN. The
adjustments to select schedule II
controlled substances and list I
chemicals occurred after DEA consulted
with HHS and determined the
utilization rates for these drugs
substantially increased due to the
treatment regimens for ventilator
patients stricken with the Coronavirus
Disease of 2019 (COVID–19) compared
to the previously estimated annual
consumption rates. While the estimates
from HHS provided a wide range in the
number of patients that would require
ventilation treatment due to COVID–19,
DEA could, under 21 CFR 1303.13 and
1315.13, adjust the APQ and AAN for
schedule II controlled substances and
list I chemicals, respectively, to ensure
manufacturing activities cover the upper
range of the estimate could occur in a
timely manner. DEA highlights factor 21
CFR 1303.13(b)(5) specifically, which
allowed the Acting Administrator to
increase the APQ and AAN for select
controlled substances and list I
chemicals to meet additional estimated
medical needs as determined by HHS
due to the unforeseen emergency caused
by the COVID–19 pandemic.
Issue: Commenters expressed general
concerns that decreasing the APQ of
controlled substances could lead to
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shortages of controlled substance
medications.
One DEA-registered entity submitted
a comment requesting the APQ for
hydrocodone (for sale) and oxycodone
(for sale) be sufficient to provide for the
estimated medical, scientific, research,
and industrial needs of the United
States, for export requirements, and for
the establishment and maintenance of
reserve stocks.
DEA Response: DEA sets APQ in a
manner to ensure that the estimated
medical, scientific, research, industrial
needs of the United States, lawful
export requirements, and for the
establishment and maintenance of
reserve stocks. As discussed in both
notices for adjustments, any
adjustments to the APQ for controlled
substances is based on factors set forth
in 21 CFR 1303.13. In the event of a
shortage, the CSA provides a
mechanism under which DEA will, in
appropriate circumstances, increase
quotas to address shortages. 21 U.S.C.
826(h). Under 21 U.S.C. 826(h)(1), after
receiving a request to address a
shortage, DEA has 30 days to complete
review of the request and determine
whether adjustments are necessary to
address the shortage. If adjustments are
necessary, DEA is required to increase
the APQ and individual production
quotas to alleviate the shortage. Id. If
DEA determines adjustments are not
necessary, DEA is required to ‘‘provide
a written response detailing the basis for
the . . . determination.’’ Id. In addition
to what Section 826(h)(1) requires,
when DEA is notified of an alleged
shortage, DEA will confer with the U.S.
Food and Drug Administration and
relevant manufacturers regarding the
amount of material in physical
inventory, current quota granted, and
the estimated legitimate medical need,
to determine whether a quota
adjustment is necessary to alleviate any
factually valid shortage.
In accordance with 21 CFR 1303.13,
DEA considered the comments for
hydrocodone (for sale) and oxycodone
(for sale), and the Acting Administrator
determined the proposed adjusted 2020
APQs for these substances as published
in the Federal Register on September 1,
2020, (85 FR 54414), are sufficient to
meet the current 2020 estimated
medical, scientific, research, and
industrial needs of the United States,
and to provide for adequate reserve
stock.
Issue: DEA received comments of
general concerns alleging decreases to
the APQ interfered with doctor-patient
relationships.
DEA Response: In determining the
APQ, DEA considers prescriptions that
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have been issued. However, DEA does
not interfere with doctor-patient
relationships. Doctors authorized to
dispense controlled substances are
responsible for adhering to the laws and
regulations set forth under the CSA,
which requires doctors to only write
prescriptions for a legitimate medical
need. DEA is responsible for enforcing
controlled substance laws and
regulations, and is committed to
ensuring an adequate and uninterrupted
supply of controlled substances in order
to meet the demand of legitimate
medical, scientific, and export needs of
the United States.
Untimely Comment Issue: The DEA
received one comment from a DEAregistered entity for previously
established value of the 2020 AAN for
pseudoephedrine (for conversion),
requesting an increase because the
established AAN is not adequate to
cover the commenter’s new projected
need for 2020.
DEA Response: The comment was
received in between the comment
periods for the two notices of
adjustment. Even though the comment
was outside the comment period that
ended on May 11, 2020, DEA
considered this comment as part of the
second comment period ending on
October 1, 2020, when setting the final
2020 AAN.
Out of Scope Comments: DEA
received comments on issues outside
the scope of this final order. The
comments were general in nature and
raised issues of specific medical
illnesses, medical treatments, and
medication costs, and therefore, are
outside of the scope of this Final Order
for 2020 and do not impact the original
analysis involved in finalizing the 2020
APQ.
Analysis for Final Adjusted 2020
Aggregate Production Quotas and
Assessment of Annual Needs
In determining the final adjusted 2020
APQ and AAN, DEA has considered the
above comments relevant to this Final
Order for calendar year 2020, along with
the factors set forth in 21 CFR 1303.13
and 21 CFR 1315.13, in accordance with
21 U.S.C. 826(a). DEA has also
considered other relevant factors,
including the 2019 year-end inventories,
initial 2020 manufacturing and import
quotas, 2020 export requirements, actual
and projected 2020 sales, research and
product development requirements,
additional applications received, and
the extent of any diversion of the
controlled substance in the class. Based
on all of the above, the Acting
Administrator is adjusting the 2020
APQ for the following: Increases for
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Amphetamine (for sale) and
Methamphetamine, based on the data
received since the publication of the
2020 proposed adjustment for APQ and
AAN in the Federal Register on
September 1, 2020 (85 FR 54414);
increases for Crotonyl Fentanyl,
Ethylone, and Isotonitazene due to the
publication of their schedule I
temporary controlled status; and
increases for Etonitazene due to
additional manufacturers entering the
reference standard market. This final
order reflects those adjustments.
Pursuant to the above, the Acting
Administrator hereby finalizes the 2020
77245
APQ for the following schedule I and II
controlled substances and the 2020
AAN for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
grams of anhydrous acid or base, as
follows:
Final revised
2020 quotas
Basic class
(g)
Temporarily Scheduled Substances
Crotonyl fentanyl ..................................................................................................................................................................................
Ethylone ...............................................................................................................................................................................................
Isotonitazene ........................................................................................................................................................................................
25
25
25
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Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ..................................................................................................................................................
1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ..................................................................................................................................
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ...........................................................................................................................
1-Benzylpiperazine ..............................................................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine ...........................................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine ...................................................................................................................................................
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ...........................................................................................................................
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) ........................................................................................................................
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) ..........................................................................................................................
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P) ...................................................................................................................
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) .......................................................................................................................................
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) ........................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) ........................................................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) ........................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) ..............................................................................................................................
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ..................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ......................................................................................................................................
2,5-Dimethoxy-4-(n)-propylthiophenethylamine ...................................................................................................................................
2,5-Dimethoxyamphetamine (DMA) ....................................................................................................................................................
2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C-T-2) ..................................................................................................................
2-(4-(Isopropylthio)-2,5-dimethoxyphenyl)ethanamine (2C-T-4) .........................................................................................................
3,4,5-Trimethoxyamphetamine ............................................................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ............................................................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) .................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) .............................................................................................................................
3,4-Methylenedioxy-N-methylcathinone (methylone) ..........................................................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) ...........................................................................................................................................
3-Fluoro-N-methylcathinone (3-FMC) ..................................................................................................................................................
3-Methylfentanyl ...................................................................................................................................................................................
3-Methylthiofentanyl .............................................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ......................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) ..................................................................................................................................
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) .........................................................................................................
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-carboximide (4CN-Cumyl-Butinaca) ........................................................
4-Fluoroisobutyryl fentanyl ...................................................................................................................................................................
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone) ...........................................................................................................................
4-Methyl-N-ethylcathinone (4-MEC) ....................................................................................................................................................
4-Methoxyamphetamine ......................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ......................................................................................................................................
4-Methylaminorex ................................................................................................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP) ..........................................................................................................................
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) ...............................................................................................................................
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP) ........................................................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol ..........................................................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) .............................
5F-CUMYL-PINACA ............................................................................................................................................................................
5F-EDMB-PINACA ...............................................................................................................................................................................
5F-MDMB-PICA ...................................................................................................................................................................................
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ............................................
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide) .....................................
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ............................
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01DEN1
20
15
10
30
30
25
10
15
30
30
30
30
100
30
30
25
30
30
25
25
25
30
30
30
55
50
40
40
35
25
30
30
30
25
25
25
30
25
25
150
25
25
45
25
25
25
50
40
25
25
25
25
25
30
77246
Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
Final revised
2020 quotas
Basic class
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(g)
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ...................................................................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ........................................................
5-Fluoro-PB-22; 5F-PB-22 ...................................................................................................................................................................
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ...........................................
5-Methoxy-3,4-methylenedioxyamphetamine ......................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ..................................................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .....................................................................................................................................................
AB-CHMINACA ....................................................................................................................................................................................
AB-FUBINACA .....................................................................................................................................................................................
AB-PINACA ..........................................................................................................................................................................................
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ..................................
Acetorphine ..........................................................................................................................................................................................
Acetyl Fentanyl ....................................................................................................................................................................................
Acetyl-alpha-methylfentanyl .................................................................................................................................................................
Acetyldihydrocodeine ...........................................................................................................................................................................
Acetylmethadol ....................................................................................................................................................................................
Acryl Fentanyl ......................................................................................................................................................................................
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ......................................................
AH-7921 ...............................................................................................................................................................................................
Allylprodine ..........................................................................................................................................................................................
Alphacetylmethadol ..............................................................................................................................................................................
Alpha-Ethyltryptamine ..........................................................................................................................................................................
Alphameprodine ...................................................................................................................................................................................
Alphamethadol .....................................................................................................................................................................................
Alphaprodine ........................................................................................................................................................................................
Alpha-Methylfentanyl ...........................................................................................................................................................................
Alpha-Methylthiofentanyl ......................................................................................................................................................................
Alpha-Methyltryptamine (AMT) ............................................................................................................................................................
Alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................
Alpha-Pyrrolidinoheptaphenone (PV8) ................................................................................................................................................
Alpha-Pyrrolidinohexanophenone (a-PHP) .........................................................................................................................................
Alpha-Pyrrolidinopentiophenone (a-PVP) ...........................................................................................................................................
Aminorex ..............................................................................................................................................................................................
Anileridine ............................................................................................................................................................................................
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) .......................................................................................
Benzethidine ........................................................................................................................................................................................
Benzylmorphine ...................................................................................................................................................................................
Betacetylmethadol ...............................................................................................................................................................................
Beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................
Beta-Hydroxyfentanyl ...........................................................................................................................................................................
Beta-Hydroxythiofentanyl .....................................................................................................................................................................
Betameprodine .....................................................................................................................................................................................
Betamethadol .......................................................................................................................................................................................
Betaprodine ..........................................................................................................................................................................................
Bufotenine ............................................................................................................................................................................................
Butylone ...............................................................................................................................................................................................
Butyryl fentanyl ....................................................................................................................................................................................
Cathinone .............................................................................................................................................................................................
Clonitazene ..........................................................................................................................................................................................
Codeine methylbromide .......................................................................................................................................................................
Codeine-N-oxide ..................................................................................................................................................................................
Cyclopentyl Fentanyl ...........................................................................................................................................................................
Cyclopropyl Fentanyl ...........................................................................................................................................................................
Cyprenorphine .....................................................................................................................................................................................
Desomorphine ......................................................................................................................................................................................
Dextromoramide ..................................................................................................................................................................................
Diampromide ........................................................................................................................................................................................
Diethylthiambutene ..............................................................................................................................................................................
Diethyltryptamine .................................................................................................................................................................................
Difenoxin ..............................................................................................................................................................................................
Dihydromorphine ..................................................................................................................................................................................
Dimenoxadol ........................................................................................................................................................................................
Dimepheptanol .....................................................................................................................................................................................
Dimethylthiambutene ...........................................................................................................................................................................
Dimethyltryptamine ..............................................................................................................................................................................
Dioxaphetyl butyrate ............................................................................................................................................................................
Dipipanone ...........................................................................................................................................................................................
Drotebanol ...........................................................................................................................................................................................
Ethylmethylthiambutene .......................................................................................................................................................................
Etonitazene ..........................................................................................................................................................................................
Etorphine ..............................................................................................................................................................................................
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01DEN1
30
30
20
25
25
25
25
30
50
30
30
25
100
30
30
25
25
50
30
25
25
25
25
25
25
30
30
25
25
25
25
25
25
20
25
25
30
25
30
30
30
25
4
25
15
25
30
40
25
30
192
30
20
25
25
25
20
20
25
9,200
753,500
25
25
20
50
25
25
25
25
25
30
Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
77247
Final revised
2020 quotas
Basic class
khammond on DSKJM1Z7X2PROD with NOTICES4
(g)
Etoxeridine ...........................................................................................................................................................................................
Fenethylline ..........................................................................................................................................................................................
Fentanyl related substances ................................................................................................................................................................
FUB-144 ...............................................................................................................................................................................................
FUB-AKB48 .........................................................................................................................................................................................
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca ........................................................................................................................................
Furanyl fentanyl ...................................................................................................................................................................................
Furethidine ...........................................................................................................................................................................................
Gamma Hydroxybutyric Acid ...............................................................................................................................................................
Heroin ..................................................................................................................................................................................................
Hydromorphinol ....................................................................................................................................................................................
Hydroxypethidine .................................................................................................................................................................................
Ibogaine ...............................................................................................................................................................................................
Isobutyryl Fentanyl ...............................................................................................................................................................................
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) ......................................................................................................................
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ...........................................................................................................................................
JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ............................................................................................................................................
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)indole) ........................................................................................................................
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ...........................................................................................................................
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ...............................................................................................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ............................................................................................................................
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ........................................................................................................................
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ............................................................................................................................
Ketobemidone ......................................................................................................................................................................................
Levomoramide .....................................................................................................................................................................................
Levophenacylmorphan .........................................................................................................................................................................
Lysergic acid diethylamide (LSD) ........................................................................................................................................................
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3carboxamide) ....................................................................................................................................................................................
MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ...............
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ...........................................
MMB-CHMICA (AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate .............................
Marihuana ............................................................................................................................................................................................
Mecloqualone .......................................................................................................................................................................................
Mescaline .............................................................................................................................................................................................
Methaqualone ......................................................................................................................................................................................
Methcathinone .....................................................................................................................................................................................
Methoxyacetyl fentanyl ........................................................................................................................................................................
Methyldesorphine .................................................................................................................................................................................
Methyldihydromorphine ........................................................................................................................................................................
Morpheridine ........................................................................................................................................................................................
Morphine methylbromide .....................................................................................................................................................................
Morphine methylsulfonate ....................................................................................................................................................................
Morphine-N-oxide ................................................................................................................................................................................
MT-45 ...................................................................................................................................................................................................
Myrophine ............................................................................................................................................................................................
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate ................................................................................................
N,N-Dimethylamphetamine ..................................................................................................................................................................
Naphyrone ...........................................................................................................................................................................................
N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................
N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................
N-Ethylamphetamine ...........................................................................................................................................................................
N-Ethylhexedrone ................................................................................................................................................................................
N-Ethylpentylone, ephylone .................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ......................................................................................................................................
N-Methyl-3-Piperidyl Benzilate ............................................................................................................................................................
Nicocodeine .........................................................................................................................................................................................
Nicomorphine .......................................................................................................................................................................................
Noracymethadol ...................................................................................................................................................................................
Norlevorphanol .....................................................................................................................................................................................
Normethadone .....................................................................................................................................................................................
Normorphine ........................................................................................................................................................................................
Norpipanone ........................................................................................................................................................................................
Ocfentanil .............................................................................................................................................................................................
Ortho-fluorofentanyl, 2-fluorofentanyl ..................................................................................................................................................
Para-chloroisobutyryl fentanyl .............................................................................................................................................................
Para-fluorofentanyl ...............................................................................................................................................................................
Para-fluorobutyryl fentanyl ...................................................................................................................................................................
Para-methoxybutyryl fentanyl ..............................................................................................................................................................
Parahexyl .............................................................................................................................................................................................
PB-22; QUPIC .....................................................................................................................................................................................
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01DEN1
25
30
600
25
25
25
30
25
29,417,000
45
40
25
30
25
35
45
45
30
30
35
30
30
30
30
25
25
40
30
30
30
25
3,200,000
30
25
60
25
30
5
25
25
5
5
150
30
25
25
25
25
25
10
24
25
30
24
30
25
25
25
55
25
40
25
25
30
30
25
25
30
5
20
77248
Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
Final revised
2020 quotas
Basic class
(g)
Pentedrone ..........................................................................................................................................................................................
Pentylone .............................................................................................................................................................................................
Phenadoxone .......................................................................................................................................................................................
Phenampromide ...................................................................................................................................................................................
Phenomorphan ....................................................................................................................................................................................
Phenoperidine ......................................................................................................................................................................................
Pholcodine ...........................................................................................................................................................................................
Piritramide ............................................................................................................................................................................................
Proheptazine ........................................................................................................................................................................................
Properidine ...........................................................................................................................................................................................
Propiram ..............................................................................................................................................................................................
Psilocybin .............................................................................................................................................................................................
Psilocyn ................................................................................................................................................................................................
Racemoramide .....................................................................................................................................................................................
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ...........................................................................................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ..............................................................................................................
Tetrahydrocannabinols ........................................................................................................................................................................
Tetrahydrofuranyl fentanyl ...................................................................................................................................................................
Thebacon .............................................................................................................................................................................................
Thiafentanil ..........................................................................................................................................................................................
Thiofentanyl .........................................................................................................................................................................................
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ......................................................................................
Tilidine ..................................................................................................................................................................................................
Trimeperidine .......................................................................................................................................................................................
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ......................................................................................
U-47700 ...............................................................................................................................................................................................
Valeryl fentanyl ....................................................................................................................................................................................
25
25
25
25
25
25
5
25
25
25
25
30
50
25
45
30
384,460
15
25
25
25
30
25
25
25
30
25
khammond on DSKJM1Z7X2PROD with NOTICES4
Schedule II
1-Phenylcyclohexylamine ....................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ....................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .........................................................................................................................................
Alfentanil ..............................................................................................................................................................................................
Alphaprodine ........................................................................................................................................................................................
Amobarbital ..........................................................................................................................................................................................
Amphetamine (for conversion) ............................................................................................................................................................
Amphetamine (for sale) .......................................................................................................................................................................
Bezitramide ..........................................................................................................................................................................................
Carfentanil ............................................................................................................................................................................................
Cocaine ................................................................................................................................................................................................
Codeine (for conversion) .....................................................................................................................................................................
Codeine (for sale) ................................................................................................................................................................................
Dextropropoxyphene ............................................................................................................................................................................
Dihydrocodeine ....................................................................................................................................................................................
Dihydroetorphine ..................................................................................................................................................................................
Diphenoxylate (for conversion) ............................................................................................................................................................
Diphenoxylate (for sale) .......................................................................................................................................................................
Ecgonine ..............................................................................................................................................................................................
Ethylmorphine ......................................................................................................................................................................................
Etorphine hydrochloride .......................................................................................................................................................................
Fentanyl ...............................................................................................................................................................................................
Glutethimide .........................................................................................................................................................................................
Hydrocodone (for conversion) .............................................................................................................................................................
Hydrocodone (for sale) ........................................................................................................................................................................
Hydromorphone ...................................................................................................................................................................................
Isomethadone ......................................................................................................................................................................................
Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................
Levomethorphan ..................................................................................................................................................................................
Levorphanol .........................................................................................................................................................................................
Lisdexamfetamine ................................................................................................................................................................................
Meperidine ...........................................................................................................................................................................................
Meperidine Intermediate-A ..................................................................................................................................................................
Meperidine Intermediate-B ..................................................................................................................................................................
Meperidine Intermediate-C ..................................................................................................................................................................
Metazocine ...........................................................................................................................................................................................
Methadone (for sale) ...........................................................................................................................................................................
Methadone Intermediate ......................................................................................................................................................................
Methamphetamine ...............................................................................................................................................................................
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01DEN1
15
25
934,956
3,260
25
20,100
14,137,578
44,330,000
25
20
73,090
3,225,000
35,341,292
35
156,713
25
14,100
770,800
78,439
30
32
934,956
25
1,250
33,997,285
3,512,651
30
25
30
31,730
21,000,000
1,119,862
30
30
30
15
25,619,700
27,673,600
1,224,109
Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices
77249
Final revised
2020 quotas
Basic class
(g)
[678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 505,231 grams for methamphetamine mostly for
conversion to a schedule III product; and 40,000 grams for methamphetamine (for sale).]
Methylphenidate ...................................................................................................................................................................................
Metopon ...............................................................................................................................................................................................
Moramide-intermediate ........................................................................................................................................................................
Morphine (for conversion) ....................................................................................................................................................................
Morphine (for sale) ..............................................................................................................................................................................
Nabilone ...............................................................................................................................................................................................
Norfentanyl ...........................................................................................................................................................................................
Noroxymorphone (for conversion) .......................................................................................................................................................
Noroxymorphone (for sale) ..................................................................................................................................................................
Opium (powder) ...................................................................................................................................................................................
Opium (tincture) ...................................................................................................................................................................................
Oripavine ..............................................................................................................................................................................................
Oxycodone (for conversion) ................................................................................................................................................................
Oxycodone (for sale) ...........................................................................................................................................................................
Oxymorphone (for conversion) ............................................................................................................................................................
Oxymorphone (for sale) .......................................................................................................................................................................
Pentobarbital ........................................................................................................................................................................................
Phenazocine ........................................................................................................................................................................................
Phencyclidine .......................................................................................................................................................................................
Phenmetrazine .....................................................................................................................................................................................
Phenylacetone .....................................................................................................................................................................................
Piminodine ...........................................................................................................................................................................................
Racemethorphan .................................................................................................................................................................................
Racemorphan ......................................................................................................................................................................................
Remifentanil .........................................................................................................................................................................................
Secobarbital .........................................................................................................................................................................................
Sufentanil .............................................................................................................................................................................................
Tapentadol ...........................................................................................................................................................................................
Thebaine ..............................................................................................................................................................................................
57,438,334
25
25
3,376,696
33,756,703
62,000
25
22,044,741
376,000
250,000
530,837
33,010,750
725,998
65,667,554
28,204,371
658,515
25,850,000
25
35
25
40
25
5
5
3,000
172,100
4,000
13,447,541
59,284,070
List I Chemicals
Ephedrine (for conversion) ..................................................................................................................................................................
Ephedrine (for sale) .............................................................................................................................................................................
Phenylpropanolamine (for conversion) ................................................................................................................................................
Phenylpropanolamine (for sale) ...........................................................................................................................................................
Pseudoephedrine (for conversion) ......................................................................................................................................................
Pseudoephedrine (for sale) .................................................................................................................................................................
The Acting Administrator further
proposes that APQ for all other schedule
I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 remain
at zero.
DEPARTMENT OF JUSTICE
Timothy J. Shea,
Acting Administrator.
National Oceanic and Atmospheric
Administration
[FR Doc. 2020–26443 Filed 11–30–20; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES4
BILLING CODE 4410–09–P
DEPARTMENT OF THE INTERIOR
DEPARTMENT OF COMMERCE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act (CERCLA), the Clean Water Act
(CWA), and the Oil Pollution Act (OPA)
and Notice of Availability of Draft
Restoration Plan/Environmental
Assessment of Restoration Project
Incorporated Into Proposed Consent
Decree
On November 12, 2020, the
Department of Justice lodged a proposed
consent decree with the United States
District Court for the Western District
VerDate Sep<11>2014
19:48 Nov 30, 2020
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100
4,756,000
14,100,000
16,590,000
1,000
200,382,900
Washington in the lawsuit entitled
United States of America, State of
Washington, Suquamish Tribe, and
Muckleshoot Indian Tribe v. City of
Seattle, Civil Action No. 16–1486 (W.D.
Wa.).
The complaint asserts claims for
natural resource damages by the United
States on behalf of the National Oceanic
and Atmospheric Administration and
the Department of the Interior; the State
of Washington; the Suquamish Tribe;
and the Muckleshoot Indian Tribe
(collectively, the ‘‘Natural Resource
Trustees’’) pursuant to the section
107(a) of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA), 42 U.S.C. 9607(a); section
311 of the Clean Water Act (CWA), 33
U.S.C. 1321; section 1002(b) of the Oil
Pollution Act (OPA), 33 U.S.C. 2702(b);
and the Washington Model Toxics
Control Act (MTCA), RCW 70.105D.
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 85, Number 231 (Tuesday, December 1, 2020)]
[Notices]
[Pages 77243-77249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26443]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-508F]
Final Adjusted 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 2020
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
-----------------------------------------------------------------------
SUMMARY: This final order establishes the final adjusted 2020 aggregate
production quotas for controlled substances in schedules I and II of
the Controlled Substances Act and the assessment of annual needs for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: This order is effective December 1, 2020.
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, VA 22152, Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Legal Authority
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 substances 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 the Drug Enforcement Administration (DEA)
pursuant to 28 CFR 0.100.
Background
DEA published the 2020 established APQ for controlled substances in
schedules I and II and for the assessment of annual needs (AAN) for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in
the Federal Register on December 2, 2019. 84 FR 66014. DEA is committed
to preventing and limiting diversion by enforcing laws and regulations
regarding controlled substances and the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine, while meeting the legitimate
medical, scientific, and export needs of the United States. This notice
stated that the Administrator would adjust, as needed, the established
APQ in 2020 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13.
In response to the public health emergency declared by the
Secretary of Health and Human Services (HHS) on January 31, 2020, DEA
published the final order titled ``Adjustments to Aggregate Production
Quotas for Certain Schedule II Controlled Substances and Assessment of
Annual Needs for the List I Chemicals Ephedrine and Pseudoephedrine for
2020'' on April 10, 2020. (85 FR 20302). While the adjustments were
effective immediately, all interested persons were invited to comment
on or object to the adjustments on or before May 11, 2020.
The 2020 proposed adjusted APQ for controlled substances in
schedules I and II and AAN for the list I chemicals
[[Page 77244]]
ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently
published in the Federal Register on September 1, 2020, (85 FR 54414),
after consideration of the criteria outlined in that notice. All
interested persons were invited to comment on or object to the proposed
APQs and AANs on or before October 1, 2020.
Comments Received
DEA received five timely comments and one untimely comment in
response to the April Federal Register notice and nine comments in
response to the September Federal Register notice from patients, DEA-
registered entities, and non-DEA entities. The comments included
appreciation of DEA's response to the public health emergency, concerns
about potential drug shortages, interference with doctor-patient
relationships, and comments outside the scope of this final order.
Issue: Commenters expressed appreciation of DEA's flexibility in
responding to the nationwide public health emergency declared by the
Secretary of HHS on January 31, 2020, by adjusting APQ for select
schedule II controlled substances and list I chemicals.
DEA Response: DEA acknowledges the expressions of appreciation to
changes in the APQ and AAN. The adjustments to select schedule II
controlled substances and list I chemicals occurred after DEA consulted
with HHS and determined the utilization rates for these drugs
substantially increased due to the treatment regimens for ventilator
patients stricken with the Coronavirus Disease of 2019 (COVID-19)
compared to the previously estimated annual consumption rates. While
the estimates from HHS provided a wide range in the number of patients
that would require ventilation treatment due to COVID-19, DEA could,
under 21 CFR 1303.13 and 1315.13, adjust the APQ and AAN for schedule
II controlled substances and list I chemicals, respectively, to ensure
manufacturing activities cover the upper range of the estimate could
occur in a timely manner. DEA highlights factor 21 CFR 1303.13(b)(5)
specifically, which allowed the Acting Administrator to increase the
APQ and AAN for select controlled substances and list I chemicals to
meet additional estimated medical needs as determined by HHS due to the
unforeseen emergency caused by the COVID-19 pandemic.
Issue: Commenters expressed general concerns that decreasing the
APQ of controlled substances could lead to shortages of controlled
substance medications.
One DEA-registered entity submitted a comment requesting the APQ
for hydrocodone (for sale) and oxycodone (for sale) be sufficient to
provide for the estimated medical, scientific, research, and industrial
needs of the United States, for export requirements, and for the
establishment and maintenance of reserve stocks.
DEA Response: DEA sets APQ in a manner to ensure that the estimated
medical, scientific, research, industrial needs of the United States,
lawful export requirements, and for the establishment and maintenance
of reserve stocks. As discussed in both notices for adjustments, any
adjustments to the APQ for controlled substances is based on factors
set forth in 21 CFR 1303.13. In the event of a shortage, the CSA
provides a mechanism under which DEA will, in appropriate
circumstances, increase quotas to address shortages. 21 U.S.C. 826(h).
Under 21 U.S.C. 826(h)(1), after receiving a request to address a
shortage, DEA has 30 days to complete review of the request and
determine whether adjustments are necessary to address the shortage. If
adjustments are necessary, DEA is required to increase the APQ and
individual production quotas to alleviate the shortage. Id. If DEA
determines adjustments are not necessary, DEA is required to ``provide
a written response detailing the basis for the . . . determination.''
Id. In addition to what Section 826(h)(1) requires, when DEA is
notified of an alleged shortage, DEA will confer with the U.S. Food and
Drug Administration and relevant manufacturers regarding the amount of
material in physical inventory, current quota granted, and the
estimated legitimate medical need, to determine whether a quota
adjustment is necessary to alleviate any factually valid shortage.
In accordance with 21 CFR 1303.13, DEA considered the comments for
hydrocodone (for sale) and oxycodone (for sale), and the Acting
Administrator determined the proposed adjusted 2020 APQs for these
substances as published in the Federal Register on September 1, 2020,
(85 FR 54414), are sufficient to meet the current 2020 estimated
medical, scientific, research, and industrial needs of the United
States, and to provide for adequate reserve stock.
Issue: DEA received comments of general concerns alleging decreases
to the APQ interfered with doctor-patient relationships.
DEA Response: In determining the APQ, DEA considers prescriptions
that have been issued. However, DEA does not interfere with doctor-
patient relationships. Doctors authorized to dispense controlled
substances are responsible for adhering to the laws and regulations set
forth under the CSA, which requires doctors to only write prescriptions
for a legitimate medical need. DEA is responsible for enforcing
controlled substance laws and regulations, and is committed to ensuring
an adequate and uninterrupted supply of controlled substances in order
to meet the demand of legitimate medical, scientific, and export needs
of the United States.
Untimely Comment Issue: The DEA received one comment from a DEA-
registered entity for previously established value of the 2020 AAN for
pseudoephedrine (for conversion), requesting an increase because the
established AAN is not adequate to cover the commenter's new projected
need for 2020.
DEA Response: The comment was received in between the comment
periods for the two notices of adjustment. Even though the comment was
outside the comment period that ended on May 11, 2020, DEA considered
this comment as part of the second comment period ending on October 1,
2020, when setting the final 2020 AAN.
Out of Scope Comments: DEA received comments on issues outside the
scope of this final order. The comments were general in nature and
raised issues of specific medical illnesses, medical treatments, and
medication costs, and therefore, are outside of the scope of this Final
Order for 2020 and do not impact the original analysis involved in
finalizing the 2020 APQ.
Analysis for Final Adjusted 2020 Aggregate Production Quotas and
Assessment of Annual Needs
In determining the final adjusted 2020 APQ and AAN, DEA has
considered the above comments relevant to this Final Order for calendar
year 2020, along with the factors set forth in 21 CFR 1303.13 and 21
CFR 1315.13, in accordance with 21 U.S.C. 826(a). DEA has also
considered other relevant factors, including the 2019 year-end
inventories, initial 2020 manufacturing and import quotas, 2020 export
requirements, actual and projected 2020 sales, research and product
development requirements, additional applications received, and the
extent of any diversion of the controlled substance in the class. Based
on all of the above, the Acting Administrator is adjusting the 2020 APQ
for the following: Increases for
[[Page 77245]]
Amphetamine (for sale) and Methamphetamine, based on the data received
since the publication of the 2020 proposed adjustment for APQ and AAN
in the Federal Register on September 1, 2020 (85 FR 54414); increases
for Crotonyl Fentanyl, Ethylone, and Isotonitazene due to the
publication of their schedule I temporary controlled status; and
increases for Etonitazene due to additional manufacturers entering the
reference standard market. This final order reflects those adjustments.
Pursuant to the above, the Acting Administrator hereby finalizes
the 2020 APQ for the following schedule I and II controlled substances
and the 2020 AAN for the list I chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine, expressed in grams of anhydrous acid or base,
as follows:
------------------------------------------------------------------------
Final revised
2020 quotas
Basic class ---------------
(g)
------------------------------------------------------------------------
Temporarily Scheduled Substances
------------------------------------------------------------------------
Crotonyl fentanyl....................................... 25
Ethylone................................................ 25
Isotonitazene........................................... 25
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine.................. 20
1-(1-Phenylcyclohexyl)pyrrolidine....................... 15
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine.......... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)....... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)...... 30
1-Benzylpiperazine...................................... 25
1-Methyl-4-phenyl-4-propionoxypiperidine................ 10
1-[1-(2-Thienyl)cyclohexyl]piperidine................... 15
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........ 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....... 30
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................ 100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)....... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)......... 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)...............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)................. 25
2,5-Dimethoxy-4-(n)-propylthiophenethylamine............ 25
2,5-Dimethoxyamphetamine (DMA).......................... 25
2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C-T-2).. 30
2-(4-(Isopropylthio)-2,5-dimethoxyphenyl)ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 30
3,4-Methylenedioxyamphetamine (MDA)..................... 55
3,4-Methylenedioxymethamphetamine (MDMA)................ 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............ 40
3,4-Methylenedioxy-N-methylcathinone (methylone)........ 40
3,4-Methylenedioxypyrovalerone (MDPV)................... 35
3-Fluoro-N-methylcathinone (3-FMC)...................... 25
3-Methylfentanyl........................................ 30
3-Methylthiofentanyl.................................... 30
4-Bromo-2,5-dimethoxyamphetamine (DOB).................. 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB).............. 25
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha- 25
PVP)...................................................
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3- 25
carboximide (4CN-Cumyl-Butinaca).......................
4-Fluoroisobutyryl fentanyl............................. 30
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone)......... 25
4-Methyl-N-ethylcathinone (4-MEC)....................... 25
4-Methoxyamphetamine.................................... 150
4-Methyl-2,5-dimethoxyamphetamine (DOM)................. 25
4-Methylaminorex........................................ 25
4-Methyl-N-methylcathinone (mephedrone)................. 45
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)......... 25
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)........... 25
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP)....... 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl- 50
phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl- 40
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5F-CUMYL-PINACA......................................... 25
5F-EDMB-PINACA.......................................... 25
5F-MDMB-PICA............................................ 25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide................
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2- 25
yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)...........
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H- 30
indazole-3-carboxamido)-3,3-dimethylbutanoate).........
[[Page 77246]]
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 30
carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5- 30
fluoropentyl)-1H-indazole-3-carboxamide)...............
5-Fluoro-PB-22; 5F-PB-22................................ 20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-3- 25
yl](2,2,3,3-tetramethylcyclopropyl)methanone...........
5-Methoxy-3,4-methylenedioxyamphetamine................. 25
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 25
AB-CHMINACA............................................. 30
AB-FUBINACA............................................. 50
AB-PINACA............................................... 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 30
(4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetorphine............................................. 25
Acetyl Fentanyl......................................... 100
Acetyl-alpha-methylfentanyl............................. 30
Acetyldihydrocodeine.................................... 30
Acetylmethadol.......................................... 25
Acryl Fentanyl.......................................... 25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 50
pentyl-1H-indazole-3-carboxamide)......................
AH-7921................................................. 30
Allylprodine............................................ 25
Alphacetylmethadol...................................... 25
Alpha-Ethyltryptamine................................... 25
Alphameprodine.......................................... 25
Alphamethadol........................................... 25
Alphaprodine............................................ 25
Alpha-Methylfentanyl.................................... 30
Alpha-Methylthiofentanyl................................ 30
Alpha-Methyltryptamine (AMT)............................ 25
Alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............. 25
Alpha-Pyrrolidinoheptaphenone (PV8)..................... 25
Alpha-Pyrrolidinohexanophenone ([alpha]-PHP)............ 25
Alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............ 25
Aminorex................................................ 25
Anileridine............................................. 20
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3- 25
carboxamide)...........................................
Benzethidine............................................ 25
Benzylmorphine.......................................... 30
Betacetylmethadol....................................... 25
Beta-Hydroxy-3-methylfentanyl........................... 30
Beta-Hydroxyfentanyl.................................... 30
Beta-Hydroxythiofentanyl................................ 30
Betameprodine........................................... 25
Betamethadol............................................ 4
Betaprodine............................................. 25
Bufotenine.............................................. 15
Butylone................................................ 25
Butyryl fentanyl........................................ 30
Cathinone............................................... 40
Clonitazene............................................. 25
Codeine methylbromide................................... 30
Codeine-N-oxide......................................... 192
Cyclopentyl Fentanyl.................................... 30
Cyclopropyl Fentanyl.................................... 20
Cyprenorphine........................................... 25
Desomorphine............................................ 25
Dextromoramide.......................................... 25
Diampromide............................................. 20
Diethylthiambutene...................................... 20
Diethyltryptamine....................................... 25
Difenoxin............................................... 9,200
Dihydromorphine......................................... 753,500
Dimenoxadol............................................. 25
Dimepheptanol........................................... 25
Dimethylthiambutene..................................... 20
Dimethyltryptamine...................................... 50
Dioxaphetyl butyrate.................................... 25
Dipipanone.............................................. 25
Drotebanol.............................................. 25
Ethylmethylthiambutene.................................. 25
Etonitazene............................................. 25
Etorphine............................................... 30
[[Page 77247]]
Etoxeridine............................................. 25
Fenethylline............................................ 30
Fentanyl related substances............................. 600
FUB-144................................................. 25
FUB-AKB48............................................... 25
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca..................... 25
Furanyl fentanyl........................................ 30
Furethidine............................................. 25
Gamma Hydroxybutyric Acid............................... 29,417,000
Heroin.................................................. 45
Hydromorphinol.......................................... 40
Hydroxypethidine........................................ 25
Ibogaine................................................ 30
Isobutyryl Fentanyl..................................... 25
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)...... 35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)................. 45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)................. 45
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl)indole)...... 30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)....... 30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 35
naphthoyl)indole)......................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)....... 30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)...... 30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)....... 30
Ketobemidone............................................ 30
Levomoramide............................................ 25
Levophenacylmorphan..................................... 25
Lysergic acid diethylamide (LSD)........................ 40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1- 30
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1- 30
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
dimethylbutanoate).....................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole- 30
3-carboxamido)-3,3-dimethylbutanoate)..................
MMB-CHMICA (AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)- 25
1H-indole-3-carboxamido)-3-methylbutanoate.............
Marihuana............................................... 3,200,000
Mecloqualone............................................ 30
Mescaline............................................... 25
Methaqualone............................................ 60
Methcathinone........................................... 25
Methoxyacetyl fentanyl.................................. 30
Methyldesorphine........................................ 5
Methyldihydromorphine................................... 25
Morpheridine............................................ 25
Morphine methylbromide.................................. 5
Morphine methylsulfonate................................ 5
Morphine-N-oxide........................................ 150
MT-45................................................... 30
Myrophine............................................... 25
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3- 25
carboxylate............................................
N,N-Dimethylamphetamine................................. 25
Naphyrone............................................... 25
N-Ethyl-1-phenylcyclohexylamine......................... 25
N-Ethyl-3-piperidyl benzilate........................... 10
N-Ethylamphetamine...................................... 24
N-Ethylhexedrone........................................ 25
N-Ethylpentylone, ephylone.............................. 30
N-Hydroxy-3,4-methylenedioxyamphetamine................. 24
N-Methyl-3-Piperidyl Benzilate.......................... 30
Nicocodeine............................................. 25
Nicomorphine............................................ 25
Noracymethadol.......................................... 25
Norlevorphanol.......................................... 55
Normethadone............................................ 25
Normorphine............................................. 40
Norpipanone............................................. 25
Ocfentanil.............................................. 25
Ortho-fluorofentanyl, 2-fluorofentanyl.................. 30
Para-chloroisobutyryl fentanyl.......................... 30
Para-fluorofentanyl..................................... 25
Para-fluorobutyryl fentanyl............................. 25
Para-methoxybutyryl fentanyl............................ 30
Parahexyl............................................... 5
PB-22; QUPIC............................................ 20
[[Page 77248]]
Pentedrone.............................................. 25
Pentylone............................................... 25
Phenadoxone............................................. 25
Phenampromide........................................... 25
Phenomorphan............................................ 25
Phenoperidine........................................... 25
Pholcodine.............................................. 5
Piritramide............................................. 25
Proheptazine............................................ 25
Properidine............................................. 25
Propiram................................................ 25
Psilocybin.............................................. 30
Psilocyn................................................ 50
Racemoramide............................................ 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30
Tetrahydrocannabinols................................... 384,460
Tetrahydrofuranyl fentanyl.............................. 15
Thebacon................................................ 25
Thiafentanil............................................ 25
Thiofentanyl............................................ 25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- 30
yl](naphthalen-1-yl)methanone).........................
Tilidine................................................ 25
Trimeperidine........................................... 25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- 25
tetramethylcyclopropyl)methanone.......................
U-47700................................................. 30
Valeryl fentanyl........................................ 25
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................. 15
1-Piperidinocyclohexanecarbonitrile..................... 25
4-Anilino-N-phenethyl-4-piperidine (ANPP)............... 934,956
Alfentanil.............................................. 3,260
Alphaprodine............................................ 25
Amobarbital............................................. 20,100
Amphetamine (for conversion)............................ 14,137,578
Amphetamine (for sale).................................. 44,330,000
Bezitramide............................................. 25
Carfentanil............................................. 20
Cocaine................................................. 73,090
Codeine (for conversion)................................ 3,225,000
Codeine (for sale)...................................... 35,341,292
Dextropropoxyphene...................................... 35
Dihydrocodeine.......................................... 156,713
Dihydroetorphine........................................ 25
Diphenoxylate (for conversion).......................... 14,100
Diphenoxylate (for sale)................................ 770,800
Ecgonine................................................ 78,439
Ethylmorphine........................................... 30
Etorphine hydrochloride................................. 32
Fentanyl................................................ 934,956
Glutethimide............................................ 25
Hydrocodone (for conversion)............................ 1,250
Hydrocodone (for sale).................................. 33,997,285
Hydromorphone........................................... 3,512,651
Isomethadone............................................ 30
Levo-alphacetylmethadol (LAAM).......................... 25
Levomethorphan.......................................... 30
Levorphanol............................................. 31,730
Lisdexamfetamine........................................ 21,000,000
Meperidine.............................................. 1,119,862
Meperidine Intermediate-A............................... 30
Meperidine Intermediate-B............................... 30
Meperidine Intermediate-C............................... 30
Metazocine.............................................. 15
Methadone (for sale).................................... 25,619,700
Methadone Intermediate.................................. 27,673,600
Methamphetamine......................................... 1,224,109
------------------------------------------------------------------------
[[Page 77249]]
[678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 505,231 grams for methamphetamine mostly for
conversion to a schedule III product; and 40,000 grams for
methamphetamine (for sale).]
------------------------------------------------------------------------
Methylphenidate......................................... 57,438,334
Metopon................................................. 25
Moramide-intermediate................................... 25
Morphine (for conversion)............................... 3,376,696
Morphine (for sale)..................................... 33,756,703
Nabilone................................................ 62,000
Norfentanyl............................................. 25
Noroxymorphone (for conversion)......................... 22,044,741
Noroxymorphone (for sale)............................... 376,000
Opium (powder).......................................... 250,000
Opium (tincture)........................................ 530,837
Oripavine............................................... 33,010,750
Oxycodone (for conversion).............................. 725,998
Oxycodone (for sale).................................... 65,667,554
Oxymorphone (for conversion)............................ 28,204,371
Oxymorphone (for sale).................................. 658,515
Pentobarbital........................................... 25,850,000
Phenazocine............................................. 25
Phencyclidine........................................... 35
Phenmetrazine........................................... 25
Phenylacetone........................................... 40
Piminodine.............................................. 25
Racemethorphan.......................................... 5
Racemorphan............................................. 5
Remifentanil............................................ 3,000
Secobarbital............................................ 172,100
Sufentanil.............................................. 4,000
Tapentadol.............................................. 13,447,541
Thebaine................................................ 59,284,070
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................. 100
Ephedrine (for sale).................................... 4,756,000
Phenylpropanolamine (for conversion).................... 14,100,000
Phenylpropanolamine (for sale).......................... 16,590,000
Pseudoephedrine (for conversion)........................ 1,000
Pseudoephedrine (for sale).............................. 200,382,900
------------------------------------------------------------------------
The Acting Administrator further proposes that APQ for all other
schedule I and II controlled substances included in 21 CFR 1308.11 and
1308.12 remain at zero.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-26443 Filed 11-30-20; 8:45 am]
BILLING CODE 4410-09-P
