Controlled Substances: Final Adjusted Aggregate Production Quotas for 2012, 55500-55503 [2012-22128]
Download as PDF
55500
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
copy from the Consent Decree Library
by mail, please enclose a check in the
amount of $3.75 ($.25 per page) payable
to the U.S. Treasury or, if by email or
fax, forward a check in that amount to
the Consent Decree Library at the
address given above.
Robert Brook,
Assistant Chief, Environmental Enforcement
Section, Environment and Natural Resources
Division.
[FR Doc. 2012–22121 Filed 9–7–12; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–363]
Controlled Substances: Final Adjusted
Aggregate Production Quotas for 2012
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice.
AGENCY:
This notice establishes final
adjusted 2012 aggregate production
quotas for controlled substances in
Schedules I and II of the Controlled
Substances Act (CSA).
FOR FURTHER INFORMATION CONTACT: John
W. Partridge, Chief, Liaison and Policy
Section, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
307–4654.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
Section 306(a) of the CSA (21 U.S.C.
826) requires that the Attorney General
establish aggregate production quotas
for each basic class of controlled
substance listed in Schedules I and II.
This responsibility has been delegated
to the Administrator of the DEA by 28
CFR 0.100. In accordance with 21 U.S.C.
826 and 21 CFR 1303.11, DEA
published in the Federal Register on
December 15, 2011, notice of the
established 2012 aggregate production
quotas for controlled substances in
Schedules I and II (76 FR 78044). That
notice stated that the Administrator
would adjust, as needed, the established
aggregate production quotas in 2012 as
provided for in 21 CFR 1303.13. The
2012 proposed adjusted aggregate
production quotas were subsequently
published in the Federal Register on
July 5, 2012 (77 FR 39737) in
consideration of the outlined criteria.
All interested persons were invited to
comment on or object to the proposed
adjusted aggregate production quotas on
or before August 6, 2012.
Analysis for Final Adjusted 2012
Aggregate Production Quotas
Consideration has been given to the
criteria outlined in the July 5, 2012,
notice of proposed adjusted aggregate
production quotas in accordance with
21 CFR 1303.13. In addition, nine
companies, eight DEA registered
manufacturers and one non-registrant,
submitted timely comments regarding a
total of 25 Schedule I and II controlled
substances. Comments received
proposed that the aggregate production
quotas for 3,4-Methylenedioxy-NMethylcathinone (methylone),
alfentanil, amphetamine (for
conversion), amphetamine (for sale),
codeine (for conversion), codeine (for
sale), desomorphine, dihydromorphine,
hydrocodone (for sale), hydromorphone,
levomethorphan, lisdexamfetamine,
methadone intermediate,
methylphenidate, morphine (for
conversion), morphine (for sale),
noroxymorphone (for conversion),
noroxymorphone (for sale), oripavine,
oxycodone (for conversion), oxycodone
(for sale), oxymorphone (for
conversion), oxymorphone (for sale),
sufentanil, and tapentadol were
insufficient 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 has taken into consideration the
above comments along with the relevant
2011 year-end inventories, initial 2012
manufacturing quotas, 2012 export
requirements, actual and projected 2012
sales, research and product
development requirements, and
additional applications received. Based
on all of the above, the Administrator
has determined that the proposed
adjusted 2012 aggregate production
quotas for 3,4Methylenedioxypyrovalerone (MDPV),
3,4-Methylenedioxy-N-Methylcathinone
(methylone), 4-Methyl-NMethylcathinone (mephedrone),
alfentanil, amphetamine (for
conversion), desomorphine,
diethyltryptamine, dihydromorphine,
gamma hydroxybutyric acid,
hydrocodone (for sale), hydromorphone,
levomethorphan, methadone,
methadone intermediate,
methylphenidate, morphine (for sale),
oxycodone (for conversion), oxycodone
(for sale), and sufentanil required
additional consideration and hereby
further adjusts the 2012 aggregate
production quotas for those substances.
Regarding amphetamine (for sale),
codeine (for conversion), codeine (for
sale), morphine (for conversion),
noroxymorphone (for conversion),
noroxymorphone (for sale), oripavine,
oxymorphone (for conversion),
oxymorphone (for sale), and tapentadol,
the Administrator hereby determines
that the proposed adjusted 2012
aggregate production quotas for these
substances as published on July 5, 2012,
at 77 FR 39737 are sufficient to meet the
current 2012 estimated medical,
scientific, research, and industrial needs
of the United States and to provide for
adequate inventories. Pursuant to the
above, the Administrator hereby
establishes the 2012 final aggregate
production quotas for Schedule I and II
controlled substances, expressed in
grams of anhydrous acid or base, as
follows:
Final adjusted
2012 quotas
mstockstill on DSK4VPTVN1PROD with NOTICES
Basic Class—Schedule I
1-[1-(2-Thienyl)cyclohexyl]piperidine .............................................................................................................................................
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ........................................................................................................
1-Butyl-3-(1-naphthoyl)indole (JWH–073) .....................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine .....................................................................................................................................
1-Pentyl-3-(1-naphthoyl)indole (JWH–018) ...................................................................................................................................
2,5-Dimethoxyamphetamine ..........................................................................................................................................................
2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................
2,5-Dimethoxy-4-n-propylthiophenethylamine ...............................................................................................................................
3-Methylfentanyl .............................................................................................................................................................................
3-Methylthiofentanyl .......................................................................................................................................................................
3,4-Methylenedioxyamphetamine (MDA) ......................................................................................................................................
VerDate Mar<15>2010
16:57 Sep 07, 2012
Jkt 226001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
E:\FR\FM\10SEN1.SGM
10SEN1
5
45
45
2
45
12
12
12
2
2
30
g
g
g
g
g
g
g
g
g
g
g
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
55501
mstockstill on DSK4VPTVN1PROD with NOTICES
Final adjusted
2012 quotas
3,4-Methylenedioxy-N-methylcathinone (methylone) ....................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) .......................................................................................................................
3,4-Methylenedioxymethamphetamine (MDMA) ...........................................................................................................................
3,4-Methylenedioxypyrovalerone (MDPV) .....................................................................................................................................
3,4,5-Trimethoxyamphetamine ......................................................................................................................................................
4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ...........................................................................................................................
4-Methoxyamphetamine ................................................................................................................................................................
4-Methylaminorex ..........................................................................................................................................................................
4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................
4-Methyl-N-methylcathinone (mephedrone) ..................................................................................................................................
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ...................................................................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol .....................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................
Acetyl-alpha-methylfentanyl ...........................................................................................................................................................
Acetyldihydrocodeine .....................................................................................................................................................................
Acetylmethadol ..............................................................................................................................................................................
Allylprodine ....................................................................................................................................................................................
Alphacetylmethadol ........................................................................................................................................................................
Alpha-ethyltryptamine ....................................................................................................................................................................
Alphameprodine .............................................................................................................................................................................
Alphamethadol ...............................................................................................................................................................................
Alpha-methylfentanyl .....................................................................................................................................................................
Alpha-methylthiofentanyl ................................................................................................................................................................
Alpha-methyltryptamine (AMT) ......................................................................................................................................................
Aminorex ........................................................................................................................................................................................
Benzylmorphine .............................................................................................................................................................................
Betacetylmethadol .........................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ......................................................................................................................................................
Beta-hydroxyfentanyl .....................................................................................................................................................................
Betameprodine ...............................................................................................................................................................................
Betamethadol .................................................................................................................................................................................
Betaprodine ....................................................................................................................................................................................
Bufotenine ......................................................................................................................................................................................
Cathinone .......................................................................................................................................................................................
Codeine-N-oxide ............................................................................................................................................................................
Desomorphine ................................................................................................................................................................................
Diethyltryptamine ...........................................................................................................................................................................
Difenoxin ........................................................................................................................................................................................
Dihydromorphine ............................................................................................................................................................................
Dimethyltryptamine ........................................................................................................................................................................
Gamma-hydroxybutyric acid ..........................................................................................................................................................
Heroin ............................................................................................................................................................................................
Hydromorphinol ..............................................................................................................................................................................
Hydroxypethidine ...........................................................................................................................................................................
Ibogaine .........................................................................................................................................................................................
Lysergic acid diethylamide (LSD) ..................................................................................................................................................
Marihuana ......................................................................................................................................................................................
Mescaline .......................................................................................................................................................................................
Methaqualone ................................................................................................................................................................................
Methcathinone ...............................................................................................................................................................................
Methyldihydromorphine ..................................................................................................................................................................
Morphine-N-oxide ..........................................................................................................................................................................
N-Benzylpiperazine ........................................................................................................................................................................
N,N-Dimethylamphetamine ............................................................................................................................................................
N-Ethylamphetamine .....................................................................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ................................................................................................................................
Noracymethadol .............................................................................................................................................................................
Norlevorphanol ...............................................................................................................................................................................
Normethadone ...............................................................................................................................................................................
Normorphine ..................................................................................................................................................................................
Para-fluorofentanyl .........................................................................................................................................................................
Phenomorphan ..............................................................................................................................................................................
Pholcodine .....................................................................................................................................................................................
Properidine .....................................................................................................................................................................................
Psilocybin .......................................................................................................................................................................................
Psilocyn ..........................................................................................................................................................................................
Tetrahydrocannabinols ..................................................................................................................................................................
Thiofentanyl ...................................................................................................................................................................................
Tilidine ............................................................................................................................................................................................
Trimeperidine .................................................................................................................................................................................
VerDate Mar<15>2010
16:57 Sep 07, 2012
Jkt 226001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\10SEN1.SGM
10SEN1
30
24
30
20
12
12
12
88
12
12
25
68
53
12
12
2
2
2
2
2
12
2
2
2
2
12
12
2
2
2
2
2
2
2
3
12
602
10
18
50
3,750,000
18
37,000,000
20
54
2
5
16
21,000
13
10
12
2
655
12
12
12
12
2
52
2
18
2
2
2
2
2
2
393,000
2
10
2
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
55502
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
Final adjusted
2012 quotas
Basic Class—Schedule II
1-Phenylcyclohexylamine ..............................................................................................................................................................
1-Piperdinocyclohexanecarbonitrile ...............................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) ...................................................................................................................................
Alfentanil ........................................................................................................................................................................................
Alphaprodine ..................................................................................................................................................................................
Amobarbital ....................................................................................................................................................................................
Amphetamine (for conversion) ......................................................................................................................................................
Amphetamine (for sale) .................................................................................................................................................................
Carfentanil ......................................................................................................................................................................................
Cocaine ..........................................................................................................................................................................................
Codeine (for conversion) ...............................................................................................................................................................
Codeine (for sale) ..........................................................................................................................................................................
Dextropropoxyphene ......................................................................................................................................................................
Dihydrocodeine ..............................................................................................................................................................................
Diphenoxylate ................................................................................................................................................................................
Ecgonine ........................................................................................................................................................................................
Ethylmorphine ................................................................................................................................................................................
Fentanyl .........................................................................................................................................................................................
Glutethimide ...................................................................................................................................................................................
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 .........................................................................................................................................................................
2
27
1,800,000
29,002
2
40,007
13,300,000
33,400,000
5
216,000
65,000,000
39,605,000
7
400,000
900,000
83,000
2
1,428,000
2
79,700,000
4,207,000
4
3
10
3,600
12,000,000
5,500,000
5
9
5
5
23,100,000
29,970,000
3,130,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,331,000 grams for methamphetamine mostly
for conversion to a schedule III product; and 49,000 grams for methamphetamine (for sale)]
mstockstill on DSK4VPTVN1PROD with NOTICES
Methylphenidate .............................................................................................................................................................................
Morphine (for conversion) ..............................................................................................................................................................
Morphine (for sale) ........................................................................................................................................................................
Nabilone .........................................................................................................................................................................................
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 ...............................................................................................................................................................................
Racemethorphan ...........................................................................................................................................................................
Remifentanil ...................................................................................................................................................................................
Secobarbital ...................................................................................................................................................................................
Sufentanil .......................................................................................................................................................................................
Tapentadol .....................................................................................................................................................................................
Thebaine ........................................................................................................................................................................................
VerDate Mar<15>2010
16:57 Sep 07, 2012
Jkt 226001
PO 00000
Frm 00052
Fmt 4703
Sfmt 9990
E:\FR\FM\10SEN1.SGM
10SEN1
64,600,000
83,000,000
48,200,000
20,502
7,200,000
1,981,000
73,000
1,000,000
15,300,000
7,600,000
105,200,000
12,800,000
5,500,000
34,000,000
5
24
2
16,000,000
2
2,500
336,002
6,730
5,400,000
116,000,000
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
g
55503
Federal Register / Vol. 77, No. 175 / Monday, September 10, 2012 / Notices
Aggregate production quotas for all
other Schedule I and II controlled
substances included in 21 CFR 1308.11
and 1308.12 remain at zero.
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–22128 Filed 9–7–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA 353]
Final Adjusted Assessment of Annual
Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2012
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Notice.
AGENCY:
This notice establishes the
Final Adjusted 2012 Assessment of
Annual Needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
DATES:
Effective Date: September 10,
2012.
John
W. Partridge, Chief, Liaison and Policy
Section, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone: (202)
307–4654.
SUPPLEMENTARY INFORMATION: The 2012
Assessment of Annual Needs represents
those quantities of ephedrine,
pseudoephedrine, and
phenylpropanolamine which may be
manufactured domestically and
imported into the United States in 2012
to provide adequate supplies of each
chemical for the estimated medical,
scientific, research, and industrial needs
of the United States, lawful export
requirements, and the establishment
and maintenance of reserve stocks of
such chemicals. Section 306 of the
Controlled Substances Act (CSA) (21
U.S.C. 826) requires that the Attorney
General establish an assessment of
annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine. This
responsibility has been delegated to the
Administrator of the DEA by 28 CFR
0.100.
On July 18, 2012, a notice entitled
‘‘Proposed Adjustment of the
Assessment of Annual Needs for the List
I Chemicals Ephedrine,
Pseudoephedrine, and
mstockstill on DSK4VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Mar<15>2010
16:57 Sep 07, 2012
Jkt 226001
Phenylpropanolamine for 2012’’ was
published in the Federal Register (77
FR 42333). That notice proposed to
adjust the 2012 Assessment of Annual
Needs for ephedrine (for sale),
ephedrine (for conversion),
pseudoephedrine (for sale),
phenylpropanolamine (for sale) and
phenylpropanolamine (for conversion).
All interested persons were invited to
comment on or object to the proposed
assessments on or before August 17,
2012.
Comments Received
DEA did not receive any comments to
the proposed adjustment of the
assessment of annual needs for
ephedrine (for sale), ephedrine (for
conversion), pseudoephedrine (for sale),
phenylpropanolamine (for sale), and
phenylpropanolamine (for conversion).
Conclusion
In determining the adjusted 2012
assessments, DEA used the calculation
methodology previously described in
the 2010 and 2011 assessment of annual
needs (74 FR 60294 and 75 FR 79407
respectively). DEA considered changes
in demand, changes in the national rate
of net disposal, and changes in the rate
of net disposal by the registrants
holding individual manufacturing or
import quotas for the chemical; whether
any increased demand or changes in the
national and/or individual rates of net
disposal are temporary, short term, or
long term; whether any increased
demand could be met through existing
inventories, increased individual
manufacturing quotas, or increased
importation without increasing the
assessment of annual needs; whether
any decreased demand would result in
excessive inventory accumulation by all
persons registered to handle the
particular chemical; and other factors
affecting the medical, scientific,
research, industrial, and importation
needs in the United States, lawful
export requirements, and reserve stocks,
as found relevant.
Other factors that DEA considered
include trends as derived from
information provided in applications for
import, manufacturing, and
procurement quotas and in import and
export declarations. The inventory,
acquisition (purchases), and disposition
(sales) data as provided by DEAregistered manufacturers and importers
reflects the most current information
available to DEA at the time of
publication of this Notice. The
underlying data used to determine the
final 2012 assessment of annual needs is
the same as that used in determining the
proposed 2012 assessment of annual
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
needs, as published on September 14,
2011, at 76 FR 56809.
In accordance with 21 U.S.C. 826(a)
and 21 CFR 1315.13, the Administrator
hereby orders that the 2012 assessment
of annual needs for ephedrine,
pseudoephedrine, and
phenylpropanolamine, expressed in
kilograms of anhydrous acid or base, is
adjusted and established as follows:
List I chemical
Final 2012
assessment of
annual needs
(kg)
Ephedrine (for sale) ..............
Phenylpropanolamine (for
sale) ..................................
Pseudoephedrine (for sale) ..
Phenylpropanolamine (for
conversion) ........................
Ephedrine (for conversion) ...
4,300
5,800
278,000
26,200
12,000
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012–22127 Filed 9–7–12; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances;
Notice of Registration; Cambrex
Charles City, Inc.
By Notice dated June 18, 2012, and
published in the Federal Register on
June 26, 2012, 77 FR 38085, Cambrex
Charles City, Inc., 1205 11th Street,
Charles City, Iowa 50616–3466, made
application by renewal to the Drug
Enforcement Administration (DEA) to
be registered as an importer of the
following basic classes of controlled
substances:
Drug
4-Anilino-N-phenethyl-4-piperidine
(8333).
Phenylacetone (8501) ..................
Opium, raw (9600) .......................
Poppy Straw Concentrate (9670)
Schedule
II
II
II
II
The company plans to import the
listed controlled substances for internal
use, and to manufacture bulk
intermediates for sale to its customers.
No comments or objections have been
received. Comments and requests for
hearings on applications to import
narcotic raw material are not
appropriate. 72 FR 3417 (2007).
DEA has considered the factors in 21
U.S.C. 823(a) and 952(a), and
determined that the registration of
Cambrex Charles City, Inc. to import the
E:\FR\FM\10SEN1.SGM
10SEN1
Agencies
[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55500-55503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22128]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-363]
Controlled Substances: Final Adjusted Aggregate Production Quotas
for 2012
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice establishes final adjusted 2012 aggregate
production quotas for controlled substances in Schedules I and II of
the Controlled Substances Act (CSA).
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and
Policy Section, Drug Enforcement Administration, 8701 Morrissette
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION:
Background
Section 306(a) of the CSA (21 U.S.C. 826) requires that the
Attorney General establish aggregate production quotas for each basic
class of controlled substance listed in Schedules I and II. This
responsibility has been delegated to the Administrator of the DEA by 28
CFR 0.100. In accordance with 21 U.S.C. 826 and 21 CFR 1303.11, DEA
published in the Federal Register on December 15, 2011, notice of the
established 2012 aggregate production quotas for controlled substances
in Schedules I and II (76 FR 78044). That notice stated that the
Administrator would adjust, as needed, the established aggregate
production quotas in 2012 as provided for in 21 CFR 1303.13. The 2012
proposed adjusted aggregate production quotas were subsequently
published in the Federal Register on July 5, 2012 (77 FR 39737) in
consideration of the outlined criteria. All interested persons were
invited to comment on or object to the proposed adjusted aggregate
production quotas on or before August 6, 2012.
Analysis for Final Adjusted 2012 Aggregate Production Quotas
Consideration has been given to the criteria outlined in the July
5, 2012, notice of proposed adjusted aggregate production quotas in
accordance with 21 CFR 1303.13. In addition, nine companies, eight DEA
registered manufacturers and one non-registrant, submitted timely
comments regarding a total of 25 Schedule I and II controlled
substances. Comments received proposed that the aggregate production
quotas for 3,4-Methylenedioxy-N-Methylcathinone (methylone),
alfentanil, amphetamine (for conversion), amphetamine (for sale),
codeine (for conversion), codeine (for sale), desomorphine,
dihydromorphine, hydrocodone (for sale), hydromorphone, levomethorphan,
lisdexamfetamine, methadone intermediate, methylphenidate, morphine
(for conversion), morphine (for sale), noroxymorphone (for conversion),
noroxymorphone (for sale), oripavine, oxycodone (for conversion),
oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for
sale), sufentanil, and tapentadol were insufficient 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 has taken into consideration the above comments along with the
relevant 2011 year-end inventories, initial 2012 manufacturing quotas,
2012 export requirements, actual and projected 2012 sales, research and
product development requirements, and additional applications received.
Based on all of the above, the Administrator has determined that the
proposed adjusted 2012 aggregate production quotas for 3,4-
Methylenedioxypyrovalerone (MDPV), 3,4-Methylenedioxy-N-Methylcathinone
(methylone), 4-Methyl-N-Methylcathinone (mephedrone), alfentanil,
amphetamine (for conversion), desomorphine, diethyltryptamine,
dihydromorphine, gamma hydroxybutyric acid, hydrocodone (for sale),
hydromorphone, levomethorphan, methadone, methadone intermediate,
methylphenidate, morphine (for sale), oxycodone (for conversion),
oxycodone (for sale), and sufentanil required additional consideration
and hereby further adjusts the 2012 aggregate production quotas for
those substances. Regarding amphetamine (for sale), codeine (for
conversion), codeine (for sale), morphine (for conversion),
noroxymorphone (for conversion), noroxymorphone (for sale), oripavine,
oxymorphone (for conversion), oxymorphone (for sale), and tapentadol,
the Administrator hereby determines that the proposed adjusted 2012
aggregate production quotas for these substances as published on July
5, 2012, at 77 FR 39737 are sufficient to meet the current 2012
estimated medical, scientific, research, and industrial needs of the
United States and to provide for adequate inventories. Pursuant to the
above, the Administrator hereby establishes the 2012 final aggregate
production quotas for Schedule I and II controlled substances,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Final adjusted
2012 quotas
------------------------------------------------------------------------
Basic Class--Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]piperidine................ 5 g
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 45 g
200)................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073).............. 45 g
1-Methyl-4-phenyl-4-propionoxypiperidine............. 2 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018)............. 45 g
2,5-Dimethoxyamphetamine............................. 12 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 12 g
2,5-Dimethoxy-4-n-propylthiophenethylamine........... 12 g
3-Methylfentanyl..................................... 2 g
3-Methylthiofentanyl................................. 2 g
3,4-Methylenedioxyamphetamine (MDA).................. 30 g
[[Page 55501]]
3,4-Methylenedioxy-N-methylcathinone (methylone)..... 30 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 24 g
3,4-Methylenedioxymethamphetamine (MDMA)............. 30 g
3,4-Methylenedioxypyrovalerone (MDPV)................ 20 g
3,4,5-Trimethoxyamphetamine.......................... 12 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)............... 12 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........... 12 g
4-Methoxyamphetamine................................. 88 g
4-Methylaminorex..................................... 12 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).............. 12 g
4-Methyl-N-methylcathinone (mephedrone).............. 25 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 68 g
hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 53 g
phenol..............................................
5-Methoxy-3,4-methylenedioxyamphetamine.............. 12 g
5-Methoxy-N,N-diisopropyltryptamine.................. 12 g
Acetyl-alpha-methylfentanyl.......................... 2 g
Acetyldihydrocodeine................................. 2 g
Acetylmethadol....................................... 2 g
Allylprodine......................................... 2 g
Alphacetylmethadol................................... 2 g
Alpha-ethyltryptamine................................ 12 g
Alphameprodine....................................... 2 g
Alphamethadol........................................ 2 g
Alpha-methylfentanyl................................. 2 g
Alpha-methylthiofentanyl............................. 2 g
Alpha-methyltryptamine (AMT)......................... 12 g
Aminorex............................................. 12 g
Benzylmorphine....................................... 2 g
Betacetylmethadol.................................... 2 g
Beta-hydroxy-3-methylfentanyl........................ 2 g
Beta-hydroxyfentanyl................................. 2 g
Betameprodine........................................ 2 g
Betamethadol......................................... 2 g
Betaprodine.......................................... 2 g
Bufotenine........................................... 3 g
Cathinone............................................ 12 g
Codeine-N-oxide...................................... 602 g
Desomorphine......................................... 10 g
Diethyltryptamine.................................... 18 g
Difenoxin............................................ 50 g
Dihydromorphine...................................... 3,750,000 g
Dimethyltryptamine................................... 18 g
Gamma-hydroxybutyric acid............................ 37,000,000 g
Heroin............................................... 20 g
Hydromorphinol....................................... 54 g
Hydroxypethidine..................................... 2 g
Ibogaine............................................. 5 g
Lysergic acid diethylamide (LSD)..................... 16 g
Marihuana............................................ 21,000 g
Mescaline............................................ 13 g
Methaqualone......................................... 10 g
Methcathinone........................................ 12 g
Methyldihydromorphine................................ 2 g
Morphine-N-oxide..................................... 655 g
N-Benzylpiperazine................................... 12 g
N,N-Dimethylamphetamine.............................. 12 g
N-Ethylamphetamine................................... 12 g
N-Hydroxy-3,4-methylenedioxyamphetamine.............. 12 g
Noracymethadol....................................... 2 g
Norlevorphanol....................................... 52 g
Normethadone......................................... 2 g
Normorphine.......................................... 18 g
Para-fluorofentanyl.................................. 2 g
Phenomorphan......................................... 2 g
Pholcodine........................................... 2 g
Properidine.......................................... 2 g
Psilocybin........................................... 2 g
Psilocyn............................................. 2 g
Tetrahydrocannabinols................................ 393,000 g
Thiofentanyl......................................... 2 g
Tilidine............................................. 10 g
Trimeperidine........................................ 2 g
------------------------------------------------------------------------
[[Page 55502]]
Basic Class--Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.............................. 2 g
1-Piperdinocyclohexanecarbonitrile................... 27 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 1,800,000 g
Alfentanil........................................... 29,002 g
Alphaprodine......................................... 2 g
Amobarbital.......................................... 40,007 g
Amphetamine (for conversion)......................... 13,300,000 g
Amphetamine (for sale)............................... 33,400,000 g
Carfentanil.......................................... 5 g
Cocaine.............................................. 216,000 g
Codeine (for conversion)............................. 65,000,000 g
Codeine (for sale)................................... 39,605,000 g
Dextropropoxyphene................................... 7 g
Dihydrocodeine....................................... 400,000 g
Diphenoxylate........................................ 900,000 g
Ecgonine............................................. 83,000 g
Ethylmorphine........................................ 2 g
Fentanyl............................................. 1,428,000 g
Glutethimide......................................... 2 g
Hydrocodone (for sale)............................... 79,700,000 g
Hydromorphone........................................ 4,207,000 g
Isomethadone......................................... 4 g
Levo-alphacetylmethadol (LAAM)....................... 3 g
Levomethorphan....................................... 10 g
Levorphanol.......................................... 3,600 g
Lisdexamfetamine..................................... 12,000,000 g
Meperidine........................................... 5,500,000 g
Meperidine Intermediate-A............................ 5 g
Meperidine Intermediate-B............................ 9 g
Meperidine Intermediate-C............................ 5 g
Metazocine........................................... 5 g
Methadone (for sale)................................. 23,100,000 g
Methadone Intermediate............................... 29,970,000 g
Methamphetamine...................................... 3,130,000 g
------------------------------------------------------------------------
[750,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,331,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 49,000 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate...................................... 64,600,000 g
Morphine (for conversion)............................ 83,000,000 g
Morphine (for sale).................................. 48,200,000 g
Nabilone............................................. 20,502 g
Noroxymorphone (for conversion)...................... 7,200,000 g
Noroxymorphone (for sale)............................ 1,981,000 g
Opium (powder)....................................... 73,000 g
Opium (tincture)..................................... 1,000,000 g
Oripavine............................................ 15,300,000 g
Oxycodone (for conversion)........................... 7,600,000 g
Oxycodone (for sale)................................. 105,200,000 g
Oxymorphone (for conversion)......................... 12,800,000 g
Oxymorphone (for sale)............................... 5,500,000 g
Pentobarbital........................................ 34,000,000 g
Phenazocine.......................................... 5 g
Phencyclidine........................................ 24 g
Phenmetrazine........................................ 2 g
Phenylacetone........................................ 16,000,000 g
Racemethorphan....................................... 2 g
Remifentanil......................................... 2,500 g
Secobarbital......................................... 336,002 g
Sufentanil........................................... 6,730 g
Tapentadol........................................... 5,400,000 g
Thebaine............................................. 116,000,000 g
------------------------------------------------------------------------
[[Page 55503]]
Aggregate production quotas for all other Schedule I and II
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at
zero.
Dated: August 31, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-22128 Filed 9-7-12; 8:45 am]
BILLING CODE 4410-09-P