Quotas - 2012
[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Notices]
[Pages 59980-59983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24089]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-365]
Established Aggregate Production Quotas for Schedule I and II
Controlled Substances and Established Assessment of Annual Needs for
the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2013
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Notice.
SUMMARY: This notice establishes the initial 2013 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA) and assessment of annual needs for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
DATES: Effective Date: October 1, 2012.
FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive
Assistant, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152,
Telephone: (202) 307-4654.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826)
requires the Attorney General to establish aggregate production quotas
for each basic class of controlled substance listed in schedules I and
II and for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. This responsibility has been delegated to the
Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn,
has redelegated this function to the Deputy Administrator pursuant to
28 CFR 0.104.
The 2013 aggregate production quotas and assessment of annual needs
represent those quantities of schedule I and II controlled substances
and the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine to be manufactured in the United States in 2013 to
provide for the estimated medical, scientific, research, and industrial
needs of the United States, lawful export requirements, and the
establishment and maintenance of reserve stocks. These quotas include
imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do
not include imports of controlled substances for use in industrial
processes.
On August 3, 2012, a notice titled, ``Proposed Aggregate Production
Quotas for Schedule I and II Controlled Substances and Proposed
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2013,'' was published in
the Federal Register (77 FR 46519). That notice proposed the 2013
aggregate production quotas for each basic class of controlled
substance listed in schedules I and II and the 2013 assessment of
annual needs for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. All interested persons were invited to comment on
or object to the proposed aggregate production quotas and the proposed
assessment of annual needs on or before September 4, 2012.
Five comments (four from DEA-registered manufacturers and one from
a non-registrant) were received within the published comment period,
offering comments on a total of 20 schedule I and II controlled
substances and one list I chemical. Commenters stated that the proposed
aggregate production quotas for amphetamine (for conversion),
amphetamine (for sale), codeine (for conversion), codeine (for sale),
gamma hydroxybutyric acid, hydrocodone (for sale), hydromorphone,
lisdexamfetamine, meperidine, methamphetamine, methylphenidate,
morphine (for conversion), morphine (for sale), noroxymorphone (for
conversion), oripavine, oxycodone (for sale), oxymorphone (for
conversion), oxymorphone (for sale), remifentanil, and sufentanil were
insufficient to provide for the estimated medical, scientific,
research, and industrial needs of the United States, export
requirements, and the establishment and maintenance of reserve stocks.
One commenter stated that the proposed assessment of annual needs quota
for phenylpropanolamine (for conversion) was insufficient to provide
for the estimated medical, scientific, research, and industrial needs
of the United States, export requirements, and the establishment and
maintenance of reserve stocks.
In determining the 2013 aggregate production quotas and assessment
of annual needs, DEA has taken into consideration the above comments
along with the factors set forth at 21 CFR 1303.11 and 21 CFR 1315.11,
in accordance with 21 U.S.C. 826(a), and other relevant factors,
including the consideration of 2012 manufacturing quotas, current 2012
sales and inventories, 2013 export requirements, industrial use,
additional applications for quotas, as well as information on research
and product development requirements. Based on this information, DEA
has determined that adjustments to the proposed aggregate production
quotas and assessment of annual needs for 3,4-methylenedioxy-N-
methylcathinone (methylone), 3,4,methylenedioxypyrovalerone (MDPV), 4-
methyl-N-methylcathinone (mephedrone), N-benzylpiperazine, amphetamine
(for conversion), amphetamine (for sale), hydrocodone (for sale),
hydromorphone, lisdexamfetamine, methylphenidate, morphine (for sale),
oxycodone (for sale), oxymorphone (for conversion), remifentanil,
sufentanil, tapentadol, ephedrine (for conversion), ephedrine (for
sale), phenylpropanolamine (for sale), and pseudoephedrine (for sale)
are warranted. This notice reflects those adjustments.
Regarding codeine (for conversion), codeine (for sale), gamma
hydroxybutyric acid, meperidine, methamphetamine, morphine (for
conversion), noroxymorphone (for conversion), oripavine, oxymorphone
(for sale), and phenylpropanolamine (for conversion), DEA has
determined that the proposed initial 2013 aggregate production quotas
and assessment of annual needs are sufficient to meet the current 2013
estimated medical, scientific, research, and industrial needs of the
United States. This notice finalizes these aggregate production quotas
at the same amounts as proposed.
DEA also specifically considered that inventory allowances granted
to individual manufacturers may not always result in the availability
of sufficient quantities to maintain an adequate reserve stock pursuant
to 21 U.S.C. 826(a), as intended. See 21 CFR 1303.24. This would be
concerning if a natural disaster or other unforeseen event resulted in
substantial disruption to the amount of controlled substances available
to provide for legitimate public need. As such, DEA included in all
schedule II aggregate production quotas, and certain schedule I
aggregate production quotas, an additional 25% of the estimated
medical, scientific, and research needs as part of the amount necessary
to ensure the establishment and maintenance of reserve stocks. The
established aggregate production quotas reflect these included amounts.
This action will not affect the ability of manufacturers to maintain
inventory allowances as specified by regulation. DEA expects that
maintaining this reserve in certain established aggregate production
quotas will mitigate adverse public effects if an unforeseen event
resulted in substantial disruption to the amount of controlled
substances available to provide for legitimate
[[Page 59981]]
public need, as determined by DEA. DEA does not anticipate utilizing
the reserve in the absence of these circumstances.
In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR
1315.11, the Deputy Administrator hereby establishes the 2013 aggregate
production quotas for the following schedule I and II controlled
substances and the 2013 assessment of annual needs for the list I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
| Basic class—Schedule I |
Established
2013 quotas |
| 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) |
45 g |
| 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) |
45 g |
| 1-[1-(2-Thienyl)cyclohexyl]piperidine |
5 g |
| 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) |
45 g |
| 1-Butyl-3-(1-naphthoyl)indole (JWH–073) |
45 g |
| 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) |
45 g |
| 1-Hexyl-3-(1-naphthoyl)indole (JWH–019) |
45 g |
| 1-Methyl-4-phenyl-4-propionoxypiperidine |
2 g |
| 1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) |
45 g |
| 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) |
45 g |
| 1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) |
45 g |
| 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) |
45 g |
| 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) |
45 g |
| 1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) |
45 g |
| 1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) |
45 g |
| 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P) |
15 g |
| 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) |
15 g |
| 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) |
15 g |
| 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) |
15 g |
| 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) |
15 g |
| 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) |
15 g |
| 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) |
15 g |
| 2,5-Dimethoxy-4-ethylamphetamine (DOET) |
12 g |
| 2,5-Dimethoxy-4-n-propylthiophenethylamine |
12 g |
| 2,5-Dimethoxyamphetamine |
12 g |
| 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) |
15 g |
| 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) |
15 g |
| 3,4,5-Trimethoxyamphetamine |
12 g |
| 3,4-Methylenedioxyamphetamine (MDA) |
30 g |
| 3,4-Methylenedioxymethamphetamine (MDMA) |
35 g |
| 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) |
24 g |
| 3,4-Methylenedioxy-N-methylcathinone (methylone) |
35 g |
| 3,4-Methylenedioxypyrovalerone (MDPV) |
25 g |
| 3-Methylfentanyl |
2 g |
| 3-Methylthiofentanyl |
2 g |
| 4-Bromo-2,5-dimethoxyamphetamine (DOB) |
12 g |
| 4-Bromo-2,5-dimethoxyphenethylamine (2–CB) |
12 g |
| 4-Methoxyamphetamine |
88 g |
| 4-Methyl-2,5-dimethoxyamphetamine (DOM) |
12 g |
| 4-Methylaminorex |
12 g |
| 4-Methyl-N-methylcathinone (mephedrone) |
25 g |
| 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol |
68 g |
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol
or CP–47, 497 C8-homolog) |
53 g |
| 5-Methoxy-3,4-methylenedioxyamphetamine |
12 g |
| 5-Methoxy-N,N-diisopropyltryptamine |
12 g |
| 5-Methoxy-N,N-dimethyltryptamine |
10 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 |
5 g |
| Diethyltryptamine |
12 g |
| Difenoxin |
50 g |
| Dihydromorphine |
3,300,000 g |
| Dimethyltryptamine |
18 g |
| Gamma-hydroxybutyric acid |
46,250,000 g |
| Heroin |
25 g |
| Hydromorphinol |
54 g |
| Hydroxypethidine |
2 g |
| Ibogaine |
5 g |
| Lysergic acid diethylamide (LSD) |
30 g |
| Marihuana |
21,000 g |
| Mescaline |
13 g |
| Methaqualone |
10 g |
| Methcathinone |
14 g |
| Methyldihydromorphine |
2 g |
| Morphine-N-oxide |
655 g |
| N,N-Dimethylamphetamine |
12 g |
| N-Benzylpiperazine |
15 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 |
4 g |
| Tetrahydrocannabinols |
491,000 g |
| Thiofentanyl |
2 g |
| Tilidine |
10 g |
| Trimeperidine |
2 g |
| Basic class—Schedule II |
Established
2013 quotas |
| 1-Phenylcyclohexylamine |
3 g |
| 1-Piperdinocyclohexanecarbonitrile |
21 g |
| 4-Anilino-N-phenethyl-4-piperidine (ANPP) |
2,250,000 g |
| Alfentanil |
38,250 g |
| Alphaprodine |
3 g |
| Amobarbital |
9 g |
| Amphetamine (for conversion) |
22,875,000 g |
| Amphetamine (for sale) |
42,625,000 g |
| Carfentanil |
6 g |
| Cocaine |
240,000 g |
| Codeine (for conversion) |
81,250,000 g |
| Codeine (for sale) |
49,506,250 g |
| Dextropropoxyphene |
19 g |
| Dihydrocodeine |
250,000 g |
| Diphenoxylate |
750,000 g |
| Ecgonine |
127,500 g |
| Ethylmorphine |
3 g |
| Fentanyl |
2,108,750 g |
| Glutethimide |
3 g |
| Hydrocodone (for sale) |
99,625,000 g |
| Hydromorphone |
5,968,750 g |
| Isomethadone |
5 g |
| Levo-alphacetylmethadol (LAAM) |
4 g |
| Levomethorphan |
6 g |
| Levorphanol |
4,500 g |
| Lisdexamfetamine |
21,000,000 g |
| Meperidine |
6,875,000 g |
| Meperidine Intermediate-A |
6 g |
| Meperidine Intermediate-B |
11 g |
| Meperidine Intermediate-C |
6 g |
| Metazocine |
6 g |
| Methadone (for sale) |
25,000,000 g |
| Methadone Intermediate |
32,500,000 g |
| Methamphetamine |
3,912,500 g |
| [987,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,863,750 grams for methamphetamine mostly for conversion to a schedule III product; and 61,250 grams for methamphetamine (for sale)]. |
| Methylphenidate |
80,750,000 g |
| Morphine (for conversion) |
103,750,000 g |
| Morphine (for sale) |
60,250,000 g |
| Nabilone |
25,628 g |
| Noroxymorphone (for conversion) |
9,000,000 g |
| Noroxymorphone (for sale) |
508,750 g |
| Opium (powder) |
91,250 g |
| Opium (tincture) |
1,287,500 g |
| Oripavine |
22,750,000 g |
| Oxycodone (for conversion) |
10,250,000 g |
| Oxycodone (for sale) |
131,500,000 g |
| Oxymorphone (for conversion) |
18,375,000 g |
| Oxymorphone (for sale) |
6,875,000 g |
| Pentobarbital |
42,500,000 g |
| Phenazocine |
6 g |
| Phencyclidine |
30 g |
| Phenmetrazine |
3 g |
| Phenylacetone |
20,000,000 g |
| Racemethorphan |
3 g |
| Remifentanil |
3,750 g |
| Secobarbital |
215,003 g |
| Sufentanil |
6,255 g |
| Tapentadol |
13,750,000 g |
| Thebaine |
145,000,000 g |
| List I Chemicals |
Established
2013 quotas |
| Ephedrine (for conversion) |
15,100,000 g |
| Ephedrine (for sale) |
3,500,000 g |
| Phenylpropanolamine (for conversion) |
25,700,000 g |
| Phenylpropanolamine (for sale) |
6,100,000 g |
| Pseudoephedrine (for sale) |
225,000,000 g |
The Deputy Administrator also establishes aggregate production
quotas for all other schedule I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 at zero. Pursuant to 21 CFR 1303.13 and
21 CFR 1315.13, upon consideration of the relevant factors, the Deputy
Administrator may adjust the 2013 aggregate production quotas and
assessment of annual needs as needed.
Dated: September 25, 2012.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2012-24089 Filed 9-28-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
