[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48193-48197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19046]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-365]


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 2013

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice.

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SUMMARY: This notice establishes final adjusted 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, as well as the 2013 aggregate production quotas 
for three recently temporarily controlled substances.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION:

Background

    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 ephedrine, 
pseudoephedrine, and phenylpropanolamine. This responsibility has been 
delegated to the Administrator of the DEA through 28 CFR 0.100. The 
Administrator, in turn, has redelegated this function to the Deputy 
Administrator, pursuant to 28 CFR 0.104. DEA published the 2013 
established aggregate production quotas for controlled substances in 
Schedules I and II and assessment of annual needs for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the 
Federal Register (77 FR 59980) on October 1, 2012. That notice stated 
that the Deputy Administrator would adjust, as needed, the established 
aggregate production quotas in 2013 as provided for in 21 CFR 1303.13 
and 21 CFR 1315.13. The 2013 proposed adjusted aggregate production 
quotas for controlled substances in Schedules I and II and assessment 
of annual needs for the List I chemicals ephedrine, pseudoephedrine, 
and phenylpropanolamine were subsequently published in the Federal 
Register on June 20, 2013, (78 FR 37237) in consideration of the 
outlined criteria. All interested persons were invited to comment on or 
object to the proposed adjusted aggregate production quotas and 
assessment of annual needs on or before July 22, 2013.

Analysis for Final Adjusted 2013 Aggregate Production Quotas and 
Assessment of Annual Needs

    Consideration has been given to the criteria outlined in the June 
20, 2013, notice of proposed adjusted aggregate production quotas and 
assessment of annual needs, in accordance with 21 CFR 1303.13 and 21 
CFR 1315.13. Six companies submitted timely comments regarding a total 
of 30 Schedule I and II controlled substances. Comments received 
proposed that the aggregate production quotas for 2-(2,5-Dimethoxy-4-
(n)-propylphenyl)ethanamine (2C-P); 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-Dimethoxyphenyl)ethanamine (2C-H); 2-
(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C); 2-(4-Iodo-2,5-
dimethoxyphenyl)ethanamine (2C-I); 2-[4-(Ethylthio)-2,5-
dimethoxyphenyl]ethanamine (2C-T-2); 2-[4-(Isopropylthio)-2,5-
dimethoxyphenyl]ethanamine (2C-T-4); 3,4-Methylenedioxymethamphetamine 
(MDMA); 4-Anilino-N-phenethyl-4-piperidine (ANPP); amphetamine (for 
sale); codeine (for conversion); dihydromorphine; diphenoxylate (for 
sale); gamma hydroxybutyric acid; hydrocodone; hydromorphone; 
levomethorphan; methadone; methadone intermediate; methylphenidate; 
morphine (for conversion); morphine (for sale); oxycodone (for sale); 
oripavine; oxymorphone (for conversion); oxymorphone (for sale); 
phenylacetone; and sufentanil 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. One manufacturer commented that the APQ 
for thebaine was insufficient; however, that commenter was referring to 
a need for procurement quota for thebaine, which does not directly 
impact the APQ and, thus, was not considered. DEA did not previously 
propose adjustments to the 2013 assessment of annual needs for 
ephedrine, pseudoephedrine, and phenylpropanolamine and received no 
comments concerning such.
    DEA has taken into consideration the above comments along with the 
relevant 2012 year-end inventories, initial 2013 manufacturing quotas 
and import quotas, 2013 export requirements, actual and projected 2013 
sales, research and product development requirements, and additional 
applications received. Based on all of the above, the Deputy 
Administrator has determined that the proposed adjusted 2013 aggregate 
production quotas and assessment of annual needs for dihydromorphine; 
diphenoxylate (for sale); gamma hydroxybutyric acid; hydromorphone; 
levomethorphan; morphine (for sale); oxymorphone (for sale); 
phenylacetone; psilocyn; sufentanil; ephedrine (for sale); 
phenylpropanolamine (for conversion); and pseudoephedrine (for sale) 
required additional consideration and hereby further adjusts the 2013 
aggregate production quotas for those substances.
    Regarding 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P); 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-Dimethoxyphenyl)ethanamine (2C-H);

[[Page 48194]]

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C); 2-(4-Iodo-2,5-
dimethoxyphenyl)ethanamine (2C-I); 2-[4-(Ethylthio)-2,5-
dimethoxyphenyl]ethanamine (2C-T-2); 2-[4-(Isopropylthio)-2,5-
dimethoxyphenyl]ethanamine (2C-T-4); 3,4-Methylenedioxymethamphetamine 
(MDMA); 4-Anilino-N-phenethyl-4-piperidine (ANPP); amphetamine (for 
sale); codeine (for conversion); hydrocodone; methadone; methadone 
intermediate; methylphenidate; morphine (for conversion); oxycodone 
(for sale); oripavine; and oxymorphone (for conversion), the Deputy 
Administrator hereby determines that the proposed adjusted 2013 
aggregate production quotas and assessment of annual needs for these 
substances and List I chemicals as published on June 20, 2013, (78 FR 
37237) are sufficient to meet the current 2013 estimated medical, 
scientific, research, and industrial needs of the United States and to 
provide for adequate inventories.
    As described in the previously published notice establishing the 
2013 aggregate production quotas and assessment of annual needs, DEA 
has 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 has included in all 
proposed revised 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 resulting adjusted established aggregate production quotas 
will 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 
public need, as determined by DEA. DEA does not anticipate utilizing 
the reserve in the absence of these circumstances.
    Pursuant to the above, the Deputy Administrator hereby finalizes 
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:

------------------------------------------------------------------------
                                                         Final adjusted
                      Basic class                          2013 quotas
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                   15 g
 tetramethylcyclopropyl)methanone (UR-144)............
[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                        15 g
 tetramethylcyclopropyl)methanone (XLR11).............
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide                  15 g
 (AKB48)..............................................
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
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-              45 g
 200).................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073)...............              45 g
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-              45 g
 18 and RCS-8)........................................
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-              15 g
 2)...................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                 15 g
 (2C-T-4).............................................
3,4,5-Trimethoxyamphetamine...........................              12 g
3,4-Methylenedioxyamphetamine (MDA)...................              30 g
3,4-Methylenedioxymethamphetamine (MDMA)..............              50 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

[[Page 48195]]

 
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)...............              25 g
4-Methylaminorex......................................              12 g
4-Methyl-N-methylcathinone (mephedrone)...............              25 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-             68 g
 phenol...............................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-              53 g
 phenol (cannabicyclohexanol or CP-47, 497 C8-homolog)
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.......................................       3,990,000 g
Dimethyltryptamine....................................              18 g
Gamma-hydroxybutyric acid.............................      67,500,000 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............................................              10 g
Psilocyn..............................................              12 g
Tetrahydrocannabinols.................................         491,000 g
Thiofentanyl..........................................               2 g
Tilidine..............................................              10 g
Trimeperidine.........................................               2 g
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine...............................               3 g
1-Piperdinocyclohexanecarbonitrile....................              21 g

[[Page 48196]]

 
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)................................      47,186,000 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.........................................         887,500 g
Ecgonine..............................................         144,000 g
Ethylmorphine.........................................               3 g
Fentanyl..............................................       2,108,750 g
Glutethimide..........................................               3 g
Hydrocodone (for sale)................................      99,625,000 g
Hydromorphone.........................................       6,750,000 g
Isomethadone..........................................               5 g
Levo-alphacetylmethadol (LAAM)........................               4 g
Levomethorphan........................................             195 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)..................................      33,125,000 g
Methadone Intermediate................................      40,500,000 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.......................................      96,750,000 g
Morphine (for conversion).............................      91,250,000 g
Morphine (for sale)...................................      61,125,000 g
Nabilone..............................................          25,628 g
Noroxymorphone (for conversion).......................       9,000,000 g
Noroxymorphone (for sale).............................       1,262,500 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)..................................     153,750,000 g
Oxymorphone (for conversion)..........................      18,375,000 g
Oxymorphone (for sale)................................       7,000,000 g
Pentobarbital.........................................      42,500,000 g
Phenazocine...........................................               6 g
Phencyclidine.........................................              30 g
Phenmetrazine.........................................               3 g
Phenylacetone.........................................      42,393,750 g
Racemethorphan........................................               3 g
Remifentanil..........................................           3,750 g
Secobarbital..........................................         215,003 g
Sufentanil............................................           6,880 g
Tapentadol............................................      13,750,000 g
Thebaine..............................................     145,000,000 g
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)............................      15,100,000 g
Ephedrine (for sale)..................................       4,200,000 g
Phenylpropanolamine (for conversion)..................      44,800,000 g
Phenylpropanolamine (for sale)........................       6,100,000 g
Pseudoephedrine (for sale)............................     246,000,000 g
------------------------------------------------------------------------


[[Page 48197]]

    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 1, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-19046 Filed 8-6-13; 8:45 am]
BILLING CODE 4410-09-P