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 2014

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-378]

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 2014

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice.

SUMMARY:

This notice establishes the initial 2014 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:

September 9, 2013.

FOR FURTHER INFORMATION CONTACT:

Ruth A. Carter, Chief, Policy Evaluation and Analysis Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

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 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 2014 aggregate production quotas and assessment of annual needs represent those quantities of Schedules I and II controlled substances and the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured in the United States in 2014 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 July 3, 2013, 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 2014,” was published in the

Federal Register

(78 FR 40186). That notice proposed the 2014 aggregate production quotas for each basic class of controlled substance listed in Schedules I and II and the 2014 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 August 2, 2013.

Comments Received

DEA received seven comments from DEA-registered manufacturers within the published comment period on a total of 23 Schedule I and II controlled substances and one List I chemical. Commenters stated that the proposed aggregate production quotas for (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11), N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48), cathinone, amphetamine (for sale), codeine (for conversion), codeine (for sale), fentanyl, hydrocodone (for sale), hydromorphone, levomethorphan, methylphenidate, morphine (for conversion), morphine (for sale), noroxymorphone (for conversion), oripavine, oxycodone (for sale), oxymorphone (for conversion), oxymorphone (for sale), phenylacetone, tapentadol, tetrahydrocannabinol, and thebaine 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.

Determination of 2014 Aggregate Production Quotas and Assessment of Annual Needs

In determining the 2014 aggregate production quotas and assessment of annual needs, the 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 2013 manufacturing quotas, current 2013 sales and inventories, 2014 export requirements, industrial use, additional applications for quotas, as well as information on research and product development requirements. Based on this information, the DEA has determined that adjustments to the proposed aggregate production quotas and assessment of annual needs for 1-[1-(2-Thienyl)cyclohexyl]piperidine, carfentanil, cathinone, dihydromorphine, dimethyltryptamine, ecgonine, hydromorphone, levomethorphan, lysergic acid diethylamide, metazocine, methamphetamine, d-methamphetamine (for conversion), methyldesorphine, noroxymorphone (for conversion), oxymorphone (for conversion), phencyclidine, phenylacetone, ephedrine (for conversion), ephedrine (for sale),

phenylpropanolamine (for conversion), and pseudoephedrine (for sale) are warranted. This notice reflects those adjustments.

Regarding (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144), [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11), N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48), amphetamine (for sale), codeine (for conversion), codeine (for sale), fentanyl, hydrocodone (for sale), methylphenidate, morphine (for conversion), morphine (for sale), oripavine, oxycodone (for sale), oxymorphone (for sale), tapentadol, tetrahydrocannabinol, thebaine, and phenylpropanolamine (for sale), the DEA has determined that the proposed initial 2014 aggregate production quotas and assessment of annual needs are sufficient to meet the current 2014 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, the 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. The 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 the DEA. The 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 2014 aggregate production quotas for the following Schedule I and II controlled substances and the 2014 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 2014 Quotas (grams)

(1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144)

15

[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11)

15

1-(1-Phenylcyclohexyl)pyrrolidine

10

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)

45

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)

45

1-[1-(2-Thienyl)cyclohexyl]piperidine

15

1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)

45

1-Butyl-3-(1-naphthoyl)indole (JWH-073)

45

1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)

45

1-Hexyl-3-(1-naphthoyl)indole (JWH-019)

45

1-Methyl-4-phenyl-4-propionoxypiperidine

2

1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)

45

1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)

45

1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)

45

1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)

45

1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)

45

1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)

45

1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)

45

2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)

30

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)

30

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)

30

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)

30

2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)

30

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)

30

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)

30

2,5-Dimethoxy-4-ethylamphetamine (DOET)

25

2,5-Dimethoxy-4-n-propylthiophenethylamine

25

2,5-Dimethoxyamphetamine

25

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)

30

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)

30

3,4,5-Trimethoxyamphetamine

25

3,4-Methylenedioxyamphetamine (MDA)

55

3,4-Methylenedioxymethamphetamine (MDMA)

50

3,4-Methylenedioxy-N-ethylamphetamine (MDEA)

40

3,4-Methylenedioxy-N-methylcathinone (methylone)

50

3,4-Methylenedioxypyrovalerone (MDPV)

35

3-Methylfentanyl

2

3-Methylthiofentanyl

2

4-Bromo-2,5-dimethoxyamphetamine (DOB)

25

4-Bromo-2,5-dimethoxyphenethylamine (2-CB)

25

4-Methoxyamphetamine

100

4-Methyl-2,5-dimethoxyamphetamine (DOM)

25

4-Methylaminorex

25

4-Methyl-N-methylcathinone (mephedrone)

45

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol

68

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47, 497 C8-homolog)

53

5-Methoxy-3,4-methylenedioxyamphetamine

25

5-Methoxy-N,N-diisopropyltryptamine

25

5-Methoxy-N,N-dimethyltryptamine

25

Acetyl-alpha-methylfentanyl

2

Acetyldihydrocodeine

2

Acetylmethadol

2

Allylprodine

2

Alphacetylmethadol

2

Alpha-ethyltryptamine

25

Alphameprodine

2

Alphamethadol

2

Alpha-methylfentanyl

2

Alpha-methylthiofentanyl

2

Alpha-methyltryptamine (AMT)

25

Aminorex

25

Benzylmorphine

2

Betacetylmethadol

2

Beta-hydroxy-3-methylfentanyl

2

Beta-hydroxyfentanyl

2

Betameprodine

2

Betaprodine

2

Bufotenine

3

Cathinone

70

Codeine Methylbromide

5

Codeine-N-oxide

200

Desomorphine

5

Diethyltryptamine

25

Difenoxin

50

Dihydromorphine

3,990,000

Dimethyltryptamine

35

Dipipanone

5

Fenethylline

5

Gamma-hydroxybutyric acid

70,250,000

Heroin

25

Hydromorphinol

2

Hydroxypethidine

2

Ibogaine

5

Lysergic acid diethylamide (LSD)

35

Marihuana

21,000

Mescaline

25

Methaqualone

10

Methcathinone

25

Methyldesorphine

2

Methyldihydromorphine

2

Morphine Methylbromide

5

Morphine Methylsulfonate

5

Morphine-N-oxide

175

N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (AKB48)

15

N-Benzylpiperazine

25

N,N-Dimethylamphetamine

25

N-Ethyl-1-phenylcyclohexylamine

5

N-Ethylamphetamine

24

N-Hydroxy-3,4-methylenedioxyamphetamine

24

Noracymethadol

2

Norlevorphanol

52

Normethadone

2

Normorphine

18

Para-fluorofentanyl

2

Parahexyl

5

Phenomorphan

2

Pholcodine

2

Properidine

2

Psilocybin

30

Psilocyn

30

Tetrahydrocannabinols

491,000

Thiofentanyl

2

Tilidine

10

Trimeperidine

2

Basic Class—Schedule II

Established 2014 Quotas (grams)

1-Phenylcyclohexylamine

3

1-Piperdinocyclohexanecarbonitrile (PCC)

3

4-Anilino-N-phenethyl-4-piperidine (ANPP)

2,687,500

Alfentanil

17,625

Alphaprodine

3

Amobarbital

9

Amphetamine (for conversion)

18,375,000

Amphetamine (for sale)

49,000,000

Carfentanil

19

Cocaine

240,000

Codeine (for conversion)

68,750,000

Codeine (for sale)

46,125,000

Dextropropoxyphene

19

Dihydrocodeine

100,750

Diphenoxylate

750,000

Ecgonine

144,000

Ethylmorphine

3

Fentanyl

2,108,750

Glutethimide

3

Hydrocodone (for sale)

99,625,000

Hydromorphone

6,750,000

Isomethadone

5

Levo-alphacetylmethadol (LAAM)

4

Levomethorphan

195

Levorphanol

2,000

Lisdexamfetamine

23,750,000

Meperidine

6,250,000

Meperidine Intermediate-A

6

Meperidine Intermediate-B

11

Meperidine Intermediate-C

6

Metazocine

19

Methadone (for sale)

31,875,000

Methadone Intermediate

38,875,000

Methamphetamine

2,811,375

[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,500,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]

Methylphenidate

96,750,000

Morphine (for conversion)

91,250,000

Morphine (for sale)

62,500,000

Nabilone

30,375

Noroxymorphone (for conversion)

17,500,000

Noroxymorphone (for sale)

1,462,500

Opium (powder)

112,500

Opium (tincture)

625,000

Oripavine

22,750,000

Oxycodone (for conversion)

9,250,000

Oxycodone (for sale)

149,375,000

Oxymorphone (for conversion)

25,000,000

Oxymorphone (for sale)

7,750,000

Pentobarbital

35,000,000

Phenazocine

6

Phencyclidine

19

Phenmetrazine

3

Phenylacetone

67,000,000

Racemethorphan

3

Remifentanil

3,750

Secobarbital

215,003

Sufentanil

6,255

Tapentadol

17,500,000

Thebaine

145,000,000

Basic Class—List I Chemicals

Proposed 2014 Quotas

Ephedrine (for conversion)

1,000,000

Ephedrine (for sale)

3,000,000

Phenylpropanolamine (for conversion)

44,800,000

Phenylpropanolamine (for sale)

5,300,000

Pseudoephedrine (for conversion)

5,000

Pseudoephedrine (for sale)

192,000,000

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 2014 aggregate production quotas and assessment of annual needs as needed.

Dated: August 30, 2013.

Thomas M. Harrigan,

Deputy Administrator.

[FR Doc. 2013-21797 Filed 9-6-13; 8:45 am]

BILLING CODE 4410-09-P