Established 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 2017

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-443F]

Established 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 2017

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Final order.

SUMMARY:

This final order establishes the initial 2017 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES:

Effective October 5, 2016.

FOR FURTHER INFORMATION CONTACT:

Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the DEA pursuant to 28 CFR 0.100.

Background

The 2017 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 that may be manufactured in the United States in 2017 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 22, 2016, a notice titled “Proposed 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 2017” was published in the

Federal Register

. 81 FR 47821. This notice proposed the 2017 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2017 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 22, 2016.

Comments Received

Thirteen comments were received from five DEA-registered manufacturers and four non-DEA registered entities within the published comment period regarding 22 different schedule I and II controlled substances. The DEA received two comments from two non-DEA registered entities within the published comment period regarding the proposed assessment of annual needs for the list I chemical ephedrine (for sale). Commenters stated that the proposed aggregate production quotas for acetyl fentanyl, AH-7921, amphetamine (for conversion), amphetamine (for sale), beta-hydroxythiofentanyl, butyryl fentanyl, cocaine, codeine (for conversion), codeine (for sale), dihydrocodeine, ecgonine, hydrocodone (for sale), hydromorphone, levorphanol, lisdexamfetamine, marihuana, meperidine, methylphenidate, nabilone, opium tincture, oxycodone (for sale), and sufentanil, as well as, the proposed assessment of annual needs for ephedrine (for sale) 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.

The DEA received one comment from a DEA-registrant and three comments by non-DEA registered entities regarding the proposed removal of the additional 25% of the estimated medical, scientific, and research needs for the United States. Two of the commenters requested that the DEA continue to include the additional 25%, one commenter requested transparency in the process of setting aggregate production quotas, and the last commenter agreed with the DEA that the additional 25% should not be included in aggregate production quotas values. The DEA has considered these comments, as well as the ones for specific controlled substances and ephedrine (for sale), in establishing the 2017 aggregate production quotas and assessment of annual needs.

Determination of 2017 Aggregate Production Quotas and Assessment of Annual Needs

In determining the 2017 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2016 manufacturing quotas, current 2016 sales and inventories, anticipated 2017 export requirements, industrial use, and additional applications for 2017 quotas, as well as information on research and product development requirements. Based on this information, the DEA has removed the additional 25% from the aggregate production quotas before determining that adjustments to the proposed aggregate production quotas for 4-anilino-n-phenethyl-piperidine, amphetamine (for conversion), amphetamine (for sale), cocaine, dihydrocodeine, ecgonine, etorphine hydrochloride, hydromorphone, levorphanol, lysergic acid dimethylamide, nabilone, opium tincture, and oripavine are warranted. Adjustment to the proposed annual assessment of needs for ephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments.

Regarding acetyl fentanyl, AH-7921, beta-hydroxythiofentanyl, butyryl fentanyl, codeine (for conversion), codeine (for sale), hydrocodone (for sale), lisdexamfetamine, marihuana, meperidine, methylphenidate, oxycodone (for sale), and sufentanil, the DEA has determined that the proposed aggregate production quotas are sufficient to provide for the 2017 estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas at the same amounts as proposed.

In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2017 aggregate production quotas for the following schedule I and II controlled substances and the 2017 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

2017

Established

quotas

(g)

Schedule I

[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)

15

1-(1-Phenylcyclohexyl)pyrrolidine

10

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

30

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

30

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

15

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

35

1-Benzylpiperazine

25

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)

35

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

30

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

30

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

30

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

30

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

30

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

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

30

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

30

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-;B-NBOMe; 25B; Cimbi-36)

25

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

30

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)

25

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

30

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)

5

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)

40

3,4-Methylenedioxypyrovalerone (MDPV)

35

3-FMC; 3-Fluoro-N-methylcathinone

25

3-Methylfentanyl

2

3-Methylthiofentanyl

2

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

25

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

25

4-FMC; Flephedrone

25

4-Methoxyamphetamine

150

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

25

4-Methylaminorex

25

4-MEC; 4-Methyl-N-ethylcathinone

25

4-Methyl-N-methylcathinone (mephedrone)

45

4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)

25

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

50

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

40

5-Fluoro-UR144, XLR11

25

5-Methoxy-3,4-methylenedioxyamphetamine

25

5-Methoxy-N,N-diisopropyltryptamine

25

5-Methoxy-N,N-dimethyltryptamine

25

AB-PINACA

15

Acetyl-alpha-methylfentanyl

2

Acetyldihydrocodeine

2

Acetylmethadol

2

AH-7921

30

Allylprodine

2

alpha-Ethyltryptamine

25

alpha-Methylfentanyl

2

alpha-Methylthiofentanyl

2

alpha-Methyltryptamine (AMT)

25

alpha-Pyrrolidinobutiophenone (α-PBP)

25

alpha-Pyrrolidinopentiophenone (α-PVP)

25

Alphacetylmethadol

2

Alphameprodine

2

Alphamethadol

2

Aminorex

25

APINCA, AKB48

25

Benzylmorphine

2

beta-Hydroxy-3-methylfentanyl

2

beta-Hydroxyfentanyl

2

beta-Hydroxythiofentanyl

30

Betacetylmethadol

2

Betameprodine

2

Betamethadol

4

Betaprodine

2

Bufotenine

3

Butylone

25

Butyryl fentanyl

30

Cathinone

24

Codeine methylbromide

5

Codeine-N-oxide

305

Desomorphine

25

Diethyltryptamine

25

Difenoxin

8,750

Dihydromorphine

1,566,000

Dimethyltryptamine

35

Dipipanone

5

Fenethylline

5

gamma

-Hydroxybutyric acid

56,200,000

Heroin

25

Hydromorphinol

2

Hydroxypethidine

2

Ibogaine

5

Lysergic acid diethylamide (LSD)

15

Marihuana

472,000

Mescaline

25

Methaqualone

10

Methcathinone

25

Methyldesorphine

5

Methyldihydromorphine

2

Morphine methylbromide

5

Morphine methylsulfonate

5

Morphine-N-oxide

350

N,N-Dimethylamphetamine

25

N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA)

50

N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)

50

N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)

15

N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl)

100

N-Ethyl-1-phenylcyclohexylamine

5

N-Ethylamphetamine

24

N-Hydroxy-3,4-methylenedioxyamphetamine

24

Naphyrone

25

Noracymethadol

2

Norlevorphanol

52

Normethadone

2

Normorphine

40

Para-fluorofentanyl

5

Parahexyl

5

Pentedrone

25

Pentylone

25

Phenomorphan

2

Pholcodine

5

Psilocybin

30

Psilocyn

50

Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)

20

Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)

20

Tetrahydrocannabinols

409,000

Thiofentanyl

2

Tilidine

25

Trimeperidine

2

UR-144

25

Schedule II

1-Phenylcyclohexylamine

4

1-Piperidinocyclohexanecarbonitrile

4

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

1,750,000

Alfentanil

4,200

Alphaprodine

2

Amobarbital

20,100

Amphetamine (for conversion)

12,000,000

Amphetamine (for sale)

42,400,000

Carfentanil

10

Cocaine

103,400

Codeine (for conversion)

40,000,000

Codeine (for sale)

45,000,000

Dextropropoxyphene

15

Dihydrocodeine

281,100

Dihydroetorphine

2

Diphenoxylate (for conversion)

15,000

Diphenoxylate (for sale)

820,000

Ecgonine

99,000

Ethylmorphine

2

Etorphine hydrochloride

32

Fentanyl

1,750,000

Glutethimide

2

Hydrocodone (for conversion)

122,000

Hydrocodone (for sale)

58,410,000

Hydromorphone

5,140,800

Isomethadone

4

Levo-alphacetylmethadol (LAAM)

3

Levomethorphan

10

Levorphanol

8,300

Lisdexamfetamine

19,000,000

Meperidine

3,706,000

Meperidine Intermediate-A

5

Meperidine Intermediate-B

9

Meperidine Intermediate-C

5

Metazocine

15

Methadone (for sale)

23,700,000

Methadone Intermediate

25,600,000

Methamphetamine

1,539,100

[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]

Methylphenidate

73,000,000

Morphine (for conversion)

27,300,000

Morphine (for sale)

41,000,000

Nabilone

19,000

Noroxymorphone (for conversion)

17,700,000

Noroxymorphone (for sale)

400,000

Opium (powder)

90,000

Opium (tincture)

907,200

Oripavine

22,000,000

Oxycodone (for conversion)

2,610,000

Oxycodone (for sale)

108,510,000

Oxymorphone (for conversion)

22,300,000

Oxymorphone (for sale)

4,200,000

Pentobarbital

27,500,000

Phenazocine

5

Phencyclidine

20

Phenmetrazine

2

Phenylacetone

20

Racemethorphan

2

Racemorphan

2

Remifentanil

3,000

Secobarbital

172,002

Sufentanil

4,000

Tapentadol

21,000,000

Thebaine

100,000,000

List I Chemicals

Ephedrine (for conversion)

50,000

Ephedrine (for sale)

5,360,000

Phenylpropanolamine (for conversion)

15,000,000

Phenylpropanolamine (for sale)

8,500,000

Pseudoephedrine (for conversion)

40

Pseudoephedrine (for sale)

200,000,000

The 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. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2017 aggregate production quotas and assessment of annual needs as needed.

Dated: September 26, 2016.

Chuck Rosenberg,

Acting Administrator.

[FR Doc. 2016-23988 Filed 10-4-16; 8:45 am]

BILLING CODE 4410-09-P