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 2018

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471F]

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 2018

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Final order.

SUMMARY:

This final order establishes the initial 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

APPLICABLE DATE:

Applicable November 8, 2017.

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 2018 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 2018 to provide for the estimated medical, scientific, research, 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 7, 2017, 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 2018” was published in the

Federal Register

. 82 FR 36830. This notice proposed the 2018 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2018 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 6, 2017.

Comments Received

Within the public comment period, the DEA received seventeen comments from three DEA-registered manufacturers regarding sixteen different schedule I and II controlled substances and one comment from a DEA-registered manufacturer regarding the proposed assessment of annual needs for the list I chemical phenylpropanolamine (for conversion). Commenters stated the proposed aggregate production quotas for 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, methylphenidate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, as well as the proposed assessment of annual needs for phenylpropanolamine (for conversion), 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. These comments were considered in setting the final 2018 Aggregate Production Quotas as discussed below.

In addition to these seventeen comments, the DEA received one comment from a DEA-registered manufacturer seeking clarification on whether DEA considers manufacturing at outsourcing facilities when determining the Aggregate Production Quotas. The DEA notes that it is the responsibility of all DEA-registered dosage form manufacturers to submit quota applications by April 1, in order for their individual business practices to be considered when the DEA proposes the Aggregate Production Quota for the following year. 21 CFR 1303.12(b). These quota applications and comments with discrete data regarding the quantities of the basic classes of schedule I or II controlled substances received during the comment period for the proposed Aggregate Production Quotas are taken into consideration before establishing the values presented in this Final Order. This DEA-registered manufacturer provided no quantitative data supporting the position that the proposed quota for 2018 will adversely impact outsourcing facilities for DEA to consider. The DEA also received one hundred five comments that expressed concern that DEA's proposed reduction of opioids by twenty percent would adversely impact the availability of pain relieving prescription drugs for people with chronic pain. These comments were general in nature, and raised issues of specific medical illnesses and medical treatment, and therefore are outside of the scope of this Final Order for 2018. As a result, these one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas.

Determination of 2018 Aggregate Production Quotas and Assessment of Annual Needs

In determining the 2018 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 2017 manufacturing quotas, current 2017 sales and inventories, anticipated 2018 export requirements, industrial use, additional applications for 2018 quotas, as well as information on research and product development requirements. Based on all of the above, the Administrator is adjusting the 2018 aggregate production quotas for 2-(4-bromo-2,5-dimethoxyphenyl)-n-(2-methoxybenzyl) ethanamine, 3,4,5-trimethoxy amphetamine, 4-bromo-2,5-dimethoxy-amphetamine, acryl fentanyl, alfentanil, amobarbital, methylphenidate, and nabilone, are warranted. Adjustment to the proposed assessment of annual needs for

pseudoephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments.

Regarding 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, and phenylpropanolamine (for conversion), the DEA has determined the proposed aggregate production quotas and assessment of annual needs are sufficient to provide for the 2018 estimated medical, scientific, research, industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas and assessment of annual needs 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 2018 aggregate production quotas for the following schedule I and II controlled substances and the 2018 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

2018

Established

quotas

(g)

Temporarily Scheduled Substances

Acryl fentanyl

25

Schedule I

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-Benzylpiperazine

25

1-Methyl-4-phenyl-4-propionoxypiperidine

2

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)

30

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)

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

30

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

30

3-Methylthiofentanyl

30

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

30

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

25

4-Fluoroisobutyryl fentanyl

30

4-FMC; Flephedrone

25

4-MEC; 4-Methyl-N-ethylcathinone

25

4-Methoxyamphetamine

150

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

25

4-Methylaminorex

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

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)

30

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1

H

-indazole-3-carboxamido)-3-methylbutanoate)

30

5F-APINACA; 5F-AKB48 (

N

-(adamantan-1-yl)-1-(5-fluoropentyl)-1

H

-indazole-3-carboxamide)

30

5-Fluoro-PB-22; 5F-PB-22

20

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1

H

indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone

25

5-Methoxy-3,4-methylenedioxyamphetamine

25

5-Methoxy-N,N-diisopropyltryptamine

25

5-Methoxy-N,N-dimethyltryptamine

25

AB-CHMINACA

30

AB-FUBINACA

50

AB-PINACA

30

ADB-FUBINACA (

N

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1

H

-indazole-3-carboxamide)

30

Acetyl Fentanyl

100

Acetyl-

alpha

-methylfentanyl

30

Acetyldihydrocodeine

30

Acetylmethadol

2

Acryl Fentanyl

25

ADB-PINACA (

N

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1

H

-indazole-3-carboxamide)

50

AH-7921

30

Allylprodine

2

Alphacetylmethadol

2

alpha-

Ethyltryptamine

25

Alphameprodine

2

Alphamethadol

2

alpha

-Methylfentanyl

30

alpha

-Methylthiofentanyl

30

alpha

-Methyltryptamine (AMT)

25

alpha

-Pyrrolidinobutiophenone (α-PBP)

25

alpha

-Pyrrolidinopentiophenone (α-PVP)

25

Aminorex

25

APINCA, AKB48 (

N

-(1-adamantyl)-1-pentyl-1

H

-indazole-3-carboxamide)

25

Benzylmorphine

30

Betacetylmethadol

2

beta

-Hydroxy-3-methylfentanyl

30

beta

-Hydroxyfentanyl

30

beta

-Hydroxythiofentanyl

30

Betameprodine

2

Betamethadol

4

Betaprodine

2

Bufotenine

3

Butylone

25

Butyryl fentanyl

30

Cathinone

24

Codeine methylbromide

30

Codeine-N-oxide

192

Desomorphine

25

Diethyltryptamine

25

Difenoxin

8,225

Dihydromorphine

1,000,160

Dimethyltryptamine

35

Dipipanone

5

Etorphine

30

Fenethylline

30

Furanyl fentanyl

30

gamma

-Hydroxybutyric acid

37,130,000

Heroin

45

Hydromorphinol

40

Hydroxypethidine

2

Ibogaine

30

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

35

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

45

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

45

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

30

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

30

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

35

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

30

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

30

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

30

Lysergic acid diethylamide (LSD)

40

MAB-CHMINACA; ADB-CHMINACA (

N

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1

H

-indazole-3-carboxamide)

30

MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1

H

-indole-3-carboxamido)-3,3-dimethylbutanoate)

30

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1

H

-indazole-3-carboxamido)-3,3-dimethylbutanoate)

30

Marihuana

443,680

Mecloqualone

30

Mescaline

25

Methaqualone

60

Methcathinone

25

Methyldesorphine

5

Methyldihydromorphine

2

Morphine methylbromide

5

Morphine methylsulfonate

5

Morphine-N-oxide

150

N,N

-Dimethylamphetamine

25

Naphyrone

25

N

-Ethyl-1-phenylcyclohexylamine

5

N

-Ethylamphetamine

24

N

-Hydroxy-3,4-methylenedioxyamphetamine

24

Noracymethadol

2

Norlevorphanol

55

Normethadone

2

Normorphine

40

Para-fluorofentanyl

25

Parahexyl

5

PB-22; QUPIC

20

Pentedrone

25

Pentylone

25

Phenomorphan

2

Pholcodine

5

Psilocybin

30

Psilocyn

50

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

45

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

30

Tetrahydrocannabinols

384,460

Thiofentanyl

25

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

30

Tilidine

25

Trimeperidine

2

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

25

U-47700

30

Schedule II

1-Phenylcyclohexylamine

4

1-Piperidinocyclohexanecarbonitrile

4

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

1,342,320

Alfentanil

6,200

Alphaprodine

2

Amobarbital

20,100

Amphetamine (for conversion)

11,280,000

Amphetamine (for sale)

39,856,000

Carfentanil

20

Cocaine

92,120

Codeine (for conversion)

15,040,000

Codeine (for sale)

40,015,800

Dextropropoxyphene

35

Dihydrocodeine

264,140

Dihydroetorphine

2

Diphenoxylate (for conversion)

14,100

Diphenoxylate (for sale)

770,800

Ecgonine

88,134

Ethylmorphine

30

Etorphine hydrochloride

32

Fentanyl

1,342,320

Glutethimide

2

Hydrocodone (for conversion)

114,680

Hydrocodone (for sale)

50,348,280

Hydromorphone

4,547,720

Isomethadone

30

Levo-alphacetylmethadol (LAAM)

5

Levomethorphan

30

Levorphanol

12,126

Lisdexamfetamine

17,869,000

Meperidine

2,717,540

Meperidine Intermediate-A

5

Meperidine Intermediate-B

30

Meperidine Intermediate-C

5

Metazocine

15

Methadone (for sale)

22,278,000

Methadone Intermediate

24,064,000

Methamphetamine

1,446,754

[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]

Methylphenidate

64,600,000

Morphine (for conversion)

4,089,000

Morphine (for sale)

33,958,440

Nabilone

31,000

Noroxymorphone (for conversion)

14,044,540

Noroxymorphone (for sale)

376,000

Opium (powder)

84,600

Opium (tincture)

564,000

Oripavine

24,534,000

Oxycodone (for conversion)

2,453,400

Oxycodone (for sale)

95,692,000

Oxymorphone (for conversion)

20,962,000

Oxymorphone (for sale)

3,395,280

Pentobarbital

25,850,000

Phenazocine

5

Phencyclidine

35

Phenmetrazine

25

Phenylacetone

40

Racemethorphan

5

Racemorphan

5

Remifentanil

2,820

Secobarbital

161,682

Sufentanil

1,880

Tapentadol

18,388,280

Thebaine

94,000,000

List I Chemicals

Ephedrine (for conversion)

47,000

Ephedrine (for sale)

4,136,000

Phenylpropanolamine (for conversion)

14,100,000

Phenylpropanolamine (for sale)

7,990,000

Pseudoephedrine (for conversion)

40

Pseudoephedrine (for sale)

180,000,000

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 2018 aggregate production quotas and assessment of annual needs as needed.

Dated: November 1, 2017.

Robert W. Patterson,

Acting Administrator.

[FR Doc. 2017-24306 Filed 11-7-17; 8:45 am]

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