[Federal Register Volume 82, Number 212 (Friday, November 3, 2017)]
[Notices]
[Pages 51293-51298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24009]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-470F]


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 2017

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

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: This final order establishes the final adjusted 2017 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.

DATES: This order is applicable November 3, 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 substances 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 Drug Enforcement Administration (DEA) 
pursuant to 28 CFR 0.100.

Background

    The DEA published the 2017 established aggregate production quotas 
for controlled substances in schedules I and II and for the assessment 
of annual needs for the list I chemicals ephedrine, pseudoephedrine, 
and phenylpropanolamine in the Federal Register on October 5, 2016. 81 
FR 69079. This notice stated that the

[[Page 51294]]

Administrator would adjust, as needed, the established aggregate 
production quotas in 2017 in accordance with 21 CFR 1303.13 and 21 CFR 
1315.13. The 2017 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 August 4, 2017, (82 FR 36449) 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 September 5, 2017.

Comments Received

    Three DEA-registered entities submitted timely comments regarding a 
total of eleven schedule I and II controlled substances. Comments 
received proposed that the aggregate production quotas for amphetamine 
(for conversion), dihydrocodeine, diphenoxylate (for sale), heroin, 
levorphanol, lisdexamfetmine, methadone intermediate, noroxymorphone 
(for conversion), oripavine, oxycodone (for sale), and oxymorphone (for 
conversion) 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. The DEA received 43 comments from non-DEA registered 
entities in response to the DEA's August 4, 2017, press release for the 
proposed 2018 aggregate production quotas. The majority of these 
commenters expressed concerns about the 20 percent decrease to the 
production quotas of controlled substances. The DEA also received two 
comments from non-DEA registered entities suggesting that the 
rescheduling of marihuana would drastically reduce opioid use, misuse, 
and addiction. These 45 comments addressed issues that were outside the 
scope of this final order, and therefore are not relevant to the 
analysis involved in finalizing the 2017 aggregate production quotas.
    The DEA received no comments from DEA-registered or non-DEA 
registered entities for previously established values of the 2017 
assessment of annual needs for ephedrine, pseudoephedrine, and 
phenylpropanolamine.

Analysis for Final Adjusted 2017 Aggregate Production Quotas and 
Assessment of Annual Needs

    In determining the final adjusted 2017 aggregate production quotas 
and assessment of annual needs, the DEA has taken into consideration 
the above comments that are specifically relevant to this Final Order 
for calendar year 2017 along with the factors set forth in 21 CFR 
1303.13 and 21 CFR 1315.13 in accordance with 21 U.S.C. 826(a), and 
other relevant factors including the 2016 year-end inventories, initial 
2017 manufacturing and import quotas, 2017 export requirements, actual 
and projected 2017 sales, research and product development 
requirements, and additional applications received. Based on all of the 
above, the Administrator is adjusting the 2017 aggregate production 
quotas and assessment of annual needs for 4-Anilino-N-Phenethyl-4-
Piperidine (ANPP), dihydrocodeine, ephedrine (for sale), fentanyl, 
hydrocodone (for sale), meperidine, methadone intermediate, morphine 
(for sale), opium (tincture), Oripavine, oxycodone (for sale), 
Oxymorphone (for conversion), Oxymorphone (for sale), 
phenylpropanolamine (for conversion), phenylpropanolamine (for sale), 
pseudoephedrine (for sale), tapentadol, and thiafentanil. This final 
order reflects those adjustments.
    Regarding diphenoxylate (for sale), heroin, levorphanol, and 
noroxymorphone (for conversion) the Administrator hereby determines 
that the proposed adjusted 2017 aggregate production quotas and 
assessment of annual needs for these substances and list I chemicals as 
published on August 4, 2017, (82 FR 36449) are sufficient to meet the 
current 2017 estimated medical, scientific, research, and industrial 
needs of the United States and to provide for adequate reserve stock. 
This final order establishes these aggregate production quotas at the 
same amounts as proposed.
    Pursuant to the above, the Administrator hereby finalizes 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:

------------------------------------------------------------------------
                                                          Final revised
                      Basic class                        2017 quotas (g)
------------------------------------------------------------------------
                               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-                                 25
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36).............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)......               30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82).............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)........               30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-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-                30
 2)....................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 T-4)..................................................
3,4,5-Trimethoxyamphetamine............................               25
3,4-Methylenedioxyamphetamine (MDA)....................               55

[[Page 51295]]

 
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).................               25
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-[alpha]-pyrrolidinopropiophenone (4-MePPP)....               25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)..
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              30
 indazole-3-carboxamido)-3,3-dimethylbutanoate)........
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate).......................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide)..............
5-Fluoro-PB-22; 5F-PB-22...............................               20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-                25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone..........
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
Acetyl Fentanyl........................................              100
Acetyl-alpha-methylfentanyl............................               30
Acetyldihydrocodeine...................................               30
Acetylmethadol.........................................                2
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-               30
 1-(4-fluorobenzyl)-1H-indazole-3-carboxamide).........
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               50
 pentyl-1H-indazole-3-carboxamide).....................
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 ([alpha]-PBP)............               25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)...........               25
Aminorex...............................................               25
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 carboxamide)..........................................
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........................................              330
Desomorphine...........................................               25
Diethyltryptamine......................................               25
Difenoxin..............................................            8,750
Dihydromorphine........................................        1,566,000
Dimethyltryptamine.....................................               35
Dipipanone.............................................                5
Etorphine..............................................               30
Fenethylline...........................................               30
Furanyl Fentanyl.......................................               30

[[Page 51296]]

 
gamma-Hydroxybutyric acid..............................       56,200,000
Heroin.................................................               45
Hydromorphinol.........................................                2
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-                             35
 naphthoyl)indole).....................................
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-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)..........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-                                30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate)....................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate).................
Marihuana..............................................          472,000
Mecloqualone...........................................               30
Mescaline..............................................               25
Methaqualone...........................................               60
Methcathinone..........................................               25
Methyldesorphine.......................................                5
Methyldihydromorphine..................................                2
Morphine methylbromide.................................                5
Morphine methylsulfonate...............................                5
Morphine-N-oxide.......................................              350
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-                              45
 methoxyphenylacetyl)indole)...........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-                             30
 benzoyl]indole).......................................
Tetrahydrocannabinols..................................          409,000
Thiofentanil...........................................               25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-1-yl)methanone)........................
Tilidine...............................................               25
Trimeperidine..........................................                2
U-47700................................................               30
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone......................
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................                4
1-Piperidinocyclohexanecarbonitrile....................                4
4-Anilino-N-phenethyl-4-piperidine (ANPP)..............        1,050,000
Alfentanil.............................................            4,200
Alphaprodine...........................................                2
Amobarbital............................................           20,100
Amphetamine (for conversion)...........................       12,000,000
Amphetamine (for sale).................................       42,400,000
Carfentanil............................................               20
Cocaine................................................          103,400
Codeine (for conversion)...............................       40,000,000
Codeine (for sale).....................................       45,000,000
Dextropropoxyphene.....................................               35

[[Page 51297]]

 
Dihydrocodeine.........................................          360,000
Dihydroetorphine.......................................                2
Diphenoxylate (for conversion).........................           15,000
Diphenoxylate (for sale)...............................        1,110,000
Ecgonine...............................................           99,000
Ethylmorphine..........................................               30
Etorphine Hydrochloride................................               32
Fentanyl...............................................        1,350,000
Glutethimide...........................................                2
Hydrocodone (for conversion)...........................          122,000
Hydrocodone (for sale).................................       51,900,000
Hydromorphone..........................................        5,140,800
Isomethadone...........................................               30
Levo-alphacetylmethadol (LAAM).........................                5
Levomethorphan.........................................               30
Levorphanol............................................           12,900
Lisdexamfetamine.......................................       19,000,000
Meperidine.............................................        2,904,000
Meperidine Intermediate-A..............................                5
Meperidine Intermediate-B..............................               30
Meperidine Intermediate-C..............................                5
Metazocine.............................................               15
Methadone (for sale)...................................       23,700,000
Methadone Intermediate.................................       28,700,000
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)....................................       35,000,000
Nabilone...............................................           19,000
Noroxymorphone (for conversion)........................       17,700,000
Noroxymorphone (for sale)..............................          400,000
Opium (powder).........................................           90,000
Opium (tincture).......................................          500,000
Oripavine..............................................       28,900,000
Oxycodone (for conversion).............................        2,610,000
Oxycodone (for sale)...................................      101,500,000
Oxymorphone (for conversion)...........................       23,000,000
Oxymorphone (for sale).................................        3,600,000
Pentobarbital..........................................       27,500,000
Phenazocine............................................                5
Phencyclidine..........................................               35
Phenmetrazine..........................................               25
Phenylacetone..........................................               40
Racemethorphan.........................................                5
Racemorphan............................................                5
Remifentanil...........................................            3,000
Secobarbital...........................................          172,002
Sufentanil.............................................            4,000
Tapentadol.............................................       18,600,000
Thiafentanil...........................................               30
Thebaine...............................................      100,000,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion).............................           50,000
Ephedrine (for sale)...................................        4,810,000
Phenylpropanolamine (for conversion)...................       13,600,000
Phenylpropanolamine (for sale).........................        7,000,000
Pseudoephedrine (for conversion).......................               40
Pseudoephedrine (for sale).............................      186,000,000
------------------------------------------------------------------------


[[Page 51298]]

    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: October 27, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-24009 Filed 11-2-17; 8:45 am]
BILLING CODE 4410-09-P