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 Department of Justice Drug Enforcement Administration [Docket No. DEA-470F]
 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 
                    ( print 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: Basic class
Final revised
                             2017 quotas 
                             (g)**Schedule I**1-(1-Phenylcyclohexyl)pyrrolidine
101-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
301-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
301-[1-(2-Thienyl)cyclohexyl]piperidine
151-Benzylpiperazine
251-Methyl-4-phenyl-4-propionoxypiperidine
22-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)
302-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)
302-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
302-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)
302-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
302-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
252-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)
302-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
252-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)
302-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
302,5-Dimethoxy-4-ethylamphetamine (DOET)
252,5-Dimethoxy-4-n-propylthiophenethylamine
252,5-Dimethoxyamphetamine
252-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)
302-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)
303,4,5-Trimethoxyamphetamine
253,4-Methylenedioxyamphetamine (MDA)
55( print page 51295)3,4-Methylenedioxymethamphetamine (MDMA)
503,4-Methylenedioxy-N-ethylamphetamine (MDEA)
403,4-Methylenedioxy-N-methylcathinone (methylone)
403,4-Methylenedioxypyrovalerone (MDPV)
353-FMC; 3-Fluoro-N-methylcathinone
253-Methylfentanyl
303-Methylthiofentanyl
304-Bromo-2,5-dimethoxyamphetamine (DOB)
254-Bromo-2,5-dimethoxyphenethylamine (2-CB)
254-Fluoroisobutyryl fentanyl
304-FMC; Flephedrone
254-MEC; 4-Methyl-N-ethylcathinone
254-Methoxyamphetamine
1504-Methyl-2,5-dimethoxyamphetamine (DOM)
254-Methylaminorex
254-Methyl-N-methylcathinone (mephedrone)
454-Methyl-α-pyrrolidinopropiophenone (4-MePPP)
255-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
505-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
405F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
305F-AMB (methyl 2-(1-(5-fluoropentyl)-1
                            *H*
                            -indazole-3-carboxamido)-3-methylbutanoate)
305F-APINACA; 5F-AKB48 (
                            *N*
                            -(adamantan-1-yl)-1-(5-fluoropentyl)-1
                            *H*
                            -indazole-3-carboxamide)
305-Fluoro-PB-22; 5F-PB-22
205-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1
                            *H*
                            indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
255-Methoxy-3,4-methylenedioxyamphetamine
255-Methoxy-N,N-diisopropyltryptamine
255-Methoxy-N,N-dimethyltryptamine
25AB-CHMINACA
30AB-FUBINACA
50AB-PINACA
30Acetyl Fentanyl
100Acetyl-
                            *alpha*
                            -methylfentanyl
30Acetyldihydrocodeine
30Acetylmethadol
2ADB-FUBINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1
                            *H*
                            -indazole-3-carboxamide)
30ADB-PINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1
                            *H*
                            -indazole-3-carboxamide)
50AH-7921
30Allylprodine
2Alphacetylmethadol
2*alpha-*
                            Ethyltryptamine
25Alphameprodine
2Alphamethadol
2*alpha*
                            -Methylfentanyl
30*alpha*
                            -Methylthiofentanyl
30*alpha*
                            -Methyltryptamine (AMT)
25*alpha*
                            -Pyrrolidinobutiophenone (α-PBP)
25*alpha*
                            -Pyrrolidinopentiophenone (α-PVP)
25Aminorex
25APINCA, AKB48 (
                            *N*
                            -(1-adamantyl)-1-pentyl-1
                            *H*
                            -indazole-3-carboxamide)
25Benzylmorphine
30Betacetylmethadol
2*beta*
                            -Hydroxy-3-methylfentanyl
30*beta*
                            -Hydroxyfentanyl
30*beta*
                            -Hydroxythiofentanyl
30Betameprodine
2Betamethadol
4Betaprodine
2Bufotenine
3Butylone
25Butyryl Fentanyl
30Cathinone
24Codeine Methylbromide
30Codeine-N-oxide
330Desomorphine
25Diethyltryptamine
25Difenoxin
8,750Dihydromorphine
1,566,000Dimethyltryptamine
35Dipipanone
5Etorphine
30Fenethylline
30Furanyl Fentanyl
30( print page 51296)*gamma*
                            -Hydroxybutyric acid
56,200,000Heroin
45Hydromorphinol
2Hydroxypethidine
2Ibogaine
30JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)
35JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
45JWH-073 (1-Butyl-3-(1-naphthoyl)indole)
45JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)
30JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)
30JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)
35JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)
30JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)
30JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)
30Lysergic acid diethylamide (LSD)
40MAB-CHMINACA; ADB-CHMINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1
                            *H*
                            -indazole-3-carboxamide)
30MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1
                            *H*
                            -indole-3-carboxamido)-3,3-dimethylbutanoate)
30MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1
                            *H*
                            -indazole-3-carboxamido)-3,3-dimethylbutanoate)
30Marihuana
472,000Mecloqualone
30Mescaline
25Methaqualone
60Methcathinone
25Methyldesorphine
5Methyldihydromorphine
2Morphine methylbromide
5Morphine methylsulfonate
5Morphine-N-oxide
350*N,N*
                            -Dimethylamphetamine
25Naphyrone
25*N*
                            -Ethyl-1-phenylcyclohexylamine
5*N*
                            -Ethylamphetamine
24*N*
                            -Hydroxy-3,4-methylenedioxyamphetamine
24Noracymethadol
2Norlevorphanol
55Normethadone
2Normorphine
40*para*
                            -Fluorofentanyl
25Parahexyl
5PB-22; QUPIC
20Pentedrone
25Pentylone
25Phenomorphan
2Pholcodine
5Psilocybin
30Psilocyn
50SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)
45SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)
30Tetrahydrocannabinols
409,000Thiofentanil
25THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30Tilidine
25Trimeperidine
2U-47700
30UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25**Schedule II**1-Phenylcyclohexylamine
41-Piperidinocyclohexanecarbonitrile
44-Anilino-N-phenethyl-4-piperidine (ANPP)
1,050,000Alfentanil
4,200Alphaprodine
2Amobarbital
20,100Amphetamine (for conversion)
12,000,000Amphetamine (for sale)
42,400,000Carfentanil
20Cocaine
103,400Codeine (for conversion)
40,000,000Codeine (for sale)
45,000,000Dextropropoxyphene
35( print page 51297)Dihydrocodeine
360,000Dihydroetorphine
2Diphenoxylate (for conversion)
15,000Diphenoxylate (for sale)
1,110,000Ecgonine
99,000Ethylmorphine
30Etorphine Hydrochloride
32Fentanyl
1,350,000Glutethimide
2Hydrocodone (for conversion)
122,000Hydrocodone (for sale)
51,900,000Hydromorphone
5,140,800Isomethadone
30Levo-alphacetylmethadol (LAAM)
5Levomethorphan
30Levorphanol
12,900Lisdexamfetamine
19,000,000Meperidine
2,904,000Meperidine Intermediate-A
5Meperidine Intermediate-B
30Meperidine Intermediate-C
5Metazocine
15Methadone (for sale)
23,700,000Methadone Intermediate
28,700,000Methamphetamine
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
73,000,000Morphine (for conversion)
27,300,000Morphine (for sale)
35,000,000Nabilone
19,000Noroxymorphone (for conversion)
17,700,000Noroxymorphone (for sale)
400,000Opium (powder)
90,000Opium (tincture)
500,000Oripavine
28,900,000Oxycodone (for conversion)
2,610,000Oxycodone (for sale)
101,500,000Oxymorphone (for conversion)
23,000,000Oxymorphone (for sale)
3,600,000Pentobarbital
27,500,000Phenazocine
5Phencyclidine
35Phenmetrazine
25Phenylacetone
40Racemethorphan
5Racemorphan
5Remifentanil
3,000Secobarbital
172,002Sufentanil
4,000Tapentadol
18,600,000Thiafentanil
30Thebaine
100,000,000**List I Chemicals**Ephedrine (for conversion)
50,000Ephedrine (for sale)
4,810,000Phenylpropanolamine (for conversion)
13,600,000Phenylpropanolamine (for sale)
7,000,000Pseudoephedrine (for conversion)
40Pseudoephedrine (for sale)
186,000,000
 
 
 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