Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Justice Drug Enforcement Administration [Docket No. DEA-471F]
 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 
                    ( print page 51874)
                    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
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)
302-(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
303,4-Methylenedioxyamphetamine (MDA)
553,4-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)
304-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
25( print page 51875)AB-CHMINACA
30AB-FUBINACA
50AB-PINACA
30ADB-FUBINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1
                            *H*
                            -indazole-3-carboxamide)
30Acetyl Fentanyl
100Acetyl-
                            *alpha*
                            -methylfentanyl
30Acetyldihydrocodeine
30Acetylmethadol
2Acryl Fentanyl
25ADB-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
192Desomorphine
25Diethyltryptamine
25Difenoxin
8,225Dihydromorphine
1,000,160Dimethyltryptamine
35Dipipanone
5Etorphine
30Fenethylline
30Furanyl fentanyl
30*gamma*
                            -Hydroxybutyric acid
37,130,000Heroin
45Hydromorphinol
40Hydroxypethidine
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
443,680Mecloqualone
30Mescaline
25Methaqualone
60Methcathinone
25Methyldesorphine
5( print page 51876)Methyldihydromorphine
2Morphine methylbromide
5Morphine methylsulfonate
5Morphine-N-oxide
150*N,N*
                            -Dimethylamphetamine
25Naphyrone
25*N*
                            -Ethyl-1-phenylcyclohexylamine
5*N*
                            -Ethylamphetamine
24*N*
                            -Hydroxy-3,4-methylenedioxyamphetamine
24Noracymethadol
2Norlevorphanol
55Normethadone
2Normorphine
40Para-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
384,460Thiofentanyl
25THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30Tilidine
25Trimeperidine
2UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25U-47700
30**Schedule II**1-Phenylcyclohexylamine
41-Piperidinocyclohexanecarbonitrile
44-Anilino-N-phenethyl-4-piperidine (ANPP)
1,342,320Alfentanil
6,200Alphaprodine
2Amobarbital
20,100Amphetamine (for conversion)
11,280,000Amphetamine (for sale)
39,856,000Carfentanil
20Cocaine
92,120Codeine (for conversion)
15,040,000Codeine (for sale)
40,015,800Dextropropoxyphene
35Dihydrocodeine
264,140Dihydroetorphine
2Diphenoxylate (for conversion)
14,100Diphenoxylate (for sale)
770,800Ecgonine
88,134Ethylmorphine
30Etorphine hydrochloride
32Fentanyl
1,342,320Glutethimide
2Hydrocodone (for conversion)
114,680Hydrocodone (for sale)
50,348,280Hydromorphone
4,547,720Isomethadone
30Levo-alphacetylmethadol (LAAM)
5Levomethorphan
30Levorphanol
12,126Lisdexamfetamine
17,869,000Meperidine
2,717,540Meperidine Intermediate-A
5Meperidine Intermediate-B
30Meperidine Intermediate-C
5Metazocine
15Methadone (for sale)
22,278,000Methadone Intermediate
24,064,000( print page 51877)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
64,600,000Morphine (for conversion)
4,089,000Morphine (for sale)
33,958,440Nabilone
31,000Noroxymorphone (for conversion)
14,044,540Noroxymorphone (for sale)
376,000Opium (powder)
84,600Opium (tincture)
564,000Oripavine
24,534,000Oxycodone (for conversion)
2,453,400Oxycodone (for sale)
95,692,000Oxymorphone (for conversion)
20,962,000Oxymorphone (for sale)
3,395,280Pentobarbital
25,850,000Phenazocine
5Phencyclidine
35Phenmetrazine
25Phenylacetone
40Racemethorphan
5Racemorphan
5Remifentanil
2,820Secobarbital
161,682Sufentanil
1,880Tapentadol
18,388,280Thebaine
94,000,000**List I Chemicals**Ephedrine (for conversion)
47,000Ephedrine (for sale)
4,136,000Phenylpropanolamine (for conversion)
14,100,000Phenylpropanolamine (for sale)
7,990,000Pseudoephedrine (for conversion)
40Pseudoephedrine (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] BILLING CODE 4410-09-P