2018-26587. 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 2018  

  • Start Preamble

    AGENCY:

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

    ACTION:

    Final order.

    SUMMARY:

    This final order establishes the final adjusted 2018 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:

    This order is effective December 10, 2018.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598-6812.

    End Further Info End Preamble Start Supplemental Information

    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 2018 established aggregate production quotas for controlled substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the Federal Register on November 8, 2017. 82 FR 51873. The DEA is committed to preventing and limiting diversion by enforcing laws and regulations regarding controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, in order to meet the demand of legitimate medical, scientific, and export needs of the United States. This notice stated that the Administrator would adjust, as needed, the established aggregate production quotas in 2018 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2018 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 23, 2018, (83 FR 42690) 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 24, 2018.

    Comments Received

    The DEA received 526 comments from doctors, nurses, veterinarians, nonprofit organizations, associations, patients, caregivers, DEA-registered entities, and non-DEA entities. The comments included concerns about drug shortages, interference with doctor-patient relationships, increase in the production of marihuana, requests for a hearing, requests for increases in specific production quotas, and comments that were outside the scope of this final order.

    There were 200 commenters that expressed general concerns about the decrease to the production quotas of controlled substances and shortages of controlled substances. There were 27 commenters that expressed general concerns alleging that decreases to the aggregate production quotas interfered with doctor-patient relationships. The DEA sets aggregate production quotas in a manner to ensure that the estimated medical needs of the United States are met. In determining the aggregate production quota, the DEA does take into account the prescriptions that have been issued. The DEA does not interfere with doctor-patient relationships. Doctors who are authorized to dispense controlled substances are responsible for adhering to the laws and regulations set forth under the CSA, which requires doctors to only write prescriptions for a legitimate medical need. The DEA is responsible for enforcing controlled substance laws and regulations. The DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet the demand of legitimate medical, scientific, and export needs of the United States. The decrease or increase in the aggregate production quota for controlled substances is based on factors set forth in 21 CFR 1303.13. In the event of a shortage, the CSA provides a mechanism under which the DEA will, in appropriate circumstances, increase quotas to address shortages. 21 U.S.C. 826(h). When DEA is notified of an alleged shortage, DEA will confer with the FDA and relevant manufacturers regarding the amount of material in physical inventory, current quota granted, and the estimated legitimate medical need, to determine whether a quota adjustment is necessary to alleviate any factually valid shortage.

    Four non-DEA registered entities expressed support to increase the production quota of marihuana for research purposes. The DEA increased the production quota for marihuana based solely on increased usage projections for federally approved research projects.

    Two non-DEA-registered individuals urged DEA to hold a public hearing in connection with their view that reducing quotas will not be effective in Start Printed Page 63534preventing the deaths and other harms associated with the opioid crisis in the United States. One of these individuals stated that the purpose of the hearing would be to obtain input from various medical professionals and patients. The second commenter expressed his view that reduction in quotas could lead to the under treatment of pain. Under the DEA regulations, the decision of whether to grant a hearing on the issues raised by the comments lies solely within the discretion of the Administrator. 21 CFR 1303.11(c) and 1303.13(c). I find that neither of the foregoing two comments, or any of the other comments, presented any evidence that would lead me to conclude that a hearing is necessary or warranted. Therefore, I decline to order a hearing on the issues presented by the comments.

    Five DEA-registered entities submitted comments regarding a total of 30 schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for 3-methylfentanyl, 4-ANPP, acetyl fentanyl, acryl fentanyl, beta-hydroxythiofentanyl, butyryl fentanyl, carfentanil, cyclopentyl fentanyl, cyclopropyl fentanyl, d-amphetamine (for conversion), diphenoxylate (for sale), fentanyl, fentanyl related substances, furanyl fentanyl, isobutyryl fentanyl, levorphanol, meperidine, methoxyacetyl fentanyl, noroxymorphone (for conversion), ocfentanil, oripavine, oxymorphone (for conversion), para-chloroisobutyryl fentanyl, para-fluorofentanyl, para-fluorobutyryl fentanyl, para-methyoxybutyryl fentanyl, remifentanil, tetrahydrofuranyl fentanyl, U-47700, and valeryl fentanyl 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 288 comments which addressed issues that are outside the scope of this final order. The comments were general in nature and raised issues of specific medical illnesses, medical treatments, and medication costs and therefore, are outside of the scope of this Final Order for 2018 and do not impact the original analysis involved in finalizing the 2018 aggregate production quotas.

    The DEA received no comments from DEA-registered or non-DEA registered entities for previously established values of the 2018 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine.

    Analysis for Final Adjusted 2018 Aggregate Production Quotas and Assessment of Annual Needs

    In determining the final adjusted 2018 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 2018 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 2017 year-end inventories, initial 2018 manufacturing and import quotas, 2018 export requirements, actual and projected 2018 sales, research and product development requirements, additional applications received, and the extent of any diversion of the controlled substance in the class. Based on all of the above, the Administrator is adjusting the 2018 aggregate production quotas for the following: Lower for codeine (for sale), hydrocodone (for sale), morphine (for sale), and oxycodone (for sale) based on the data received since the publication of the 2018 Proposed Revised Aggregate Production Quotas and Assessment of Annual Needs in the Federal Register on August 23, 2018, (83 FR 42690); higher for cyclopentyl fentanyl, fentanyl related substances, methoxyacetyl fentanyl, para-chloroisobutyryl fentanyl, and para-methyoxybutyryl fentanyl due to the publication of their schedule I temporary controlled status; higher for noroxymorphone (for conversion) and oripavine based on their involvement in the synthesis pathway to produce the FDA approved drugs used in the medically assisted treatment of opioid addiction. This final order reflects those adjustments.

    Regarding 3-methyl fentanyl, 4-ANPP, acetyl fentanyl, acryl fentanyl, beta-hydroxythiofentanyl, butyryl fentanyl, carfentanil, cyclopropyl fentanyl, d-amphetamine (for conversion), diphenoxylate (for sale), fentanyl, furanyl fentanyl, isobutyryl fentanyl, levorphanol, meperidine, ocfentanil, oxymorphone (for conversion), para-fluorofentanyl, para-fluorobutyryl fentanyl, remifentanil, tetrahydrofuranyl fentanyl, U-47700, and valeryl fentanyl, the Administrator hereby determines that the proposed adjusted 2018 aggregate production quotas and assessment of annual needs for these substances and list I chemicals as published on August 23, 2018, (83 FR 42690) are sufficient to meet the current 2018 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 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 classFinal revised 2018 quotas (g)
    Temporarily Scheduled Substances
    1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-carboxamide25
    1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboxamide25
    Cyclopropyl Fentanyl20
    Cyclopentyl fentanyl30
    Fentanyl related substances40
    Isobutyryl Fentanyl25
    Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate25
    Methoxyacetyl fentanyl30
    N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide25
    Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate25
    Ocfentanil25
    Ortho-fluorofentanyl30
    Para-chloroisobutyryl fentanyl30
    Para-fluorobutyryl fentanyl25
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    Para-methoxybutyryl fentanyl30
    Tetrahydrofuranyl fentanyl5
    Valeryl fentanyl25
    Schedule I
    1-[1-(2-Thienyl)cyclohexyl]pyrrolidine20
    1-(1-Phenylcyclohexyl)pyrrolidine15
    1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine10
    1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)30
    1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694)30
    1-[1-(2-Thienyl)cyclohexyl]piperidine15
    1-Benzylpiperazine25
    1-Methyl-4-phenyl-4-propionoxypiperidine10
    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)-propylthiophenethylamine25
    2,5-Dimethoxyamphetamine25
    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-Trimethoxyamphetamine30
    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-methylcathinone25
    3-Methylfentanyl30
    3-Methylthiofentanyl30
    4-Bromo-2,5-dimethoxyamphetamine (DOB)30
    4-Bromo-2,5-dimethoxyphenethylamine (2C-B)25
    4-Fluoroisobutyryl fentanyl30
    4-FMC; Flephedrone25
    4-MEC; 4-Methyl-N-ethylcathinone25
    4-Methoxyamphetamine150
    4-Methyl-2,5-dimethoxyamphetamine (DOM)25
    4-Methylaminorex25
    4-Methyl-N-methylcathinone (mephedrone)45
    4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)25
    5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol50
    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)-1H-indazole-3-carboxamido)-3-methylbutanoate)30
    5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)30
    5-Fluoro-PB-22; 5F-PB-2220
    5-Fluoro-UR-144, XLR11 [1-(5-Fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone25
    5-Methoxy-3,4-methylenedioxyamphetamine25
    5-Methoxy-N,N-diisopropyltryptamine25
    5-Methoxy-N-N-dimethyltryptamine25
    AB-CHMINACA30
    AB-FUBINACA50
    AB-PINACA30
    ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)30
    Acetyl Fentanyl100
    Acetyl-alpha-methylfentanyl30
    Acetyldihydrocodeine30
    Acetylmethadol2
    Acryl fentanyl25
    ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)50
    AH-792130
    Allylprodine2
    Alphacetylmethadol2
    alpha-ethyltryptamine25
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    Alphameprodine2
    Alphamethadol2
    alpha-methylfentanyl30
    alpha-methylthiofentanyl30
    alpha-methyltryptamine (AMT)25
    alpha-Pyrrolidinobutiophenone (α-PBP)25
    alpha-Pyrrolidinopentiophenone (α-PVP)25
    Aminorex25
    Anileridine20
    APINACA, AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide)25
    Benzylmorphine30
    Betacetylmethadol2
    beta-Hydroxy-3-methylfentanyl30
    beta-Hydroxyfentanyl30
    beta-Hydroxythiofentanyl30
    Betameprodine2
    Betamethadol4
    Betaprodine2
    Bufotenine3
    Butylone25
    Butyryl fentanyl30
    Cathinone24
    Codeine methylbromide30
    Codeine-N-oxide192
    Desomorphine25
    Diampromide20
    Diethylthiambutene20
    Diethyltryptamine25
    Difenoxin8,225
    Dihydromorphine1,000,160
    Dimethyltryptamine50
    Dipipanone5
    Etorphine30
    Fenethylline30
    Furanyl fentanyl30
    Gamma-Hydroxybutyric Acid37,130,000
    Heroin45
    Hydromorphinol40
    Hydroxypethidine2
    Ibogaine30
    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-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide)30
    MDMB-CHMICA; MMB-CHMINACA(Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate)30
    MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
    Marihuana1,140,216
    Mecloqualone30
    Mescaline25
    Methaqualone60
    Methcathinone25
    Methyldesorphine5
    Methyldihydromorphine2
    Morphine methylbromide5
    Morphine methylsulfonate5
    Morphine-N-oxide150
    N,N-Dimethylamphetamine25
    Naphyrone25
    N-Ethyl-1-phenylcyclohexylamine5
    N-Ethyl-3-piperidyl benzilate10
    N-Ethylamphetamine24
    N-Hydroxy-3,4-methylenedioxyamphetamine24
    Noracymethadol2
    Norlevorphanol55
    Start Printed Page 63537
    Normethadone2
    Normorphine40
    Para-fluorofentanyl25
    Parahexyl5
    PB-22; QUPIC20
    Pentedrone25
    Pentylone25
    Phenomorphan2
    Pholcodine5
    Psilocybin30
    Psilocyn50
    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
    Tetrahydrocannabinols384,460
    Thiofentanyl25
    THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl) methanone)30
    Tilidine25
    Trimeperidine2
    UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl) methanone25
    U-4770030
    Schedule II
    1-Phenylcyclohexylamine15
    1-Piperidinocyclohexanecarbonitrile25
    4-Anilino-N-phenethyl-4-piperidine (ANPP)1,342,000
    Alfentanil6,200
    Alphaprodine2
    Amobarbital20,100
    Amphetamine (for conversion)12,000,000
    Amphetamine (for sale)39,856,000
    Carfentanil20
    Cocaine92,120
    Codeine (for conversion)13,536,000
    Codeine (for sale)36,114,260
    Dextropropoxyphene35
    Dihydrocodeine264,140
    Dihydroetorphine2
    Diphenoxylate (for conversion)14,100
    Diphenoxylate (for sale)770,800
    Ecgonine88,134
    Ethylmorphine30
    Etorphine hydrochloride32
    Fentanyl1,342,320
    Glutethimide2
    Hydrocodone (for conversion)114,680
    Hydrocodone (for sale)43,027,640
    Hydromorphone4,547,720
    Isomethadone30
    Levo-alphacetylmethadol (LAAM)5
    Levomethorphan2,200
    Levorphanol38,000
    Lisdexamfetamine19,000,000
    Meperidine1,913,148
    Meperidine Intermediate-A30
    Meperidine Intermediate-B30
    Meperidine Intermediate-C30
    Metazocine15
    Methadone (for sale)22,278,000
    Methadone Intermediate24,064,000
    Methamphetamine1,446,754
    [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)]
    Methylphenidate64,600,000
    Morphine (for conversion)4,089,000
    Morphine (for sale)29,353,676
    Nabilone62,000
    Noroxymorphone (for conversion)17,804.670
    Noroxymorphone (for sale)376,000
    Opium (powder)84,600
    Start Printed Page 63538
    Opium (tincture)564,000
    Oripavine26,629,500
    Oxycodone (for conversion)2,453,400
    Oxycodone (for sale)79,596,606
    Oxymorphone (for conversion)20,962,000
    Oxymorphone (for sale)3,137,240
    Pentobarbital25,850,000
    Phenazocine5
    Phencyclidine35
    Phenmetrazine25
    Phenylacetone40
    Racemethorphan5
    Racemorphan5
    Remifentanil3,000
    Secobarbital172,100
    Sufentanil1,880
    Tapentadol18,388,280
    Thebaine84,600,000
    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)1,000
    Pseudoephedrine (for sale)180,000,000

    Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.

    Start Signature

    Dated: December 3, 2018.

    Uttam Dhillon,

    Acting Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2018-26587 Filed 12-7-18; 8:45 am]

    BILLING CODE 4410-09-P

Document Information

Effective Date:
12/10/2018
Published:
12/10/2018
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Final order.
Document Number:
2018-26587
Dates:
This order is effective December 10, 2018.
Pages:
63533-63538 (6 pages)
Docket Numbers:
Docket No. DEA-471A
PDF File:
2018-26587.pdf