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Notice

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 2020

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Start Preamble

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Final order.

SUMMARY:

This final order establishes the final adjusted 2020 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 effective December 1, 2020.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (571) 362-3261.

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 (APQ) 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

DEA published the 2020 established APQ for controlled substances in schedules I and II and for the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the Federal Register on December 2, 2019. 84 FR 66014. 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, while meeting the legitimate medical, scientific, and export needs of the United States. This notice stated that the Administrator would adjust, as needed, the established APQ in 2020 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13.

In response to the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, DEA published the final order titled “Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine and Pseudoephedrine for 2020” on April 10, 2020. (85 FR 20302). While the adjustments were effective immediately, all interested persons were invited to comment on or object to the adjustments on or before May 11, 2020.

The 2020 proposed adjusted APQ for controlled substances in schedules I and II and AAN for the list I chemicals Start Printed Page 77244ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the Federal Register on September 1, 2020, (85 FR 54414), after consideration of the criteria outlined in that notice. All interested persons were invited to comment on or object to the proposed APQs and AANs on or before October 1, 2020.

Comments Received

DEA received five timely comments and one untimely comment in response to the April Federal Register notice and nine comments in response to the September Federal Register notice from patients, DEA-registered entities, and non-DEA entities. The comments included appreciation of DEA's response to the public health emergency, concerns about potential drug shortages, interference with doctor-patient relationships, and comments outside the scope of this final order.

Issue: Commenters expressed appreciation of DEA's flexibility in responding to the nationwide public health emergency declared by the Secretary of HHS on January 31, 2020, by adjusting APQ for select schedule II controlled substances and list I chemicals.

DEA Response: DEA acknowledges the expressions of appreciation to changes in the APQ and AAN. The adjustments to select schedule II controlled substances and list I chemicals occurred after DEA consulted with HHS and determined the utilization rates for these drugs substantially increased due to the treatment regimens for ventilator patients stricken with the Coronavirus Disease of 2019 (COVID-19) compared to the previously estimated annual consumption rates. While the estimates from HHS provided a wide range in the number of patients that would require ventilation treatment due to COVID-19, DEA could, under 21 CFR 1303.13 and 1315.13, adjust the APQ and AAN for schedule II controlled substances and list I chemicals, respectively, to ensure manufacturing activities cover the upper range of the estimate could occur in a timely manner. DEA highlights factor 21 CFR 1303.13(b)(5) specifically, which allowed the Acting Administrator to increase the APQ and AAN for select controlled substances and list I chemicals to meet additional estimated medical needs as determined by HHS due to the unforeseen emergency caused by the COVID-19 pandemic.

Issue: Commenters expressed general concerns that decreasing the APQ of controlled substances could lead to shortages of controlled substance medications.

One DEA-registered entity submitted a comment requesting the APQ for hydrocodone (for sale) and oxycodone (for sale) be sufficient 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.

DEA Response: DEA sets APQ in a manner to ensure that the estimated medical, scientific, research, industrial needs of the United States, lawful export requirements, and for the establishment and maintenance of reserve stocks. As discussed in both notices for adjustments, any adjustments to the APQ 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 DEA will, in appropriate circumstances, increase quotas to address shortages. 21 U.S.C. 826(h). Under 21 U.S.C. 826(h)(1), after receiving a request to address a shortage, DEA has 30 days to complete review of the request and determine whether adjustments are necessary to address the shortage. If adjustments are necessary, DEA is required to increase the APQ and individual production quotas to alleviate the shortage. Id. If DEA determines adjustments are not necessary, DEA is required to “provide a written response detailing the basis for the . . . determination.” Id. In addition to what Section 826(h)(1) requires, when DEA is notified of an alleged shortage, DEA will confer with the U.S. Food and Drug Administration 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.

In accordance with 21 CFR 1303.13, DEA considered the comments for hydrocodone (for sale) and oxycodone (for sale), and the Acting Administrator determined the proposed adjusted 2020 APQs for these substances as published in the Federal Register on September 1, 2020, (85 FR 54414), are sufficient to meet the current 2020 estimated medical, scientific, research, and industrial needs of the United States, and to provide for adequate reserve stock.

Issue: DEA received comments of general concerns alleging decreases to the APQ interfered with doctor-patient relationships.

DEA Response: In determining the APQ, DEA considers prescriptions that have been issued. However, DEA does not interfere with doctor-patient relationships. Doctors 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. DEA is responsible for enforcing controlled substance laws and regulations, and 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.

Untimely Comment Issue: The DEA received one comment from a DEA-registered entity for previously established value of the 2020 AAN for pseudoephedrine (for conversion), requesting an increase because the established AAN is not adequate to cover the commenter's new projected need for 2020.

DEA Response: The comment was received in between the comment periods for the two notices of adjustment. Even though the comment was outside the comment period that ended on May 11, 2020, DEA considered this comment as part of the second comment period ending on October 1, 2020, when setting the final 2020 AAN.

Out of Scope Comments: DEA received comments on issues 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 2020 and do not impact the original analysis involved in finalizing the 2020 APQ.

Analysis for Final Adjusted 2020 Aggregate Production Quotas and Assessment of Annual Needs

In determining the final adjusted 2020 APQ and AAN, DEA has considered the above comments relevant to this Final Order for calendar year 2020, 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). DEA has also considered other relevant factors, including the 2019 year-end inventories, initial 2020 manufacturing and import quotas, 2020 export requirements, actual and projected 2020 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 Acting Administrator is adjusting the 2020 APQ for the following: Increases for Start Printed Page 77245Amphetamine (for sale) and Methamphetamine, based on the data received since the publication of the 2020 proposed adjustment for APQ and AAN in the Federal Register on September 1, 2020 (85 FR 54414); increases for Crotonyl Fentanyl, Ethylone, and Isotonitazene due to the publication of their schedule I temporary controlled status; and increases for Etonitazene due to additional manufacturers entering the reference standard market. This final order reflects those adjustments.

Pursuant to the above, the Acting Administrator hereby finalizes the 2020 APQ for the following schedule I and II controlled substances and the 2020 AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:

Basic classFinal revised 2020 quotas
(g)
Temporarily Scheduled Substances
Crotonyl fentanyl25
Ethylone25
Isotonitazene25
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 (AM694)30
1-Benzylpiperazine25
1-Methyl-4-phenyl-4-propionoxypiperidine10
1-[1-(2-Thienyl)cyclohexyl]piperidine15
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)100
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-Dimethoxyamphetamine (DMA)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-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-Fluoro-N-methylcathinone (3-FMC)25
3-Methylfentanyl30
3-Methylthiofentanyl30
4-Bromo-2,5-dimethoxyamphetamine (DOB)30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP)25
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-carboximide (4CN-Cumyl-Butinaca)25
4-Fluoroisobutyryl fentanyl30
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone)25
4-Methyl-N-ethylcathinone (4-MEC)25
4-Methoxyamphetamine150
4-Methyl-2,5-dimethoxyamphetamine (DOM)25
4-Methylaminorex25
4-Methyl-N-methylcathinone (mephedrone)45
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)25
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)25
4-Methyl-alpha-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-CUMYL-PINACA25
5F-EDMB-PINACA25
5F-MDMB-PICA25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide25
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)25
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
Start Printed Page 77246
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)-1H-indazole-3-carboxamide)30
5-Fluoro-PB-22; 5F-PB-2220
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 H- indol-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
Acetorphine25
Acetyl Fentanyl100
Acetyl-alpha-methylfentanyl30
Acetyldihydrocodeine30
Acetylmethadol25
Acryl Fentanyl25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)50
AH-792130
Allylprodine25
Alphacetylmethadol25
Alpha - Ethyltryptamine25
Alphameprodine25
Alphamethadol25
Alphaprodine25
Alpha-Methylfentanyl30
Alpha-Methylthiofentanyl30
Alpha-Methyltryptamine (AMT)25
Alpha-Pyrrolidinobutiophenone (α-PBP)25
Alpha-Pyrrolidinoheptaphenone (PV8)25
Alpha - Pyrrolidinohexanophenone (α-PHP)25
Alpha-Pyrrolidinopentiophenone (α-PVP)25
Aminorex25
Anileridine20
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1 H-indazole-3-carboxamide)25
Benzethidine25
Benzylmorphine30
Betacetylmethadol25
Beta-Hydroxy-3-methylfentanyl30
Beta-Hydroxyfentanyl30
Beta-Hydroxythiofentanyl30
Betameprodine25
Betamethadol4
Betaprodine25
Bufotenine15
Butylone25
Butyryl fentanyl30
Cathinone40
Clonitazene25
Codeine methylbromide30
Codeine-N-oxide192
Cyclopentyl Fentanyl30
Cyclopropyl Fentanyl20
Cyprenorphine25
Desomorphine25
Dextromoramide25
Diampromide20
Diethylthiambutene20
Diethyltryptamine25
Difenoxin9,200
Dihydromorphine753,500
Dimenoxadol25
Dimepheptanol25
Dimethylthiambutene20
Dimethyltryptamine50
Dioxaphetyl butyrate25
Dipipanone25
Drotebanol25
Ethylmethylthiambutene25
Etonitazene25
Etorphine30
Start Printed Page 77247
Etoxeridine25
Fenethylline30
Fentanyl related substances600
FUB-14425
FUB-AKB4825
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca25
Furanyl fentanyl30
Furethidine25
Gamma Hydroxybutyric Acid29,417,000
Heroin45
Hydromorphinol40
Hydroxypethidine25
Ibogaine30
Isobutyryl Fentanyl25
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
Ketobemidone30
Levomoramide25
Levophenacylmorphan25
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)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
MMB-CHMICA (AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate25
Marihuana3,200,000
Mecloqualone30
Mescaline25
Methaqualone60
Methcathinone25
Methoxyacetyl fentanyl30
Methyldesorphine5
Methyldihydromorphine25
Morpheridine25
Morphine methylbromide5
Morphine methylsulfonate5
Morphine-N-oxide150
MT-4530
Myrophine25
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate25
N,N-Dimethylamphetamine25
Naphyrone25
N-Ethyl-1-phenylcyclohexylamine25
N-Ethyl-3-piperidyl benzilate10
N-Ethylamphetamine24
N - Ethylhexedrone25
N - Ethylpentylone, ephylone30
N-Hydroxy-3,4-methylenedioxyamphetamine24
N-Methyl-3-Piperidyl Benzilate30
Nicocodeine25
Nicomorphine25
Noracymethadol25
Norlevorphanol55
Normethadone25
Normorphine40
Norpipanone25
Ocfentanil25
Ortho-fluorofentanyl, 2-fluorofentanyl30
Para-chloroisobutyryl fentanyl30
Para-fluorofentanyl25
Para-fluorobutyryl fentanyl25
Para-methoxybutyryl fentanyl30
Parahexyl5
PB-22; QUPIC20
Start Printed Page 77248
Pentedrone25
Pentylone25
Phenadoxone25
Phenampromide25
Phenomorphan25
Phenoperidine25
Pholcodine5
Piritramide25
Proheptazine25
Properidine25
Propiram25
Psilocybin30
Psilocyn50
Racemoramide25
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
Tetrahydrofuranyl fentanyl15
Thebacon25
Thiafentanil25
Thiofentanyl25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)30
Tilidine25
Trimeperidine25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone25
U-4770030
Valeryl fentanyl25
Schedule II
1-Phenylcyclohexylamine15
1-Piperidinocyclohexanecarbonitrile25
4-Anilino-N-phenethyl-4-piperidine (ANPP)934,956
Alfentanil3,260
Alphaprodine25
Amobarbital20,100
Amphetamine (for conversion)14,137,578
Amphetamine (for sale)44,330,000
Bezitramide25
Carfentanil20
Cocaine73,090
Codeine (for conversion)3,225,000
Codeine (for sale)35,341,292
Dextropropoxyphene35
Dihydrocodeine156,713
Dihydroetorphine25
Diphenoxylate (for conversion)14,100
Diphenoxylate (for sale)770,800
Ecgonine78,439
Ethylmorphine30
Etorphine hydrochloride32
Fentanyl934,956
Glutethimide25
Hydrocodone (for conversion)1,250
Hydrocodone (for sale)33,997,285
Hydromorphone3,512,651
Isomethadone30
Levo-alphacetylmethadol (LAAM)25
Levomethorphan30
Levorphanol31,730
Lisdexamfetamine21,000,000
Meperidine1,119,862
Meperidine Intermediate-A30
Meperidine Intermediate-B30
Meperidine Intermediate-C30
Metazocine15
Methadone (for sale)25,619,700
Methadone Intermediate27,673,600
Methamphetamine1,224,109
Start Printed Page 77249
[678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 505,231 grams for methamphetamine mostly for conversion to a schedule III product; and 40,000 grams for methamphetamine (for sale).]
Methylphenidate57,438,334
Metopon25
Moramide-intermediate25
Morphine (for conversion)3,376,696
Morphine (for sale)33,756,703
Nabilone62,000
Norfentanyl25
Noroxymorphone (for conversion)22,044,741
Noroxymorphone (for sale)376,000
Opium (powder)250,000
Opium (tincture)530,837
Oripavine33,010,750
Oxycodone (for conversion)725,998
Oxycodone (for sale)65,667,554
Oxymorphone (for conversion)28,204,371
Oxymorphone (for sale)658,515
Pentobarbital25,850,000
Phenazocine25
Phencyclidine35
Phenmetrazine25
Phenylacetone40
Piminodine25
Racemethorphan5
Racemorphan5
Remifentanil3,000
Secobarbital172,100
Sufentanil4,000
Tapentadol13,447,541
Thebaine59,284,070
List I Chemicals
Ephedrine (for conversion)100
Ephedrine (for sale)4,756,000
Phenylpropanolamine (for conversion)14,100,000
Phenylpropanolamine (for sale)16,590,000
Pseudoephedrine (for conversion)1,000
Pseudoephedrine (for sale)200,382,900

The Acting Administrator further proposes that APQ for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero.

Start Signature

Timothy J. Shea,

Acting Administrator.

End Signature End Supplemental Information

[FR Doc. 2020-26443 Filed 11-30-20; 8:45 am]

BILLING CODE 4410-09-P