Diversion Control Division, US Department of Justice, Drug Enforcement Administration

RESOURCES > Federal Register Notices > Quotas - 2020 > Proposed Adjustments to the 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

Quotas - 2020

[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Notices]
[Pages 54414-54421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19308]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-508A2]

Proposed Adjustments to the 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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.


SUMMARY: The Drug Enforcement Administration proposes to adjust the 2020 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before October 1, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2020 adjusted aggregate production quotas for schedule I and II controlled substances, and an adjusted assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference "Docket No. DEA-508A2" on all correspondence, including any attachments. DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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, Virginia 22152, Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase "PERSONAL IDENTIFYING INFORMATION" in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your

[[Page 54415]]

comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase "CONFIDENTIAL BUSINESS INFORMATION" in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Legal Authority and Background

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 DEA pursuant to 28 CFR 0.100.

DEA established the 2020 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on December 2, 2019 (84 FR 66014). That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment. DEA issued a notice and final order on April 10, 2020, to adjust the 2020 aggregate production quota for certain schedule II controlled substances and the assessment of annual needs for ephedrine and pseudoephedrine (85 FR 20302) in response to the coronavirus disease 2019 public health emergency.

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

DEA proposes to adjust the established 2020 aggregate production quotas and assessment of annual needs for certain schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2020 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.

Factors for Determining the Proposed Adjustments

In determining the proposed adjustment, the Acting Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The Acting Administrator is authorized to increase or reduce the aggregate production quota at any time. 21 CFR 1303.13(a) and 1315.13(a). DEA regulations state that there are five factors that shall be considered in determining to adjust the aggregate production quota and the assessment of annual needs. 21 CFR 1303.13(b) and 1315.13(b).

DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2020 by considering: (1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, changes in the national rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for that class or chemical or import quotas for that chemical, and changes in the extent of any diversion in the class of controlled substance; (2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term; (3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota or assessment of annual needs, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to Sections 1303.24(b) and 1315.24(b); (4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to Sections 1303.24(b) and 1315.24(b) or abandoned pursuant to Sections 1303.27 and 1315.27; and (5) other factors affecting medical, and reserve stocks, scientific, research, and industrial needs in the United States, lawful export requirements, and other factors affecting importation needs of listed chemicals in the United States as the Acting Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or chemical or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires. 21 CFR 1303.13(b) and 1315(b). These quotas do not include imports of controlled substances for use in industrial processes.

DEA considered the change in the extent of diversion of all controlled substances in proposing adjustments to the aggregate production quotas as required by 21 CFR 1303.13(b)(1). Through these considerations, it has been determined that any calculated changes from the previously determined initial calculations are slight and statistically indistinguishable from the quantities originally calculated for the extent of diversion that were applied to the initial aggregate production quota valuations.

DEA also considered updated information obtained from 2019 year-end inventories, 2019 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the Acting Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form

[[Page 54416]]

manufacturers, and other pertinent information. In determining the proposed adjusted 2020 assessment of annual needs, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively).

Considerations Based Upon the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act

Pursuant to 21 U.S.C. 826(a)(1), "production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance." However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 (SUPPORT Act), Pub. L. 115-271, provides an exception to that general rule by now giving DEA the authority to establish quotas in terms of pharmaceutical dosage forms if the agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance.

DEA has stated before that while there is the authority to set aggregate production quotas in terms of pharmaceutical dosage form, DEA will not be using that authority at this time. Furthermore, when DEA does utilize the authority, it will be doing so at the individual dosage-form manufacturing level, as that is where it is most appropriate to do so. As such, there are no adjustments to set any controlled substances in terms of pharmaceutical dosage forms.

Under the SUPPORT Act, when setting the aggregate production quota, DEA must estimate the amount of diversion of any substance that is considered a "covered controlled substance," as defined by the SUPPORT Act. 21 U.S.C. 826(i)(1)(A). The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone. The SUPPORT Act also requires DEA to "make appropriate quota reductions, as determined by the [Administrator],\1\ from the quota the [Administrator] would have otherwise established had such diversion not been considered." 21 U.S.C. 826(i)(1)(C). When estimating diversion, the "[Administrator] (i) shall consider information the [Administrator], in consultation with the Secretary of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and (ii) may take into consideration whatever other sources of information the [Administrator] determines reliable." \2\ Id.

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\1\ All functions vested in the Attorney General by the CSA have been delegated to the Administrator of DEA. 28 CFR 0.100(b).

\2\ DEA intends to finalize amendments to the Agency's regulations that will implement the amendments to the CSA made by the SUPPORT Act. Although these amendments to the regulations have not yet been issued, the statutory requirements stated above became effective upon enactment of the SUPPORT Act, and DEA is therefore obligated to adhere to them in issuing these adjusted aggregate production quotas.

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DEA consulted with the U.S. Department of Health and Human Services (HHS) and DEA was advised that the Centers for Disease Control and Prevention (CDC) may have data that can provide reliable rates of overdose deaths. CDC provided DEA with data from their National Vital Statistics System-Mortality files. CDC determined that the current available data, calendar year 2016, regarding rates of overdose deaths and public health impact does not reflect each controlled substance individually (i.e., as a basic class and the quantity ingested), but groups them together functionally (opioid or psychostimulant), without regard to illicit or licit manufacturing. Without specificity to basic class and whether the substance was lawfully manufactured, DEA is unable to determine the basic class that led to the overdose from this information. DEA cannot determine from the data if the patient overdosed on an illicit opioid or a U.S. Food and Drug Administration-approved opioid product. Nor can DEA determine if the overdose was a result of accidental or intentional ingestion. As such, the number of overdose deaths resulting from fentanyl, oxycodone, hydrocodone, hydromorphone, and oxymorphone diverted from legitimate sources is unknown. The overdose deaths provided by CDC in its current form cannot be reliably utilized to estimate the amount of diversion for the five covered controlled substances in 2020.

In further consultation with HHS, DEA was advised that the Centers for Medicare and Medicaid Services (CMS) may have reliable rates of overprescribing. DEA was informed by CMS that CMS had reviewed their internal databases and does not have the ability to systematically distinguish between appropriate and inappropriate prescriptions without investigations.

To update the estimates of diversion, DEA used data from the Drug Theft and Loss Report, Statistical Management Analysis & Reporting Tools System, and System to Retrieve Information on Drug Evidence databases to aggregate the active pharmaceutical ingredient (API) of each covered controlled substance by metric weight. From the databases, DEA gathered data involving employee theft, break-ins, armed robberies, and material lost in transit. DEA also used seizure data obtained from submitted reports by law enforcement agencies nationwide. This data was categorized by basic drug class and the amount of API in the dosage form was delineated with an appropriate metric for use in proposing the adjusted aggregate production quota values. Using the data, DEA calculated the estimates for the amount of diversion by multiplying the strength of the API listed for each finished dosage form by the total amount of units reported to estimate the metric weight in kilograms of the controlled substance being diverted. In DEA's previous adjustment for 2020, the diversion estimates were listed for fentanyl, hydromorphone, and oxymorphone, as those were the only covered controlled substances being adjusted. (April 10, 2020, 85 FR 20302.) Below, DEA has updated the chart to include estimations of diversion for each of the other covered controlled substances that will have proposed adjustments from what was established.

Diversion Estimates for 2019 (kg)
Fentanyl 0.090
Hydrocodone 30.294
Hydromorphone 1.424
Oxycodone 60.959
Oxymorphone 1.311

Proposed Adjustments for the 2020 Aggregate Production Quotas and Assessment of Annual Needs

The Acting Administrator, therefore, proposes to adjust the 2020 aggregate production quotas for certain schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:

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Basic Class Established
2020 Quotas
(g)
Proposed
Revised 2020
Quotas
(g)
Temporarily Scheduled
Etoxeridine N/A 25
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA N/A 25
Norfentanyl N/A 25
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine 20 no change
1-(1-Phenylcyclohexyl)pyrrolidine 15 no change
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine 10 no change
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 30 no change
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) 30 no change
1-Benzylpiperazine 25 no change
1-Methyl-4-phenyl-4-propionoxypiperidine 10 no change
1-[1-(2-Thienyl)cyclohexyl]piperidine 15 no change
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) 30 no change
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) 30 no change
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) 30 no change
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) 30 no change
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) 100 no change
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 30 no change
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) 30 no change
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 25 no change
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) 30 no change
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) 30 no change
2,5-Dimethoxy-4-ethylamphetamine (DOET) 25 no change
2,5-Dimethoxy-4-n-propylthiophenethylamine 25 no change
2,5-Dimethoxyamphetamine (DMA) 25 no change
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30 no change
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) 30 no change
3,4,5-Trimethoxyamphetamine 30 no change
3,4-Methylenedioxyamphetamine (MDA) 55 no change
3,4-Methylenedioxymethamphetamine (MDMA) 50 no change
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 40 no change
3,4-Methylenedioxy-N-methylcathinone (methylone) 40 no change
3,4-Methylenedioxypyrovalerone (MDPV) 35 no change
3-Fluoro-N-methylcathinone (3-FMC) 25 no change
3-Methylfentanyl 30 no change
3-Methylthiofentanyl 30 no change
4-Bromo-2,5-dimethoxyamphetamine (DOB) 30 no change
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 25 no change
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP) 25 no change
4CN-Cumyl-Butinaca, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide 25 no change
4-Fluoroisobutyryl fentanyl 30 no change
4-Fluoro-N-methylcathinone (4-FMC; Flephedrone) 25 no change
4-Methyl-N-ethylcathinone (4-MEC) 25 no change
4-Methoxyamphetamine 150 no change
4-Methyl-2,5-dimethoxyamphetamine (DOM) 25 no change
4-Methylaminorex 25 no change
4-Methyl-N-methylcathinone (mephedrone) 45 no change
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP) 25 no change
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) 25 no change
4-Methyl-alpha-pyrrolidinopropiophenone (4-MePPP) 25 no change
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 50 no change
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) 40 no change
5F-CUMYL-PINACA 25 no change
5F-EDMB-PINACA 25 no change
5F-MDMB-PICA 25 no change
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide 25 no change
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide) 25 no change
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 30 no change
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) 30 no change
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) 30 no change
5-Fluoro-PB-22; 5F-PB-22 20 no change
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 25 no change
5-Methoxy-3,4-methylenedioxyamphetamine 25 no change
5-Methoxy-N,N-diisopropyltryptamine 25 no change
5-Methoxy-N,N-dimethyltryptamine 25 no change
AB-CHMINACA 30 no change
AB-FUBINACA 50 no change
AB-PINACA 30 no change
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) 30 no change
Acetorphine 25 no change
Acetyl Fentanyl 100 no change
Acetyl-alpha-methylfentanyl 30 no change
Acetyldihydrocodeine 30 no change
Acetylmethadol 25 no change
Acryl Fentanyl 25 no change
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 50 no change
AH-7921 30 no change
Allylprodine 25 no change
Alphacetylmethadol 2 25
Alpha-Ethyltryptamine 25 no change
Alphameprodine 2 25
Alphamethadol 2 25
Alphaprodine 25 no change
Alpha-Methylfentanyl 30 no change
Alpha-Methylthiofentanyl 30 no change
Alpha-Methyltryptamine (AMT) 25 no change
Alpha-Pyrrolidinobutiophenone (α-PBP) 25 no change
Alpha-Pyrrolidinoheptaphenone (PV8) 25 no change
Alpha-Pyrrolidinohexanophenone (α-PHP) 25 no change
Alpha-Pyrrolidinopentiophenone (α-PVP) 25 no change
Aminorex 25 no change
Anileridine 20 no change
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) 25 no change
Benzethidine 25 no change
Benzylmorphine 30 no change
Betacetylmethadol 2 25
Beta-Hydroxy-3-methylfentanyl 30 no change
Beta-Hydroxyfentanyl 30 no change
Beta-Hydroxythiofentanyl 30 no change
Betameprodine 25 no change
Betamethadol 4 no change
Betaprodine 25 no change
Bufotenine 15 no change
Butylone 25 no change
Butyryl fentanyl 30 no change
Cathinone 40 no change
Clonitazene 25 no change
Codeine methylbromide 30 no change
Codeine-N-oxide 192 no change
Cyclopentyl Fentanyl 30 no change
Cyclopropyl Fentanyl 20 no change
Cyprenorphine 25 no change
Desomorphine 25 no change
Dextromoramide 25 no change
Diapromide 20 no change
Diethylthiambutene 20 no change
Diethyltryptamine 25 no change
Difenoxin 9,200 no change
Dihydromorphine 753,500 no change
Dimenoxadol 25 no change
Dimepheptanol 25 no change
Dimethylthiambutene 20 no change
Dimethyltryptamine 50 no change
Dioxyaphetyl butyrate 25 no change
Dipipanone 5 25
Drotebanol 25 no change
Ethylmethylthiambutene 25 no change
Etorphine 30 no change
Fenethylline 30 no change
Fentanyl related substances 40 600
FUB-144 25 no change
FUB-AKB48 25 no change
Furanyl fentanyl 30 no change
Furethidine 25 no change
Gamma-Hydroxybutyric Acid 25,417,000 29,417,000
Heroin 45 no change
Hydromorphinol 40 no change
Hydroxypethidine 25 no change
Ibogaine 30 no change
Isobutyryl Fentanyl 25 no change
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) 35 no change
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) 45 no change
JWH-073 (1-Butyl-3-(1-naphthoyl)indole) 45 no change
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) 30 no change
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) 30 no change
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) 35 no change
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) 30 no change
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) 30 no change
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) 30 no change
Ketobemidone 30 no change
Levomoramide 25 no change
Levophenacylmorphan 25 no change
Lysergic acid diethylamide (LSD) 40 no change
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 30 no change
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 30 no change
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 30 no change
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate 25 no change
Marihuana 3,200,000 no change
Mecloqualone 30 no change
Mescaline 25 no change
Methaqualone 60 no change
Methcathinone 25 no change
Methyoxyacetyl fentanyl 30 no change
Methyldesorphine 5 no change
Methyldihydromorphine 25 no change
Morpheridine 25 no change
Morphine methylbromide 5 no change
Morphine methylsulfonate 5 no change
Morphine-N-oxide 150 no change
MT-45 30 no change
Myrophine 25 no change
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 25 no change
N,N-Dimethylamphetamine 25 no change
Naphyrone 25 no change
N-Ethyl-1-phenylcyclohexylamine 5 25
N-Ethyl-3-piperidyl benzilate 10 no change
N-Ethylamphetamine 24 no change
N-Ethylhexedrone 25 no change
N-Ethylpentylone, ephylone 30 no change
N-Hydroxy-3,4-methylenedioxyamphetamine 24 no change
N-Methyl-3-Piperidyl Benzilate 30 no change
Nicocodeine 25 no change
Nicomorphine 25 no change
Noracymethadol 25 no change
Norlevorphanol 55 no change
Normethadone 25 no change
Normorphine 40 no change
Norpipanone 25 no change
Ocfentanil 25 no change
Ortho-fluorofentanyl, 2-fluorofentanyl 30 no change
Para-chloroisobutyryl fentanyl 30 no change
Para-fluorofentanyl 25 no change
Para-fluorobutyryl fentanyl 25 no change
Para-methoxybutyryl fentanyl 30 no change
Parahexyl 5 no change
PB-22; QUPIC 20 no change
Pentedrone 25 no change
Pentylone 25 no change
Phenadoxone 25 no change
Phenampromide 25 no change
Phenomorphan 25 no change
Phenoperidine 25 no change
Pholcodine 5 no change
Piritramide 25 no change
Proheptazine 25 no change
Properidine 25 no change
Propiram 25 no change
Psilocybin 30 no change
Psilocyn 50 no change
Racemoramide 25 no change
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) 45 no change
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30 no change
Tetrahydrocannabinols 384,460 no change
Tetrahydrofuranyl fentanyl 15 no change
Thebacon 25 no change
Thiafentanil 25 no change
Thiofentanyl 25 no change
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) 30 no change
Tilidine 25 no change
Trimeperidine 25 no change
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 25 no change
U-47700 30 no change
Valeryl fentanyl 25 no change
Schedule II
1-Phenylcyclohexylamine 15 no change
1-Piperidinocyclohexanecarbonitrile 25 no change
4-Anilino-N-phenethyl-4-piperidine (ANPP) 934,956 no change
Alfentanil 3,260 no change
Alphaprodine 2 25
Amobarbital 20,100 no change
Amphetamine (for conversion) 14,137,578 no change
Amphetamine (for sale) 47,000,000 42,400,000
Bezitramide 25 no change
Carfentanil 20 no change
Cocaine 82,127 73,090
Codeine (for conversion) 3,225,000 no change
Codeine (for sale) 35,341,292 no change
Dextropropoxyphene 35 no change
Dihydrocodeine 156,713 no change
Dihydroetorphine 2 25
Diphenoxylate (for conversion) 14,100 no change
Diphenoxylate (for sale) 770,800 no change
Ecgonine 88,134 78,439
Ethylmorphine 30 no change
Etorphine hydrochloride 32 no change
Fentanyl 934,956 no change
Glutethimide 25 no change
Hydrocodone (for conversion) 1,250 no change
Hydrocodone (for sale) 34,836,854 33,997,285
Hydromorphone 3,512,651 no change
Isomethadone 30 no change
Levo-alphacetylmethadol (LAAM) 5 25
Levomethorphan 30 no change
Levorphanol 38,000 31,730
Lisdexamfetamine 21,000,000 no change
Meperidine 1,463,873 1,119,862
Meperidine Intermediate-A 30 no change
Meperidine Intermediate-B 30 no change
Meperidine Intermediate-C 30 no change
Metazocine 15 no change
Methadone (for sale) 25,619,700 no change
Methadone Intermediate 27,673,600 no change
Methamphetamine 1,213,603 no change
[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 29,494 grams for methamphetamine (for sale)]
Methylphenidate 57,438,334 no change
Metopon 25 no change
Moramide-intermediate 25 no change
Morphine (for conversion) 4,089,000 3,376,696
Morphine (for sale) 33,756,703 no change
Nabilone 62,000 no change
Noroxymorphone (for conversion) 22,044,741 no change
Noroxymorphone (for sale) 376,000 no change
Opium (powder) 250,000 no change
Opium (tincture) 530,837 no change
Oripavine 33,010,750 no change
Oxycodone (for conversion) 914,010 725,998
Oxycodone (for sale) 67,593,983 65,667,554
Oxymorphone (for conversion) 28,204,371 no change
Oxymorphone (for sale) 829,051 658,515
Pentobarbital 25,850,000 no change
Phenazocine 25 no change
Phencyclidine 35 no change
Phenmetrazine 25 no change
Phenylacetone 40 no change
Piminodine 25 no change
Racemethorphan 5 no change
Racemorphan 5 no change
Remifentanil 3,000 no change
Secobarbital 172,100 no change
Sufentanil 4,000 no change
Tapentadol 13,447,541 no change
Thebaine 70,829,235 59,284,070
List I Chemicals
Ephedrine (for conversion) 25 100
Ephedrine (for sale) 4,756,000 no change
Phenylpropanolamine (for conversion) 14,100,000 no change
Phenylpropanolamine (for sale) 7,990,000 16,590,000
Pseudoephedrine (for conversion) 1,000 no change
Pseudoephedrine (for sale) 200,382,900 no change

[[Page 54421]]

The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2020 aggregate production quotas and assessment of annual needs as needed.

Conclusion

After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the Federal Register a final order establishing any adjustment of 2020 aggregate production quota for each basic class of controlled substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 21 CFR 1303.13(c) and 1315.13(f).

Timothy J. Shea,
Acting Administrator.

[FR Doc. 2020-19308 Filed 8-31-20; 8:45 am]

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NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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