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

RESOURCES > Federal Register Notices > Quotas - 2021 > 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 2021

Quotas - 2021

[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49346-49354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18935]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688A]

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 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.


SUMMARY: The Drug Enforcement Administration proposes to adjust the 2021 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 4, 2021. 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 her 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 2021 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-688A" 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 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) 776-2265.

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 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

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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 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 DEA pursuant to 28 CFR 0.100.

DEA established the 2021 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 November 30, 2020 (85 FR 76604). 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.

Analysis for Proposed Adjusted 2021 Aggregate Production Quotas and Assessment of Annual Needs

DEA proposes to adjust the established 2021 aggregate production quotas to be manufactured in the United States in 2021 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. However, DEA's analysis does not suggest the need for adjustment of the 2021 assessment of annual needs for the List I chemicals.

Factors for Determining the Proposed Adjustments

In determining the proposed adjustments, the 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 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 2021 by considering the factors summarized below:

(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, 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 Sec. 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 Sec. 1303.24(b) and 1315.24(b) or abandoned pursuant to Sec. 1303.27 and 1315.27; and

(5) other factors affecting medical, 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 Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class 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).

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). Pursuant to these factors, DEA has determined that any calculated changes from the previously determined initial calculations are slight and not statistically significant 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 2020 year-end inventories, 2020 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 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 manufacturers, and other pertinent information.

In evaluating whether there is a need for adjustment of the 2021 assessment of annual needs for List I chemicals, 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). However, DEA's analysis does not suggest the need for adjustment of the 2021 assessment of annual needs.

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 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

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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." 21 U.S.C. 826(i)(1)(B).

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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).

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In February 2021, DEA sent letters to the Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), and the states requesting overdose death and overprescribing data that could be considered for estimating diversion. DEA did not receive information from CMS. However, DEA did receive information from the CDC in June 2021 and has started to receive information from the states. DEA has begun to receive Prescription Drug Monitoring Program (PDMP) data from the states in a format that will allow the Agency to develop a more robust methodology to assist in the determination of the diversion estimate in the future. This information will be considered in determining the estimates of diversion for the five covered controlled substances in the 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 2022.

To update the estimates of diversion, DEA used data from the Drug Theft and Loss Report, Statistical Management Analysis & Reporting Tools System (SMARTS), and System to Retrieve Information on Drug Evidence (STRIDE) 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 reports submitted 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 grams of the controlled substance being diverted. Below, DEA has updated the chart to include estimations of diversion for each of the covered controlled substances.

Diversion Estimates for 2020 (g)
Fentanyl 184
Hydrocodone 20,759
Hydromorphone 946
Oxycodone 47,316
Oxymorphone 534

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). Pursuant to these factors, DEA has determined that any calculated changes from the previously determined initial calculations are slight and not statistically significant from the quantities originally calculated for the extent of diversion that were applied to the initial aggregate production quota valuations.

Proposed Adjustments for the 2021 Aggregate Production Quotas and Assessment of Annual Needs

DEA is proposing significant increases to the APQs of the schedule I substances psilocybin, psilocin, marihuana, and marihuana extract, which are directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes. DEA firmly believes in supporting regulated research of schedule I controlled substances. Therefore, the APQ increases reflect the need to fulfill research and development requirements in the production of new drug products, and the study of marijuana effects in particular, as necessary steps toward potential Food and Drug Administration (FDA) approval of new drug products.

The DEA established the 2021 aggregate production quotas for substances in schedules I and II on November 30, 2020 (85 FR 76604). Subsequent to that publication, DEA published in the Federal Register two final rules to permanently schedule 14 specific fentanyl-related substances under the CSA (86 FR 22113, April 27, 2021, and 86 FR 23602, May 4, 2021). The specific fentanyl-related substances are 2'-fluoro 2-fluorofentanyl, 4'-Methyl acetyl fentanyl, beta-Methyl fentanyl, beta-Phenyl fentanyl, Fentanyl carbamate, ortho-Fluoroacryl fentanyl, ortho-Fluorobutyryl fentanyl, ortho-Fluoroisobutyryl fentanyl, ortho-Methyl acetylfentanyl, ortho-Methyl methoxyacetyl fentanyl, para-Fluoro furanyl fentanyl, para-Methylfentanyl, Phenyl fentanyl, and Thiofuranyl fentanyl. As a result, these substances will continue to be subject to the CSA schedule I controls and are now being assigned individual aggregate production quotas.

On March 1, 2021, DEA published a temporary scheduling order placing Brorphine in schedule I of the CSA (86 FR 11862), making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This notice proposes to establish an aggregate production quota for this substance.

On May 7, 2021, DEA published an interim final rule placing serdexmethylphenidate, a component in a combination drug product recently approved by FDA for the treatment of ADHD in patients six years of age and older, in schedule IV of the CSA (86 FR 24487). Serdexmethylphenidate is manufactured from methylphenidate, a schedule II controlled substance. In order to more accurately estimate and manage the quantity of methylphenidate necessary for direct formulation into schedule II drug products versus the

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quantity of methylphenidate necessary for the manufacturing of serdexmethylphenidate or other substances, DEA has delineated methylphenidate into methylphenidate (for sale) and methylphenidate (for conversion). This notice proposes to establish an aggregate production quota for methylphenidate (for conversion).

On June 20, 2021, DEA published the final rule to place oliceridine, a medication recently approved by FDA for medical use as an intravenous drug for the management of acute pain severe enough to require an intravenous opioid analgesic and for patients for whom alternative treatments are inadequate, in schedule II of the CSA effective July 12, 2021 (86 FR 30772). The placement of oliceridine in schedule II of the CSA, makes all regulatory controls pertaining to schedule II controlled substances applicable to the manufacture of this substance, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303.

The Administrator, therefore, proposes to adjust the 2021 aggregate production quotas for certain schedule I and II controlled substances. The Administrator does not propose an adjustment to the assessments of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The proposed adjusted APQs, as expressed in grams of anhydrous acid or base, are as follows:

Basic Class Established
2021
Quotas
(g)
Proposed
Revised 2021
Quotas
(g)
Temporarily Scheduled
Brorphine N/A 30
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine 20 no change
1-(1-Phenylcyclohexyl)pyrrolidine 15 30
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'-fluoro 2-fluorofentanyl N/A 30
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-FMC; 3-Fluoro-N-methylcathinone 25 no change
3-Methylfentanyl 30 no change
3-Methylthiofentanyl 30 no change
4′-Methyl acetyl fentanyl N/A 30
4-Bromo-2,5-dimethoxyamphetamine (DOB) 30 no change
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 25 no change
4-Chloro-α-pyrrolidinovalerophenone (4-chloro-alpha-PVP) 25 no change
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide 25 no change
4-Fluoroisobutyryl fentanyl 30 no change
4-FMC; Flephedrone 25 no change
4-MEC; 4-Methyl-N-ethylcathinone 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-α-ethylaminopentiophenone (4-MEAP) 25 no change
4-Methyl-α-pyrrolidinohexiophenone (MPHP) 25 no change
4-Methyl-α-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 35 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
All other tetrahydrocannabinol 1,000 no change
Allylprodine 25 no change
Alphacetylmethadol 25 no change
alpha-Ethyltryptamine 25 no change
Alphameprodine 25 no change
Alphamethadol 25 no change
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
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) 25 no change
Benzethidine 25 no change
Benzylmorphine 30 no change
Betacetylmethadol 25 no change
beta-Hydroxy-3-methylfentanyl 30 no change
beta-Hydroxyfentanyl 30 no change
beta-Hydroxythiofentanyl 30 no change
beta-Methyl fentanyl N/A 30
beta-Phenyl fentanyl N/A 30
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
d-9-THC 384,460 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 25 no change
Drotebanol 25 no change
Ethylmethylthiambutene 25 no change
Etorphine 30 no change
Etoxeridine 25 no change
Fenethylline 30 no change
Fentanyl carbamate N/A 30
Fentanyl related substances 600 no change
FUB-144 25 no change
FUB-AKB48 25 no change
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca 25 no change
Furanyl fentanyl 30 no change
Furethidine 25 no change
gamma-Hydroxybutyric acid 29,417,000 no change
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 1,500,000 2,000,000
Marihuana extract 200,000 500,000
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 25 no change
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 2,550 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
ortho-Fluoroacryl fentanyl N/A 30
ortho-Fluorobutyryl fentanyl N/A 30
ortho-Fluoroisobutyryl fentanyl N/A 30
ortho-Methyl acetylfentanyl N/A 30
ortho-Methyl methoxyacetyl fentanyl N/A 30
Para-chloroisobutyryl fentanyl 30 no change
Para-fluorofentanyl 25 no change
Para-fluorobutyryl fentanyl 25 no change
para-Fluoro furanyl fentanyl N/A 30
para-Methylfentanyl N/A 30
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
Phenyl fentanyl N/A 30
Pholcodine 5 no change
Piritramide 25 no change
Proheptazine 25 no change
Properidine 25 no change
Propiram 25 no change
Psilocybin 30 1,500
Psilocyn 50 1,000
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
Tetrahydrofuranyl fentanyl 15 no change
Thebacon 25 no change
Thiafentanil 25 no change
Thiofentanyl 25 no change
Thiofuranyl fentanyl N/A 30
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) 937,758 no change
Alfentanil 3,260 no change
Alphaprodine 25 no change
Amobarbital 20,100 no change
Bezitramide 25 no change
Carfentanil 20 no change
Cocaine 68,576 no change
Codeine (for conversion) 1,612,500 no change
Codeine (for sale) 27,616,684 no change
D-amphetamine (for sale) 21,200,000 no change
D,l-amphetamine 21,200,000 no change
D-amphetamine (for conversion) 14,137,578 16,068,789
Dextropropoxyphene 35 no change
Dihydrocodeine 156,713 no change
Dihydroetorphine 25 no change
Diphenoxylate (for conversion) 14,100 no change
Diphenoxylate (for sale) 770,800 no change
Ecgonine 68,576 no change
Ethylmorphine 30 no change
Etorphine hydrochloride 32 no change
Fentanyl 731,452 no change
Glutethimide 25 no change
Hydrocodone (for conversion) 1,250 no change
Hydrocodone (for sale) 30,821,224 no change
Hydromorphone 2,827,940 2,743,101
Isomethadone 30 no change
L-amphetamine 30 no change
Levo-alphacetylmethadol (LAAM) 25 no change
Levomethorphan 30 no change
Levorphanol 26,495 no change
Lisdexamfetamine 21,000,000 no change
L-methamphetamine 587,229 no change
Meperidine 856,695 no change
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 50 no change
D-methamphetamine (for conversion) 485,020 no change
D-methamphetamine (for sale) 40,000 no change
Methylphenidate (for conversion) 0 15,300,000
Methylphenidate (for sale) 57,438,334 no change
Metopon 25 no change
Moramide-intermediate 25 no change
Morphine (for conversion) 3,376,696 no change
Morphine (for sale) 27,784,062 26,505,995
Nabilone 62,000 no change
Norfentanyl 25 no change
Noroxymorphone (for conversion) 22,044,741 no change
Noroxymorphone (for sale) 376,000 no change
Oliceridine N/A 22,500
Opium (powder) 250,000 no change
Opium (tincture) 530,837 no change
Oripavine 33,010,750 no change
Oxycodone (for conversion) 620,887 no change
Oxycodone (for sale) 57,110,032 no change
Oxymorphone (for conversion) 28,204,371 no change
Oxymorphone (for sale) 563,174 no change
Pentobarbital 25,850,000 30,766,670
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 57,137,944 no change
List I Chemicals
Ephedrine (for conversion) 100 no change
Ephedrine (for sale) 4,136,000 no change
Phenylpropanolamine (for conversion) 14,878,320 no change
Phenylpropanolamine (for sale) 16,690,000 no change
Pseudoephedrine (for conversion) 1,000 no change
Pseudoephedrine (for sale) 174,246,000 no change

[[Page 49354]]

The 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 Administrator may adjust the 2021 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 Administrator will issue and publish in the Federal Register a final order establishing any adjustment of 2021 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).

Anne Milgram,
Administrator.

[FR Doc. 2021-18935 Filed 9-1-21; 8:45 am]

BILLING CODE 4410-09-P

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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