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

Federal RegisterSep 2, 2021

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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

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

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],

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).

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

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

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

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

no change.

1-(1-Phenylcyclohexyl)pyrrolidine

30.

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine

no change.

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)

no change.

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)

no change.

1-Benzylpiperazine

no change.

1-Methyl-4-phenyl-4-propionoxypiperidine

no change.

1-[1-(2-Thienyl)cyclohexyl]piperidine

no change.

2′-fluoro 2-fluorofentanyl

N/A

30.

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)

no change.

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)

no change.

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)

no change.

2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)

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)

no change.

2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)

no change.

2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)

no change.

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)

no change.

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)

no change.

2,5-Dimethoxy-4-ethylamphetamine (DOET)

no change.

2,5-Dimethoxy-4-n-propylthiophenethylamine

no change.

2,5-Dimethoxyamphetamine (DMA)

no change.

2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)

no change.

2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)

no change.

3,4,5-Trimethoxyamphetamine

no change.

3,4-Methylenedioxyamphetamine (MDA)

no change.

3,4-Methylenedioxymethamphetamine (MDMA)

no change.

3,4-Methylenedioxy-N-ethylamphetamine (MDEA)

no change.

3,4-Methylenedioxy-N-methylcathinone (methylone)

no change.

3,4-Methylenedioxypyrovalerone (MDPV)

no change.

3-FMC; 3-Fluoro-N-methylcathinone

no change.

3-Methylfentanyl

no change.

3-Methylthiofentanyl

no change.

4′-Methyl acetyl fentanyl

N/A

30.

4-Bromo-2,5-dimethoxyamphetamine (DOB)

no change.

4-Bromo-2,5-dimethoxyphenethylamine (2-CB)

no change.

4-Chloro-α-pyrrolidinovalerophenone (4-chloro-alpha-PVP)

no change.

4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide

no change.

4-Fluoroisobutyryl fentanyl

no change.

4-FMC; Flephedrone

no change.

4-MEC; 4-Methyl-N-ethylcathinone

no change.

4-Methoxyamphetamine

150

no change.

4-Methyl-2,5-dimethoxyamphetamine (DOM)

no change.

4-Methylaminorex

no change.

4-Methyl-N-methylcathinone (mephedrone)

no change.

4-Methyl-α-ethylaminopentiophenone (4-MEAP)

no change.

4-Methyl-α-pyrrolidinohexiophenone (MPHP)

no change.

4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)

no change.

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol

no change.

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)

no change.

5F-CUMYL-PINACA

no change.

5F-EDMB-PINACA

no change.

5F-MDMB-PICA

no change.

5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide

no change.

5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)

no change.

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)

no change.

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1

-indazole-3-carboxamido)-3-methylbutanoate)

no change.

5F-APINACA; 5F-AKB48 (

-(adamantan-1-yl)-1-(5-fluoropentyl)-1

-indazole-3-carboxamide)

no change.

5-Fluoro-PB-22; 5F-PB-22

no change.

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1

H-

indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone

no change.

5-Methoxy-3,4-methylenedioxyamphetamine

no change.

5-Methoxy-N,N-diisopropyltryptamine

no change.

5-Methoxy-N,N-dimethyltryptamine

no change.

AB-CHMINACA

no change.

AB-FUBINACA

no change.

AB-PINACA

no change.

ADB-FUBINACA (

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1

-indazole-3-carboxamide)

no change.

Acetorphine

no change.

Acetyl Fentanyl

100

no change.

Acetyl-

alpha

-methylfentanyl

no change.

Acetyldihydrocodeine

no change.

Acetylmethadol

no change.

Acryl Fentanyl

no change.

ADB-PINACA (

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1

-indazole-3-carboxamide)

no change.

AH-7921

no change.

All other tetrahydrocannabinol

1,000

no change.

Allylprodine

no change.

Alphacetylmethadol

no change.

alpha-

Ethyltryptamine

no change.

Alphameprodine

no change.

Alphamethadol

no change.

Alphaprodine

no change.

alpha

-Methylfentanyl

no change.

alpha

-Methylthiofentanyl

no change.

alpha

-Methyltryptamine (AMT)

no change.

alpha

-Pyrrolidinobutiophenone (α-PBP)

no change.

alpha

-Pyrrolidinoheptaphenone (PV8)

no change.

alpha-

Pyrrolidinohexanophenone (α-PHP)

no change.

alpha

-Pyrrolidinopentiophenone (α-PVP)

no change.

Aminorex

no change.

Anileridine

no change.

APINCA, AKB48 (

-(1-adamantyl)-1-pentyl-1

-indazole-3-carboxamide)

no change.

Benzethidine

no change.

Benzylmorphine

no change.

Betacetylmethadol

no change.

beta

-Hydroxy-3-methylfentanyl

no change.

beta

-Hydroxyfentanyl

no change.

beta

-Hydroxythiofentanyl

no change.

beta

-Methyl fentanyl

N/A

30.

beta

-Phenyl fentanyl

N/A

30.

Betameprodine

no change.

Betamethadol

no change.

Betaprodine

no change.

Bufotenine

no change.

Butylone

no change.

Butyryl fentanyl

no change.

Cathinone

no change.

Clonitazene

no change.

Codeine methylbromide

no change.

Codeine-N-oxide

192

no change.

Cyclopentyl Fentanyl

no change.

Cyclopropyl Fentanyl

no change.

Cyprenorphine

no change.

d-9-THC

384,460

no change.

Desomorphine

no change.

Dextromoramide

no change.

Diapromide

no change.

Diethylthiambutene

no change.

Diethyltryptamine

no change.

Difenoxin

9,200

no change.

Dihydromorphine

753,500

no change.

Dimenoxadol

no change.

Dimepheptanol

no change.

Dimethylthiambutene

no change.

Dimethyltryptamine

no change.

Dioxyaphetyl butyrate

no change.

Dipipanone

no change.

Drotebanol

no change.

Ethylmethylthiambutene

no change.

Etorphine

no change.

Etoxeridine

no change.

Fenethylline

no change.

Fentanyl carbamate

N/A

30.

Fentanyl related substances

600

no change.

FUB-144

no change.

FUB-AKB48

no change.

FUB-AMB, MMB-Fubinaca, AMB-Fubinaca

no change.

Furanyl fentanyl

no change.

Furethidine

no change.

gamma

-Hydroxybutyric acid

29,417,000

no change.

Heroin

no change.

Hydromorphinol

no change.

Hydroxypethidine

no change.

Ibogaine

no change.

Isobutyryl Fentanyl

no change.

JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)

no change.

JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)

no change.

JWH-073 (1-Butyl-3-(1-naphthoyl)indole)

no change.

JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)

no change.

JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)

no change.

JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)

no change.

JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)

no change.

JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)

no change.

JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)

no change.

Ketobemidone

no change.

Levomoramide

no change.

Levophenacylmorphan

no change.

Lysergic acid diethylamide (LSD)

no change.

MAB-CHMINACA; ADB-CHMINACA (

-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1

-indazole-3-carboxamide)

no change.

MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1

-indole-3-carboxamido)-3,3-dimethylbutanoate)

no change.

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1

-indazole-3-carboxamido)-3,3-dimethylbutanoate)

no change.

MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate

no change.

Marihuana

1,500,000

2,000,000.

Marihuana extract

200,000

500,000.

Mecloqualone

no change.

Mescaline

no change.

Methaqualone

no change.

Methcathinone

no change.

Methyoxyacetyl fentanyl

no change.

Methyldesorphine

no change.

Methyldihydromorphine

no change.

Morpheridine

no change.

Morphine methylbromide

no change.

Morphine methylsulfonate

no change.

Morphine-N-oxide

150

no change.

MT-45

no change.

Myrophine

no change.

NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate

no change.

N,N

-Dimethylamphetamine

no change.

Naphyrone

no change.

-Ethyl-1-phenylcyclohexylamine

no change.

-Ethyl-3-piperidyl benzilate

no change.

-Ethylamphetamine

no change.

N-

Ethylhexedrone

no change.

N-

Ethylpentylone, ephylone

no change.

-Hydroxy-3,4-methylenedioxyamphetamine

no change.

N-Methyl-3-Piperidyl Benzilate

no change.

Nicocodeine

no change.

Nicomorphine

no change.

Noracymethadol

no change.

Norlevorphanol

2,550

no change.

Normethadone

no change.

Normorphine

no change.

Norpipanone

no change.

Ocfentanil

no change.

Ortho-fluorofentanyl, 2-fluorofentanyl

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

no change.

Para-fluorofentanyl

no change.

Para-fluorobutyryl fentanyl

no change.

para

-Fluoro furanyl fentanyl

N/A

30.

para

-Methylfentanyl

N/A

30.

Para-methoxybutyryl fentanyl

no change.

Parahexyl

no change.

PB-22; QUPIC

no change.

Pentedrone

no change.

Pentylone

no change.

Phenadoxone

no change.

Phenampromide

no change.

Phenomorphan

no change.

Phenoperidine

no change.

Phenyl fentanyl

N/A

30.

Pholcodine

no change.

Piritramide

no change.

Proheptazine

no change.

Properidine

no change.

Propiram

no change.

Psilocybin

1,500.

Psilocyn

1,000.

Racemoramide

no change.

SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)

no change.

SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)

no change.

Tetrahydrofuranyl fentanyl

no change.

Thebacon

no change.

Thiafentanil

no change.

Thiofentanyl

no change.

Thiofuranyl fentanyl

N/A

30.

THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)

no change.

Tilidine

no change.

Trimeperidine

no change.

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone

no change.

U-47700

no change.

Valeryl fentanyl

no change.

Schedule II

1-Phenylcyclohexylamine

no change.

1-Piperidinocyclohexanecarbonitrile

no change.

4-Anilino-N-phenethyl-4-piperidine (ANPP)

937,758

no change.

Alfentanil

3,260

no change.

Alphaprodine

no change.

Amobarbital

20,100

no change.

Bezitramide

no change.

Carfentanil

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

no change.

Dihydrocodeine

156,713

no change.

Dihydroetorphine

no change.

Diphenoxylate (for conversion)

14,100

no change.

Diphenoxylate (for sale)

770,800

no change.

Ecgonine

68,576

no change.

Ethylmorphine

no change.

Etorphine hydrochloride

no change.

Fentanyl

731,452

no change.

Glutethimide

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

no change.

L-amphetamine

no change.

Levo-alphacetylmethadol (LAAM)

no change.

Levomethorphan

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

no change.

Meperidine Intermediate-B

no change.

Meperidine Intermediate-C

no change.

Metazocine

no change.

Methadone (for sale)

25,619,700

no change.

Methadone Intermediate

27,673,600

no change.

Methamphetamine

no change.

D-methamphetamine (for conversion)

485,020

no change.

D-methamphetamine (for sale)

40,000

no change.

Methylphenidate (for conversion)

15,300,000.

Methylphenidate (for sale)

57,438,334

no change.

Metopon

no change.

Moramide-intermediate

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

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

no change.

Phencyclidine

no change.

Phenmetrazine

no change.

Phenylacetone

no change.

Piminodine

no change.

Racemethorphan

no change.

Racemorphan

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.

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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.