102638 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 

1Established 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 2024, 89 FR 407. 

2Proposed 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 2024, 89 FR 78764 

(September 25, 2024). 

3Adjustment to the Aggregate Production Quota 

for Lisdexamfetamine and d-Amphetamine (for 

Conversion) for 2024, 89 FR 72424 (Sept. 5, 2024). 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1228F] 

Final Adjusted Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2024 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: This final order establishes 

the final adjusted 2024 aggregate 

production quotas for controlled 

substances in schedules I and II of the 

Controlled Substances Act and the 

assessment of annual needs for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 

DATES: This order is effective December 

17, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Heather E. Achbach, Regulatory Drafting 

and Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (571) 362–3261. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

Section 306 of the Controlled 

Substances Act (CSA) (21 U.S.C. 826) 

requires the Attorney General to 

establish production quotas for each 

basic class of controlled substances 

listed in schedules I and II and for 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of the Drug 

Enforcement Administration (DEA) 

pursuant to 28 CFR 0.100. 

Background 

DEA published the 2024 established 

aggregate production quotas (APQs) for 

controlled substances in schedules I and 

II and for the assessment of annual 

needs (AAN) for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine in the Federal 

Register (FR) on January 3, 2024.1 This 

notice stated that the Administrator 

would adjust, as needed, the established 

APQ in 2024 in accordance with 21 CFR 

1303.13 and 21 CFR 1315.13. DEA is 

committed to preventing and limiting 

diversion by enforcing laws and 

regulations regarding controlled 

substances and the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, while meeting 

the legitimate medical, scientific, and 

export needs of the United States. 

The 2024 proposed adjusted APQ for 

controlled substances in schedules I and 

II and AAN for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine were 

subsequently published in the Federal 

Register on September 25, 2024 2 after 

consideration of the criteria outlined in 

that notice. All interested persons were 

invited to comment on or object to the 

proposed APQs and AANs on or before 

October 25, 2024. Prior to this notice, 

DEA also published a final order to 

increase the 2024 APQ for 

lisdexamfetamine and d-amphetamine 

(for conversion).3 Therefore, DEA 

proposed no additional changes for 

those substances. 

Comments Received 

DEA received 20 timely comments in 

response to the September Federal 

Register notice, from chronic pain 

patients and DEA-registered entities. 

The comments included requests to 

ensure sufficient availability in the APQ 

for select schedule I and schedule II 

controlled substances including 

increasing specific APQs if necessary; 

requests that DEA utilize its regulatory 

authority in additional ways; opioid 

shortage concerns; and comments 

outside the scope of this final order. 

DEA restricted three comments from 

public view due to confidential business 

information and/or confidential 

personal identifying information. 

DEA’s Regulatory Authority 

Issue: DEA-registered manufacturers 

requested the APQs for 4-Anilino-NPhenethyl-4-Piperidine, fentanyl, 

hydromorphone, morphine (for 

conversion), oxymorphone (for 

conversion), and sufentanil be reviewed 

for sufficiency and adjusted if 

necessary. 

DEA Response: DEA sets the APQs in 

a manner to meet the estimated medical, 

scientific, research, industrial needs of 

the United States, lawful export 

requirements, and for the establishment 

and maintenance of reserve stocks. As of 

the date the comment period closed for 

the proposed adjusted 2024 APQ and 

AAN, DEA believes that the proposed 

adjusted 2024 APQs are sufficient to 

meet the current estimated 2024 

legitimate medical, scientific, research, 

and industrial needs of the United 

States, for lawful export requirements, 

and to provide for adequate reserve 

stock. 

Issue: A DEA-registered manufacturer 

suggested several changes that it 

believes are necessary to deter 

companies from using the quota process 

to gain competitive advantage and to 

ensure that quota is available when 

supply chain circumstances change. 

Among these, the commenter suggested 

that DEA needs to obtain authority to 

reallocate manufacturing quota from one 

registered bulk manufacturer to another 

in the event that a finished dosage form 

manufacturer wishes, midyear, to 

procure bulk material from a different 

bulk manufacturer than originally 

planned. 

DEA Response: This comment is 

outside the scope of the current action, 

but DEA notes the commenter’s 

suggestion for future consideration. DEA 

currently can reallocate or revoke quotas 

in specific circumstances as discussed 

in 21 CFR 1303.26 and 1303.36. 

Issue: The same commenter who 

raised the immediately preceding issue 

also suggested that DEA should change 

the procurement quota application form 

(DEA Form 250) so that applicants can 

specify multiple suppliers from which 

they may procure a basic class of bulk 

controlled substance, as well as the 

estimated timeframe for receipt of the 

basic class from each supplier. 

DEA Response: The current 

procurement quota application form 

(DEA Form 250) allows for the 

applicants to specify multiple suppliers 

from which they may procure a basic 

class of bulk controlled substance, as 

well as the estimated timeframe for 

receipt of the basic class from each 

supplier. 

Issue: The same commenter who 

raised the two immediately preceding 

issues suggested that DEA specify, when 

granting quota, to which specific 

finished dosage forms the quota is to be 

applied and the proportion of the 

authorized amount that is to be used 

toward each identified dosage form. The 

manufacturer further requested that 

DEA verify during DEA inspections the 

manufacturer’s compliance with the 

details specified in the quota grant. 

DEA Response: In 21 U.S.C. 826(a)(2), 

Congress granted DEA the authority to 

delineate quota by pharmaceutical 

dosage form (tablets, capsules, oral 


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Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102639 

4Schedules of Controlled Substances: Temporary 

Placement of N-Desethyl Isotonitazene and NPiperidinyl Etonitazene in Schedule I, 89 FR 60817. 

5Schedules of Controlled Substances: Placement 

of Ethylphenidate in Schedule I, 89 FR 84281. 

liquids, etc.) if DEA determines it will 

assist in avoiding overproduction, 

shortages, or diversion of a controlled 

substance. DEA currently believes the 

designation of quota by dosage forms at 

the bulk manufacturing level could lead 

to unforeseen circumstances such as 

interference with production schedules 

or hindrance of the supply chain. 

Moreover, in compliance with 

Congress’s directive, DEA would need 

to consider whether the application of 

such detail to quotas would assist in 

avoiding overproduction, shortages, or 

diversion. 

When a manufacturer has several 

customers that use the same active 

pharmaceutical ingredient (API) to 

manufacture similar dosage forms (i.e. 

brand and generic formulations), the 

terms of the contractual agreements 

govern the transaction in normal 

circumstances. DEA does not grant 

quota to fulfill specific business 

contracts between registrants; rather, 

DEA grants quota to meet the legitimate 

medical, scientific, research, and export 

requirements while ensuring the ability 

to maintain adequate reserve stock. 

Issue: The same commenter who 

raised the three immediately preceding 

issues suggested that DEA assess ‘‘quota 

usage’’ on a quarterly or semi-annual 

basis to verify that manufacturers timely 

distribute materials that they are 

authorized under quota to manufacture, 

and to require companies to surrender 

unused quotas so that those unused 

amounts can be reassigned to others 

who can then supply the market. 

DEA Response: DEA has in the past 

and will continue to ask manufacturers 

to surrender quota that they will not be 

able to utilize in a timely manner (e.g., 

due to production scheduling issues, 

malfunctioning of manufacturing lines, 

etc.). While DEA will note for potential 

future consideration the commenter’s 

suggestion that DEA periodically assess 

quota usage, in a series of meetings held 

in the spring of 2024, numerous API and 

dosage form manufacturers informed 

DEA that a requirement to utilize quota 

quarterly would not be feasible because 

of limited capacity of production lines 

and manufacturers’ strict adherence to 

production schedules. As a result of the 

discussion, DEA is allotting commercial 

manufacturing procurement quotas for 

Schedule II non-injectable products on 

a semi-annual basis. 

Opioid Shortage Concerns 

Issue: Nine commenters expressed 

general concerns regarding a perceived 

nationwide shortage of opioid 

medication due to patients experiencing 

intermittent out-of-stock or backordered situations at pharmacies while 

attempting to fill their prescriptions. 

DEA Response: DEA utilizes the 

available, reliable data and information 

received by the agency in advance of 

publication; however drug shortages 

may occur due to factors outside of 

DEA’s control such as manufacturing 

and quality problems, processing 

delays, supply chain disruptions, or 

discontinuations. In such 

circumstances, if the drug manufacturer 

notifies the U.S. Food and Drug 

Administration (FDA) Drug Shortage 

Staff, FDA will coordinate with DEA to 

address and minimize the impact of 

drug shortages if both agencies believe 

action is warranted. Currently, FDA has 

not issued notice of any nationwide 

shortages of the type of opioid 

medications mentioned by these 

commenters. 

Out of Scope Comments: DEA 

received other comments that were 

general in nature and raised issues with 

respect to specific medical illnesses and 

medical treatments. All of the issues 

raised are outside of the scope of this 

final order for 2024 and do not impact 

the analysis involved in finalizing the 

2024 APQs. 

Analysis for Final Adjusted 2024 

Aggregate Production Quotas and 

Assessment of Annual Needs 

In determining the final adjusted 2024 

APQs and AANs, DEA has considered 

the above comments relevant to this 

final order for calendar year 2024, along 

with the factors set forth in 21 CFR 

1303.13 and 21 CFR 1315.13, in 

accordance with 21 U.S.C. 826(a). DEA 

has also considered other relevant 

factors, including the 2023 year-end 

inventories, initial 2024 manufacturing 

and import quotas, 2024 export 

requirements, actual and projected 2024 

sales, research and product 

development requirements, additional 

applications received, and the extent of 

any diversion of the controlled 

substance in the class. Based on all of 

the above, the Administrator is 

finalizing the adjusted APQs in the 

same amounts as proposed. 

On July 29, 2024, DEA published a 

temporary scheduling order placing Ndesethyl isotonitazene and Npiperidinyl etonitazene in schedule I of 

the CSA, 4 and on October 25, 2024, 

DEA published a final rule placing 

ethylphenidate in schedule I of the 

CSA, 5 making all regulatory controls 

pertaining to schedule I controlled 

substances applicable to the 

manufacture of these substances, 

including the requirement to establish 

an APQ pursuant to 21 U.S.C. 826 and 

21 CFR part 1303. This final order 

establishes an APQ for these substances 

for the first time. 

Pursuant to the above, the 

Administrator hereby finalizes the 2024 

APQs for the following schedule I and 

II controlled substances and the 2024 

AANs for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

BILLING CODE 4410–P 


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Final Adjusted 

Basic Class 2024 Quotas 

(2) 

Schedule I 

-[ 1-(2-Thieny l)cyclohexy l ]pyrrolidine 20 

1-( 1-Pheny lcyclohexyl)pyrrolidine 30 

1-(2-Pheny lethy 1)-4-pheny 1-4-acetoxypiperidine 10 

1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 30 

1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) 30 

1-[ 1-(2-Thieny I )cyclohexy l]piperidine 15 

2'-fluoro 2-fluorofentanyl 30 

1-Benzylpiperazine 25 

1-Methy 1-4-phenyl-4-propionoxypiperidine 10 

2-(2,5-D imethoxy-4-ethy lpheny l)ethanamine (2C-E) 30 

2-(2,5-Dimcthoxy-4-mcthylphcnyl)cthanaminc (2C- 30 D) 

2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) 30 

2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C- 30 P) 

2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) 100 

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-

methoxybenzyl)ethanamine (25B-NBOMe; 2C-B- 30 

NBOMe; 25B; Cimbi-36) 

2-( 4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) 30 

2-( 4-Chloro-2,5-dimethoxyphenyl)-N-(2-

methoxybenzyl)ethanamine (25C-NBOMe; 2C-C- 25 

NBOMe; 25C; Cimhi-82) 

2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) 30 

2-( 4-Iodo-2,5-dimethoxyphenyl)-N-(2-

methoxybenzyl)ethanamine (251-NBOMe; 2C-I- 30 

NBOMe; 251; Cimbi-5) 

2,5-Dimethoxy-4-ethylamphetamine (DOET) 25 

2,5-Dimcthoxy-4-n-propylthiophcncthylaminc 25 

2,5-Dimethoxyamphetamine 25 

2-[ 4-(Ethylthio )-2,5-dimethoxyphenyl]ethanamine 30 (2C-T-2) 

2-[ 4-(Isopropylthio )-2,5- 30 dimethoxypheny l]ethanamine (2C-T-4) 

2-Methyl AP-237 30 

3 ,4,5-Trimethoxyamphetamine 30 

3,4-Methylenedioxyamphetamine (MDA) 12,000 

3 ,4-Methy lenedioxymethamphetamine (MD MA) 12,000 

3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 40 

3,4-Methylenedioxy-N-methylcathinone (methylone) 5,200 

3 ,4-Methy lenedioxypyrovalerone (MDPV) 35 
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3-FMC; 3-Fluoro-N-methylcathinone 25 

3-Methylfentanyl 30 

3-Methylmethcathinone 30 

3-Methylthiofentanyl 30 

4,4'-Dimethylaminorex 30 

4-Bromo-2,5-dimethoxyamphetamine (DOB) 30 

4-Bromo-2,5-dimelhoxyphenelhy lamine (2-CB) 5,100 

4-Chloro-alpha-pyrrolidinovalerophenone ( 4-chloro- 25 alpha-PVP) 

4-CN-Cumyl-Butinaca 25 

4-Fluoroisobutyryl fentanyl 30 

4F-MDMB-BINACA 30 

4F-MDMB-BUTTCA 30 

4-PMC; Plephedrone 25 

4-MEC; 4-Melhyl-N-ethylcalhinone 25 

4-Methoxyamphetamine 150 

4-methyl-l-phenyl-2-(pyrrolidin-l-yl)pentan-l-one 30 (alpha-PiHP) 

4-Methyl-2,5-dimethoxyamphetamine (DOM) 25 

4-Methylaminorex 25 

4-Methyl-N-methylcathinone ( mephedrone) 45 

4-Methyl-alpha-ethylaminopentiophenone ( 4-MEAP) 25 

4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) 25 

4'-Methyl acetyl fentanyl 30 

4-Methyl-a-pyrrolidinopropiophenone ( 4-MePPP) 25 

5-(1, 1-Dimethylheptyl)-2-[(lR,3S)-3- 50 hvdroxvcvclohexvll-ohenol 

5-( 1, l-Dimethyloctyl)-2-[(lR,3S)-3-

hydroxycyclohexyl]-phenol ( cannabicyclohexanol or 40 

CP-47.497 C8-homolog) 

5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2- 25 yl)-1-(5-fluoropentyl)-lH-indazole-3-carboxamide 

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-

fluoropentyl)-1 H-indazole-3-carboxamido )-3,3- 25 

dimethvlbutanoate) 

5P-CUMYL-P7AICA; 1-(5-Pluoropentyl)-N-(2-

phenylpropan-2-yl)-1H-pyrrolo[2,3-b ]pyridine- 25 

3carboximide 

5F-CUMYL-PINACA 25 

5F-EDMB-PICA 30 

5F-EDMB-PINACA 25 

5F-MDMB-PICA r _:, 

5F-AMB (methyl 2-(1-(5-fluoropentyl)-lH-indazole3-carboxamido)-3-methvlbutanoate) 

r _:, 

5F-APINACA; 5F-AKB48 (N-(adamantan-l-yl)-1-(5-

fluoropentyl)-1 H-indazole-3-carboxamide) 

r _:, 

5-Fluoro-PB-22; 5F-PB-22 25 
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5-Fluoro-UR144, XLRl l ([1-(5-fluoro-pentyl)-

11Iindol-3-yl](2,2,3,3- 25 

tetramethy lcyclopropyl)methanone 

5-Methoxy-3 ,4-methylenedioxyamphetamine 25 

5-Methoxy-N,N-diisopropyltryptamine 25 

5-Methoxy-N,N-dimethyltryptamine 11,000 

AB-CHMINACA 30 

AB-FUBTNACA 50 

AB-PINACA 30 

ADB-4en-PINACA 30 

ADB-BUTINACA 30 

ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-

oxobutan-2-yl)-1-( 4-fluorobenzyl)-lH-indazole-3- 30 

carboxan1ide) 

Acetorphine 25 

Acetyl Fentanyl 100 

Acetyl-alpha-methy lfentanyl 30 

Acetyldihydrocodeine 30 

Acctylmcthadol 25 

Acryl Fentanyl 25 

ADB-PINACA (N-(1-amino-3,3-dimethyl-1- 50 oxobutan-2-yl)-l-pentyl-1 H-indazole-3-carboxamide) 

AH-7921 30 

All other tetrahydrocannabinol 1,166,130 

Allylprodine 25 

Alphacctylmcthadol 25 

alpha-Ethyltryptamine 25 

Alphameprodine 25 

Alphamethadol 25 

alpha-Methylfentanyl 30 

alpha-Methylthiofentanyl 30 

alpha-Methyltryptamine (AMT) 25 

alpha-Pyrrolidinobutiophcnonc ( a-PBP) 25 

alpha-pyrrolidinoheptaphenone (PV8) 25 

alpha-pyrrolidinohexabophenone ( alpha-PHP) 25 

alpha-Pyrrolidinopentiophenone ( a-PVP) 25 

Amineptine 30 

Aminorex 25 

Anileridine 20 

APINCA, AKB48 (N-(l-adamantyl)-1-pentyl-lII- 25 indazole-3-carboxamide) 

Bcnzcthidinc 25 

Benzy !morphine 30 

Betacetylmethadol 25 

beta-Hydroxy-3-methylfentanyl 30 

beta-Hydroxyfentanyl 30 
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beta-Hydroxythiofentanyl 30 

beta-Methyl fentanyl 30 

beta'-Phenyl fentanyl 30 

Betameprodine 25 

Bctamcthadol 4 

Betaprodine 25 

Brorphine 30 

Bufotenine 15 

Butonitazene 30 

Butylone 25 

Butyryl fentanyl 30 

Cathinone 40 

Clonazolam 30 

Clonitazene 25 

Codeine methylbromide 30 

Codeine-N-oxide 192 

Crotonyl Fentanyl 25 

CUMYL-PEGACLONE 30 

Cyclopentyl Fentanyl 30 

Cyclopropyl Fentanyl 20 

Cyprenorphine 25 

d-9-THC 1,523,040 

Desomorphine 25 

Dextromoramide 25 

Diapromide 20 

Diclazepam 30 

Diethylthiambutene 20 

Diethy ltryptamine 25 

Difcnoxin 9,300 

Dihydromorphine 639,954 

Dimenoxadol 25 

Dimepheptanol 25 

Dimethylthiambutene 20 

Dimethyltryptamine 11,000 

Dioxyaphetyl butyrate 25 

Dipipanonc 25 

Drotebanol 25 

Ethylmethylthiambutene 25 

Ethylone 25 

Ethylphenidale 30 

Etizolam 30 

Etodesnitazene 30 

Etonitazene 25 

Etorphine 30 

Etoxeridine 25 
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Eutylone 30 

Fenethylline 30 

Fentanyl carbamate 30 

Fentanyl related substances 600 

Flualprazolam 30 

Flubromazolam 30 

Flunitazene 30 

FUB-144 25 

FUB-AKB48 25 

Fub-AMB, MMB-Fubinaca, AMB-Fubinaca 25 

Furanyl fentanyl 30 

Furethidine 25 

gamma-Hydroxybutyric acid 29,417,000 

Heroin 150 

Hydromorphinol 40 

Hydroxypethidine 25 

Ibogaine 150 

Isobutyryl Fentanyl 25 

lsotonitazine 25 

JWH-018 and AM678 (l-Pentyl-3-(1- 35 naphthoy 1 )indole) 

JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) 45 

JWH-073 (l-Butyl-3-(1-naphthoyl)indole) 45 

JWH-081 (1-Pentyl-3-[l-(4- 30 methoxynaphthoy I) lindole) 

JWH-122 (1-Pentyl-3-( 4-methyl-1-naphthoyl)indole) 30 

.IWH-200 (1-l2-(4-Morpholinyl)ethylj-3-(l- 35 naohthov l)indole) 

JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) 30 

JWH-250 (1-Pentyl-3-(2- 30 methoxypheny lacetyl)indole) 

JWH-398 (1-Pentyl-3-( 4-chloro-1-naphthoyl)indole) 30 

Ketobemidone 30 

Levomoramide 25 

T .evophenyacylmorphan 25 

Lysergic acid diethylamide (LSD) 1,200 

MAB-CHMINACA; ADB-CHMINACA (N-(1-

aniino-3 ,3-dimethyl-1-oxobutan-2-yl)-1- 30 

(cvclohexv lmethv l)-1 H-indazole-3-carboxamide) 

MDMB-4en-PINACA 30 

MDMB-CHMTCJ\; MMB-CHMTNJ\CJ\(methyl 2-(1-

( cyclohexylmethyl)-lH-indole-3-carboxamido )-3,3- 30 

dimcthv lbutanoatc) 

MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)- 30 1 H-indazole-3-carboxan1ido)-3,3-dimethylbutanoate) 

MMB-CHMICA-(AMB-CHIMCA ); Methyl-2-(1- 25 ( cvclohexvlmethyl)-lH-indole-3-carboxamido )-3-
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methy lbutanoate 

MMB-FUBICA 30 

Marijuana 6,675,000 

Marijuana extract 1,000,000 

Mecloqualone 30 

Mescaline 1,200 

Mesocarb 30 

Methaqualone 60 

Methcathinone 25 

Methiopropamine 30 

Methoxetamine 30 

Methoxyacety I fentany I 30 

Methyldesorphine 5 

Methyldihydromorphine 25 

Metodesnitazene 30 

Metonitazene 30 

Morpheridine 25 

Morphine methylbromide 5 

Morphine methylsulfonate 5 

Morphine-N-oxide 150 

MT-45 30 

Myrophine 25 

NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-lH- 25 indole-3-carboxylate 

N,N-Dimethylamphetamine 25 

Naphyronc 25 

N-Ethyl-1-phenylcyclohexylamine 25 

N-Ethyl-3-piperidyl benzilate 10 

N-Ethylamphetamine 24 

N-Ethy lhexedrone 25 

N-Ethylpentylone, ephylone 30 

N-Hydroxy-3,4-methylenedioxyamphetamine 24 

Nicocodeine 25 

Nicomorphine 25 

N-Desethyl Isotonitazene 30 

N-methyl-3-piperidyl benzilate 30 

N-Piperidiny I Etonitazene 30 

N-Pyrrolidino Etonitazene 30 

Noracymcthadol 25 

Norlevorphanol 2,550 

Normethadone 25 

Normorphine 40 

Norpipanone 25 

Ocfentanil 25 

ortho-Fluoroacryl fentanyl 30 
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ortho-Fluoro butyry l fentany l 30 

ortho-Pluorofentany 1,2-Pluorofentany 1 30 

ortho-Fluoroisobutyryl fentanyl 30 

ortho-Methyl acetylfentanyl 30 

ortho-Methyl methoxyacetyl fentanyl 30 

Para-Chloriso butyrl fentany 1 30 

Para-flourobutyryl fentanyl 25 

Para-fl uorof entany l 25 

para-Fluoro furanyl fentanyl 30 

Para-Methoxybutyrl fentanyl 30 

Para-methoxymethamphetamine 30 

para-Methy lfentany 1 30 

Parahexyl 5 

PB-22; QUPIC 20 

Pentedrone 25 

Pentylone 25 

Phenadoxone 25 

Phenampromide 25 

Phenomorphan 25 

Phenoperidine 25 

Phenyl fentanyl 30 

Pholcodine 5 

Piritran1ide 25 

Proheptazine 25 

Properidine 25 

Propiram 25 

Protonitazene 30 

Psilocybin 30,000 

Psilocyn 36,000 

Racemoran1ide 25 

SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45 methoxypheny lacety 1 )indole) 

SR-19 and RCS-4 (l-Pentyl-3-[(4-methoxy)- 30 benzoy 1 lindole) 

Tetrahydrofuranyl fentanyl 15 

Thebacon 25 

Thiafentanil 25 

Thiofcntanyl 25 

Thiofuranyl frntanyl 30 

THJ-2201 ( [1-(5-fluoropentyl)-IH-indazol-3- 30 yll(naphthalen-1-yl)methanone) 

Tilidine 25 

Trimeperidine 25 

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- 25 tetramethy lcyclopropyl)methanone 

U-47700 30 
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102647 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.093</GPH>

Valeryl fentanyl 25 

Zipeprol 30 

Schedule II 

1-Phenylcyclohexylamine 15 

1-P iperidinocyclohexanecarbonitrile 25 

4-Anilino-N-phenethyl-4-piperidine (ANPP) 937,874 

Alfentanil 5,000 

Alphaprodine 25 

Amo barbital 20,100 

Beziiramide 25 

Carfentanil 20 

Cocaine 60,492 

Codeine (for conversion) 942,452 

Codeine (for sale) 19,262,957 

cl-amphetamine (for sale) 21,200,000 

d,1-amphetamine 21,200,000 

cl-amphetamine (for conversion) 23,688,235 

Dexmethylphenidate (for sale) 6,200,000 

Dexmethylphenidate (for conversion) 5,374,683 

Dextropropoxyphene 35 

Dihydrocodeine 115,227 

Dihydroctorphinc 25 

Diphenoxylate (for conversion) 14,100 

Diphenoxylate (for sale) 770,800 

Ecgonine 60,492 

Ethylmorphine 30 

Etorphine hydrochloride 32 

Fentanyl 731,341 

Glutethimide 25 

Hydrocodone (for conversion) 1,250 

Hydrocodone (for sale) 27,121,498 

Hydromorphone 1,951,508 

Isomethadone 30 

L-amphetamine 30 

Levo-alphacetylmethadol (LAAM) 25 

Levomethorphan 30 

Levorphanol 20,000 

Lisdexamfetamine 32,736,000 

Meperidine 681,184 

Meperidine Intermediate-A 30 

Meperidine Intermediate-B 30 

Meperidine lntermediate-C 30 

Metazocine 15 

Methadone (for sale) 25,619,700 
102648 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 

BILLING CODE 4410–C The Administrator also establishes 

that APQs for all other schedule I and 

II controlled substances included in 21 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.094</GPH>

Methadone Intermediate 27,673,600 

d,1-Methamphetamine 150 

d-methamphetamine (for conversion) 485,020 

d-methamphetamine (for sale) 47,000 

1-methamphetamine 587,229 

Methylphenidate (for sale) 53,283,000 

Methylphenidate (for conversion) 19,975,468 

Metopon 25 

Moramidc-intcrmcdiatc 25 

Morphine (for conversion) 2,393,200 

Morphine (for sale) 20,805,957 

Nabilone 62,000 

Norfentanyl 25 

Noroxymorphone (for conversion) 24,756,979 

Noroxymorphone (for sale) 1,000 

Oliceridine 25,100 

Opium (powder) 250,000 

Opiwn (tincture) 530,837 

Oripavine 37,721,950 

Oxycodonc (for conversion) 437,827 

Oxycodone (for sale) 53,584,449 

Oxymorphone (for conversion) 31,773,105 

Oxymorphone (for sale) 464,464 

Pentobarbital 40,000,000 

Phenazocine 25 

Phencyclidine 35 

Phenmetrazine 25 

Pheny lacetone 100 

Piminodine 25 

Racemethorphan 5 

Racemorphan 5 

Remifentanil 3,000 

Secobarbital 172,100 

Sufentanil 4,000 

Tapentadol 10,390,226 

Thebaine 57,137,944 

List I Chemicals 

Ephedrine (for conversion) 41,100 

Ephedrine ( for sale) 3,933,336 

Phenylpropanolamine (for conversion) 14,878,320 

Phenylpropanolamine (for sale) 7,990,000 

Pseudoephedrine (for conversion) 1,000 

Pseudoephedrine (for sale) 186,617,466 
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102649 

1Proposed 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 2025, 89 FR 78772 

(September 25, 2024). 

CFR 1308.11 and 1308.12 remain at 

zero. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 13, 2024, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2024–30019 Filed 12–16–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1413E] 

Established 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 2025 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: This final order establishes 

the initial 2025 aggregate production 

quotas for controlled substances in 

schedules I and II of the Controlled 

Substances Act and the assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

DATES: This order is effective December 

17, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Heather E. Achbach, Regulatory Drafting 

and Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (571) 776–3882. 

SUPPLEMENTARY INFORMATION: 

I. Legal Authority 

Section 306 of the Controlled 

Substances Act (CSA) (21 U.S.C. 826) 

requires the Attorney General to 

establish production quotas for each 

basic class of controlled substance listed 

in schedule I and II and ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of the Drug 

Enforcement Administration (DEA) 

pursuant to 28 CFR 0.100. 

II. Background 

The 2025 aggregate production quotas 

(APQ) and assessment of annual needs 

(AAN) represent those quantities of 

schedule I and II controlled substances 

and the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine that may be 

manufactured in the United States in 

2025, in order to provide for the 

estimated medical, scientific, research, 

and industrial needs of the U.S., lawful 

export requirements, and the 

establishment and maintenance of 

reserve stocks. These quotas include 

imports of ephedrine, pseudoephedrine, 

and phenylpropanolamine, but do not 

include imports of controlled 

substances for use in industrial 

processes. 

On September 25, 2024, a notice titled 

‘‘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 2025’’ was 

published in the Federal Register.1 This 

notice proposed the 2025 APQs for each 

basic class of controlled substance listed 

in schedules I and II and the 2025 AANs 

for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. All interested 

persons were invited to comment on or 

object to the proposed APQs and the 

proposed AANs on or before October 25, 

2024. 

III. Comments Received 

Within the public comment period, 

DEA received 1,882 comments from 

DEA registrants, chronic pain patients, 

patients with attention deficit/ 

hyperactivity disorder (ADHD), pain 

advocacy associations, U.S. professional 

associations, U.S. doctors and nurses, 

and others. The comments included 

concerns about potential domestic 

opioid drug shortages due to further 

quota reductions; patient difficulty 

filling authorized opioid prescriptions; 

increases in drug overdose deaths 

despite a continued decrease in 

production quotas; requests for an 

extension to the comment period; 

stimulant drug shortages in the United 

States; concerns that medical 

professionals might be impeded from 

exercising their medical expertise 

regarding opioid prescriptions; requests 

for a public hearing; and comments not 

pertaining to DEA-regulated activities. 

While all comments were posted to 

regulations.gov, DEA restricted the 

attachments to 10 comments from 

public view due to confidential business 

information and/or confidential 

personal identifying information. 

Opioid Adequacy 

Issue (National Production Levels of 

Proposed APQs for Opioids Compared 

to 2024 levels): DEA received a 

significant number of comments from 

pain advocacy groups, hospital 

associations, health professionals, and 

others who raised concerns over the 

proposed APQs for certain opioids in 

2025, which were proposed at a level 

lower than the established production 

levels for 2024. The commenters 

suggested that the proposed APQ levels 

could exacerbate shortages experienced 

in 2024. 

DEA Response: DEA considers 

numerous factors in determining an 

APQ, including total net disposal of the 

class by all manufacturers during the 

current and two preceding years, trends 

in the national rate of net disposal of the 

class, total actual or estimated 

inventories of the class and of all 

substances manufactured from the class, 

information obtained from the Food and 

Drug Administration (FDA), and 

changes in the currently accepted 

medical use in treatment. 21 U.S.C. 

826(a); 21 CFR 1303.11(b). Additional 

factors considered can be found in 21 

CFR 1303.11(b). After considering all of 

the relevant factors, DEA has 

determined that the proposed APQs for 

the five covered controlled substances— 

fentanyl, hydrocodone, hydromorphone, 

oxycodone and oxymorphone—are 

sufficient to meet the forecasted 

legitimate domestic and foreign needs 

and allow for maintenance of reserve 

stocks. These considerations also lead 

DEA to conclude that U.S. 

manufacturers will need to manufacture 

approximately the same amount of those 

opioids in 2025 as in 2024 in order to 

meet legitimate needs. 

Accordingly, DEA proposed the 2025 

APQs for those five substances at the 

same level as in DEA’s proposed revised 

APQs for 2024 published on September 


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