78772 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

15 21 CFR 1303.13(c) and 1315.13(c). 

Basic class 

Established 

2024 quotas 

(g) 

Proposed 

revised 2024 

quotas 

(g) 

Sufentanil ................................................................................................................................................................. 4,000 no change 

Tapentadol ............................................................................................................................................................... 10,390,226 no change 

Thebaine .................................................................................................................................................................. 57,137,944 no change 

List I Chemicals 

Ephedrine (for conversion) ...................................................................................................................................... 41,100 no change 

Ephedrine (for sale) ................................................................................................................................................. 3,933,336 no change 

Phenylpropanolamine (for conversion) .................................................................................................................... 14,878,320 no change 

Phenylpropanolamine (for sale) ............................................................................................................................... 7,990,000 no change 

Pseudoephedrine (for conversion) .......................................................................................................................... 1,000 no change 

Pseudoephedrine (for sale) ..................................................................................................................................... 186,617,466 no change 

The Administrator further proposes 

that the APQ 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 2024 APQ 

and AAN 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 the 

2024 APQ for each basic class of 

controlled substances in schedules I and 

II and AAN for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine.15

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on September 20, 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. 2024–21960 Filed 9–20–24; 4:15 pm] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1413P] 

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 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes to 

establish the 2025 aggregate production 

quotas for controlled substances in 

schedules I and II of the Controlled 

Substances Act (CSA) and the 

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 1303.11(c) and 

1315.11(d). Electronic comments must 

be submitted, and written comments 

must be postmarked, on or before 

October 25, 2024. 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 2025 aggregate 

production quotas for schedule I and II 

controlled substances, and an 

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–1413P’’ 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/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

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, Virginia 

22152, Telephone: (571) 776–3882. 


ddrumheller on DSK120RN23PROD with NOTICES7
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78773 

1Proposed Adjustments to the Aggregate 

Production Quotas for Schedule I and II Controlled 

Substances and Assessment of Annual Needs for 

List I Chemicals Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2020, 85 FR 54414 (Sept. 

1, 2020) and Proposed Aggregate Production Quotas 

for Schedule I and II Controlled Substances and 

Assessment of Annual Needs for List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2021, 85 FR 54407 (Sept. 

1, 2020). 

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 

Section 306 of the Controlled 

Substances Act (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 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. 

Analysis for Proposed 2025 Aggregate 

Production Quotas and Assessment of 

Annual Needs 

The proposed 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, to be 

manufactured in the United States in 

2025 to provide for the estimated 

medical, scientific, research, and 

industrial needs of the United States, 

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. 

Aggregate Production Quotas 

In determining the proposed 2025 

APQ, the Administrator has taken into 

account the criteria of 21 U.S.C. 826(a) 

and 21 CFR 1303.11, including the 

following seven factors: 

(1) Total net disposal of the class by 

all manufacturers during the current 

and two preceding years; 

(2) Trends in the national rate of net 

disposal of the class; 

(3) Total actual (or estimated) 

inventories of the class and of all 

substances manufactured from the class, 

and trends in inventory accumulation; 

(4) Projected demand for such class as 

indicated by procurement quotas 

requested pursuant to [21 CFR] 1303.12; 

(5) The extent of any diversion of the 

controlled substance in the class; 

(6) Relevant information obtained 

from the Department of Health and 

Human Services (HHS), including from 

the Food and Drug Administration 

(FDA), the Centers for Disease Control 

and Prevention (CDC), and the Centers 

for Medicare and Medicaid Services 

(CMS), and relevant information 

obtained from the states; and 

(7) Other factors affecting medical, 

scientific, research, and industrial needs 

in the United States and lawful export 

requirements, as the Administrator finds 

relevant, including changes in the 

currently accepted medical use in 

treatment with the class or the 

substances 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 1303.11(b). 

DEA formally solicited input from 

FDA and CDC in February of 2024 and 

from the states in April 2024, as 

required by 21 U.S.C. 826 and 21 CFR 

part 1303. DEA did not solicit input 

from CMS for reasons discussed in 

previous notices.1 DEA requested 

information on trends in the legitimate 

use of select schedule I and II controlled 

substances from FDA and rates of 

overdose deaths for covered controlled 

substances from CDC. DEA’s request for 

information from the states was made 

directly to the Prescription Drug 

Monitoring Program (PDMP) 

Administrators in each state as well as 

through the National Association of 

State Controlled Substances Authorities 

(NASCSA). 

Assessment of Annual Needs 

In similar fashion, in determining the 

proposed 2025 AAN for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine, the 

Administrator has taken into account 

the criteria of 21 U.S.C. 826(a) and 21 

CFR 1315.11, including the following 

five factors: 

(1) Total net disposal of the chemical 

by all manufacturers and importers 

during the current and two preceding 

years; 

(2) Trends in the national rate of net 

disposal of each chemical; 

(3) Total actual (or estimated) 

inventories of the chemical and of all 

substances manufactured from the 

chemical, and trends in inventory 

accumulation; 

(4) Projected demand for each 

chemical as indicated by procurement 

and import quotas requested pursuant to 

[21 CFR] 1315.32; and 

(5) Other factors affecting medical, 

scientific, research, and industrial needs 

in the United States, lawful export 

requirements, and the establishment 

and maintenance of reserve stocks, as 

the Administrator finds relevant, 

including changes in the currently 

accepted medical use in treatment with 

the chemicals or the substances 

manufactured from them, the economic 


ddrumheller on DSK120RN23PROD with NOTICES7
78774 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

2New Long-Haul COVID Clinics Treat Mysterious 

and Ongoing Symptoms, Scientific American, June 

30, 2021; Successful Treatment of Post-COVID–19 

ADHD-like Syndrome-A case Report, J Atten 

Disord., 2023 Aug; 27(10): 1092–1098. 

3Adjustment to the Aggregate Production Quota 

for Lisdexamfetamine and d-Amphetamine (for 

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

4The estimates of diversion for five ‘‘covered 

controlled substances’’ as required by 21 U.S.C. 

826(i) are discussed later in the document. 

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 1315.11(b). 

In determining the proposed 2025 

AAN, DEA used the calculation 

methodology previously described in 

the 2010 and 2011 assessments of 

annual needs (74 FR 60294 (Nov. 20, 

2009) and 75 FR 79407 (Dec. 20, 2010), 

respectively). 

Estimates of Medical Need for Schedule 

II Opioids and Stimulants 

In accordance with 21 CFR part 1303, 

21 U.S.C. 826, and 42 U.S.C. 242, HHS 

continues to provide DEA with 

estimates of the quantities of select 

schedule I and II controlled substances 

and three list I chemicals that will be 

required to meet the legitimate medical 

needs of the United States for a given 

calendar year. The responsibility to 

provide these estimates of legitimate 

domestic medical needs resides with 

FDA. FDA provides DEA with predicted 

estimates of domestic medical usage for 

selected controlled substances based on 

information available to them at a 

specific point in time in order to meet 

statutory requirements. 

FDA predicts that levels of medical 

need for schedule II opioids in the 

United States in calendar year 2025 will 

decline on average 6.6 percent from 

calendar year 2024 levels. These 

declines are expected to occur across a 

variety of schedule II opioids including 

fentanyl, hydrocodone, hydromorphone, 

oxycodone, and oxymorphone. DEA 

considered the potential for diversion of 

schedule II opioids, as required by 21 

CFR 1303.11(b)(5), as well as a potential 

increase in demand for certain opioids 

identified as being necessary to support 

the previously postponed elective 

surgeries now that the COVID–19 public 

health emergency (PHE) has ended, 

pursuant to 21 CFR 1303.11(b)(7), in 

developing the proposed 2025 APQ. 

FDA predicted an average of a 3.5 

percent increase in domestic medical 

use of the schedule II stimulants 

amphetamine, methylphenidate 

(including dexmethylphenidate), and 

lisdexamfetamine, which are prescribed 

to treat patients with attention deficit 

hyperactivity disorder (ADHD) and 

more recently prescribed off-label to 

treat patients diagnosed with longCOVID symptoms commonly known as 

brain fog where fatigue and cognitive 

impairment persist 4 to 12 weeks after 

a COVID infection.2 FDA also raised 

concerns over drug shortage 

notifications it received since 2022 from 

patients for specific ADHD medications 

containing amphetamine, 

lisdexamfetamine, and 

methylphenidate. FDA’s stated reasons 

for these specific shortages include 

increased prescribing potentially related 

to the growth in telemedicine during 

and after the COVID–19 PHE, supply 

chain issues, manufacturing and quality 

issues, lack of active ingredients, and 

business decisions of manufacturers. 

DEA considered FDA’s concerns when 

determining the APQ for these 

substances. Additionally, DEA 

considered manufacturer and 

distributor-reported data which shows 

inventories for both amphetamine and 

methylphenidate-based products have 

increased year-over-year throughout the 

supply chain. DEA believes these 

increases in inventories combined with 

the established APQs are adequate to 

address FDA’s estimated increases in 

domestic medical use for amphetamine 

and methylphenidate. With respect to 

lisdexamfetamine, DEA recently 

increased the APQ pursuant to a final 

order published on September 5, 2024 

to address reported shortages.3 In sum, 

DEA believes that manufacturers will be 

able to meet the increase in domestic 

medical need for these three schedule II 

stimulants with the APQs proposed in 

this notice. 

DEA Projected Trends for Certain 

Schedule I Controlled Substances 

DEA is proposing a higher APQ for 

ibogaine than DEA granted for 2024 to 

support manufacturing activities related 

to the increased level of research and 

clinical trials with this schedule I 

controlled substance. Additionally, DEA 

proposes a higher APQ for gamma 

hydroxybutyric acid (GHB) to allow for 

an anticipated increase in domestic bulk 

manufacturing to meet forecasted and 

continued domestic market need due to 

the closure of a foreign manufacturing 

facility. Imports of the schedule III 

oxybate form of GHB from that 

manufacturing facility have supplied an 

estimated 78% of the domestic need. 

Their foreign plant closure will be 

approximately one year in duration. 

GHB (oxybate) products are used in the 

treatment of patients diagnosed with 

narcolepsy and cataplexy. 

Information Received for Consideration 

of the Remaining Factors 

For the factors listed in 21 CFR 

1303.11(b)(3) and (4), DEA registered 

manufacturers of controlled substances 

in schedules I and II provide 

information such as inventory, 

distribution, manufacturing, sales 

forecasts and quota requests to DEA 

database systems. See 21 CFR 1303.12, 

1303.22, and part 1304. 

The regulation at 21 CFR 

1303.11(b)(5) requires DEA to consider 

the extent of diversion of controlled 

substances.4 Diversion is defined as all 

distribution, dispensing, or other use of 

controlled substances for other than 

legitimate medical purposes. In order to 

consider the extent of diversion, DEA 

analyzed reports of diversion of 

controlled substances from 2023 

submitted to its Theft Loss Report 

database. This database is comprised of 

DEA registrant reports documenting 

diversion from the legitimate 

distribution chain, including employee 

thefts, break-ins, armed robberies, and 

material lost in transit. The data was 

categorized by basic drug class, and the 

amount of active pharmaceutical 

ingredient (API) in the dosage form was 

delineated with an appropriate metric 

for use in proposing aggregate 

production quota values (i.e., weight). 

In this proposed 2025 APQ notice, 

DEA continues to consider the lingering 

effects of the COVID–19 pandemic on 

the global supply chain, pursuant to 21 

CFR 1303.11(b)(7), and specifically the 

continued impacts on the availability of 

raw materials for use in the domestic 

manufacturing process. Additionally, 

DEA considered the impact of the 

demand for surgical care for elective 

surgeries that were deferred during the 

COVID–19 PHE. 

Estimates of Diversion of Covered 

Controlled Substances 

In establishing any quota . . . , or any 

procurement quota established by [DEA] 

by regulation, for fentanyl, oxycodone, 

hydrocodone, oxymorphone, or 

hydromorphone (in this subsection 

referred to as a ‘‘covered controlled 

substance’’), [DEA] shall estimate the 

amount of diversion of the covered 

controlled substance that occurs in the 

United States. 21 U.S.C. 826(i)(1)(A). 

In estimating diversion under that 

provision, DEA: 

(i) shall consider information . . . , in 

consultation with the Secretary of 

Health and Human Services, [it] 

determines reliable on rates of overdose 


ddrumheller on DSK120RN23PROD with NOTICES7
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78775 

5 21 U.S.C. 826(i)(1)(C). 

6National Association of Boards of Pharmacy 

(NABP) coalition consensus document 

‘‘Stakeholders’ Challenges and Red Flag Warning 

Signs Related to Prescribing and Dispensing 

Controlled Substances’’ (2015). 

www.nabp.pharmacy/resources/reports. 

7The Medicine Shoppe, 79 FR 59504, 59507, 

59512–13 (Oct. 2, 2014); Holiday CVS, L.L.C., d/b/ 

a CVS Pharmacy Nos. 219 and 5195, 77 FR 62316 

(Oct. 12, 2012). 

8The mere indicia of red flags alone is not proof 

of violation of 21 U.S.C. 824 or any other provision 

of the CSA. This rule discusses only their use by 

DEA as an analytical tool to estimate diversion. 

9NASCSA formatted DEA’s request into an 

analytics model developed by one of its associates, 

Appriss Inc. 

10Frank’s Corner Pharmacy, 60 FR 17574 (Apr. 6, 

1995); Holiday CVS, L.L.C., d/b/a CVS Pharmacy 

Nos. 219 and 5195, 77 FR 62316 (Oct. 12, 2012). 

11This total does not include insurance copayments made with cash. 

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 

[it] determines reliable. 

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

The statute further mandates that DEA 

‘‘make appropriate quota reductions, as 

determined by [DEA], from the quota [it] 

would have otherwise established had 

such diversion not been considered.’’ 5

In estimating the amount of diversion 

of each covered controlled substance 

that occurs in the United States, DEA 

considered information from state 

PDMP Administrators and from 

legitimate distribution chain 

participants. 

Consideration of Information From 

Certain State PDMPs and From National 

Sales Data 

Pursuant to 21 CFR 1303.11(b)(6), 

DEA requested state PDMP data for the 

purpose of establishing its APQ. DEA 

believes state PDMPs to be an essential, 

reliable source of information for use in 

effectively estimating diversion of the 

five covered controlled substances. In 

April 2024, DEA sent a letter to 

NASCSA requesting its assistance in 

obtaining aggregated PDMP data for the 

five covered controlled substances from 

each state covering the years 2021–2023. 

The letter indicated that DEA was 

specifically interested in an analysis of 

prescription data from each state’s 

PDMP that would assist DEA in 

estimating diversion and setting 

appropriate quotas in compliance with 

21 U.S.C. 826(i). In its request, DEA 

provided specific questions, discussed 

in detail below, based on common 

indicia of potential diversion known as 

‘‘red flags’’ by physicians, pharmacists, 

manufacturers, distributors, and federal 

and state regulatory and law 

enforcement agencies.6 DEA 

investigators and administrative 

prosecutors also rely on Agency case 

law in which these red flags of diversion 

have been upheld as indicia of potential 

diversion.7 Certain state regulations 

now include red flag circumstances as 

potential indicators of illegitimate 

prescriptions, and thus of potential 

abuse and diversion of controlled 

substances.8 See, e.g., The Pharmacy 

Place Order, 86 FR 21008, 21012 (Apr. 

21, 2021) (citing 22 Tex. Admin. Code 

291.29(c)(4), specifying the geographical 

distance between the practitioner and 

the patient or between the pharmacy 

and the patient as a red flag). 

DEA requested responses from state 

PDMP Administrators by June 15, 2024. 

NASCSA disseminated DEA’s request to 

its PDMP Administrators and provided 

them with a report tool to ensure that 

responses to DEA’s questions were 

extracted consistently across all 

responsive states. Twenty-nine states 

and three territories provided DEA with 

summarized PDMP data as of July 2024, 

utilizing the standardized report 

developed by NASCSA.9 See Table 1a 

below. 

TABLE 1a—STATES/TERRITORIES THAT

RESPONDED TO DEA’S DATA REQUEST

State/territory 

1. Alabama. 

2. Alaska. 

3. Arkansas. 

4. Commonwealth of Northern Mariana Islands. 

5. Connecticut. 

6. Delaware. 

7. District of Columbia. 

8. Idaho. 

9. Indiana. 

10. Kansas. 

11. Kentucky. 

12. Louisiana. 

13. Maryland. 

14. Massachusetts. 

15. Michigan. 

16. Minnesota. 

17. Mississippi. 

18. Montana. 

19. Nevada. 

20. New Jersey. 

21. New Mexico. 

22. North Carolina. 

23. Oklahoma. 

24. Oregon. 

25. Pennsylvania. 

26. Puerto Rico. 

27. South Carolina. 

28. South Dakota. 

29. Utah. 

30. Vermont. 

31. Virginia. 

32. Washington. 

Pharmacies are required by state law 

to enter controlled substance dispensing 

data into the state’s PDMP database, 

including the prescriber’s name, 

registered address and DEA number; 

prescription information (such as drug 

name); dispensing date; dosage 

dispensed; pharmacy registered address; 

and patient name and address. DEA 

considers PDMP data to be an accurate 

representation of dispensing activities 

in states. DEA received data for the 

following red-flag metrics: 

• The total number of patients who 

saw three or more prescribers in a 90- 

day period and were dispensed an 

opioid following each visit. For this 

metric, DEA requested and was 

provided the number of prescriptions 

for the five covered controlled 

substances dispensed to these patients, 

as a percentage of the total prescriptions 

dispensed for that particular covered 

controlled substance, as well as the 

corresponding quantity of the covered 

controlled substance dispensed. This 

metric (patients being prescribed 

covered controlled substances from 

three or more prescribers in a 90-day 

period) is used to identify potential 

doctor shopping, a common technique 

to obtain a high number of controlled 

substances, which may lead to abuse or 

diversion of controlled substances. DEA 

has long considered doctor shopping to 

be an indicator of potential diversion.10

• The number of patients that were 

dispensed prescriptions for each of the 

five covered controlled substances that 

exceeded 240 morphine milligram 

equivalents (MME) daily. States 

provided the raw number of such 

prescriptions dispensed, the number of 

prescriptions as a percentage of the total 

covered controlled substance 

prescriptions dispensed, and the 

corresponding quantity of the covered 

controlled substance dispensed. DEA 

believes that accounting for quantities 

in excess of 240 MME daily allows for 

consideration of oncology patients with 

legitimate medical needs for covered 

controlled substance prescriptions with 

high MME. Higher dosages place 

individuals at higher risk of overdose 

and death. Prescriptions involving 

dosages exceeding 240 MME daily may 

indicate diversion, such as illegal 

distribution of controlled substances or 

prescribing outside the usual course of 

professional practice. 

• The number of patients that paid 

cash for covered controlled substance 

prescriptions, without submitting for 

insurance reimbursement.11 States also 

provided the number of prescriptions 

paid entirely with cash as a percentage 


ddrumheller on DSK120RN23PROD with NOTICES7
78776 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

12Suntree Pharmacy and Suntree Medical 

Equipment, LLC, 85 FR 73753 (Nov. 19, 2020) 

(finding that the pharmacy filled prescriptions 

despite the presence of multiple unresolved red 

flags, including cash payments); Pharmacy Doctors 

Enterprises d/b/a Zion Clinic Pharmacy, 83 FR 

10876 (Mar. 13, 2018) (revoking pharmacy’s 

registration for filling prescriptions that raised the 

red flag of customers paying cash for their 

prescriptions, among other red flags). 

13 DEA has purchased this data from IQVIA for 

decades and routinely uses this information to 

administer several regulatory functions, including 

the administration of DEA’s quota program. 

14Both DEA and FDA released this letter on Aug. 

1, 2023. It is available at: https://www.dea.gov/sites/ 

default/files/2023-08/DEA%20and%20FDA

%20Issue%20Joint%20Letter%20to%20the%20

Public.pdf. 

of the total prescriptions for the five 

covered controlled substances 

dispensed, as well as the corresponding 

quantity of the covered controlled 

substances dispensed. When 

investigating potential diversion, cash 

payments are one element considered in 

identifying prescriptions filled for 

nonmedical purposes. Unusually high 

percentages of cash payments made to a 

prescriber or pharmacy for controlled 

substances may indicate diversion.12

DEA received PDMP data from the 

states in a standardized format that 

allowed DEA to aggregate the data. The 

PDMP data sample represents a 

population of approximately 112.35 

million people, which is approximately 

34 percent of the U.S. population. DEA 

believes this sample is sufficient to 

derive a reasonable nationwide 

estimate. 

While PDMP data is useful in 

estimating diversion, it is not 

conclusive. Further investigation would 

be required before concluding that any 

of the subject prescriptions were 

actually diverted. DEA continues to 

evaluate its methodologies in estimating 

diversion in an effort to set quotas more 

efficiently. State participation is crucial 

to accurate data analysis, and DEA 

anticipates working closely with states, 

as well as other federal and state 

entities, in future quota determinations. 

To calculate a national diversion 

estimate for each of the covered 

controlled substances from the 

responses received from state PDMP 

Administrators, DEA relied upon the 

number of individuals who received a 

prescription for a covered controlled 

substance that met any of the three redflag metrics for each of calendar years 

2021–2023. Using the population of the 

states responding to DEA’s request, DEA 

then calculated the percentage of the 

population issued a prescription with a 

red flag. Using this estimated percentage 

for 2021–2023, DEA analyzed trends in 

the data to predict the estimated 

percentage of patients who would be 

expected to be included in these red-flag 

metrics for 2025. 

DEA also reviewed aggregate sales 

data for each of the covered controlled 

substances, which it extracted from 

IQVIA’s National Sales Perspective.13

IQVIA sales data was selected to help 

quantify diversion at the national level 

because it reflects the best national 

estimate for all prescriptions written 

and filled, including the total quantity 

available for diversion or misuse. DEA 

analyzed trends in IQVIA sales data 

from January 2021–April 2024, in order 

to predict the estimated national sales 

for 2025. 

To estimate diversion for each of the 

covered controlled substances, DEA 

multiplied the forecasted percentage of 

patients likely to receive a prescription 

for a covered controlled substance that 

meet any of the three red-flag metrics in 

2025 by the forecasted sales data from 

IQVIA for 2025. The resulting estimate 

of diversion from data submitted by 

state PDMP Administrators is 

summarized below in Table 1b. This 

data contributed to the final diversion 

estimate set forth in Table 3. 

TABLE 1b—DIVERSION ESTIMATES FOR

2025 BASED ON STATE PDMP 

DATA FOR COVERED CONTROLLED

SUBSTANCES FROM 2021–2023 

Controlled substance (g) 

Fentanyl ........................................ 26 

Hydrocodone ................................ 90,396 

Hydromorphone ............................ 699 

Oxycodone .................................... 234,372 

Oxymorphone ............................... 000 

Consideration of Registrant Reported 

Diversion in the Legitimate Distribution 

Chain 

DEA extracted data from its Theft 

Loss Report database and categorized it 

by each basic drug class. DEA calculated 

the estimated amount of diversion by 

multiplying the quantity of API in each 

finished dosage form by the total 

amount of units reported stolen or lost 

to estimate the metric weight in grams 

of the controlled substance being 

diverted. This estimate of diversion 

from the legitimate supply chain for 

each of the covered controlled 

substances is displayed in Table 2. This 

data contributed to the final diversion 

estimates set forth in Table 3. 

TABLE 2—DIVERSION ESTIMATES

BASED ON SUPPLY CHAIN DIVERSION DATA FOR COVERED CONTROLLED SUBSTANCES

Controlled substance (g) 

Fentanyl ........................................ 73 

Hydrocodone ................................ 12,528 

Hydromorphone ............................ 481 

TABLE 2—DIVERSION ESTIMATES

BASED ON SUPPLY CHAIN DIVERSION DATA FOR COVERED CONTROLLED SUBSTANCES—Continued 

Controlled substance (g) 

Oxycodone .................................... 30,265 

Oxymorphone ............................... 165 

In accordance with 21 U.S.C. 826(i), 

DEA’s estimate of diversion for the five 

controlled substances was calculated by 

combining the values in Tables 1b and 

2. 

TABLE 3—TOTAL ESTIMATES OF DIVERSION FOR COVERED CONTROLLED SUBSTANCES TO BE CONSIDERED IN THE 2025 APQS

Controlled substance (g) 

Fentanyl ........................................ 99 

Hydrocodone ................................ 102,924 

Hydromorphone ............................ 1,180 

Oxycodone .................................... 264,637 

Oxymorphone ............................... 165 

Continuing Efforts To Anticipate and 

Prevent Drug Shortages 

Beginning in the latter half of 2022, 

the DEA and FDA observed an increase 

in the number of drug shortages 

reported by manufacturers of schedule II 

stimulants including mixed-salt 

amphetamine products starting in April 

2022 and lisdexamfetamine and 

methylphenidate starting in July 2023. 

As DEA and FDA stated in an open 

letter in 2023,14 we remain committed 

to doing all we can to prevent stimulant 

drug shortages, limit their impact, and 

resolve them as quickly as possible. 

In particular, DEA continues to seek 

additional information that will assist 

the agency to more accurately forecast 

export requirements, especially for 

those substances controlled 

domestically in schedule I or II that are 

not controlled internationally. DEA 

understands that manufacturers have 

contractual obligations that dictate 

business decisions regarding the 

quantities of finished dosage forms they 

will produce under a single DEA-issued 

quota, which applies to products 

manufactured with an active ingredient, 

whether for domestic or foreign markets. 

DEA has purchased third-party data to 

improve its understanding of the 

dynamic changes in foreign markets. In 

February 2024, DEA began utilizing 

IQVIA’s foreign (non-U.S.) sales tracking 


ddrumheller on DSK120RN23PROD with NOTICES7
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78777 

15Management of Quotas for Controlled 

Substances and List I Chemicals, 88 FR 60,117 

(Aug. 31, 2023) (effective Nov. 29, 2023). 

data module, MIDAS (Multi 

International Data Analysis System), 

which provides valuable insight into the 

growing export markets for schedule II 

stimulants. Building off the recently 

issued quota management rule,15 DEA 

also intends to add new subcategories to 

individual manufacturing quotas and 

procurement quotas, to distinguish 

between domestic requirements and 

export requirements. 

As part of DEA’s continuing effort to 

prevent shortages and be more nimble 

in its administration of the quota 

program, DEA intends to continue to 

allocate procurement quotas to DEAregistered manufacturers of schedule II 

controlled substances on a semi-annual 

basis for the 2025 quota year, except 

that it will continue to allocate 

procurement quotas relating to 

injectable drug products containing 

schedule II controlled substances on an 

annual basis. DEA announced this 

change in a letter to DEA-registered 

manufacturers on April 29, 2024. No 

further change is being implemented at 

this time. DEA remains committed to 

ensuring that all patients with legitimate 

medical need can access appropriately 

prescribed medications. 

The Administrator, therefore, 

proposes to establish the 2025 APQ for 

certain schedule I and II controlled 

substances and AAN for the list I 

chemicals ephedrine, pseudoephedrine, 

and phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

Basic class 

Proposed 2025 

quotas 

(g) 

Schedule I 

-[1-(2-Thienyl)cyclohexyl]pyrrolidine .................................................................................................................................................. 20 

1-(1-Phenylcyclohexyl)pyrrolidine ...................................................................................................................................................... 30 

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ................................................................................................................................ 10 

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

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

1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................................. 15 

2′-fluoro 2-fluorofentanyl .................................................................................................................................................................... 30 

1-Benzylpiperazine ............................................................................................................................................................................ 25 

1-Methyl-4-phenyl-4-propionoxypiperidine ......................................................................................................................................... 10 

2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ......................................................................................................................... 30 

2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) ...................................................................................................................... 30 

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

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

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

2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) ...................... 30 

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

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

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

2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ................................ 30 

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

2,5-Dimethoxy-4-n-propylthiophenethylamine ................................................................................................................................... 25 

2,5-Dimethoxyamphetamine .............................................................................................................................................................. 25 

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

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

3,4,5-Trimethoxyamphetamine .......................................................................................................................................................... 30 

2-Methyl AP-237 ................................................................................................................................................................................ 30 

3,4-Methylenedioxyamphetamine (MDA) .......................................................................................................................................... 12,000 

3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................................................... 12,000 

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

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

3,4-Methylenedioxypyrovalerone (MDPV) ......................................................................................................................................... 35 

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-dimethoxyphenethylamine (2-CB) ................................................................................................................................ 5,100 

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

4-CN-Cumyl-Butinaca ........................................................................................................................................................................ 25 

4-Fluoroisobutyryl fentanyl ................................................................................................................................................................. 30 

4F-MDMB-BINACA ............................................................................................................................................................................ 30 

4-FMC; Flephedrone .......................................................................................................................................................................... 25 

4-MEC; 4-Methyl-N-ethylcathinone .................................................................................................................................................... 25 

4-Methoxyamphetamine .................................................................................................................................................................... 150 

4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (alpha-PiHP) ....................................................................................................... 30 

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 


ddrumheller on DSK120RN23PROD with NOTICES7
78778 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

Basic class 

Proposed 2025 

quotas 

(g) 

4′-Methyl acetyl fentanyl .................................................................................................................................................................... 30 

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

4F-MDMB-BUTICA ............................................................................................................................................................................ 30 

5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ....................................................................................................... 50 

5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) ......................... 40 

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

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .......................... 25 

5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide ..................................... 25 

5F-CUMYL-PINACA .......................................................................................................................................................................... 25 

5F-EDMB-PICA .................................................................................................................................................................................. 30 

5F-EDMB-PINACA ............................................................................................................................................................................. 25 

5F-MDMB-PICA ................................................................................................................................................................................. 25 

5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ................................................................. 25 

5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ...................................................... 25 

5-Fluoro-PB-22; 5F-PB-22 ................................................................................................................................................................. 25 

5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone .......................................... 25 

5-Methoxy-3,4-methylenedioxyamphetamine .................................................................................................................................... 25 

5-Methoxy-N,N-diisopropyltryptamine ................................................................................................................................................ 25 

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

AB-CHMINACA .................................................................................................................................................................................. 30 

AB-FUBINACA ................................................................................................................................................................................... 50 

AB-PINACA ........................................................................................................................................................................................ 30 

ADB-BUTINACA ................................................................................................................................................................................ 30 

ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ................................ 30 

Acetorphine ........................................................................................................................................................................................ 25 

Acetyl Fentanyl .................................................................................................................................................................................. 100 

Acetyl-alpha-methylfentanyl ............................................................................................................................................................... 30 

Acetyldihydrocodeine ......................................................................................................................................................................... 30 

Acetylmethadol .................................................................................................................................................................................. 25 

Acryl Fentanyl .................................................................................................................................................................................... 25 

ADB-4en-PINACA .............................................................................................................................................................................. 30 

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

AH-7921 ............................................................................................................................................................................................. 30 

All other tetrahydrocannabinol ........................................................................................................................................................... 1,166,130 

Allylprodine ........................................................................................................................................................................................ 25 

Alphacetylmethadol ............................................................................................................................................................................ 25 

alpha-Ethyltryptamine ........................................................................................................................................................................ 25 

Alphameprodine ................................................................................................................................................................................. 25 

Alphamethadol ................................................................................................................................................................................... 25 

alpha-Methylfentanyl .......................................................................................................................................................................... 30 

alpha-Methylthiofentanyl .................................................................................................................................................................... 30 

alpha-Methyltryptamine (AMT) .......................................................................................................................................................... 25 

alpha-Pyrrolidinobutiophenone (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-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ....................................................................................... 25 

Benzethidine ...................................................................................................................................................................................... 25 

Benzylmorphine ................................................................................................................................................................................. 30 

Betacetylmethadol ............................................................................................................................................................................. 25 

beta-Hydroxy-3-methylfentanyl .......................................................................................................................................................... 30 

beta-Hydroxyfentanyl ......................................................................................................................................................................... 30 

beta-Hydroxythiofentanyl ................................................................................................................................................................... 30 

beta-Methyl fentanyl .......................................................................................................................................................................... 30 

beta′-Phenyl fentanyl ......................................................................................................................................................................... 30 

Betameprodine ................................................................................................................................................................................... 25 

Betamethadol ..................................................................................................................................................................................... 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 


ddrumheller on DSK120RN23PROD with NOTICES7
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78779 

Basic class 

Proposed 2025 

quotas 

(g) 

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 

Diethyltryptamine ............................................................................................................................................................................... 25 

Difenoxin ............................................................................................................................................................................................ 9,300 

Dihydromorphine ................................................................................................................................................................................ 639,954 

Dimenoxadol ...................................................................................................................................................................................... 25 

Dimepheptanol ................................................................................................................................................................................... 25 

Dimethylthiambutene ......................................................................................................................................................................... 20 

Dimethyltryptamine ............................................................................................................................................................................ 11,000 

Dioxyaphetyl butyrate ........................................................................................................................................................................ 25 

Dipipanone ......................................................................................................................................................................................... 25 

Drotebanol ......................................................................................................................................................................................... 25 

Ethylmethylthiambutene ..................................................................................................................................................................... 25 

Ethylone ............................................................................................................................................................................................. 25 

Etizolam ............................................................................................................................................................................................. 30 

Etodesnitazene .................................................................................................................................................................................. 30 

Etonitazene ........................................................................................................................................................................................ 25 

Etorphine ............................................................................................................................................................................................ 30 

Etoxeridine ......................................................................................................................................................................................... 25 

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 .............................................................................................................................................................. 49,675,266 

Heroin ................................................................................................................................................................................................ 150 

Hydromorphinol .................................................................................................................................................................................. 40 

Hydroxypethidine ............................................................................................................................................................................... 25 

Ibogaine ............................................................................................................................................................................................. 210 

Isobutyryl Fentanyl ............................................................................................................................................................................. 25 

Isotonitazine ....................................................................................................................................................................................... 25 

JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) .................................................................................................................... 35 

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

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

JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ..................................................................................................................... 30 

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

JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ............................................................................................................. 35 

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

JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ...................................................................................................................... 30 

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

Ketobemidone .................................................................................................................................................................................... 30 

Levomoramide ................................................................................................................................................................................... 25 

Levophenyacylmorphan ..................................................................................................................................................................... 25 

Lysergic acid diethylamide (LSD) ...................................................................................................................................................... 1,200 

MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3- 

carboxamide) .................................................................................................................................................................................. 30 

MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ............... 30 

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

MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ........................... 25

Marijuana ........................................................................................................................................................................................... 6,675,000 

Marijuana extract ............................................................................................................................................................................... 1,000,000 

MDMB-4en-PINACA .......................................................................................................................................................................... 30 

MMB-FUBICA .................................................................................................................................................................................... 30 

Mecloqualone ..................................................................................................................................................................................... 30 

Mescaline ........................................................................................................................................................................................... 1,200 

Mesocarb ........................................................................................................................................................................................... 30 

Methaqualone .................................................................................................................................................................................... 60 


ddrumheller on DSK120RN23PROD with NOTICES7
78780 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

Basic class 

Proposed 2025 

quotas 

(g) 

Methcathinone ................................................................................................................................................................................... 25 

Methiopropamine ............................................................................................................................................................................... 30 

Methoxetamine .................................................................................................................................................................................. 30 

Methoxyacetyl fentanyl ...................................................................................................................................................................... 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)-1H-indole-3-carboxylate ................................................................................................ 25 

N,N-Dimethylamphetamine ................................................................................................................................................................ 25 

Naphyrone ......................................................................................................................................................................................... 25 

N-Desethyl isotonitazene ................................................................................................................................................................... 30 

N-Ethyl-1-phenylcyclohexylamine ...................................................................................................................................................... 25 

N-Ethyl-3-piperidyl benzilate .............................................................................................................................................................. 10 

N-Ethylamphetamine ......................................................................................................................................................................... 24 

N-Ethylhexedrone .............................................................................................................................................................................. 25 

N-Ethylpentylone, ephylone ............................................................................................................................................................... 30 

N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................................................... 24 

Nicocodeine ....................................................................................................................................................................................... 25 

Nicomorphine ..................................................................................................................................................................................... 25 

N-methyl-3-piperidyl benzilate ........................................................................................................................................................... 30 

N-piperidinyl etonitazene ................................................................................................................................................................... 30 

N-Pyrrolidino Etonitazene .................................................................................................................................................................. 30 

Noracymethadol ................................................................................................................................................................................. 25 

Norlevorphanol ................................................................................................................................................................................... 2,550 

Normethadone ................................................................................................................................................................................... 25 

Normorphine ...................................................................................................................................................................................... 40 

Norpipanone ...................................................................................................................................................................................... 25 

Ocfentanil ........................................................................................................................................................................................... 25 

ortho-Fluoroacryl fentanyl .................................................................................................................................................................. 30 

ortho-Fluorobutyryl fentanyl ............................................................................................................................................................... 30 

Ortho-Fluorofentanyl,2-Fluorofentanyl ............................................................................................................................................... 30 

ortho-Fluoroisobutyryl fentanyl .......................................................................................................................................................... 30 

ortho-Methyl acetylfentanyl ................................................................................................................................................................ 30 

ortho-Methyl methoxyacetyl fentanyl ................................................................................................................................................. 30 

Para-Chlorisobutyrl fentanyl .............................................................................................................................................................. 30 

Para-flourobutyryl fentanyl ................................................................................................................................................................. 25 

Para-fluorofentanyl ............................................................................................................................................................................. 25 

para-Fluoro furanyl fentanyl ............................................................................................................................................................... 30 

Para-Methoxybutyrl fentanyl .............................................................................................................................................................. 30 

Para-methoxymethamphetamine ....................................................................................................................................................... 30 

para-Methylfentanyl ........................................................................................................................................................................... 30 

Parahexyl ........................................................................................................................................................................................... 5 

PB-22; QUPIC ................................................................................................................................................................................... 20 

Pentedrone ........................................................................................................................................................................................ 25 

Pentylone ........................................................................................................................................................................................... 25 

Phenadoxone ..................................................................................................................................................................................... 25 

Phenampromide ................................................................................................................................................................................. 25 

Phenomorphan .................................................................................................................................................................................. 25 

Phenoperidine .................................................................................................................................................................................... 25 

Phenyl fentanyl .................................................................................................................................................................................. 30 

Pholcodine ......................................................................................................................................................................................... 5 

Piritramide .......................................................................................................................................................................................... 25 

Proheptazine ...................................................................................................................................................................................... 25 

Properidine ......................................................................................................................................................................................... 25 

Propiram ............................................................................................................................................................................................ 25 

Protonitazene ..................................................................................................................................................................................... 30 

Psilocybin ........................................................................................................................................................................................... 30,000 

Psilocin ............................................................................................................................................................................................... 36,000 

Racemoramide ................................................................................................................................................................................... 25 

SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ......................................................................................... 45 

SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ............................................................................................................ 30 

Tetrahydrofuranyl fentanyl ................................................................................................................................................................. 15 

Thebacon ........................................................................................................................................................................................... 25 

Thiafentanil ........................................................................................................................................................................................ 25 

Thiofentanyl ....................................................................................................................................................................................... 25 


ddrumheller on DSK120RN23PROD with NOTICES7
Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 78781 

Basic class 

Proposed 2025 

quotas 

(g) 

Thiofuranyl fentanyl ........................................................................................................................................................................... 30 

THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) .................................................................................. 30 

Tilidine ................................................................................................................................................................................................ 25 

Trimeperidine ..................................................................................................................................................................................... 25 

UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................................... 25 

U-47700 ............................................................................................................................................................................................. 30 

Valeryl fentanyl .................................................................................................................................................................................. 25 

Zipeprol .............................................................................................................................................................................................. 30 

Schedule II 

1-Phenylcyclohexylamine .................................................................................................................................................................. 15 

1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................. 25 

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

Alfentanil ............................................................................................................................................................................................ 5,000 

Alphaprodine ...................................................................................................................................................................................... 25 

Amobarbital ........................................................................................................................................................................................ 20,100 

Bezitramide ........................................................................................................................................................................................ 25 

Carfentanil .......................................................................................................................................................................................... 20 

Cocaine .............................................................................................................................................................................................. 60,492 

Codeine (for conversion) ................................................................................................................................................................... 942,452 

Codeine (for sale) .............................................................................................................................................................................. 19,262,957 

d-amphetamine (for sale) .................................................................................................................................................................. 21,200,000 

d,l-amphetamine ................................................................................................................................................................................ 21,200,000 

d-amphetamine (for conversion) ........................................................................................................................................................ 23,688,235 

Dexmethylphenidate (for sale) ........................................................................................................................................................... 6,200,000 

Dexmethylphenidate (for conversion) ................................................................................................................................................ 5,374,683 

Dextropropoxyphene .......................................................................................................................................................................... 35 

Dihydrocodeine .................................................................................................................................................................................. 115,227 

Dihydroetorphine ................................................................................................................................................................................ 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 Intermediate-C ................................................................................................................................................................ 30 

Metazocine ......................................................................................................................................................................................... 15 

Methadone (for sale) ......................................................................................................................................................................... 25,619,700 

Methadone Intermediate .................................................................................................................................................................... 27,673,600 

d,l-Methamphetamine ........................................................................................................................................................................ 150 

d-methamphetamine (for conversion) ................................................................................................................................................ 485,020 

d-methamphetamine (for sale) .......................................................................................................................................................... 47,000 

l-methamphetamine ........................................................................................................................................................................... 587,229 

Methylphenidate (for sale) ................................................................................................................................................................. 53,283,000 

Methylphenidate (for conversion) ...................................................................................................................................................... 19,975,468 

Metopon ............................................................................................................................................................................................. 25 

Moramide-intermediate ...................................................................................................................................................................... 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 

Opium (tincture) ................................................................................................................................................................................. 530,837 

Oripavine ............................................................................................................................................................................................ 37,721,950 

Oxycodone (for conversion) .............................................................................................................................................................. 437,827 


ddrumheller on DSK120RN23PROD with NOTICES7
78782 Federal Register / Vol. 89, No. 186 / Wednesday, September 25, 2024 / Notices 

Basic class 

Proposed 2025 

quotas 

(g) 

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 

Phenylacetone ................................................................................................................................................................................... 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 

The Administrator further proposes 

that the APQ for all other schedule I and 

II controlled substances included in 21 

CFR 1308.11 and 1308.12 remain at 

zero. 

These proposed 2025 quotas reflect 

the quantities that DEA believes are 

necessary to meet the estimated 

medical, scientific, research, and 

industrial needs of the United States, 

lawful export requirements; and the 

establishment and maintenance of 

reserve stocks. 

In accordance with 21 CFR 1303.13 

and 1315.13, upon consideration of the 

relevant factors, the Administrator may 

adjust the 2025 APQ and AAN 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 the 2025 APQ for 

controlled substances in schedules I and 

II and establishing an AAN for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine, as directed by 21 

CFR 1303.11(c) and 1315.11(f). 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on September 20, 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. 2024–21962 Filed 9–20–24; 4:15 pm] 

BILLING CODE 4410–09–P 


ddrumheller on DSK120RN23PROD with NOTICES7