Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102649 

1Proposed Aggregate Production Quotas for 

Schedule I and II Controlled Substances and 

Assessment of Annual Needs for the List I 

Chemicals Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2025, 89 FR 78772 

(September 25, 2024). 

CFR 1308.11 and 1308.12 remain at 

zero. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 13, 2024, by Administrator 

Anne Milgram. That document with the 

original signature and date is 

maintained by DEA. For administrative 

purposes only, and in compliance with 

requirements of the Office of the Federal 

Register, the undersigned DEA Federal 

Register Liaison Officer has been 

authorized to sign and submit the 

document in electronic format for 

publication, as an official document of 

DEA. This administrative process in no 

way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

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

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1413E] 

Established Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2025 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final order. 

SUMMARY: This final order establishes 

the initial 2025 aggregate production 

quotas for controlled substances in 

schedules I and II of the Controlled 

Substances Act and the assessment of 

annual needs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine. 

DATES: This order is effective December 

17, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Heather E. Achbach, Regulatory Drafting 

and Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (571) 776–3882. 

SUPPLEMENTARY INFORMATION: 

I. Legal Authority 

Section 306 of the Controlled 

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

requires the Attorney General to 

establish production quotas for each 

basic class of controlled substance listed 

in schedule I and II and ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. The Attorney 

General has delegated this function to 

the Administrator of the Drug 

Enforcement Administration (DEA) 

pursuant to 28 CFR 0.100. 

II. Background 

The 2025 aggregate production quotas 

(APQ) and assessment of annual needs 

(AAN) represent those quantities of 

schedule I and II controlled substances 

and the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine that may be 

manufactured in the United States in 

2025, in order to provide for the 

estimated medical, scientific, research, 

and industrial needs of the U.S., lawful 

export requirements, and the 

establishment and maintenance of 

reserve stocks. These quotas include 

imports of ephedrine, pseudoephedrine, 

and phenylpropanolamine, but do not 

include imports of controlled 

substances for use in industrial 

processes. 

On September 25, 2024, a notice titled 

‘‘Proposed Aggregate Production Quotas 

for Schedule I and II Controlled 

Substances and Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2025’’ was 

published in the Federal Register.1 This 

notice proposed the 2025 APQs for each 

basic class of controlled substance listed 

in schedules I and II and the 2025 AANs 

for the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. All interested 

persons were invited to comment on or 

object to the proposed APQs and the 

proposed AANs on or before October 25, 

2024. 

III. Comments Received 

Within the public comment period, 

DEA received 1,882 comments from 

DEA registrants, chronic pain patients, 

patients with attention deficit/ 

hyperactivity disorder (ADHD), pain 

advocacy associations, U.S. professional 

associations, U.S. doctors and nurses, 

and others. The comments included 

concerns about potential domestic 

opioid drug shortages due to further 

quota reductions; patient difficulty 

filling authorized opioid prescriptions; 

increases in drug overdose deaths 

despite a continued decrease in 

production quotas; requests for an 

extension to the comment period; 

stimulant drug shortages in the United 

States; concerns that medical 

professionals might be impeded from 

exercising their medical expertise 

regarding opioid prescriptions; requests 

for a public hearing; and comments not 

pertaining to DEA-regulated activities. 

While all comments were posted to 

regulations.gov, DEA restricted the 

attachments to 10 comments from 

public view due to confidential business 

information and/or confidential 

personal identifying information. 

Opioid Adequacy 

Issue (National Production Levels of 

Proposed APQs for Opioids Compared 

to 2024 levels): DEA received a 

significant number of comments from 

pain advocacy groups, hospital 

associations, health professionals, and 

others who raised concerns over the 

proposed APQs for certain opioids in 

2025, which were proposed at a level 

lower than the established production 

levels for 2024. The commenters 

suggested that the proposed APQ levels 

could exacerbate shortages experienced 

in 2024. 

DEA Response: DEA considers 

numerous factors in determining an 

APQ, including total net disposal of the 

class by all manufacturers during the 

current and two preceding years, trends 

in the national rate of net disposal of the 

class, total actual or estimated 

inventories of the class and of all 

substances manufactured from the class, 

information obtained from the Food and 

Drug Administration (FDA), and 

changes in the currently accepted 

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

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

factors considered can be found in 21 

CFR 1303.11(b). After considering all of 

the relevant factors, DEA has 

determined that the proposed APQs for 

the five covered controlled substances— 

fentanyl, hydrocodone, hydromorphone, 

oxycodone and oxymorphone—are 

sufficient to meet the forecasted 

legitimate domestic and foreign needs 

and allow for maintenance of reserve 

stocks. These considerations also lead 

DEA to conclude that U.S. 

manufacturers will need to manufacture 

approximately the same amount of those 

opioids in 2025 as in 2024 in order to 

meet legitimate needs. 

Accordingly, DEA proposed the 2025 

APQs for those five substances at the 

same level as in DEA’s proposed revised 

APQs for 2024 published on September 


ddrumheller on DSK120RN23PROD with NOTICES2
102650 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 

2See Proposed Adjustments to the Aggregate 

Production Quotas for Schedule I and II Controlled 

Substances and Assessment of Annual Needs for 

the List I Chemicals Ephedrine, Pseudoephedrine, 

and Phenylpropanolamine for 2024, 89 FR 78764 

(Sept. 25, 2024). 

3 21 U.S.C. 826(i)(1)(C). 

4See Revised Regulation Allows DEA-Registered 

Pharmacies to Transfer Electronic Prescriptions at 

a Patient’s Request, DEA.gov (Sept. 1, 2023), 

https://www.dea.gov/stories/2023/2023-09/2023-09- 

01/revised-regulation-allows-dea-registeredpharmacies-transfer. 

25, 2024.2 In that publication, DEA 

proposed minor reductions to the 2024 

APQs for 4 of the 5 substances to reflect 

DEA’s updated calculations of 

diversion, as required by Congress. 

Specifically, Congress requires DEA to 

make appropriate quota reductions 

‘‘from the quota [DEA] would have 

otherwise established had such 

diversion not been considered.’’ 3 DEA 

applied the same estimates of diversion 

in proposing and finalizing the 2025 

APQs and has reduced the 2025 APQs 

accordingly. The APQs for those five 

controlled substances are lower than the 

initial 2024 established APQs by 

approximately 0.1% combined. These 

decreases in the APQs will not affect the 

ability of the APQs to provide all 

material necessary for the estimated 

medical, scientific, research, and 

industrial needs of the U.S., lawful 

export requirements, and the 

establishment and maintenance of 

reserve stocks. 

Issue (Medication Out of Stock at 

Pharmacy Level): DEA received 

comments questioning whether the 2025 

proposed APQs for Schedule II opioids 

will be adequate to meet legitimate 

medical needs of patients. Commenters 

said that because of decreases in APQs 

for specific opioids, they have had 

difficulty filling legitimate prescriptions 

at pharmacies. These issues have 

negatively impacted their quality of life 

and caused mental health-related issues, 

including the possibility of suicide. 

DEA Response: DEA is committed to 

ensuring an adequate and uninterrupted 

supply of controlled substances in order 

to meet legitimate medical, scientific, 

and export needs of the United States. 

DEA sets the APQs for controlled 

substances based on the available data 

and information received at that specific 

point in time; however, subsequent 

factors outside of DEA’s control, 

including changes to manufacturers’ 

business practices may emerge 

afterwards and potentially contribute to 

a temporary lack of inventory of 

controlled substances at the point of 

dispensation. In recent years, these 

factors have included labor shortages 

and a lack of production capacity. In 

such circumstances, DEA, in 

coordination with FDA, can utilize tools 

under the CSA to try to prevent or 

alleviate drug shortages so that patients 

are able to fill legitimate prescriptions 

for controlled substances without undue 

delay. Additionally, if patients are faced 

with a delay in receiving their 

medications, the patients may request a 

one-time transfer of initial dispensing of 

an electronic prescription for Schedules 

II—V controlled substances from one 

retail pharmacy to another retail 

pharmacy if authorized under state 

law.4 If the medication is a controlled 

substance in Schedules III—V and 

includes authorized refills, the refills 

can also be transferred with the initial 

prescription to the receiving pharmacy. 

Issue (Nationwide Opioid Shortages): 

DEA received many comments stating 

there is a nationwide shortage of opioid 

medication because the commenters’ 

local pharmacies were often out of 

stock, forcing the commenters to spend 

significant time contacting additional 

pharmacies, and traveling further to get 

prescriptions filled. Commenters stated 

that many times they were unsuccessful 

in their attempts to fill the prescription. 

DEA Response: Drug shortages may 

occur due to factors outside of DEA’s 

control such as manufacturing and 

quality problems, processing delays, 

supply chain disruptions, or 

discontinuations. In such 

circumstances, if the drug manufacturer 

notifies the FDA Drug Shortage Staff, 

FDA will coordinate with DEA to 

address and minimize the impact of 

drug shortages if both agencies believe 

action is warranted. Currently, FDA has 

not issued notice of any nationwide 

shortages of the types of opioid 

medications mentioned by these 

commenters. 

Issue (Failure to Acknowledge Drug 

Shortages): One commenter expressed 

that DEA is failing to acknowledge and 

address opioid drug shortages that are 

complicating access to prescribed 

medications, effectively creating 

conditions such as ‘‘pharmacy deserts.’’ 

DEA Response: DEA is aware of 

specific product shortages of pain 

medicines and works with FDA and 

DEA-registered manufacturers to 

alleviate them. Patients and medical 

professionals may notice specific drug 

products are out of stock in particular 

areas; however, DEA cannot dictate DEA 

registrants’ distributions of drug 

products. If a drug manufacturer notifies 

FDA of a manufacturing-related 

shortage, FDA and DEA can take 

additional steps to help alleviate the 

shortage if action is warranted. 

Issue (Patients Switching to Illicit 

Fentanyl or Medications Obtained from 

Illegal Sources): Several commenters 

expressed concerns that because of 

DEA’s reduction of quotas for pain 

relieving controlled substances, chronic 

pain sufferers who were unable to fill 

their legitimate prescriptions eventually 

turned to illegal fentanyl or medications 

obtained from illegitimate sources as a 

substitute relief that could increase the 

risk of overdose death. These 

commenters stated that overdose deaths 

in the United States continue to rise 

because of illegal fentanyl or illegitimate 

medications, not from pharmaceutical 

medications prescribed to chronic pain 

patients. 

DEA Response: While overdose 

deaths may occur because of use of 

illicit substances, DEA’s quota 

regulations have been implemented to 

prevent misuse and diversion of 

pharmaceutical controlled substances. 

In this way, these quotas can reduce the 

occurrence of overdose and death from 

the use of legitimate controlled 

substances. Patients should work 

closely with their providers to utilize 

other FDA-approved medications for 

their conditions and fill their 

prescriptions only from DEA-registered 

pharmacies. The only safe medications 

containing controlled substances are 

ones prescribed by a trusted, DEAregistered medical professional and 

dispensed by a licensed pharmacist at a 

DEA-registered pharmacy. The 

medications received from unregistered 

internet sources may, in fact, be 

manufactured or laced with illicit 

substances including illicit fentanyl, 

which contributes to rates of overdose 

deaths. 

Issue (Opioid Prescribing Hesitancy): 

Many commenters, mostly selfidentified chronic pain patients, 

expressed that the goal of the 2016 

Centers for Disease Control and 

Prevention Guidelines was to decrease 

opioid overdoses, but instead there has 

been an increase in overdoses 

nationwide of over 400 percent due to 

illegal fentanyl or illegally 

manufactured pain pills. Commenters 

stated that many chronic pain patients 

have been harmed, and some have died 

by suicide, due to the inability to get 

prescriptions because of the APQ 

reductions made by DEA. Many 

commenters also stated that restrictions 

imposed by DEA have caused opioid 

medications to be under-prescribed due 

to fear of prosecution. Commenters said 

doctors should have latitude in making 

treatment decisions to prescribe opioid 

pain medications based on individual 

patient needs. 

DEA Response: Pursuant to 21 U.S.C. 

826(i), DEA is mandated to estimate 

diversion for 5 controlled substances— 


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Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102651 

5 Dispensing Controlled Substances for the 

Treatment of Pain, 71 FR 52716 (September 6, 

2006). 

6The Medicine Shoppe, 29 FR 59504, 59507, 

59512–13 (2014); Holiday CVS, LLC, d/b/a CVS 

Pharmacy Nos. 219 and 5195, 57 FR 62316 (2012). 

fentanyl, hydrocodone, hydromorphone, 

oxycodone and oxymorphone—and this 

estimation includes the consideration of 

rates of overdose deaths. While 

overdose deaths may occur as a result of 

the use of illegal fentanyl or illegally 

manufactured pain medications, quotas 

are being set by DEA to prevent misuse 

and diversion of pharmaceutical 

controlled substances, and thus reduce 

the occurrence of overdose and death 

from the use of legitimate controlled 

substances. Additionally, DEA’s 

regulations do not impose restrictions 

on the amount and the type of 

medication that licensed practitioners 

can prescribe. DEA has consistently 

emphasized and supported the authority 

of individual practitioners under the 

CSA to administer, dispense, and 

prescribe controlled substances for the 

legitimate treatment of pain within 

acceptable medical standards, as 

outlined in DEA’s policy statement 

published in the Federal Register on 

September 6, 2006, titled ‘‘Dispensing 

Controlled Substances for the Treatment 

of Pain.’’ 5

Attention Deficit/Hyperactivity Disorder 

(ADHD) Medication 

Issue (Shortage): DEA received 

comments expressing general concerns 

regarding the ongoing drug shortages for 

stimulant medications used in the 

treatment of ADHD. 

DEA Response: DEA is committed to 

ensuring an adequate and uninterrupted 

supply of controlled substances in order 

to meet the estimated legitimate 

medical, scientific, research, and 

industrial needs of the United States, for 

lawful export requirements, and for the 

establishment and maintenance of 

reserve stocks. DEA sets the APQs to 

provide for all legitimate medical 

purposes and for anticipated foreign 

demand. Additionally, DEA and FDA 

coordinate efforts to prevent or alleviate 

drug shortages. Such efforts may 

include the adjustment of the APQs and 

individual domestic manufacturers’ 

quotas, FDA’s approval of additional 

market competitors, and coordination 

between the agencies to allow 

importation of foreign-manufactured 

drug products that meet FDA approval. 

If the actual prescribing rates of these 

substances are significantly higher than 

the 2025 estimates of medical needs, the 

Administrator has the authority to 

increase the aggregate production quota 

at any time. 21 CFR 1303.13(a). 

Insufficient Gamma Hydroxybutyric 

Acid (GHB) 

Issue (GHB APQ Insufficient to 

Support New FDA-Approved Generic 

Medications Entering the Market as well 

as Existing Branded Drug Products): 

DEA received one comment from a law 

firm that voiced concern that the 

proposed 2025 GHB APQ will be 

insufficient to provide for existing 

branded products on the market as well 

as emerging generic products with 

anticipated FDA-approval dates near the 

end of calendar year 2025. The 

commenter noted that FDA has 

expanded the conditions for which the 

branded products can be prescribed as 

part of an effective treatment. 

DEA response: DEA is aware of the 

current FDA-approved GHB branded 

drug products and their exclusivity 

timelines as well as the numerous 

generic drug applications that are 

pending before FDA for approval. The 

2025 APQ for GHB is being finalized at 

49,675,266 grams, which is 20,258,266 

grams higher than the 2024 APQ. This 

equates to an almost 70 percent increase 

in the amount of bulk active 

pharmaceutical ingredient (API) that 

can be made available in 2025 to 

provide for legitimate medical need, as 

compared to 2024. This additional API 

can be utilized in the manufacture of 

existing drug products on the market, 

product development activities leading 

to FDA-approved generic drugs, as well 

as inventory necessary to begin calendar 

year 2026 without shortages. The 2025 

APQ is based on all available data 

including company-submitted 

information, U.S. export data, U.S. 

import data, and FDA drug data 

highlighting emerging and changing 

drug products containing GHB 

prescribed to the relevant patient 

population. 

Diversion Estimates 

Issue (Impact of Diversion Estimate on 

Opioids): Commenters voiced concern 

with the ‘‘red flags’’ associated with 

diversion data gathered from state 

Prescription Drug Monitoring Program 

(PDMP) data, which DEA uses to 

estimate diversion for the five covered 

controlled substances. Commenters 

worried that repeated attempts to fill 

prescriptions would be shown in the 

state PDMP data and result in concerns 

that they were engaged in ‘‘doctor 

shopping,’’ and their conduct could be 

misperceived as a ‘‘red flag’’ of actively 

seeking prescribed covered controlled 

substances from three or more 

prescribers in a 90-day period. 

Commenters were concerned that such 

misperceptions could render them 

unable to fill validly issued 

prescriptions. 

DEA Response: In the event that a 

patient’s general pharmacy does not 

have sufficient stock of a particular 

drug, a patient visiting multiple 

pharmacies to fill a single prescription 

would not be included in the ‘‘red flag’’ 

metric of patients actively seeking 

prescribed covered controlled 

substances from three or more 

prescribers in a 90-day period. The state 

PDMP data submitted was adequate to 

allow DEA to draw reliable inferences 

regarding the state and U.S. 

populations. The sample is large enough 

to allow DEA to accurately generalize 

the data to the whole population of the 

United States for use in the calculation 

of estimated national levels of diversion 

of the covered controlled substances. 

DEA developed the metric of patients 

prescribed covered controlled 

substances from three or more 

prescribers in a 90-day period to 

identify potential doctor shopping, a 

common technique used to obtain large 

amounts of controlled substances for the 

purpose of abuse or diversion. Federal 

administrative and criminal case law 

demonstrates that multiple 

prescriptions from multiple prescribers 

in a short timeframe is a reliable 

indicator of diversion.6 In addition, 

DEA did not consider prescriptions 

written for the five covered controlled 

substances in quantities lower than 240 

morphine milligram equivalents (MME) 

daily because some patients, including 

oncology patients in particular, have 

legitimate medical needs for covered 

controlled substance prescriptions in 

excess of 90 MME daily. DEA did not 

wish to inadvertently include legitimate 

prescriptions for these patients in its 

calculation of diversion. Daily dosages 

higher than 240 MME place individuals 

at a higher risk of overdose and death, 

and correlate with a heightened risk of 

diversion. DEA received aggregated data 

from state PDMPs that reflected only 

individual filled prescriptions. 

Data Collection and Analysis 

Issue (Data Accuracy): Several 

commenters stated that FDA’s 

estimation of medical needs and DEA’s 

data collection process are flawed and 

inaccurate. 

DEA Response: FDA utilizes a variety 

of data sources in developing its 

estimates of domestic medical needs. 

When determining the 2025 APQs, DEA 

considered the estimation of domestic 

medical needs data provided by FDA, 


ddrumheller on DSK120RN23PROD with NOTICES2
102652 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 

7 21 CFR 1303.11(c). 

8 21 CFR 1303.13. 

9Schedules of Controlled Substances: Placement 

of Ethylphenidate in Schedule I, 89 FR 84281 

(October 22, 2024). 

10 89 FR 78772 (Sept. 25, 2024). 

and also considered other data sources 

including prescriptions dispensed in 

prior and current years reported in 

IQVIA, research and clinical trial 

information from DEA-registered 

researchers and manufacturers, 

information provided in quota 

applications from DEA-registered 

manufacturers, as well as historic and 

current year export data and future 

estimations of export requirements. DEA 

is actively reevaluating and improving 

the data collection process to ensure 

that the APQs are set at an adequate 

level to meet legitimate medical, 

scientific, research, and export needs 

while establishing and maintaining 

reserve stocks. 

Issue (Lack of Data Transparency): 

Two commenters stated that there is a 

lack of transparency in the quota setting 

process. 

DEA Response: DEA is considering 

methods that might increase 

transparency in its quota setting 

process. Future regulatory proposals 

may include steps such as public 

notification and an opportunity for 

public input when prescribing rates for 

controlled substances substantially 

deviate from FDA’s estimate of medical 

needs. DEA must strike a balance 

between increasing transparency and 

complying with the applicable laws and 

regulations aimed at protecting 

confidential business and patient 

information. 

Comments and Quota Applications 

From DEA-Registered Manufacturers 

Issue: DEA received additional quota 

applications as well as comments from 

DEA-registered manufacturers regarding 

a specific schedule I controlled 

substance, requesting the APQs be 

established at a sufficient level to allow 

for their manufacturing to meet medical 

and scientific needs. 

DEA Response: DEA considered the 

additional quota applications and 

comments from DEA-registered 

manufacturers and determined that 

DEA’s APQ for dimethyltryptamine 

(DMT) should be increased to support 

legitimate research and scientific efforts 

toward an FDA-approved drug product. 

The increase is reflected below in the 

section titled, ‘‘Determination of 2025 

Aggregate Production Quotas and 

Assessment of Annual Needs.’’ 

Request for Hearing and Extension of 

Comment Period 

Issue: Several individual commenters 

suggested that DEA consider holding a 

public hearing regarding the APQs and 

AANs. 

DEA Response: The decision whether 

to grant a hearing on the issues raised 

by the commenters lies solely within the 

discretion of the Administrator.7 While 

hearings are required when requested by 

states in certain situations, these 

requests were not submitted by states. 

These requests did not include any 

evidence that would lead to the 

conclusion that a hearing is necessary or 

warranted. DEA has addressed specific 

points raised by the commenters in the 

issues and responses above. 

Issue: DEA received three comments 

requesting an extension of the comment 

period so the commenters can better 

research the issues and submit 

additional comments. 

DEA Response: DEA declines to 

extend the comment period. The 

number and scope of comments indicate 

that the provided 30 days was adequate. 

Additionally, DEA may propose to 

adjust these established APQs and 

AANs at any time after they have been 

established, at which time additional 

comments will be accepted.8

Out of Scope Comments 

DEA received comments that are 

outside the scope of this order. The 

comments were general in nature and 

raised issues with respect to specific 

medical illnesses, medical treatments 

and medication costs. These comments 

do not impact the analysis involved in 

establishing the 2025 APQs. 

IV. Determination of 2025 Aggregate 

Production Quotas and Assessment of 

Annual Needs 

In determining the established 2025 

APQs and AANs, DEA has considered 

the above comments along with the 

factors set forth in 21 CFR 1303.11 and 

21 CFR 1315.11, in accordance with 21 

U.S.C. 826(a). These factors include, but 

are not limited to, the 2024 

manufacturing quotas, current 2024 

sales and inventories, anticipated 2025 

export requirements, industrial use, 

additional applications for 2025 quotas, 

and information on research and 

product development requirements. 

On October 25, 2024, DEA published 

a final rule placing ethylphenidate in 

schedule I of the CSA,9 making all 

regulatory controls pertaining to 

schedule I controlled substances 

applicable to the manufacture of these 

substances, including the requirement 

to establish an aggregate production 

quota pursuant to 21 U.S.C. 826 and 21 

CFR part 1303. This final order 

establishes an aggregate production 

quota for this substance. 

Estimates of Diversion 

As specified in the proposal, and as 

required by 21 U.S.C. 826(i), DEA 

calculated a national diversion estimate 

for each of the five covered controlled 

substances. This data, which remains 

unchanged, was published in the 

Proposed Aggregate Production Quotas 

for Schedule I and II Controlled 

Substances and Assessment of Annual 

Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2025.10

In accordance with 21 U.S.C. 826, 21 

CFR 1303.11, and 21 CFR 1315.11, the 

Administrator hereby establishes the 

2025 APQs for the following schedule I 

and II controlled substances and the 

2025 AANs for the list I chemicals 

ephedrine, pseudoephedrine, and 

phenylpropanolamine, expressed in 

grams of anhydrous acid or base, as 

follows: 

BILLING CODE P 


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Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102653 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.095</GPH>

Basic Class 

Schedule I 

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

1-(1-Phenylcyclohexyl)pyrrolidine 

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

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

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

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

2'-fluoro 2-fluorofentanyl 

1-Bcnzy lpipcrazinc 

1-Meth. y 1-4-pheny 1-4-propionoxypiperidine 

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

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

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

2-(2,5-Dimethoxy-4-n-propy lpheny l )ethanamine (2C-P) 

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

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

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

25B; Cimbi-36) 

2-( 4-Chloro-2,5-dimethoxypheny 1 )ethanamine (2C-C) 

2-( 4-Chloro-2,5-dimethoxypheny 1 )-N-(2-

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

25C; Cimbi-82) 

2-( 4-lodo-2,5-dimethoxyphenyl)ethanamine (2C-l) 

2-( 4-Iodo-2,5-dimethoxypheny 1 )-N-(2-

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

251; Cimbi-5) 

2,5-Dimethoxy-4-ethylamphetamine (DOE'l') 

2,5-Dimethoxy-4-n-propylthiophenethylamine 

2,5-Dimethoxyamphetamine 

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

2-[ 4-(lsopropylthio )-2,5-dimethoxyphenyl]ethanamine (2CT-4) 

3,4,5-Trimethoxyamphetamine 

2-Methyl AP-237 

3,4-Methylenedioxyamphetamine (MDA) 

3,4-Methylenedioxymethamphetamine (MOMA) 

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

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

3,4-Methylenedioxypyrovalerone (MDPV) 

3-FMC; 3-Fluoro-N-methylcathinone 

3-Methylfentanyl 

3-Methy lmethcathinone 

Established 2025 

Quotas 

(g) 

20 

30 

10 

30 

30 

15 

30 

25 

10 

30 

30 

30 

30 

100 

30 

30 

25 

30 

30 

25 

25 

25 

30 

30 

30 

30 

12,000 

12,000 

40 

5,200 

35 

25 

30 

30 
102654 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.096</GPH>

3-Mcthy lthiofcntany 1 30 

4,4 '-Dimethy laminorex 30 

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

4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 5,100 

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

PVP) 

4-CN-Cumy 1-Butinaca 25 

4-Fluoroisobutyry 1 fentany 1 30 

4P-MDMB-DINACA 30 

4-FMC; Flephedrone 25 

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

4-Methoxyamphetamine 150 

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

PiHP) 

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

4-Methy laminorex 25 

4-Methyl-N-methy lcathinone (mephedrone) 45 

4-Methy 1-alpha-ethy laminopentiophenone ( 4-MEAP) 25 

4-Methyl-alpha-pyrrolidinohexiophenone (MPHP) 25 

4'-Methyl acetyl fentanyl 30 

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

4F-MDMB-BUTICA 30 

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

phenol 

5-(1, 1-Dimethyloctyl)-2-[ (1 R,3 S)-3-hydroxycyclohexy l]- 40 

phenol (cannabicvclohexanol or CP-47,497 C8-homolog) 

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

( 5-.0uoropentv 1)-1 H-indazole-3-carboxamide 

5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5- 25 

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

dimethy lbutanoate) 

5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2- 25 

phenylpropan-2-yl)-l H-pyrrolo [2,3-b ]pyridine3carboximide 

5F-CUMYL-PINACA 25 

5F-EDMB-PICA 30 

5F-EDMB-PlNACA 25 

5F-MDMB-PICA 25 

5F-AMB (methyl 2-(1-(5-fluoropentyl)-lH-indazole-3- 25 

carboxamido)-3-methvlbutanoate) 

5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5- 25 

fluoropentvl)-1 H-indazole-3-carboxamide) 

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

5-Fluoro-URl 44, XLRl 1 ([1-(5-fluoro-pentyl)-lHindol-3- 25 

yl](2,2,3,3-tetramethylcvclopropyl)methanone 

5-Methoxy-3,4-methylenedioxyamphetamine 25 

5-Methoxy-N ,N-diisopropy ltryptamine 25 
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102655 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.097</GPH>

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

AB-CHMINACA 30 

AB-FUBINACA 50 

AB-PINACA 30 

ADB-BUTINACA 30 

ADB-FU BINA CA (N-(1-amino-3 ,3-dimethy 1-1-oxobutan- 30 

2-vl)-1-( 4-:fluorobenzvl)-lH-indazole-3-carboxamide) 

Acetorphine 25 

Acetyl Fentanyl 100 

Acetyl-alpha-methylfentanyl 30 

Acetyldihydrocodeine 30 

Acety lmethadol 25 

Acryl Fentanyl 25 

ADB--4en-PINACA 30 

ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2- 50 

yl)-l-pentyl-lH-indazole-3-carboxamide) 

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-(l-adamantyl)-1-pentyl-IH-indazole- 25 

3-carboxamide) 

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 
102656 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.098</GPH>

Brorphine 30 

Bufotenine 15 

Butonitazene 30 

Butylone 25 

Butyryl fentanyl 30 

Cathinone 40 

Clonazolam 30 

Clonitazcnc 25 

Codeine methy I bromide 30 

Codeine-N-oxide 192 

Crotonyl Fentanyl 25 

CUMYL-PEGACLONE 30 

Cyclopentyl Fentanyl 30 

Cyclopropyl Fentanyl 20 

Cyprenorphine 25 

d-9-THC 1,523,040 

Deso morphine 25 

Dextromoramide 25 

Diapromide 20 

Diclazepam 30 

Diethy lthiambutene 20 

Diethy ltryptamine 25 

Difenoxin 9,300 

Dihydromorphine 639,954 

Dimenoxadol 25 

Dimepheptanol 25 

Dimethy lthiambutene 20 

Dimethy ltryptamine 20,000 

Dioxyaphetyl butyrate 25 

Dipipanone 25 

Drotebanol 25 

Ethylmethylthiambutene 25 

Ethylene 25 

Ethylphenidate 30 

Etizolam 30 

Etodesni tazene 30 

Etonitazene 25 

Etorphine 30 

Etoxeridine 25 

Eutylone 30 

F enethy lline 30 

r entany 1 carbamate 30 

Fentanyl related substances 600 

Flualprazolam 30 

rlubromazolam 30 
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102657 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.099</GPH>

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 

IIydroxypethidine 25 

lbogaine 210 

Isobutyryl Fentanyl 25 

Tsotonitazine 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-[l-(4-methoxynaphthoyl)]indole) 30 

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

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

naphthoyl)indole) 

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

JWH-250 ( l-Pentyl-3-(2-methoxyphenylacetyl)indole) 30 

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

Ketobemidone 30 

Levomoramide 25 

Levophenyacy lmorphan 25 

Lysergic acid diethylamide (LSD) 1,200 

MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3- 30 

dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-lHindazole-3-carboxamide) 

MDMB-CIIMICA; MMB-CIIMINACA(methyl 2-( 1- 30 

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

dimethylbutanoate) 

MDMB-FUBINACA (methyl 2-(1-(4-tluorobenzyl)-lH- 30 

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

MMB-CHMlCA-(AMB-CHlMCA); Methyl-2-(1- 25 

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

methvlbutanoate 

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 
102658 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.100</GPH>

Methcathinone 25 

Methiopropamine 30 

Mcthoxctaminc 30 

Methoxyacety 1 fentany 1 30 

Mcthyldcsorphinc 5 

Methy ldihydromorphine 25 

Metodesnitazene 30 

Metonitazene 30 

Morpheridine 25 

Morphine methylbromide 5 

Morphine methylsulfonate 5 

Morphine-N-oxide 150 

MT-45 30 

Myrophine 25 

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

carboxylate 

N ,N-Dimethylamphetamine 25 

Naphyrone 25 

N-Desethyl isotonitazene 30 

N-Ethyl-1-phenylcyclohexylamine 25 

N-Ethyl-3-piperidyl benzilate 10 

N-Ethy !amphetamine 24 

N-Ethylhexedrone 25 

N-Ethy lpenty lone, ephy lone 30 

N-Hydroxy-3 ,4-methy lenedioxyamphetamine 24 

Nicocodeine 25 

Nico morphine 25 

N-methyl-3-piperidyl benzilate 30 

N-piperidiny 1 etonitazene 30 

N-Pyrrolidino Etonitazene 30 

N oracymethadol 25 

Norlevorphanol 2,550 

N ormethadone 25 

Normorphine 40 

Norpipanone 25 

Ocfentanil 25 

ortho-Fluoroacryl fentanyl 30 

ortho-Fluorobutyryl fcntanyl 30 

Ortho-Fluorofentanyl,2-Fluorofentanyl 30 

ortho-Fluoroisobutyryl fcntanyl 30 

ortho-Methyl acetylfentanyl 30 

ortho-Mcthyl mcthoxyacctyl fcntanyl 30 

Para-Chlorisobutyrl fentanyl 30 

Para-flourobutyryl fentanyl 25 

Para-fluorofentanyl 25 
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102659 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.101</GPH>

para-Fluoro furanyl fentanyl 30 

Para-Methoxyhutyrl fentanyl 30 

Para-methoxymethamphetamine 30 

para-Methylfentanyl 30 

Parahexyl 5 

PB-22; QUPIC 20 

Pentedrone 25 

Pentylone 25 

Phenadoxone 25 

Phcnampromidc 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- 45 

methoxyphenylacetyl)indole) 

SR-19 and RCS-4 (1-Pcntyl-3-[(4-mcthoxy)- 30 

benzovllindole) 

Tctrahydrofuranyl fcntanyl 15 

Thebacon 25 

Thiafentanil 25 

Thiofentany 1 25 

Thiofuranyl fentanyl 30 

TIU-2201 ( [1-(5-fluoropentyl)-lH-indazol-3- 30 

y ll(naphthalen-1-y l)methanone) 

Tilidine 25 

Trimeperidine 25 

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

tetramethylcyclopropvl)methanone 

U-47700 30 

Valeryl fentanyl 25 

Zipcprol 30 

Schedule II 

1-Phenylcyclohexy lamine 15 

1-Piperidinocyclohexanecarbonitrile 25 

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

Alfentanil 5,000 
102660 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.102</GPH>

Alphaprodine 25 

Amo barbital 20,100 

Bezitramide 25 

Carfentanil 20 

Cocaine 60,492 

Codeine (for conversion) 942,452 

Codeine (for sale) 19,262,957 

d-amphctaminc (for sale) 21,200,000 

d,1-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-alphacety lmethadol (LAAM) 25 

Levomethorphan 30 

Levorphanol 20,000 

Lisdexamfetamine 32,736,000 

Meperidine 681,184 

Meperidine Intermediate-A 30 

Mcpcridinc Intcrmcdiatc-B 30 

Meperidine Intennediate-C 30 

Metazocine 15 

Methadone (for sale) 25,619,700 

Methadone Intermediate 27,673,600 

d,1-Methamphetamine 150 

d-methamphetamine (for conversion) 485,020 

d-methamphetamine ( for sale) 47,000 

1-methamphetamine 587,229 

Methylphenidate (for sale) 53,283,000 

Methylphenidate (for conversion) 19,975,468 

Mctopon 25 
Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 102661 

BILLING CODE C 

The Administrator also establishes 

APQs for all other schedule I and II 

controlled substances included in 21 

CFR 1308.11 and 1308.12 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 2025 APQ and AAN as 

needed. 


ddrumheller on DSK120RN23PROD with NOTICES2EN17DE24.103</GPH>

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 

Oxycodone (for sale) 53,584,449 

Oxymorphone (for conversion) 31,773,105 

Oxymorphone (for sale) 464,464 

Pentobarbital 40,000,000 

Phenazocine 25 

Phencyclidine 35 

Phenmetrazine 25 

Pheny lacetone 100 

Piminodine 25 

Racemethorphan 5 

Racemorphan 5 

Remifentanil 3,000 

Secobarbital 172,100 

Sufentanil 4,000 

Tapentadol 10,390,226 

Thebaine 57,137,944 

List I Chemicals 

Ephedrine (for conversion) 41,100 

Ephedrine (for sale) 3,933,336 

Phenylpropanolamine (for conversion) 14,878,320 

Phenylpropanolamine (for sale) 7,990,000 

Pseudoephedrine (for conversion) 1,000 

Pseudoephedrine (for sale) 186,617,466 
102662 Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on December 11, 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. 2024–30023 Filed 12–16–24; 8:45 am] 

BILLING CODE P 


ddrumheller on DSK120RN23PROD with NOTICES2