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, 78772-78782 [2024-21962]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78772-78782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21962]


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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.

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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 
https://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.

[[Page 78773]]


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 https://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 https://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 https://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).
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    \1\ Proposed 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).
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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

[[Page 78774]]

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 long-COVID 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.
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    \2\ New 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.
    \3\ Adjustment to the Aggregate Production Quota for 
Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR 
72424 (Sept. 5, 2024).
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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).
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    \4\ The estimates of diversion for five ``covered controlled 
substances'' as required by 21 U.S.C. 826(i) are discussed later in 
the document.
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    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

[[Page 78775]]

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\
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    \5\ 21 U.S.C. 826(i)(1)(C).
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    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).
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    \6\ National 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.
    \7\ The 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).
    \8\ The 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.
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    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.
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    \9\ NASCSA formatted DEA's request into an analytics model 
developed by one of its associates, Appriss Inc.

    Table 1a--States/Territories That Responded to DEA's Data Request
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                             State/territory
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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.
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    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\
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    \10\ Frank'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).
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     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

[[Page 78776]]

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\
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    \11\ This total does not include insurance co-payments made with 
cash.
    \12\ Suntree 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).
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    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 red-flag 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.
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    \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.
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    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
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.
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    \14\ Both 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%20Public.pdf.
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    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

[[Page 78777]]

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.
---------------------------------------------------------------------------

    \15\ Management of Quotas for Controlled Substances and List I 
Chemicals, 88 FR 60,117 (Aug. 31, 2023) (effective Nov. 29, 2023).
---------------------------------------------------------------------------

    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 DEA-registered 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:

------------------------------------------------------------------------
                                                          Proposed 2025
                      Basic class                           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-                                 30
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36).............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)......               30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82).............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)........               30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5)..............................................
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-                30
 2)....................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 T-4)..................................................
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-              25
 PVP)..................................................
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                     30
 (alpha-PiHP)..........................................
4-Methyl-2,5-dimethoxyamphetamine (DOM)................               25
4-Methylaminorex.......................................               25
4-Methyl-N-methylcathinone (mephedrone)................               45
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)........               25
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)..........               25

[[Page 78778]]

 
4'-Methyl acetyl fentanyl..............................               30
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)....               25
4F-MDMB-BUTICA.........................................               30
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)..
5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-                25
 fluoropentyl)-1H-indazole-3-carboxamide...............
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              25
 indazole-3-carboxamido)-3,3-dimethylbutanoate)........
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-              25
 yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide............
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-                   25
 carboxamido)-3-methylbutanoate).......................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        25
 fluoropentyl)-1H-indazole-3-carboxamide)..............
5-Fluoro-PB-22; 5F-PB-22...............................               25
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-                25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone..........
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)-               30
 1-(4-fluorobenzyl)-1H-indazole-3-carboxamide).........
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-               50
 pentyl-1H-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 ([alpha]-PBP)............               25
alpha-pyrrolidinoheptaphenone (PV8)....................               25
alpha-pyrrolidinohexabophenone (alpha-PHP).............               25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)...........               25
Amineptine.............................................               30
Aminorex...............................................               25
Anileridine............................................               20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 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
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

[[Page 78779]]

 
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-                             35
 naphthoyl)indole).....................................
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-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)..........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-                                30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate)....................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate).................
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-              25
 1H-indole-3-carboxamido)-3-methylbutanoate............
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

[[Page 78780]]

 
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-                25
 carboxylate...........................................
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-                              45
 methoxyphenylacetyl)indole)...........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-                             30
 benzoyl]indole).......................................
Tetrahydrofuranyl fentanyl.............................               15
Thebacon...............................................               25
Thiafentanil...........................................               25
Thiofentanyl...........................................               25

[[Page 78781]]

 
Thiofuranyl fentanyl...................................               30
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-1-yl)methanone)........................
Tilidine...............................................               25
Trimeperidine..........................................               25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone......................
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

[[Page 78782]]

 
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