Notice2025-21509
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 2026
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Published
November 28, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) proposes to establish the 2026 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.
Full Text
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<title>Federal Register, Volume 90 Issue 227 (Friday, November 28, 2025)</title>
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[Federal Register Volume 90, Number 227 (Friday, November 28, 2025)]
[Notices]
[Pages 54745-54760]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21509]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1568P]
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 2026
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 2026 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 December 15, 2025. 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 his 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 2026
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. 1568P'' 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://Regulations.gov">Regulations.gov</a>. 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.
SUPPLEMENTARY INFORMATION:
[[Page 54746]]
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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 2026 Aggregate Production Quotas and Assessment
of Annual Needs
The proposed 2026 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 2026 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 2026 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 & 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 data from the HHS agency FDA in March 2025
and from the states in April 2025, pursuant to 21 CFR part 1303. DEA
did not solicit input from CMS for reasons discussed in previous
notices.\1\ While DEA is requesting data from CDC, this request has
been inadvertently delayed. Data received from the CDC that is relevant
to the 2026 APQs will be considered in finalizing and/or adjusting the
APQs. DEA requested information on trends in the legitimate use of
select schedule I and II controlled substances from FDA. 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 2026 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
[[Page 54747]]
manufactured from them, 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 1315.11(b).
In determining the proposed 2026 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. In July 2025, FDA provided DEA with the predicted
estimates of domestic medical usage for selected controlled substances
for 2026, which DEA considered in developing the proposed 2026 APQ.
DEA observed an average of a 10.56 percent decrease in the medical
usage of the schedule II opioids codeine, morphine, fentanyl,
hydrocodone, hydromorphone, oxycodone and oxymorphone for the United
States in 2024 compared to 2023. DEA projects that the medical usage of
these controlled substances will continue to decline in 2026 based on a
review of domestic usage data from IQVIA. DEA also considered the
potential for diversion of these opioids, as required by 21 CFR
1303.11(b)(5). Additionally, DEA has observed a significant decline in
requests for product development quotas to support manufacturing
towards FDA approval of drug products containing oxycodone.
Accordingly, the APQs for codeine (for sale), morphine (for sale),
fentanyl, hydrocodone (for sale), hydromorphone, oxycodone (for sale),
and oxymorphone (for sale) are being proposed as reductions from their
2025 established APQ value.
DEA is proposing a slight increase to the remifentanil APQ from the
2025 established APQ. Remifentanil is a schedule II synthetic opioid
analgesic that is primarily administered intravenously to manage pain
during and after surgical procedures. DEA reviewed the most recently
available domestic usage data from IQVIA and export data from DEA's
internal database. Domestic medical usage of remifentanil has been
increasing every year since 2020. Additionally, exports of this active
pharmaceutical ingredient (API) have also increased from 2022 to 2024.
Thus, DEA is proposing a higher APQ of remifentanil for 2026 than DEA
initially established for 2025, to support increasing domestic medical
use and export requirements.
DEA is also proposing an increase to the noroxymorphone (for sale)
APQ from the 2025 established APQ to accommodate a manufacturer's
request to manufacture reference standards, and to evaluate and
identify unknown impurities in the manufacturing process. This
additional APQ will also accommodate the manufacturer's need to conduct
additional product development manufacturing activities to optimize the
synthesis of noroxymorphone (for sale).
DEA observed an average of a 6.74 percent increase in domestic
medical use of the schedule II stimulants amphetamine, methylphenidate
(including dexmethylphenidate), and lisdexamfetamine in 2024 compared
to 2023. Medications containing one of these controlled substances are
commonly prescribed to treat patients with attention deficit
hyperactivity disorder (ADHD). In 2025, dosage form manufacturers
reported shortages of specific ADHD medications containing amphetamine,
lisdexamfetamine, and methylphenidate to FDA. The stated reasons for
these specific shortages include increases in product demand, supply
chain issues, manufacturing and quality issues, lack of active
ingredients, and business decisions of manufacturers. DEA considered
drug shortage concerns when determining the proposed APQs for these
substances.
In proposing the APQs for d-amphetamine (for sale), d,l-
amphetamine, and methylphenidate, DEA considered manufacturers'
reported inventories for amphetamine and methylphenidate-based products
and determined that the 2026 APQs should be proposed at their 2025
adjusted APQ levels. DEA believes the inventories, when combined with
the proposed 2026 APQs, will be sufficient to support the estimated
increases in domestic medical use and export requirements of
amphetamine and methylphenidate-based products.
With respect to lisdexamfetamine, DEA is proposing an increase from
the 2025 established lisdexamfetamine APQ to address increased
prescribing, export requirements, and to ensure sufficient inventory
for domestic manufacturers of FDA-approved lisdexamfetamine drug
products. DEA recognizes that global consumption is increasing with
almost 30 countries approving the use of lisdexamfetamine drug products
to treat specific medical conditions. DEA reviewed the most recently
available domestic usage data from IQVIA and export data from DEA's
internal database and Multi International Data Analysis System (MIDAS).
Extrapolation of the data predicts domestic use will increase 8.94
percent and export requirements will increase 14.85 percent in 2026.
This double-digit increase in export requirements follows from the
brand name product, Vyvanse, successfully being approved to treat
patients suffering from attention-deficit/hyperactivity disorder (ADHD)
in 29 countries in addition to the United States. Furthermore, Vyvanse
is expected to launch in additional foreign countries between 2025 and
2027. Additional U.S. dosage form manufacturers have also begun
exporting lisdexamfetamine finished dosage-form products according to
the data extracted from DEA's internal databases. Reviewing internal
databases, DEA determined that bulk manufacturers started 2025 with
less than the 40% inventory allowance permitted by 21 CFR 1303.24.
Increasing the lisdexamfetamine APQ in 2026 would allow the
manufacturers to maintain the 40% inventory allowance permitted by 21
CFR 1303.24 while meeting the estimated increasing legitimate domestic
and global demands. Thus, DEA is proposing a higher lisdexamfetamine
APQ for 2026 than DEA initially established for 2025.
DEA is also proposing a corresponding increase to the APQ of d-
amphetamine (for conversion) over the 2025 level. The synthesis route
to manufacture lisdexamfetamine requires the manufacturing of a
controlled substance intermediate, d-amphetamine (for conversion). In
most synthesis pathways, lisdexamfetamine cannot be manufactured
without synthesizing d-amphetamine (for conversion) as an intermediate
step, thus the APQ of d-amphetamine (for conversion) is proposed to
increase commensurately to the lisdexamfetamine APQ increase.
DEA Projected Trends for Certain Schedule I Controlled Substances
DEA is proposing a higher APQ than the 2025 established APQs for
the
[[Page 54748]]
following schedule I controlled substances: 3,4-methylenedioxy-N-
methylcathinone, 5-methyoxy-N-N-dimethyltryptamine, psilocybin and
psilocyn to support manufacturing activities related to the increased
level of research and clinical trials. Research and clinical trials are
being conducted with these substances for potential treatment of
conditions such as post-traumatic stress disorder (PTSD) and
depression.
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.\2\ 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 2024 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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\2\ 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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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 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.'' \3\
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\3\ 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 2025, 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 2022-2024. 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.\4\ 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.\5\
Certain state regulations now include red flag circumstances as
potential indicators of illegitimate prescriptions, and thus of
potential abuse and diversion of controlled substances.\6\ 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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\4\ 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.
\5\ 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).
\6\ 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,
2025. 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.
Thirty-one states and three territories provided DEA with summarized
PDMP data as of July 2025, utilizing the standardized report developed
by NASCSA.\7\ See Table 1a below.
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\7\ 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. Arizona.
4. Arkansas.
5. Commonwealth of Northern Mariana Islands.
6. Connecticut.
7. Delaware.
8. District of Columbia.
9. Idaho.
10. Indiana.
11. Iowa.
12. Kansas.
13. Kentucky.
14. Louisiana.
15. Maine.
16. Maryland.
17. Michigan.
18. Minnesota.
19. Mississippi.
20. Missouri.
21. Montana.
22. Nevada.
23. New Jersey.
24. New Mexico.
25. North Carolina.
26. Ohio.
27. Oregon.
28. Pennsylvania.
29. Puerto Rico.
30. South Carolina.
31. South Dakota.
32. Texas.
33. Utah.
34. Virginia.
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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,
[[Page 54749]]
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:
<bullet> 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.\8\
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\8\ 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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<bullet> 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.
<bullet> The number of patients that paid cash for covered
controlled substance prescriptions, without submitting for insurance
reimbursement.\9\ States also provided the number of prescriptions paid
entirely with cash as a percentage 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.\10\
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\9\ This total does not include insurance co-payments made with
cash.
\10\ 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 2022-2024. 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 2021-2024, 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 2026.
DEA also reviewed aggregate sales data for each of the covered
controlled substances, which it extracted from IQVIA's National Sales
Perspective.\11\ 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 2025, in order to predict the
estimated national sales for 2026.
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\11\ 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 2026 by the forecasted sales data
from IQVIA for 2026. 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 2026 Based on State PDMP Data for
Covered Controlled Substances from 2022-2024.
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Controlled substance (g)
------------------------------------------------------------------------
Fentanyl................................................ 27
Hydrocodone............................................. 124,656
Hydromorphone........................................... 477
Oxycodone............................................... 302,819
Oxymorphone............................................. 0
------------------------------------------------------------------------
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. Additional data was provided by a DEA field office based on
the conclusion of a regulatory inspection. In January 2025, DEA
Diversion Investigators conducted an inspection at a DEA-registered
pharmaceutical company and discovered a significant quantity of
oxycodone medications missing from various production stages. DEA fined
the company who surrendered their DEA registration license at the
conclusion of the investigation. This estimate of diversion from the
legitimate supply chain for each of the covered controlled substances
is displayed in Table 2. This
[[Page 54750]]
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................................................ 78
Hydrocodone............................................. 18,765
Hydromorphone........................................... 1,653
Oxycodone............................................... 43,978
Oxymorphone............................................. 97
------------------------------------------------------------------------
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 2026 APQs
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl................................................ 105
Hydrocodone............................................. 143,421
Hydromorphone........................................... 2,130
Oxycodone............................................... 346,797
Oxymorphone............................................. 97
------------------------------------------------------------------------
Continuing Efforts To Anticipate and Prevent Drug Shortages
DEA remains committed to monitoring drug shortages, limiting their
impact, and resolving them as quickly as possible. DEA continues to
seek additional information that will assist in accurately forecasting
domestic medical usage and export requirements of schedule I or II
substances. In February 2024, DEA began utilizing IQVIA's foreign (non-
U.S.) sales tracking data module, MIDAS, which provides valuable
insight into the growing export markets for schedule II stimulants. In
March 2025, DEA sent a letter requesting approximately 700 DEA-
registered manufacturers and distributors to voluntarily switch their
DEA ARCOS database reporting from a quarterly to monthly basis.
On April 29, 2024, DEA announced to DEA-registered manufacturers
that procurement quotas for the purpose of commercial manufacturing of
schedule II-controlled substances will be allocated on a semi-annual
basis, except that procurement quotas relating to injectable drug
products will be allocated annually. In a continuing effort to prevent
drug shortages and be more agile in its administration of the quota
program, DEA will continue to administer applicable procurement quotas
on a semi-annual basis. DEA remains committed to ensuring that all
patients with legitimate medical need can access appropriately
prescribed medications.
The Administrator, therefore, proposes to establish the 2026 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:
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BILLING CODE 4410-09-C
The Administrator further proposes that the APQ for all other
schedule I and II controlled substances included in 21
[[Page 54760]]
CFR 1308.11 and 1308.12 remain at zero.
These proposed 2026 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 2026 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 2026 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
November 25, 2025, by Administrator Terrance Cole. 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. 2025-21509 Filed 11-25-25; 4:15 pm]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on November 28, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.