Notice2025-19335
Adjustment to the Aggregate Production Quota for d-Amphetamine (For Sale) and Methylphenidate (For Sale) for 2025 Pursuant to 21 U.S.C. 826(h)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 2, 2025
Effective
October 2, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is adjusting the 2025 aggregate production quota for the schedule II-controlled substances d-amphetamine (for sale) and methylphenidate (for sale). In making this determination, DEA has considered the factors set forth in 21 CFR 1303.13(b) in accordance with 21 U.S.C. 826(a) and is expediting publication of this determination to comply with the timeframes specified in 21 U.S.C. 826(h)(1).
Full Text
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<title>Federal Register, Volume 90 Issue 189 (Thursday, October 2, 2025)</title>
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[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Notices]
[Pages 47825-47827]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19335]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1413M]
Adjustment to the Aggregate Production Quota for d-Amphetamine
(For Sale) and Methylphenidate (For Sale) for 2025 Pursuant to 21
U.S.C. 826(h)
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final order.
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SUMMARY: The Drug Enforcement Administration (DEA) is adjusting the
2025 aggregate production quota for the schedule II-controlled
substances d-amphetamine (for sale) and methylphenidate (for sale). In
making this determination, DEA has considered the factors set forth in
21 CFR 1303.13(b) in accordance with 21 U.S.C. 826(a) and is expediting
publication of this determination to comply with the timeframes
specified in 21 U.S.C. 826(h)(1).
DATES: This final order is effective October 2, 2025.
FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory
Drafting and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration, Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Legal Authority
Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826)
requires the Attorney General to establish aggregate production quotas
(APQ) for each basic class of controlled substance listed in schedule I
and II. The Attorney General has delegated this function to the
Administrator of DEA pursuant to 28 CFR 0.100.
Under 21 U.S.C. 826(h), when a request for individual manufacturing
quota is submitted by a DEA-registered manufacturer pertaining to a
schedule II-controlled substance that is contained in a drug on the
Food and Drug Administration's (FDA's) list of drugs in shortage, DEA
must complete review of such request not later than 30 days after
receipt of the request. If, after the review is completed, DEA finds
that an increase in the aggregate and individual production quotas is
necessary to address a shortage of that controlled substance, DEA is to
increase the aggregate and individual production quotas of that
controlled substance and any ingredient therein to the level requested.
21 U.S.C. 826(h)(1)(B)(i). However, if it is determined that the level
requested is not necessary to address the shortage, DEA is to provide a
written response detailing the basis for the determination. 21 U.S.C.
826(h)(1)(B)(ii).
Background
DEA published the 2025 established APQ for controlled substances in
schedules I and II in the Federal Register on December 17, 2024. 89 FR
102649. The 2025 established APQ represents those quantities of
schedule I and II controlled substances that may be manufactured in the
United States to provide for the estimated medical, scientific,
research, and industrial needs of the United States, for lawful export
requirements, and for the establishment and maintenance of reserve
stocks. These quotas do not include imports of controlled substances
for use in industrial processes. The final order stipulated that all
APQ are subject to an adjustment, in accordance with 21 CFR 1303.15.\1\
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\1\ Established Aggregate Production Quotas for Schedule I and
II Controlled Substances and Assessment of Annual Needs for the List
I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2025, 89 FR 102649 (December 17, 2024).
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Quotas Applicable to Drugs in Shortage Pursuant to 21 U.S.C. 826(h)
Under 21 U.S.C. 356c, manufacturers of drugs that are life-
supporting, life-sustaining, or intended for the treatment or
prevention of debilitating diseases or conditions must notify FDA of
any permanent discontinuation or interruption in manufacturing likely
to result in a meaningful disruption of the drug's supply in the United
States. d-Amphetamine (for sale) and methylphenidate (for sale) are
drugs intended for use in the prevention or
[[Page 47826]]
treatment of a debilitating disease or condition and therefore fall
under the notification requirements of 21 U.S.C. 356c. This provision
further requires FDA to assess whether the notifications received from
manufacturers concern controlled substances that are subject to
production quotas in accordance with 21 U.S.C. 826.
On August 15, 2025, DEA received a request from a DEA registered
manufacturer of the schedule II-controlled substance d-amphetamine to
increase its 2025 individual manufacturing quota pertaining to d-
amphetamine (for sale). Also on August 15, 2025, DEA received a request
from a separate DEA registered manufacturer of the schedule II-
controlled substance methylphenidate to increase its 2025 individual
manufacturing quota pertaining to methylphenidate (for sale). DEA
reviewed the FDA drug shortage list and found manufacturers reported a
domestic shortage of products containing d-amphetamine and products
containing methylphenidate. Multiple manufacturers cited ``shortage of
an active ingredient'' as the reason identified for the domestic
shortages. Pursuant to this request, DEA began its review under the
timeframes specified by 21 U.S.C. 826(h)(1).
Analysis for the Adjustment to the 2025 d-Amphetamine (For Sale) and
Methylphenidate (For Sale) Aggregate Production Quotas
In conducting the review under 21 U.S.C. 826(h) in order to
determine the necessity of this adjustment, the Administrator has
considered the criteria in accordance with 21 CFR 1303.13 (adjustment
of APQ for controlled substances). The Administrator is authorized to
increase or reduce the APQ at any time. 21 CFR 1303.13(a). DEA
regulations state that there are five factors that shall be considered
in determining whether to adjust the APQ. 21 CFR 1303.13(b).
Accordingly, the Administrator has taken into account the following
factors described below for 2025: (1) changes in the demand for that
class, changes in the national rate of net disposal of the class,
changes in the rate of net disposal of the class by registrants holding
individual manufacturing quotas for that class, and changes in the
extent of any diversion in the class; (2) whether any increased demand
for that class, the national and/or individual rates of net disposal of
that class are temporary, short term, or long term; (3) whether any
increased demand for that class can be met through existing
inventories, increased individual manufacturing quotas, or increased
importation, without increasing the APQ, taking into account production
delays and the probability that other individual manufacturing quotas
may be suspended pursuant to 21 CFR 1303.24(b); (4) whether any
decreased demand for that class will result in excessive inventory
accumulation by all persons registered to handle that class (including
manufacturers, distributors, practitioners, importers, and exporters),
notwithstanding the possibility that individual manufacturing quotas
may be suspended pursuant to 21 CFR 1303.24(b) or abandoned pursuant to
21 CFR 1303.27; and (5) 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 which are 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 1303.13(b). Based on that
review, DEA is increasing the current d-amphetamine (for sale) and
methylphenidate (for sale) APQs.
DEA reviewed domestic and export data from DEA's internal
databases, IQVIA, and Multi International Data Analysis System (MIDAS).
Please note, IQVIA and MIDAS do not use the sub-categories of ``for
sale'' and ``for conversion.'' This is a U.S. concept to clarify how
the substances are used domestically. Extrapolation of the data
predicts global consumption will increase 15.16 percent for d-
amphetamine drug products and 7.59 percent for methylphenidate drug
products in 2025 when compared to 2024. DEA also reviewed global
production and consumption data of d-amphetamine and methylphenidate
published in the 2024 Psychotropic Technical Report by the
International Narcotics Control Board (INCB).\2\ Please note, INCB also
does not use the sub-categories of ``for sale'' and ``for conversion.''
The report stated global manufacturing of both d-amphetamine and
methylphenidate increased in 2023 compared to 2022, with United States
being the largest manufacturer of both substances. According to the
INCB report, global imports of d-amphetamine have been increasing in
the past decade, with forty-one countries and territories reporting
imports in 2023. The volume of methylphenidate imports also increased
in 2023 compared to 2022, with 120 countries and territories reporting.
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\2\ INCB Psychotropics--Technical Report Psychotropic Substances
2024, Statistics for 2023, Assessments of Annual Medical Scientific
Requirements for Substances for 2025.
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Upon reviewing domestic and export data, along with the inventory
reports provided by the bulk and dosage manufacturers, DEA has
determined that although the current d-amphetamine (for sale) and
methylphenidate (for sale) APQs are adequate to address both the
domestic and foreign medical demand, they are insufficient to
accommodate an unexpected rise of quota requests for product
development activities. DEA is proposing to increase the APQs of d-
amphetamine (for sale) and methylphenidate (for sale) to support the
requests for product development activities by bulk and dosage form
manufacturers submitted after the publication of the Established
Aggregate Production Quotas for Schedule I and II Controlled Substances
and Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2025.\3\ The proposed
increases are to support manufacturers' product development activities
toward obtaining FDA approval of new API manufacturing processes, as
well as FDA approval of new drug products.
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\3\ Established Aggregate Production Quotas for Schedule I and
II Controlled Substances and Assessment of Annual Needs for the List
I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2025, 89 FR 102649 (December 17, 2024).
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After considering these factors, DEA determined that it is
necessary to increase the established 2025 APQ for the schedule II
controlled substances d-amphetamine (for sale) and methylphenidate (for
sale) to be manufactured in the United States to provide for the
estimated legitimate medical needs of the United States, export
requirements to meet foreign demand, the maintenance of reserve stocks,
and to support estimated needs for product development activities.
These adjustments are necessary to ensure that the United States has an
adequate and uninterrupted supply of d-amphetamine (for sale) and
methylphenidate (for sale) to meet legitimate patient needs both
domestically and globally as well as to support product development
requirements of both bulk and finished dosage form manufacturers.
Additional Legal Considerations
The procedures previously adopted by DEA for adjustment of APQ are
set
[[Page 47827]]
forth in DEA regulations in 21 CFR 1303.13. Under that provision, the
Administrator, upon determining that an adjustment of the APQ of any
basic class of controlled substance is necessary, shall publish in the
Federal Register general notice of an adjustment in the APQ for that
class. The regulation further directs that DEA will allow any
interested person to file comments or objections to the adjusted APQ
within the time specified by the Administrator in the notice. Section
1303.13 further provides that, ``[a]fter consideration of any comments
or objections . . . the Administrator shall issue and publish in the
Federal Register his final order determining the APQ for the basic
class of controlled substance.''
The statutory timeframe applicable to actions taken under 21 U.S.C.
826(h) was enacted by Congress after DEA established its regulations in
21 CFR 1303.13. DEA has determined that it is not possible to increase
the APQ within the Congressionally-mandated 30-day period while also
complying with the procedures that DEA previously had laid out in 21
CFR 1303.13. Therefore, the Administrator has determined that, in order
to comply with the 30-day timeframe in 21 U.S.C. 826(h), this final
order must be published without opportunity for comment and made
effective immediately.
Determination of 2025 d-Amphetamine (For Sale) and Methylphenidate (For
Sale) Aggregate Production Quota
In determining the adjustment of the 2025 d-amphetamine (for sale)
and methylphenidate (for sale) APQs, DEA has taken into consideration
the factors set forth in 21 CFR 1303.13(b) in accordance with 21 U.S.C.
826(a) as well as 826(h). Based on all of the above, the Administrator
is adjusting the 2025 APQs for d-amphetamine (for sale) and
methylphenidate (for sale).
The Administrator hereby adjusts the 2025 APQ for the following
schedule II-controlled substances expressed in grams of anhydrous acid
or base, as follows:
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Controlled substance Current APQ (g) Adjusted APQ (g)
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Schedule II
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d-amphetamine (for sale).......... 21,200,000 26,450,000
methylphenidate (for sale)........ 53,283,000 58,283,000
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The APQ for all other schedule I and II controlled substances
included in the 2025 established APQ remain at this time as established
in other Notices.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 5, 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. 2025-19335 Filed 10-1-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on October 2, 2025.
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