Adjustment to the 2026 Aggregate Production Quota for d,l-Amphetamine, d-Amphetamine (for Sale), Hydromorphone and Methylphenidate (for Sale) Pursuant to 21 U.S.C. 826(h)

Issuing agencies

Abstract

The Drug Enforcement Administration (DEA) is adjusting the 2026 aggregate production quota for the schedule II controlled substances d,l-amphetamine, d-amphetamine (for sale), hydromorphone, 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 91 Issue 216 (Tuesday, November 10, 2026)</title>
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[Federal Register Volume 91, Number 216 (Tuesday, November 10, 2026)]
[Notices]
[Pages 72564-72566]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22842]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1568M]


Adjustment to the 2026 Aggregate Production Quota for d,l-
Amphetamine, d-Amphetamine (for Sale), Hydromorphone and 
Methylphenidate (for Sale) 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 
2026 aggregate production quota for the schedule II controlled 
substances d,l-amphetamine, d-amphetamine (for sale), hydromorphone, 
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 November 10, 2026.

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 on the Food and Drug Administration's 
(FDA) list of drugs in shortage, DEA must complete review of such 
request no 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 2026 established APQ for controlled substances in 
schedules I and II in the Federal Register on January 5, 2026. 91 FR 
287. The 2026 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 
2026, 91 FR 287 (January 5, 2026).
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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 use in 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. Schedule II controlled substances d,l-amphetamine, d-
amphetamine (for sale), hydromorphone, and methylphenidate (for sale) 
are drugs intended for use in the prevention or 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.
    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 calendar year 2026: (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

[[Page 72565]]

(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,l-
amphetamine, d-amphetamine (for sale), hydromorphone, and 
methylphenidate (for sale) APQs.

Analysis for the Adjustment to the 2026 d,l-Amphetamine and d-
Amphetamine (for Sale) Aggregate Production Quota

    On August 14 and August 24, 2026, DEA received two requests from 
two DEA registered manufacturers of the schedule II controlled 
substance d,l-amphetamine for an increase to their 2026 individual 
manufacturing quota pertaining to d,l-amphetamine. On August 14, 2026, 
DEA also received a request from a DEA registered manufacturer of the 
schedule II controlled substance d-amphetamine for an increase to its 
2026 individual manufacturing quota pertaining to d-amphetamine (for 
sale). DEA reviewed the FDA drug shortage list and found multiple 
manufacturers reported a domestic shortage of amphetamine mixed salts 
tablets. Some manufacturers cited ``shortage of an active ingredient'' 
as the reason identified for the domestic shortages. Pursuant to these 
requests, DEA began its review under the timeframes specified by 21 
U.S.C. 826(h)(1).
    DEA reviewed the data provided by FDA in July 2026 on the domestic 
medical use of d,l-amphetamine and d-amphetamine (for sale), as well as 
export data and inventory reports from both bulk and dosage 
manufacturers. FDA predicted the domestic medical need for d,l-
amphetamine and d-amphetamine in 2026 will increase by 23.6 percent and 
23.7 percent respectively when compared to the 2025 observed domestic 
medical need. DEA also reviewed the global consumption data from Multi 
International Data Analysis System (MIDAS). Extrapolation of the global 
sales of d,l-amphetamine and d-amphetamine predicts an increase of 4.36 
percent and 4.07 percent respectively in 2026 when compared to 2025. 
While sufficient quota was granted to meet legitimate patient needs 
both domestically and globally, DEA has determined that due to the 
increase in domestic and global medical needs, an increase to the d,l-
amphetamine and d-amphetamine (for sale) is necessary to allow for the 
adequate manufacturing of reserve stocks to start the next calendar 
year.
    DEA also saw an increase in quota requests for product development 
activities by bulk and dosage form manufacturers of d,l-amphetamine and 
d-amphetamine (for sale) to synthesize engineering and validation 
batches to support the filing of new drug applications for FDA review. 
Year-to-date amounts approved for product development by bulk and 
dosage manufacturers have increased 173 percent for d,l-amphetamine and 
32 percent for d-amphetamine (for sale) in 2026 when compared to 2025, 
respectively. DEA has determined that it is necessary to increase the 
2026 d,l-amphetamine and d-amphetamine (for sale) APQs to allow for the 
maintenance of reserve stocks and increased product development needs 
after considering all estimated consumption data and projected product 
development needs.

Analysis for the Adjustment to the 2026 Hydromorphone Aggregate 
Production Quota

    On July 24, 2026, DEA received a request from a DEA registered 
manufacturer of the schedule II controlled substance hydromorphone for 
an increase to its 2026 individual manufacturing quota pertaining to 
hydromorphone. DEA reviewed the FDA drug shortage list and found 
multiple manufacturers reported a domestic shortage of hydromorphone 
hydrochloride injectable products. The manufacturers cited ``demand 
increase for the drug or delay of manufacturing'' as the reasons 
identified for the domestic shortages. Pursuant to this request, DEA 
began its review under the timeframe specified by 21 U.S.C. 826(h)(1).
    DEA reviewed the most recent domestic usage data from IQVIA, as 
well as data provided by the FDA on the domestic medical use of 
hydromorphone. FDA predicted the domestic medical need for 
hydromorphone in 2026 will increase by 20.9 percent compared to the 
2025 observed medical need. DEA also reviewed export information 
provided by bulk manufacturers, export data from DEA's internal 
database, and global consumption data from MIDAS. Export data shows 
that the 2026 exports of hydromorphone will increase 142 percent when 
compared to 2025 because one bulk manufacturer is planning to 
significantly increase its export of hydromorphone in 2026. DEA has 
determined that an increase to the hydromorphone APQ is necessary to 
support the estimated increase in domestic medical need and projected 
new export requirements.

Analysis for the Adjustment to the 2026 Methylphenidate (for Sale) 
Aggregate Production Quota

    On July 31, August 1, and August 20, 2026, DEA received requests 
from DEA registered manufacturers of the schedule II controlled 
substance methylphenidate for an increase to their 2026 individual 
manufacturing quota pertaining to methylphenidate (for sale). DEA 
reviewed the FDA drug shortage list and found multiple manufacturers 
reported a domestic shortage of methylphenidate tablets and film. The 
manufacturers cited ``demand increase for the drug'' or 
``discontinuation of the manufacture of the drug'' as the reasons 
identified for their portion of the domestic shortages. Pursuant to 
these requests, DEA began its review under the timeframes specified by 
21 U.S.C. 826(h)(1).
    Following a review of domestic and export data, as well as 
inventory reports from both the bulk and dosage manufacturers, DEA has 
determined that an increase to the APQ of methylphenidate (for sale) is 
necessary to address the increasing global medical demand and to allow 
domestic manufacturers of FDA-approved methylphenidate drug products to 
replenish their inventories to levels authorized by DEA regulations. 
FDA predicted the domestic medical need for methylphenidate in 2026 
will increase by 23.4 percent compared to the 2025 observed medical 
need. DEA also reviewed the methylphenidate export data from DEA's 
internal database, as well as global consumption data from MIDAS. 
Extrapolation of the sales data from MIDAS predicts global consumption 
will increase by 8.01 percent for methylphenidate drug products in 2026 
when compared to 2025.
    DEA also reviewed global production and consumption data of 
methylphenidate published in the 2025 Psychotropic Technical Report by 
the International Narcotics Control Board

[[Page 72566]]

(INCB).\2\ The INCB reported the United States as the leading 
manufacturer of methylphenidate, and although the total manufacturing 
of methylphenidate was reported to be at the highest level since INCB 
began receiving data, the global stocks of methylphenidate decreased by 
11 tons, from 91.6 tons in 2023 to 80.6 tons in 2024. After considering 
all the domestic and global data, DEA has determined that an increase 
to the 2026 methylphenidate (for sale) APQ is necessary to allow for 
the adjustment of reserve stocks to support the increasing global 
medical demand.
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    \2\ INCB Psychotropics--Technical Report Psychotropic Substances 
2025, Statistics for 2024, Assessments of Annual Medical Scientific 
Requirements for Substances for 2026.
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    After considering the factors set forth in 21 CFR 1303.13(b) in 
accordance with 21 U.S.C. 826(a) as well as 826(h), DEA determined that 
it is necessary to increase the established 2026 APQs for the schedule 
II controlled substances d,l-amphetamine, d-amphetamine (for sale), 
hydromorphone, and methylphenidate (for sale) to be manufactured in the 
United States to provide for the estimated legitimate medical needs of 
the United States and export requirements to meet foreign demand. These 
adjustments are necessary to ensure that the United States has an 
adequate and uninterrupted supply of d,l-amphetamine, d-amphetamine 
(for sale), hydromorphone, and methylphenidate (for sale) to meet 
legitimate patient needs both domestically and globally.

Additional Legal Considerations

    The procedures previously adopted by DEA for adjustment of APQ are 
set 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 a 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 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 2026 d,l-Amphetamine, d-Amphetamine (for Sale), 
Hydromorphone, and Methylphenidate (for Sale) Aggregate Production 
Quota

    In determining the adjustment of the 2026 d,l-amphetamine, d-
amphetamine (for sale), hydromorphone, 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 2026 APQs for 
d,l-amphetamine, d-amphetamine (for sale), hydromorphone, and 
methylphenidate (for sale).
    The Administrator hereby adjusts the 2026 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,l-amphetamine.............................................................       24,234,443        31,654,915
d-amphetamine (for sale)....................................................       26,450,000        37,108,041
hydromorphone...............................................................        1,949,378         2,356,798
methylphenidate (for sale)..................................................       58,283,000        69,502,651
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    The APQ for all other schedule I and II controlled substances 
included in the 2026 established APQ remain at this time as previously 
established.\3\
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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 
2026, 91 FR 287 (January 5, 2026).
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Signing Authority

    This document of the Drug Enforcement Administration was signed on 
November 4, 2026, by DEA Administrator Terrance C. 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. 2026-22842 Filed 11-9-26; 8:45 am]
BILLING CODE 4410-09-P


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