[Federal Register Volume 88, Number 190 (Tuesday, October 3, 2023)]
[Notices]
[Pages 68147-68149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22059]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1051M]


Adjustment to the Aggregate Production Quota for Methylphenidate 
(for Sale) for 2023

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration is adjusting the 2023 
aggregate production quota for the schedule II controlled substance 
methylphenidate (for sale).

DATES: This final order is effective October 3, 2023.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, 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 the Drug Enforcement Administration (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 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 it 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 2023 established APQ for controlled substances in 
schedules I and II in the Federal Register on December 2, 2022. 87 FR 
74168. The 2023 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\
---------------------------------------------------------------------------

    \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 
2023, 87 FR 74168 (December 2, 2022).
---------------------------------------------------------------------------

Quotas Applicable to Drugs in Shortage Pursuant to 21 U.S.C. 826(h)

    DEA received written correspondence from FDA on August 10, 2023, in 
accordance with 21 U.S.C. 356c, addressing the domestic drug shortage

[[Page 68148]]

of methylphenidate HCl extended-release tablets. In this letter, FDA 
advised DEA that on July 26, 2023, FDA added methylphenidate 
hydrochloride (HCl) extended-release tablets to its drug shortage list 
pursuant to 21 U.S.C. 356e. 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. That provision further requires FDA to 
assess whether notifications received from manufacturers concern 
controlled substances subject to production quotas in accordance with 
21 U.S.C. 826.
    FDA's August 10th letter requested that DEA increase the APQ and 
individual manufacturing quotas for methylphenidate to a level that FDA 
deems necessary to address a shortage based on the best available 
market data.\2\ On September 15, 2023, FDA clarified to DEA that 
methylphenidate is ``intended for use in the prevention or treatment of 
a debilitating disease or condition'' and therefore falls under the 
notification requirements of 21 U.S.C. 356c.
---------------------------------------------------------------------------

    \2\ As the FDA's specific requested levels would reveal 
proprietary manufacturing data, DEA is not specifying the requested 
levels in this document.
---------------------------------------------------------------------------

    On September 14, 2023, DEA received a request for increased 2023 
manufacturing quota pertaining to methylphenidate from a DEA registrant 
that is a manufacturer of that Schedule II controlled substance. 
Pursuant to this request, and following the receipt of the letter from 
FDA on August 10, DEA began its review under the timeframes specified 
by 21 U.S.C. 826(h)(1).

Analysis for the Adjustment to the 2023 Methylphenidate (for Sale) 
Aggregate Production Quota

    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 aggregate production quota at any time. 21 CFR 
1303.13(a). DEA regulations state that there are five factors that 
shall be considered in determining to adjust the aggregate production 
quota. 21 CFR 1303.13(b). Accordingly, the Administrator has taken into 
account the following factors described below for 2023: (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 aggregate production 
quota, 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).
    DEA reviewed domestic data from the latest IQVIA report on 
stimulant prescribing that described a 9.1 percent increase in 
prescribing of methylphenidate HCl products from 2021 to 2022.\3\ 
However, FDA's estimate of domestic medical need for methylphenidate 
drug products predicted a 0.11 percent increase for 2023 domestic need 
when compared to 2022 observed need. DEA believes that manufacturers 
can easily meet this insignificant increase in domestic medical need 
with currently established quotas.
---------------------------------------------------------------------------

    \3\ Stimulant Prescription Trends in the United States from 
2012-2022. IQVIA Government Solutions, Inc., August 31, 2023.
---------------------------------------------------------------------------

    DEA also reviewed published reporting of methylphenidate production 
and consumption globally found in the INCB's Psychotropic Technical 
Report for 2022.<SUP>4</SUP> This report outlines that U.S. production 
of methylphenidate accounted for 72.5 percent of global production and 
the U.S. was the leading exporter of methylphenidate in 2021. The 
number of countries and territories reporting the importation and 
consumption of methylphenidate drug products increased 5 percent and 8 
percent, respectively, from 2020 to 2021. The report states that 
consumption rates in several European countries increased in 2021. 
Additionally, DEA reviewed export data extracted from DEA's internal 
databases and reported to the United Nations as part of the U.S.' 
treaty obligations for controlled substances. The export data showed 
that exports of drug products containing methylphenidate increased from 
13,083kg in 2021 to 15,792kg in 2022. Extrapolation utilizing previous 
years' reported export data suggests a similar quantity of drug 
products containing methylphenidate HCl will be exported from the U.S. 
in 2023.
---------------------------------------------------------------------------

    \4\ INCB Psychotropics--Technical Report Psychotropic Substances 
2022, Statistics for 2021, Assessments of Annual Medical Scientific 
Requirements for Substances for 2023.
---------------------------------------------------------------------------

    After considering these factors, DEA determined that it is 
necessary to increase the established 2023 APQ for the schedule II-
controlled substance methylphenidate (for sale) to be manufactured in 
the United States to provide for the estimated needs of the United 
States and export requirements to meet global demand. This adjustment 
is necessary to ensure that the United States has an adequate and 
uninterrupted supply of 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 aggregate 
production quota of any basic class of controlled substance is 
necessary, shall publish in the Federal Register general notice of an 
adjustment in the aggregate production quota 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

[[Page 68149]]

Register his final order determining the aggregate production quota 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 2023 Adjusted Methylphenidate (for Sale) Aggregate 
Production Quota

    In determining the adjustment of the 2023 methylphenidate (for 
sale) aggregate production quota, 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 2023 aggregate production quota for methylphenidate 
(for sale).
    The Administrator hereby adjusts the 2023 APQ for the following 
schedule II-controlled substance expressed in grams of anhydrous acid 
or base, as follows:

----------------------------------------------------------------------------------------------------------------
                            Controlled substance                               Current APQ (g)  Adjusted APQ (g)
----------------------------------------------------------------------------------------------------------------
                                                   Schedule II
----------------------------------------------------------------------------------------------------------------
Methylphenidate (for sale)..................................................       41,800,000        53,283,000
----------------------------------------------------------------------------------------------------------------

    The APQ for all other schedule I and II controlled substances 
included in the 2023 established APQ remain at this time as previously 
established.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
September 29, 2023, 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. 2023-22059 Filed 9-29-23; 4:15 pm]
BILLING CODE 4410-09-P