`[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Notices]
[Pages 102649-102662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30023]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1413E]


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the initial 2025 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act and the assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: This order is effective December 17, 2024.

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, VA 22152, Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

I. Legal Authority

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish production quotas for each 
basic class of controlled substance listed in schedule I and II and 
ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney 
General has delegated this function to the Administrator of the Drug 
Enforcement Administration (DEA) pursuant to 28 CFR 0.100.

II. Background

    The 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 that may be manufactured in the United States in 
2025, in order to provide for the estimated medical, scientific, 
research, and industrial needs of the U.S., 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.
    On September 25, 2024, a notice titled ``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'' was published in 
the Federal Register.\1\ This notice proposed the 2025 APQs for each 
basic class of controlled substance listed in schedules I and II and 
the 2025 AANs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. All interested persons were invited to comment on 
or object to the proposed APQs and the proposed AANs on or before 
October 25, 2024.
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    \1\ 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, 89 FR 78772 (September 25, 2024).
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III. Comments Received

    Within the public comment period, DEA received 1,882 comments from 
DEA registrants, chronic pain patients, patients with attention 
deficit/hyperactivity disorder (ADHD), pain advocacy associations, U.S. 
professional associations, U.S. doctors and nurses, and others. The 
comments included concerns about potential domestic opioid drug 
shortages due to further quota reductions; patient difficulty filling 
authorized opioid prescriptions; increases in drug overdose deaths 
despite a continued decrease in production quotas; requests for an 
extension to the comment period; stimulant drug shortages in the United 
States; concerns that medical professionals might be impeded from 
exercising their medical expertise regarding opioid prescriptions; 
requests for a public hearing; and comments not pertaining to DEA-
regulated activities. While all comments were posted to 
regulations.gov, DEA restricted the attachments to 10 comments from 
public view due to confidential business information and/or 
confidential personal identifying information.

Opioid Adequacy

    Issue (National Production Levels of Proposed APQs for Opioids 
Compared to 2024 levels): DEA received a significant number of comments 
from pain advocacy groups, hospital associations, health professionals, 
and others who raised concerns over the proposed APQs for certain 
opioids in 2025, which were proposed at a level lower than the 
established production levels for 2024. The commenters suggested that 
the proposed APQ levels could exacerbate shortages experienced in 2024.
    DEA Response: DEA considers numerous factors in determining an APQ, 
including total net disposal of the class by all manufacturers during 
the current and two preceding years, trends in the national rate of net 
disposal of the class, total actual or estimated inventories of the 
class and of all substances manufactured from the class, information 
obtained from the Food and Drug Administration (FDA), and changes in 
the currently accepted medical use in treatment. 21 U.S.C. 826(a); 21 
CFR 1303.11(b). Additional factors considered can be found in 21 CFR 
1303.11(b). After considering all of the relevant factors, DEA has 
determined that the proposed APQs for the five covered controlled 
substances--fentanyl, hydrocodone, hydromorphone, oxycodone and 
oxymorphone--are sufficient to meet the forecasted legitimate domestic 
and foreign needs and allow for maintenance of reserve stocks. These 
considerations also lead DEA to conclude that U.S. manufacturers will 
need to manufacture approximately the same amount of those opioids in 
2025 as in 2024 in order to meet legitimate needs.
    Accordingly, DEA proposed the 2025 APQs for those five substances 
at the same level as in DEA's proposed revised APQs for 2024 published 
on September

[[Page 102650]]

25, 2024.\2\ In that publication, DEA proposed minor reductions to the 
2024 APQs for 4 of the 5 substances to reflect DEA's updated 
calculations of diversion, as required by Congress. Specifically, 
Congress requires DEA to make appropriate quota reductions ``from the 
quota [DEA] would have otherwise established had such diversion not 
been considered.'' \3\ DEA applied the same estimates of diversion in 
proposing and finalizing the 2025 APQs and has reduced the 2025 APQs 
accordingly. The APQs for those five controlled substances are lower 
than the initial 2024 established APQs by approximately 0.1% combined. 
These decreases in the APQs will not affect the ability of the APQs to 
provide all material necessary for the estimated medical, scientific, 
research, and industrial needs of the U.S., lawful export requirements, 
and the establishment and maintenance of reserve stocks.
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    \2\ See Proposed Adjustments to the 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 2024, 89 FR 78764 (Sept. 25, 2024).
    \3\ 21 U.S.C. 826(i)(1)(C).
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    Issue (Medication Out of Stock at Pharmacy Level): DEA received 
comments questioning whether the 2025 proposed APQs for Schedule II 
opioids will be adequate to meet legitimate medical needs of patients. 
Commenters said that because of decreases in APQs for specific opioids, 
they have had difficulty filling legitimate prescriptions at 
pharmacies. These issues have negatively impacted their quality of life 
and caused mental health-related issues, including the possibility of 
suicide.
    DEA Response: DEA is committed to ensuring an adequate and 
uninterrupted supply of controlled substances in order to meet 
legitimate medical, scientific, and export needs of the United States. 
DEA sets the APQs for controlled substances based on the available data 
and information received at that specific point in time; however, 
subsequent factors outside of DEA's control, including changes to 
manufacturers' business practices may emerge afterwards and potentially 
contribute to a temporary lack of inventory of controlled substances at 
the point of dispensation. In recent years, these factors have included 
labor shortages and a lack of production capacity. In such 
circumstances, DEA, in coordination with FDA, can utilize tools under 
the CSA to try to prevent or alleviate drug shortages so that patients 
are able to fill legitimate prescriptions for controlled substances 
without undue delay. Additionally, if patients are faced with a delay 
in receiving their medications, the patients may request a one-time 
transfer of initial dispensing of an electronic prescription for 
Schedules II--V controlled substances from one retail pharmacy to 
another retail pharmacy if authorized under state law.\4\ If the 
medication is a controlled substance in Schedules III--V and includes 
authorized refills, the refills can also be transferred with the 
initial prescription to the receiving pharmacy.
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    \4\ See Revised Regulation Allows DEA-Registered Pharmacies to 
Transfer Electronic Prescriptions at a Patient's Request, DEA.gov 
(Sept. 1, 2023), https://www.dea.gov/stories/2023/2023-09/2023-09-01/revised-regulation-allows-dea-registered-pharmacies-transfer.
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    Issue (Nationwide Opioid Shortages): DEA received many comments 
stating there is a nationwide shortage of opioid medication because the 
commenters' local pharmacies were often out of stock, forcing the 
commenters to spend significant time contacting additional pharmacies, 
and traveling further to get prescriptions filled. Commenters stated 
that many times they were unsuccessful in their attempts to fill the 
prescription.
    DEA Response: Drug shortages may occur due to factors outside of 
DEA's control such as manufacturing and quality problems, processing 
delays, supply chain disruptions, or discontinuations. In such 
circumstances, if the drug manufacturer notifies the FDA Drug Shortage 
Staff, FDA will coordinate with DEA to address and minimize the impact 
of drug shortages if both agencies believe action is warranted. 
Currently, FDA has not issued notice of any nationwide shortages of the 
types of opioid medications mentioned by these commenters.
    Issue (Failure to Acknowledge Drug Shortages): One commenter 
expressed that DEA is failing to acknowledge and address opioid drug 
shortages that are complicating access to prescribed medications, 
effectively creating conditions such as ``pharmacy deserts.''
    DEA Response: DEA is aware of specific product shortages of pain 
medicines and works with FDA and DEA-registered manufacturers to 
alleviate them. Patients and medical professionals may notice specific 
drug products are out of stock in particular areas; however, DEA cannot 
dictate DEA registrants' distributions of drug products. If a drug 
manufacturer notifies FDA of a manufacturing-related shortage, FDA and 
DEA can take additional steps to help alleviate the shortage if action 
is warranted.
    Issue (Patients Switching to Illicit Fentanyl or Medications 
Obtained from Illegal Sources): Several commenters expressed concerns 
that because of DEA's reduction of quotas for pain relieving controlled 
substances, chronic pain sufferers who were unable to fill their 
legitimate prescriptions eventually turned to illegal fentanyl or 
medications obtained from illegitimate sources as a substitute relief 
that could increase the risk of overdose death. These commenters stated 
that overdose deaths in the United States continue to rise because of 
illegal fentanyl or illegitimate medications, not from pharmaceutical 
medications prescribed to chronic pain patients.
    DEA Response: While overdose deaths may occur because of use of 
illicit substances, DEA's quota regulations have been implemented to 
prevent misuse and diversion of pharmaceutical controlled substances. 
In this way, these quotas can reduce the occurrence of overdose and 
death from the use of legitimate controlled substances. Patients should 
work closely with their providers to utilize other FDA-approved 
medications for their conditions and fill their prescriptions only from 
DEA-registered pharmacies. The only safe medications containing 
controlled substances are ones prescribed by a trusted, DEA-registered 
medical professional and dispensed by a licensed pharmacist at a DEA-
registered pharmacy. The medications received from unregistered 
internet sources may, in fact, be manufactured or laced with illicit 
substances including illicit fentanyl, which contributes to rates of 
overdose deaths.
    Issue (Opioid Prescribing Hesitancy): Many commenters, mostly self-
identified chronic pain patients, expressed that the goal of the 2016 
Centers for Disease Control and Prevention Guidelines was to decrease 
opioid overdoses, but instead there has been an increase in overdoses 
nationwide of over 400 percent due to illegal fentanyl or illegally 
manufactured pain pills. Commenters stated that many chronic pain 
patients have been harmed, and some have died by suicide, due to the 
inability to get prescriptions because of the APQ reductions made by 
DEA. Many commenters also stated that restrictions imposed by DEA have 
caused opioid medications to be under-prescribed due to fear of 
prosecution. Commenters said doctors should have latitude in making 
treatment decisions to prescribe opioid pain medications based on 
individual patient needs.
    DEA Response: Pursuant to 21 U.S.C. 826(i), DEA is mandated to 
estimate diversion for 5 controlled substances--

[[Page 102651]]

fentanyl, hydrocodone, hydromorphone, oxycodone and oxymorphone--and 
this estimation includes the consideration of rates of overdose deaths. 
While overdose deaths may occur as a result of the use of illegal 
fentanyl or illegally manufactured pain medications, quotas are being 
set by DEA to prevent misuse and diversion of pharmaceutical controlled 
substances, and thus reduce the occurrence of overdose and death from 
the use of legitimate controlled substances. Additionally, DEA's 
regulations do not impose restrictions on the amount and the type of 
medication that licensed practitioners can prescribe. DEA has 
consistently emphasized and supported the authority of individual 
practitioners under the CSA to administer, dispense, and prescribe 
controlled substances for the legitimate treatment of pain within 
acceptable medical standards, as outlined in DEA's policy statement 
published in the Federal Register on September 6, 2006, titled 
``Dispensing Controlled Substances for the Treatment of Pain.'' \5\
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    \5\ Dispensing Controlled Substances for the Treatment of Pain, 
71 FR 52716 (September 6, 2006).
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Attention Deficit/Hyperactivity Disorder (ADHD) Medication

    Issue (Shortage): DEA received comments expressing general concerns 
regarding the ongoing drug shortages for stimulant medications used in 
the treatment of ADHD.
    DEA Response: DEA is committed to ensuring an adequate and 
uninterrupted supply of controlled substances in order to meet the 
estimated legitimate medical, scientific, research, and industrial 
needs of the United States, for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. DEA sets the APQs to 
provide for all legitimate medical purposes and for anticipated foreign 
demand. Additionally, DEA and FDA coordinate efforts to prevent or 
alleviate drug shortages. Such efforts may include the adjustment of 
the APQs and individual domestic manufacturers' quotas, FDA's approval 
of additional market competitors, and coordination between the agencies 
to allow importation of foreign-manufactured drug products that meet 
FDA approval. If the actual prescribing rates of these substances are 
significantly higher than the 2025 estimates of medical needs, the 
Administrator has the authority to increase the aggregate production 
quota at any time. 21 CFR 1303.13(a).

Insufficient Gamma Hydroxybutyric Acid (GHB)

    Issue (GHB APQ Insufficient to Support New FDA-Approved Generic 
Medications Entering the Market as well as Existing Branded Drug 
Products): DEA received one comment from a law firm that voiced concern 
that the proposed 2025 GHB APQ will be insufficient to provide for 
existing branded products on the market as well as emerging generic 
products with anticipated FDA-approval dates near the end of calendar 
year 2025. The commenter noted that FDA has expanded the conditions for 
which the branded products can be prescribed as part of an effective 
treatment.
    DEA response: DEA is aware of the current FDA-approved GHB branded 
drug products and their exclusivity timelines as well as the numerous 
generic drug applications that are pending before FDA for approval. The 
2025 APQ for GHB is being finalized at 49,675,266 grams, which is 
20,258,266 grams higher than the 2024 APQ. This equates to an almost 70 
percent increase in the amount of bulk active pharmaceutical ingredient 
(API) that can be made available in 2025 to provide for legitimate 
medical need, as compared to 2024. This additional API can be utilized 
in the manufacture of existing drug products on the market, product 
development activities leading to FDA-approved generic drugs, as well 
as inventory necessary to begin calendar year 2026 without shortages. 
The 2025 APQ is based on all available data including company-submitted 
information, U.S. export data, U.S. import data, and FDA drug data 
highlighting emerging and changing drug products containing GHB 
prescribed to the relevant patient population.

Diversion Estimates

    Issue (Impact of Diversion Estimate on Opioids): Commenters voiced 
concern with the ``red flags'' associated with diversion data gathered 
from state Prescription Drug Monitoring Program (PDMP) data, which DEA 
uses to estimate diversion for the five covered controlled substances. 
Commenters worried that repeated attempts to fill prescriptions would 
be shown in the state PDMP data and result in concerns that they were 
engaged in ``doctor shopping,'' and their conduct could be misperceived 
as a ``red flag'' of actively seeking prescribed covered controlled 
substances from three or more prescribers in a 90-day period. 
Commenters were concerned that such misperceptions could render them 
unable to fill validly issued prescriptions.
    DEA Response: In the event that a patient's general pharmacy does 
not have sufficient stock of a particular drug, a patient visiting 
multiple pharmacies to fill a single prescription would not be included 
in the ``red flag'' metric of patients actively seeking prescribed 
covered controlled substances from three or more prescribers in a 90-
day period. The state PDMP data submitted was adequate to allow DEA to 
draw reliable inferences regarding the state and U.S. populations. The 
sample is large enough to allow DEA to accurately generalize the data 
to the whole population of the United States for use in the calculation 
of estimated national levels of diversion of the covered controlled 
substances. DEA developed the metric of patients prescribed covered 
controlled substances from three or more prescribers in a 90-day period 
to identify potential doctor shopping, a common technique used to 
obtain large amounts of controlled substances for the purpose of abuse 
or diversion. Federal administrative and criminal case law demonstrates 
that multiple prescriptions from multiple prescribers in a short 
timeframe is a reliable indicator of diversion.\6\ In addition, DEA did 
not consider prescriptions written for the five covered controlled 
substances in quantities lower than 240 morphine milligram equivalents 
(MME) daily because some patients, including oncology patients in 
particular, have legitimate medical needs for covered controlled 
substance prescriptions in excess of 90 MME daily. DEA did not wish to 
inadvertently include legitimate prescriptions for these patients in 
its calculation of diversion. Daily dosages higher than 240 MME place 
individuals at a higher risk of overdose and death, and correlate with 
a heightened risk of diversion. DEA received aggregated data from state 
PDMPs that reflected only individual filled prescriptions.
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    \6\ The Medicine Shoppe, 29 FR 59504, 59507, 59512-13 (2014); 
Holiday CVS, LLC, d/b/a CVS Pharmacy Nos. 219 and 5195, 57 FR 62316 
(2012).
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Data Collection and Analysis

    Issue (Data Accuracy): Several commenters stated that FDA's 
estimation of medical needs and DEA's data collection process are 
flawed and inaccurate.
    DEA Response: FDA utilizes a variety of data sources in developing 
its estimates of domestic medical needs. When determining the 2025 
APQs, DEA considered the estimation of domestic medical needs data 
provided by FDA,

[[Page 102652]]

and also considered other data sources including prescriptions 
dispensed in prior and current years reported in IQVIA, research and 
clinical trial information from DEA-registered researchers and 
manufacturers, information provided in quota applications from DEA-
registered manufacturers, as well as historic and current year export 
data and future estimations of export requirements. DEA is actively 
reevaluating and improving the data collection process to ensure that 
the APQs are set at an adequate level to meet legitimate medical, 
scientific, research, and export needs while establishing and 
maintaining reserve stocks.
    Issue (Lack of Data Transparency): Two commenters stated that there 
is a lack of transparency in the quota setting process.
    DEA Response: DEA is considering methods that might increase 
transparency in its quota setting process. Future regulatory proposals 
may include steps such as public notification and an opportunity for 
public input when prescribing rates for controlled substances 
substantially deviate from FDA's estimate of medical needs. DEA must 
strike a balance between increasing transparency and complying with the 
applicable laws and regulations aimed at protecting confidential 
business and patient information.

Comments and Quota Applications From DEA-Registered Manufacturers

    Issue: DEA received additional quota applications as well as 
comments from DEA-registered manufacturers regarding a specific 
schedule I controlled substance, requesting the APQs be established at 
a sufficient level to allow for their manufacturing to meet medical and 
scientific needs.
    DEA Response: DEA considered the additional quota applications and 
comments from DEA-registered manufacturers and determined that DEA's 
APQ for dimethyltryptamine (DMT) should be increased to support 
legitimate research and scientific efforts toward an FDA-approved drug 
product. The increase is reflected below in the section titled, 
``Determination of 2025 Aggregate Production Quotas and Assessment of 
Annual Needs.''

Request for Hearing and Extension of Comment Period

    Issue: Several individual commenters suggested that DEA consider 
holding a public hearing regarding the APQs and AANs.
    DEA Response: The decision whether to grant a hearing on the issues 
raised by the commenters lies solely within the discretion of the 
Administrator.\7\ While hearings are required when requested by states 
in certain situations, these requests were not submitted by states. 
These requests did not include any evidence that would lead to the 
conclusion that a hearing is necessary or warranted. DEA has addressed 
specific points raised by the commenters in the issues and responses 
above.
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    \7\ 21 CFR 1303.11(c).
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    Issue: DEA received three comments requesting an extension of the 
comment period so the commenters can better research the issues and 
submit additional comments.
    DEA Response: DEA declines to extend the comment period. The number 
and scope of comments indicate that the provided 30 days was adequate. 
Additionally, DEA may propose to adjust these established APQs and AANs 
at any time after they have been established, at which time additional 
comments will be accepted.\8\
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    \8\ 21 CFR 1303.13.
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Out of Scope Comments

    DEA received comments that are outside the scope of this order. The 
comments were general in nature and raised issues with respect to 
specific medical illnesses, medical treatments and medication costs. 
These comments do not impact the analysis involved in establishing the 
2025 APQs.

IV. Determination of 2025 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the established 2025 APQs and AANs, DEA has 
considered the above comments along with the factors set forth in 21 
CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a). 
These factors include, but are not limited to, the 2024 manufacturing 
quotas, current 2024 sales and inventories, anticipated 2025 export 
requirements, industrial use, additional applications for 2025 quotas, 
and information on research and product development requirements.
    On October 25, 2024, DEA published a final rule placing 
ethylphenidate in schedule I of the CSA,\9\ making all regulatory 
controls pertaining to schedule I controlled substances applicable to 
the manufacture of these substances, including the requirement to 
establish an aggregate production quota pursuant to 21 U.S.C. 826 and 
21 CFR part 1303. This final order establishes an aggregate production 
quota for this substance.
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    \9\ Schedules of Controlled Substances: Placement of 
Ethylphenidate in Schedule I, 89 FR 84281 (October 22, 2024).
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Estimates of Diversion

    As specified in the proposal, and as required by 21 U.S.C. 826(i), 
DEA calculated a national diversion estimate for each of the five 
covered controlled substances. This data, which remains unchanged, was 
published in the 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.\10\
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    \10\ 89 FR 78772 (Sept. 25, 2024).
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    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2025 APQs for the 
following schedule I and II controlled substances and the 2025 AANs 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 C
    The Administrator also establishes APQs for all other schedule I 
and II controlled substances included in 21 CFR 1308.11 and 1308.12 at 
zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon 
consideration of the relevant factors, the Administrator may adjust the 
2025 APQ and AAN as needed.

[[Page 102662]]

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
December 11, 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. 2024-30023 Filed 12-16-24; 8:45 am]
BILLING CODE P`