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, 102649-102662 [2024-30023]
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Federal Register / Vol. 89, No. 242 / Tuesday, December 17, 2024 / Notices
CFR 1308.11 and 1308.12 remain at
zero.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on December 13, 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. 2024–30019 Filed 12–16–24; 8:45 am]
BILLING CODE 4410–09–P
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
Drug Enforcement
Administration, Department of Justice.
ACTION: Final order.
AGENCY:
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:
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SUMMARY:
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
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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.
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
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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102649
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
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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.
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
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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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.
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
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/2023/2023-09/2023-0901/revised-regulation-allows-dea-registeredpharmacies-transfer.
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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, DEAregistered 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 selfidentified 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—
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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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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).
5 Dispensing Controlled Substances for the
Treatment of Pain, 71 FR 52716 (September 6,
2006).
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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
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102651
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.
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,
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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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.
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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.
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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.
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
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
7 21
8 21
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CFR 1303.13.
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Sfmt 4703
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.
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
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:
BILLING CODE P
9 Schedules of Controlled Substances: Placement
of Ethylphenidate in Schedule I, 89 FR 84281
(October 22, 2024).
10 89 FR 78772 (Sept. 25, 2024).
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Established 2025
Quotas
(g)
Basic Class
20
30
10
30
30
15
30
25
10
30
30
30
30
100
30
-[ 1-(2-Thienyl)cyclohexy I]pyrrolidine
1-(1-Phenylcyclohexyl)pyrrolidine
1-(2-Phenylethy1)-4-pheny1-4-acetoxypiperidine
1-(5-Fluoropenty 1)-3-(1-naphthoyl)indole (AM2201)
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
1-[ 1-(2-Thienyl)cyclohexy I]piperidine
2'-fluoro 2-fluorofentanyl
1-Bcnzy lpipcrazinc
1-Meth. y1-4-pheny1-4-propionoxypiperidine
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
2-(2,5-Dimethoxy-4-n-propy lpheny l)ethanamine (2C-P)
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe;
25B; Cimbi-36)
2-(4-Chloro-2,5-dimethoxypheny 1)ethanamine (2C-C)
2-(4-Chloro-2,5-dimethoxypheny1)-N-(2methoxybenzyl)ethanamine (25C-NDOMe; 2C-C-NDOMe;
25C; Cimbi-82)
2-(4-lodo-2,5-dimethoxyphenyl)ethanamine (2C-l)
2-(4-Iodo-2,5-dimethoxypheny 1)-N-(2methoxybenzyl)ethanamine (251-NBOMe; 2C-I-NBOMe;
251; Cimbi-5)
2,5-Dimethoxy-4-ethylamphetamine (DOE'l')
2,5-Dimethoxy-4-n-propylthiophenethylamine
2,5-Dimethoxyamphetamine
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)
2-[4-(lsopropylthio )-2,5-dimethoxyphenyl]ethanamine (2CT-4)
3,4,5-Trimethoxyamphetamine
2-Methyl AP-237
3,4-Methylenedioxyamphetamine (MDA)
3,4-Methylenedioxymethamphetamine (MOMA)
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
3,4-Methylenedioxy-N-methylcathinone (methylone)
3,4-Methylenedioxypyrovalerone (MDPV)
3-FMC; 3-Fluoro-N-methylcathinone
3-Methylfentanyl
3-Methy lmethcathinone
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30
30
25
25
25
30
30
30
30
12,000
12,000
40
5,200
35
25
30
30
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3-Mcthylthiofcntany1
4,4 '-Dimethy laminorex
4-Bromo-2,5-dimethoxyamphetamine (DOB)
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alphaPVP)
4-CN-Cumy1-Butinaca
4-Fluoroisobutyry1 fentany 1
4P-MDMB-DINACA
4-FMC; Flephedrone
4-MEC; 4-Methyl-N-ethylcathinone
4-Methoxyamphetamine
4-methyl-l-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (alphaPiHP)
4-Methyl-2,5-dimethoxyamphetamine (DOM)
4-Methylaminorex
4-Methyl-N-methy lcathinone (mephedrone)
4-Methy1-alpha-ethylaminopentiophenone (4-MEAP)
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)
4'-Methyl acetyl fentanyl
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP)
4F-MDMB-BUTICA
5-(1, 1-Dimethylheptyl)-2-[( 1R,3 S)-3-hydroxycyclohexyl]phenol
5-(1, 1-Dimethyloctyl)-2-[ (1 R,3 S)-3-hydroxycyclohexy l]phenol (cannabicvclohexanol or CP-47,497 C8-homolog)
5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1( 5-.0uoropentv 1)-1 H-indazole-3-carboxamide
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5fluoropentyl)-1 H-indazole-3-carboxamido )-3,3dimethy lbutanoate)
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2phenylpropan-2-yl)-l H-pyrrolo [2,3-b]pyridine3carboximide
5F-CUMYL-PINACA
5F-EDMB-PICA
5F-EDMB-PlNACA
5F-MDMB-PICA
5F-AMB (methyl 2-(1-(5-fluoropentyl)-lH-indazole-3carboxamido)-3-methvlbutanoate)
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5fluoropentvl)-1 H-indazole-3-carboxamide)
5-Fluoro-PB-22; 5F-PB-22
5-Fluoro-URl 44, XLRl 1 ([1-(5-fluoro-pentyl)-lHindol-3yl](2,2,3,3-tetramethylcvclopropyl)methanone
5-Methoxy-3,4-methylenedioxyamphetamine
5-Methoxy-N ,N-diisopropy ltryptamine
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25
25
30
30
25
25
150
30
25
25
45
25
25
30
25
30
50
40
25
25
25
25
30
25
25
25
25
25
25
25
25
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102655
5-Methoxy-N,N-dimethyltryptamine
AB-CHMINACA
AB-FUBINACA
AB-PINACA
ADB-BUTINACA
ADB-FU BINA CA (N-(1-amino-3 ,3-dimethy 1-1-oxobutan2-vl)-1-(4-:fluorobenzvl)-lH-indazole-3-carboxamide)
Acetorphine
Acetyl Fentanyl
Acetyl-alpha-methylfentanyl
Acetyldihydrocodeine
Acety lmethadol
Acryl Fentanyl
ADB--4en-PINACA
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2yl)-l-pentyl-lH-indazole-3-carboxamide)
AH-7921
All other tetrahydrocannabinol
Allylprodine
Alphacetylmethadol
alpha-Ethyltryptamine
Alphameprodine
Alphamethadol
alpha-Methylfentanyl
alpha-Methylthiofentanyl
alpha-Methyltryptamine (AMT)
alpha-Pyrrolidinobutiophenone (a-PBP)
alpha-pyrrolidinoheptaphenone (PV8)
alpha-pyrrolidinohexabophenone (alpha-PHP)
alpha-Pyrrolidinopentiophenone (a-PVP)
Amineptine
Aminorex
Anileridine
APINCA, AKB48 (N-(l-adamantyl)-1-pentyl-IH-indazole3-carboxamide)
Benzethidine
Benzylmorphine
Betacetylmethadol
beta-Hydroxy-3-methylfentanyl
beta-Hydroxyfentanyl
beta-Hydroxythiofentanyl
beta-Methyl fentanyl
beta'-Phenyl fentanyl
Betameprodine
Betamethadol
Betaprodine
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11,000
30
50
30
30
30
25
100
30
30
25
25
30
50
30
1,166,130
25
25
25
25
25
30
30
25
25
25
25
25
30
25
20
25
25
30
25
30
30
30
30
30
25
4
25
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Brorphine
Bufotenine
Butonitazene
Butylone
Butyryl fentanyl
Cathinone
Clonazolam
Clonitazcnc
Codeine methy Ibromide
Codeine-N-oxide
Crotonyl Fentanyl
CUMYL-PEGACLONE
Cyclopentyl Fentanyl
Cyclopropyl Fentanyl
Cyprenorphine
d-9-THC
Deso morphine
Dextromoramide
Diapromide
Diclazepam
Diethy lthiambutene
Diethy ltryptamine
Difenoxin
Dihydromorphine
Dimenoxadol
Dimepheptanol
Dimethy lthiambutene
Dimethy ltryptamine
Dioxyaphetyl butyrate
Dipipanone
Drotebanol
Ethylmethylthiambutene
Ethylene
Ethylphenidate
Etizolam
Etodesni tazene
Etonitazene
Etorphine
Etoxeridine
Eutylone
Fenethy lline
r entany1 carbamate
Fentanyl related substances
Flualprazolam
rlubromazolam
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30
15
30
25
30
40
30
25
30
192
25
30
30
20
25
1,523,040
25
25
20
30
20
25
9,300
639,954
25
25
20
20,000
25
25
25
25
25
30
30
30
25
30
25
30
30
30
600
30
30
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102656
102657
Flunitazene
FUB-144
FUB-AKB48
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca
Furanyl fentanyl
Furethidine
gamma-Hydroxybutyric acid
Heroin
Hydromorphinol
IIydroxypethidine
lbogaine
Isobutyryl Fentanyl
Tsotonitazine
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)
JWH-081 (1-Pentyl-3-[l-(4-methoxynaphthoyl)]indole)
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-( 1naphthoyl)indole)
JWH-203 ( l-Pentyl-3-(2-chlorophenylacetyl)indole)
JWH-250 ( l-Pentyl-3-(2-methoxyphenylacetyl)indole)
JWH-398 (l-Pentyl-3-(4-chloro-1-naphthoyl)indole)
Ketobemidone
Levomoramide
Levophenyacylmorphan
Lysergic acid diethylamide (LSD)
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-lHindazole-3-carboxamide)
MDMB-CIIMICA; MMB-CIIMINACA(methyl 2-( 1(cyclohexylmethyl)-lH-indole-3-carboxamido)-3,3dimethylbutanoate)
MDMB-FUBINACA (methyl 2-(1-(4-tluorobenzyl)-lHindazole-3-carboxamido )-3,3-dimethylbutanoate)
MMB-CHMlCA-(AMB-CHlMCA); Methyl-2-(1(cyclohexylmethyl)-lH-indole-3-carboxamido)-3methvlbutanoate
Marijuana
Marijuana extract
MDMB--4en-PINACA
MMB-FUBICA
Mecloqualone
Mescaline
Mesocarb
Methaqualone
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30
25
25
25
30
25
49,675,266
150
40
25
210
25
25
35
45
45
30
30
35
30
30
30
30
25
25
1,200
30
30
30
25
6,675,000
1,000,000
30
30
30
1,200
30
60
17DEN2
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Methcathinone
Methiopropamine
Mcthoxctaminc
Methoxyacety1 fentany 1
Mcthyldcsorphinc
Methy ldihydromorphine
Metodesnitazene
Metonitazene
Morpheridine
Morphine methylbromide
Morphine methylsulfonate
Morphine-N-oxide
MT-45
Myrophine
NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-lH-indole-3carboxylate
N,N-Dimethylamphetamine
Naphyrone
N-Desethyl isotonitazene
N-Ethyl-1-phenylcyclohexylamine
N-Ethyl-3-piperidyl benzilate
N-Ethy !amphetamine
N-Ethylhexedrone
N-Ethy lpenty lone, ephy lone
N-Hydroxy-3 ,4-methy lenedioxyamphetamine
Nicocodeine
Nico morphine
N-methyl-3-piperidyl benzilate
N-piperidiny1 etonitazene
N-Pyrrolidino Etonitazene
N oracymethadol
Norlevorphanol
N ormethadone
Normorphine
Norpipanone
Ocfentanil
ortho-Fluoroacryl fentanyl
ortho-Fluorobutyryl fcntanyl
Ortho-Fluorofentanyl,2-Fluorofentanyl
ortho-Fluoroisobutyryl fcntanyl
ortho-Methyl acetylfentanyl
ortho-Mcthyl mcthoxyacctyl fcntanyl
Para-Chlorisobutyrl fentanyl
Para-flourobutyryl fentanyl
Para-fluorofentanyl
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25
30
30
25
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5
150
30
25
25
25
25
30
25
10
24
25
30
24
25
25
30
30
30
25
2,550
25
40
25
25
30
30
30
30
30
30
30
25
25
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para-Fluoro furanyl fentanyl
Para-Methoxyhutyrl fentanyl
Para-methoxymethamphetamine
para-Methylfentanyl
Parahexyl
PB-22; QUPIC
Pentedrone
Pentylone
Phenadoxone
Phcnampromidc
Phenomorphan
Phenoperidine
Phenyl fentanyl
Pholcodine
Piritramide
Proheptazine
Properidine
Propiram
Protonitazene
Psilocybin
Psilocin
Racemoramide
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2methoxyphenylacetyl)indole)
SR-19 and RCS-4 (1-Pcntyl-3-[(4-mcthoxy)benzovllindole)
Tctrahydrofuranyl fcntanyl
Thebacon
Thiafentanil
Thiofentany 1
Thiofuranyl fentanyl
TIU-2201 ( [1-(5-fluoropentyl)-lH-indazol-3yll(naphthalen-1-y l)methanone)
Tilidine
Trimeperidine
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3tetramethylcyclopropvl)methanone
U-47700
Valeryl fentanyl
Zipcprol
30
30
30
30
5
20
25
25
25
25
25
25
30
5
25
25
25
25
30
30,000
36,000
25
45
30
15
25
25
25
30
30
25
25
25
30
25
30
15
25
937,874
5,000
1-Phenylcyclohexylamine
1-Piperidinocyclohexanecarbonitrile
4-Anilino-N-phenethyl-4-piperidine (ANPP)
Alfentanil
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Alphaprodine
Amo barbital
Bezitramide
Carfentanil
Cocaine
Codeine (for conversion)
Codeine (for sale)
d-amphctaminc (for sale)
d,1-amphetamine
d-amphetamine (for conversion)
Dexmethylphenidate (for sale)
Dexmethylphenidate (for conversion)
Dextropropoxyphene
Dihydrocodeine
Dihydroetorphine
Diphenoxylate (for conversion)
Diphenoxylate (for sale)
Ecgonine
Ethylmorphine
Etorphine hydrochloride
Fentanyl
Glutethimide
Hydrocodone (for conversion)
Hydrocodone (for sale)
Hydromorphone
Isomethadone
L-amphetamine
Levo-alphacety lmethadol (LAAM)
Levomethorphan
Levorphanol
Lisdexamfetamine
Meperidine
Meperidine Intermediate-A
Mcpcridinc Intcrmcdiatc-B
Meperidine Intennediate-C
Metazocine
Methadone (for sale)
Methadone Intermediate
d,1-Methamphetamine
d-methamphetamine (for conversion)
d-methamphetamine ( for sale)
1-methamphetamine
Methylphenidate (for sale)
Methylphenidate (for conversion)
Mctopon
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25
20,100
25
20
60,492
942,452
19,262,957
21,200,000
21,200,000
23,688,235
6,200,000
5,374,683
35
115,227
25
14,100
770,800
60,492
30
32
731,341
25
1,250
27,121,498
1,951,508
30
30
25
30
20,000
32,736,000
681,184
30
30
30
15
25,619,700
27,673,600
150
485,020
47,000
587,229
53,283,000
19,975,468
25
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Moramide-intermediate
Morphine (for conversion)
Morphine (for sale)
Nabilone
Norfentanyl
Noroxymorphone (for conversion)
Noroxymorphone (for sale)
Oliceridine
Opium (powder)
Opium (tincture)
Oripavine
Oxycodone (for conversion)
Oxycodone (for sale)
Oxymorphone (for conversion)
Oxymorphone (for sale)
Pentobarbital
Phenazocine
Phencyclidine
Phenmetrazine
Phenylacetone
Piminodine
Racemethorphan
Racemorphan
Remifentanil
Secobarbital
Sufentanil
Tapentadol
Thebaine
102661
25
2,393,200
20,805,957
62,000
25
24,756,979
1,000
25,100
250,000
530,837
37,721,950
437,827
53,584,449
31,773,105
464,464
40,000,000
25
35
25
100
25
5
5
3,000
172,100
4,000
10,390,226
57,137,944
List I Chemicals
Ephedrine (for conversion)
Ephedrine (for sale)
Phenylpropanolamine (for conversion)
Phenylpropanolamine (for sale)
Pseudoephedrine (for conversion)
Pseudoephedrine (for sale)
The Administrator also establishes
APQs for all other schedule I and II
controlled substances included in 21
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CFR 1308.11 and 1308.12 at zero. In
accordance with 21 CFR 1303.13 and 21
CFR 1315.13, upon consideration of the
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relevant factors, the Administrator may
adjust the 2025 APQ and AAN as
needed.
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BILLING CODE C
41,100
3,933,336
14,878,320
7,990,000
1,000
186,617,466
102662
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ddrumheller on DSK120RN23PROD with NOTICES2
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
VerDate Sep<11>2014
23:08 Dec 16, 2024
Jkt 265001
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
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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
E:\FR\FM\17DEN2.SGM
17DEN2
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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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[[Page 102653]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.095
[[Page 102654]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.096
[[Page 102655]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.097
[[Page 102656]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.098
[[Page 102657]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.099
[[Page 102658]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.100
[[Page 102659]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.101
[[Page 102660]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.102
[[Page 102661]]
[GRAPHIC] [TIFF OMITTED] TN17DE24.103
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