Notice2024-21962
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
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Published
September 25, 2024
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) proposes to establish the 2025 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Full Text
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<title>Federal Register, Volume 89 Issue 186 (Wednesday, September 25, 2024)</title>
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[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78772-78782]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21962]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1413P]
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
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice with request for comments.
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SUMMARY: The Drug Enforcement Administration (DEA) proposes to
establish the 2025 aggregate production quotas for controlled
substances in schedules I and II of the Controlled Substances Act (CSA)
and the assessment of annual needs for the list I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine.
DATES: Interested persons may file written comments on this notice in
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments
must be submitted, and written comments must be postmarked, on or
before October 25, 2024. Commenters should be aware that the electronic
Federal Docket Management System will not accept comments after 11:59
p.m. Eastern Time on the last day of the comment period.
Based on comments received in response to this notice, the
Administrator may hold a public hearing on one or more issues raised.
In the event the Administrator decides in her sole discretion to hold
such a hearing, the Administrator will publish a notice of any such
hearing in the Federal Register. After consideration of any comments or
objections, or after a hearing, if one is held, the Administrator will
publish in the Federal Register a final order establishing the 2025
aggregate production quotas for schedule I and II controlled
substances, and an assessment of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1413P'' on all correspondence, including any
attachments. DEA encourages that all comments be submitted
electronically through the Federal eRulemaking Portal, which provides
the ability to type short comments directly into the comment field on
the web page or attach a file for lengthier comments. Please go to
<a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online instructions at that
site for submitting comments. Upon completion of your submission, you
will receive a Comment Tracking Number for your comment.
Please be aware that submitted comments are not instantaneously
available for public view on <a href="http://Regulations.gov">Regulations.gov</a>. If you have received a
Comment Tracking Number, your comment has been successfully submitted,
and there is no need to resubmit the same comment. Paper comments that
duplicate electronic submissions are not necessary and are discouraged.
Should you wish to mail a paper comment in lieu of an electronic
comment, it should be sent via regular or express mail to: Drug
Enforcement Administration, Attention: DEA Federal Register
Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia
22152.
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, Virginia 22152, Telephone: (571) 776-3882.
[[Page 78773]]
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by the Drug Enforcement
Administration (DEA) for public inspection online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Such information includes personal identifying
information (such as your name, address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act applies to all comments received. If
you want to submit personal identifying information (such as your name,
address, etc.) as part of your comment, but do not want it to be made
publicly available, you must include the phrase ``PERSONAL IDENTIFYING
INFORMATION'' in the first paragraph of your comment. You must also
place all the personal identifying information you do not want made
publicly available in the first paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified and located as directed
above will generally be made available in redacted form. If a comment
contains so much confidential business information or personal
identifying information that it cannot be effectively redacted, all or
part of that comment may not be made publicly available. Comments
posted to <a href="http://www.regulations.gov">http://www.regulations.gov</a> may include any personal
identifying information (such as name, address, and phone number)
included in the text of your electronic submission that is not
identified as directed above as confidential.
An electronic copy of this document is available at <a href="http://www.regulations.gov">http://www.regulations.gov</a> for easy reference.
Legal Authority
Section 306 of the Controlled Substances Act (21 U.S.C. 826)
requires the Attorney General to establish production quotas for each
basic class of controlled substances listed in schedules I and II, and
for the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine. The Attorney General has delegated this function
to the Administrator of DEA pursuant to 28 CFR 0.100.
Analysis for Proposed 2025 Aggregate Production Quotas and Assessment
of Annual Needs
The proposed 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, to be manufactured in the
United States in 2025 to provide for the estimated medical, scientific,
research, and industrial needs of the United States, 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.
Aggregate Production Quotas
In determining the proposed 2025 APQ, the Administrator has taken
into account the criteria of 21 U.S.C. 826(a) and 21 CFR 1303.11,
including the following seven factors:
(1) Total net disposal of the class by all manufacturers during the
current and two preceding years;
(2) Trends in the national rate of net disposal of the class;
(3) Total actual (or estimated) inventories of the class and of all
substances manufactured from the class, and trends in inventory
accumulation;
(4) Projected demand for such class as indicated by procurement
quotas requested pursuant to [21 CFR] 1303.12;
(5) The extent of any diversion of the controlled substance in the
class;
(6) Relevant information obtained from the Department of Health and
Human Services (HHS), including from the Food and Drug Administration
(FDA), the Centers for Disease Control and Prevention (CDC), and the
Centers for Medicare and Medicaid Services (CMS), and relevant
information obtained from the states; and
(7) Other factors affecting medical, scientific, research, and
industrial needs in the United States and lawful export requirements,
as the Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the class or the substances
manufactured from it, the economic and physical availability of raw
materials for use in manufacturing and for inventory purposes, yield
and stability problems, potential disruptions to production (including
possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
21 CFR 1303.11(b).
DEA formally solicited input from FDA and CDC in February of 2024
and from the states in April 2024, as required by 21 U.S.C. 826 and 21
CFR part 1303. DEA did not solicit input from CMS for reasons discussed
in previous notices.\1\ DEA requested information on trends in the
legitimate use of select schedule I and II controlled substances from
FDA and rates of overdose deaths for covered controlled substances from
CDC. DEA's request for information from the states was made directly to
the Prescription Drug Monitoring Program (PDMP) Administrators in each
state as well as through the National Association of State Controlled
Substances Authorities (NASCSA).
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\1\ Proposed Adjustments to the Aggregate Production Quotas for
Schedule I and II Controlled Substances and Assessment of Annual
Needs for List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2020, 85 FR 54414 (Sept. 1, 2020) and
Proposed Aggregate Production Quotas for Schedule I and II
Controlled Substances and Assessment of Annual Needs for List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for
2021, 85 FR 54407 (Sept. 1, 2020).
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Assessment of Annual Needs
In similar fashion, in determining the proposed 2025 AAN for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
the Administrator has taken into account the criteria of 21 U.S.C.
826(a) and 21 CFR 1315.11, including the following five factors:
(1) Total net disposal of the chemical by all manufacturers and
importers during the current and two preceding years;
(2) Trends in the national rate of net disposal of each chemical;
(3) Total actual (or estimated) inventories of the chemical and of
all substances manufactured from the chemical, and trends in inventory
accumulation;
(4) Projected demand for each chemical as indicated by procurement
and import quotas requested pursuant to [21 CFR] 1315.32; and
(5) Other factors affecting medical, scientific, research, and
industrial needs in the United States, lawful export requirements, and
the establishment and maintenance of reserve stocks, as the
Administrator finds relevant, including changes in the currently
accepted medical use in treatment with the chemicals or the substances
manufactured from them, the economic
[[Page 78774]]
and physical availability of raw materials for use in manufacturing and
for inventory purposes, yield and stability problems, potential
disruptions to production (including possible labor strikes), and
recent unforeseen emergencies such as floods and fires.
21 CFR 1315.11(b).
In determining the proposed 2025 AAN, DEA used the calculation
methodology previously described in the 2010 and 2011 assessments of
annual needs (74 FR 60294 (Nov. 20, 2009) and 75 FR 79407 (Dec. 20,
2010), respectively).
Estimates of Medical Need for Schedule II Opioids and Stimulants
In accordance with 21 CFR part 1303, 21 U.S.C. 826, and 42 U.S.C.
242, HHS continues to provide DEA with estimates of the quantities of
select schedule I and II controlled substances and three list I
chemicals that will be required to meet the legitimate medical needs of
the United States for a given calendar year. The responsibility to
provide these estimates of legitimate domestic medical needs resides
with FDA. FDA provides DEA with predicted estimates of domestic medical
usage for selected controlled substances based on information available
to them at a specific point in time in order to meet statutory
requirements.
FDA predicts that levels of medical need for schedule II opioids in
the United States in calendar year 2025 will decline on average 6.6
percent from calendar year 2024 levels. These declines are expected to
occur across a variety of schedule II opioids including fentanyl,
hydrocodone, hydromorphone, oxycodone, and oxymorphone. DEA considered
the potential for diversion of schedule II opioids, as required by 21
CFR 1303.11(b)(5), as well as a potential increase in demand for
certain opioids identified as being necessary to support the previously
postponed elective surgeries now that the COVID-19 public health
emergency (PHE) has ended, pursuant to 21 CFR 1303.11(b)(7), in
developing the proposed 2025 APQ.
FDA predicted an average of a 3.5 percent increase in domestic
medical use of the schedule II stimulants amphetamine, methylphenidate
(including dexmethylphenidate), and lisdexamfetamine, which are
prescribed to treat patients with attention deficit hyperactivity
disorder (ADHD) and more recently prescribed off-label to treat
patients diagnosed with long-COVID symptoms commonly known as brain fog
where fatigue and cognitive impairment persist 4 to 12 weeks after a
COVID infection.\2\ FDA also raised concerns over drug shortage
notifications it received since 2022 from patients for specific ADHD
medications containing amphetamine, lisdexamfetamine, and
methylphenidate. FDA's stated reasons for these specific shortages
include increased prescribing potentially related to the growth in
telemedicine during and after the COVID-19 PHE, supply chain issues,
manufacturing and quality issues, lack of active ingredients, and
business decisions of manufacturers. DEA considered FDA's concerns when
determining the APQ for these substances. Additionally, DEA considered
manufacturer and distributor-reported data which shows inventories for
both amphetamine and methylphenidate-based products have increased
year-over-year throughout the supply chain. DEA believes these
increases in inventories combined with the established APQs are
adequate to address FDA's estimated increases in domestic medical use
for amphetamine and methylphenidate. With respect to lisdexamfetamine,
DEA recently increased the APQ pursuant to a final order published on
September 5, 2024 to address reported shortages.\3\ In sum, DEA
believes that manufacturers will be able to meet the increase in
domestic medical need for these three schedule II stimulants with the
APQs proposed in this notice.
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\2\ New Long-Haul COVID Clinics Treat Mysterious and Ongoing
Symptoms, Scientific American, June 30, 2021; Successful Treatment
of Post-COVID-19 ADHD-like Syndrome-A case Report, J Atten Disord.,
2023 Aug; 27(10): 1092-1098.
\3\ Adjustment to the Aggregate Production Quota for
Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR
72424 (Sept. 5, 2024).
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DEA Projected Trends for Certain Schedule I Controlled Substances
DEA is proposing a higher APQ for ibogaine than DEA granted for
2024 to support manufacturing activities related to the increased level
of research and clinical trials with this schedule I controlled
substance. Additionally, DEA proposes a higher APQ for gamma
hydroxybutyric acid (GHB) to allow for an anticipated increase in
domestic bulk manufacturing to meet forecasted and continued domestic
market need due to the closure of a foreign manufacturing facility.
Imports of the schedule III oxybate form of GHB from that manufacturing
facility have supplied an estimated 78% of the domestic need. Their
foreign plant closure will be approximately one year in duration. GHB
(oxybate) products are used in the treatment of patients diagnosed with
narcolepsy and cataplexy.
Information Received for Consideration of the Remaining Factors
For the factors listed in 21 CFR 1303.11(b)(3) and (4), DEA
registered manufacturers of controlled substances in schedules I and II
provide information such as inventory, distribution, manufacturing,
sales forecasts and quota requests to DEA database systems. See 21 CFR
1303.12, 1303.22, and part 1304.
The regulation at 21 CFR 1303.11(b)(5) requires DEA to consider the
extent of diversion of controlled substances.\4\ Diversion is defined
as all distribution, dispensing, or other use of controlled substances
for other than legitimate medical purposes. In order to consider the
extent of diversion, DEA analyzed reports of diversion of controlled
substances from 2023 submitted to its Theft Loss Report database. This
database is comprised of DEA registrant reports documenting diversion
from the legitimate distribution chain, including employee thefts,
break-ins, armed robberies, and material lost in transit. The data was
categorized by basic drug class, and the amount of active
pharmaceutical ingredient (API) in the dosage form was delineated with
an appropriate metric for use in proposing aggregate production quota
values (i.e., weight).
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\4\ The estimates of diversion for five ``covered controlled
substances'' as required by 21 U.S.C. 826(i) are discussed later in
the document.
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In this proposed 2025 APQ notice, DEA continues to consider the
lingering effects of the COVID-19 pandemic on the global supply chain,
pursuant to 21 CFR 1303.11(b)(7), and specifically the continued
impacts on the availability of raw materials for use in the domestic
manufacturing process. Additionally, DEA considered the impact of the
demand for surgical care for elective surgeries that were deferred
during the COVID-19 PHE.
Estimates of Diversion of Covered Controlled Substances
In establishing any quota . . . , or any procurement quota
established by [DEA] by regulation, for fentanyl, oxycodone,
hydrocodone, oxymorphone, or hydromorphone (in this subsection referred
to as a ``covered controlled substance''), [DEA] shall estimate the
amount of diversion of the covered controlled substance that occurs in
the United States. 21 U.S.C. 826(i)(1)(A).
In estimating diversion under that provision, DEA:
(i) shall consider information . . . , in consultation with the
Secretary of Health and Human Services, [it] determines reliable on
rates of overdose
[[Page 78775]]
deaths and abuse and overall public health impact related to the
covered controlled substance in the United States; and
(ii) may take into consideration whatever other sources of
information [it] determines reliable.
21 U.S.C. 826(i)(1)(B).
The statute further mandates that DEA ``make appropriate quota
reductions, as determined by [DEA], from the quota [it] would have
otherwise established had such diversion not been considered.'' \5\
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\5\ 21 U.S.C. 826(i)(1)(C).
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In estimating the amount of diversion of each covered controlled
substance that occurs in the United States, DEA considered information
from state PDMP Administrators and from legitimate distribution chain
participants.
Consideration of Information From Certain State PDMPs and From National
Sales Data
Pursuant to 21 CFR 1303.11(b)(6), DEA requested state PDMP data for
the purpose of establishing its APQ. DEA believes state PDMPs to be an
essential, reliable source of information for use in effectively
estimating diversion of the five covered controlled substances. In
April 2024, DEA sent a letter to NASCSA requesting its assistance in
obtaining aggregated PDMP data for the five covered controlled
substances from each state covering the years 2021-2023. The letter
indicated that DEA was specifically interested in an analysis of
prescription data from each state's PDMP that would assist DEA in
estimating diversion and setting appropriate quotas in compliance with
21 U.S.C. 826(i). In its request, DEA provided specific questions,
discussed in detail below, based on common indicia of potential
diversion known as ``red flags'' by physicians, pharmacists,
manufacturers, distributors, and federal and state regulatory and law
enforcement agencies.\6\ DEA investigators and administrative
prosecutors also rely on Agency case law in which these red flags of
diversion have been upheld as indicia of potential diversion.\7\
Certain state regulations now include red flag circumstances as
potential indicators of illegitimate prescriptions, and thus of
potential abuse and diversion of controlled substances.\8\ See, e.g.,
The Pharmacy Place Order, 86 FR 21008, 21012 (Apr. 21, 2021) (citing 22
Tex. Admin. Code 291.29(c)(4), specifying the geographical distance
between the practitioner and the patient or between the pharmacy and
the patient as a red flag).
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\6\ National Association of Boards of Pharmacy (NABP) coalition
consensus document ``Stakeholders' Challenges and Red Flag Warning
Signs Related to Prescribing and Dispensing Controlled Substances''
(2015). www.nabp.pharmacy/resources/reports.
\7\ The Medicine Shoppe, 79 FR 59504, 59507, 59512-13 (Oct. 2,
2014); Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77
FR 62316 (Oct. 12, 2012).
\8\ The mere indicia of red flags alone is not proof of
violation of 21 U.S.C. 824 or any other provision of the CSA. This
rule discusses only their use by DEA as an analytical tool to
estimate diversion.
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DEA requested responses from state PDMP Administrators by June 15,
2024. NASCSA disseminated DEA's request to its PDMP Administrators and
provided them with a report tool to ensure that responses to DEA's
questions were extracted consistently across all responsive states.
Twenty-nine states and three territories provided DEA with summarized
PDMP data as of July 2024, utilizing the standardized report developed
by NASCSA.\9\ See Table 1a below.
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\9\ NASCSA formatted DEA's request into an analytics model
developed by one of its associates, Appriss Inc.
Table 1a--States/Territories That Responded to DEA's Data Request
------------------------------------------------------------------------
State/territory
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1. Alabama.
2. Alaska.
3. Arkansas.
4. Commonwealth of Northern Mariana Islands.
5. Connecticut.
6. Delaware.
7. District of Columbia.
8. Idaho.
9. Indiana.
10. Kansas.
11. Kentucky.
12. Louisiana.
13. Maryland.
14. Massachusetts.
15. Michigan.
16. Minnesota.
17. Mississippi.
18. Montana.
19. Nevada.
20. New Jersey.
21. New Mexico.
22. North Carolina.
23. Oklahoma.
24. Oregon.
25. Pennsylvania.
26. Puerto Rico.
27. South Carolina.
28. South Dakota.
29. Utah.
30. Vermont.
31. Virginia.
32. Washington.
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Pharmacies are required by state law to enter controlled substance
dispensing data into the state's PDMP database, including the
prescriber's name, registered address and DEA number; prescription
information (such as drug name); dispensing date; dosage dispensed;
pharmacy registered address; and patient name and address. DEA
considers PDMP data to be an accurate representation of dispensing
activities in states. DEA received data for the following red-flag
metrics:
<bullet> The total number of patients who saw three or more
prescribers in a 90-day period and were dispensed an opioid following
each visit. For this metric, DEA requested and was provided the number
of prescriptions for the five covered controlled substances dispensed
to these patients, as a percentage of the total prescriptions dispensed
for that particular covered controlled substance, as well as the
corresponding quantity of the covered controlled substance dispensed.
This metric (patients being prescribed covered controlled substances
from three or more prescribers in a 90-day period) is used to identify
potential doctor shopping, a common technique to obtain a high number
of controlled substances, which may lead to abuse or diversion of
controlled substances. DEA has long considered doctor shopping to be an
indicator of potential diversion.\10\
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\10\ Frank's Corner Pharmacy, 60 FR 17574 (Apr. 6, 1995);
Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 FR
62316 (Oct. 12, 2012).
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<bullet> The number of patients that were dispensed prescriptions
for each of the five covered controlled substances that exceeded 240
morphine milligram equivalents (MME) daily. States provided the raw
number of such prescriptions dispensed, the number of prescriptions as
a percentage of the total covered controlled substance prescriptions
dispensed, and the corresponding quantity of the covered controlled
substance dispensed. DEA believes that accounting for quantities in
excess of 240 MME daily allows for consideration of oncology patients
with legitimate medical needs for covered controlled substance
prescriptions with high MME. Higher dosages place individuals at higher
risk of overdose and death. Prescriptions involving dosages exceeding
240 MME daily may indicate diversion, such as illegal distribution of
controlled substances or prescribing outside the usual course of
professional practice.
<bullet> The number of patients that paid cash for covered
controlled substance prescriptions, without submitting for insurance
reimbursement.\11\ States also provided the number of prescriptions
paid entirely with cash as a percentage
[[Page 78776]]
of the total prescriptions for the five covered controlled substances
dispensed, as well as the corresponding quantity of the covered
controlled substances dispensed. When investigating potential
diversion, cash payments are one element considered in identifying
prescriptions filled for nonmedical purposes. Unusually high
percentages of cash payments made to a prescriber or pharmacy for
controlled substances may indicate diversion.\12\
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\11\ This total does not include insurance co-payments made with
cash.
\12\ Suntree Pharmacy and Suntree Medical Equipment, LLC, 85 FR
73753 (Nov. 19, 2020) (finding that the pharmacy filled
prescriptions despite the presence of multiple unresolved red flags,
including cash payments); Pharmacy Doctors Enterprises d/b/a Zion
Clinic Pharmacy, 83 FR 10876 (Mar. 13, 2018) (revoking pharmacy's
registration for filling prescriptions that raised the red flag of
customers paying cash for their prescriptions, among other red
flags).
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DEA received PDMP data from the states in a standardized format
that allowed DEA to aggregate the data. The PDMP data sample represents
a population of approximately 112.35 million people, which is
approximately 34 percent of the U.S. population. DEA believes this
sample is sufficient to derive a reasonable nationwide estimate.
While PDMP data is useful in estimating diversion, it is not
conclusive. Further investigation would be required before concluding
that any of the subject prescriptions were actually diverted. DEA
continues to evaluate its methodologies in estimating diversion in an
effort to set quotas more efficiently. State participation is crucial
to accurate data analysis, and DEA anticipates working closely with
states, as well as other federal and state entities, in future quota
determinations.
To calculate a national diversion estimate for each of the covered
controlled substances from the responses received from state PDMP
Administrators, DEA relied upon the number of individuals who received
a prescription for a covered controlled substance that met any of the
three red-flag metrics for each of calendar years 2021-2023. Using the
population of the states responding to DEA's request, DEA then
calculated the percentage of the population issued a prescription with
a red flag. Using this estimated percentage for 2021-2023, DEA analyzed
trends in the data to predict the estimated percentage of patients who
would be expected to be included in these red-flag metrics for 2025.
DEA also reviewed aggregate sales data for each of the covered
controlled substances, which it extracted from IQVIA's National Sales
Perspective.\13\ IQVIA sales data was selected to help quantify
diversion at the national level because it reflects the best national
estimate for all prescriptions written and filled, including the total
quantity available for diversion or misuse. DEA analyzed trends in
IQVIA sales data from January 2021-April 2024, in order to predict the
estimated national sales for 2025.
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\13\ DEA has purchased this data from IQVIA for decades and
routinely uses this information to administer several regulatory
functions, including the administration of DEA's quota program.
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To estimate diversion for each of the covered controlled
substances, DEA multiplied the forecasted percentage of patients likely
to receive a prescription for a covered controlled substance that meet
any of the three red-flag metrics in 2025 by the forecasted sales data
from IQVIA for 2025. The resulting estimate of diversion from data
submitted by state PDMP Administrators is summarized below in Table 1b.
This data contributed to the final diversion estimate set forth in
Table 3.
Table 1b--Diversion Estimates for 2025 Based on State PDMP Data for
Covered Controlled Substances From 2021-2023
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl..................................................... 26
Hydrocodone.................................................. 90,396
Hydromorphone................................................ 699
Oxycodone.................................................... 234,372
Oxymorphone.................................................. 000
------------------------------------------------------------------------
Consideration of Registrant Reported Diversion in the Legitimate
Distribution Chain
DEA extracted data from its Theft Loss Report database and
categorized it by each basic drug class. DEA calculated the estimated
amount of diversion by multiplying the quantity of API in each finished
dosage form by the total amount of units reported stolen or lost to
estimate the metric weight in grams of the controlled substance being
diverted. This estimate of diversion from the legitimate supply chain
for each of the covered controlled substances is displayed in Table 2.
This data contributed to the final diversion estimates set forth in
Table 3.
Table 2--Diversion Estimates Based on Supply Chain Diversion Data for
Covered Controlled Substances
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl..................................................... 73
Hydrocodone.................................................. 12,528
Hydromorphone................................................ 481
Oxycodone.................................................... 30,265
Oxymorphone.................................................. 165
------------------------------------------------------------------------
In accordance with 21 U.S.C. 826(i), DEA's estimate of diversion
for the five controlled substances was calculated by combining the
values in Tables 1b and 2.
Table 3--Total Estimates of Diversion for Covered Controlled Substances
To Be Considered in the 2025 APQs
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl..................................................... 99
Hydrocodone.................................................. 102,924
Hydromorphone................................................ 1,180
Oxycodone.................................................... 264,637
Oxymorphone.................................................. 165
------------------------------------------------------------------------
Continuing Efforts To Anticipate and Prevent Drug Shortages
Beginning in the latter half of 2022, the DEA and FDA observed an
increase in the number of drug shortages reported by manufacturers of
schedule II stimulants including mixed-salt amphetamine products
starting in April 2022 and lisdexamfetamine and methylphenidate
starting in July 2023. As DEA and FDA stated in an open letter in
2023,\14\ we remain committed to doing all we can to prevent stimulant
drug shortages, limit their impact, and resolve them as quickly as
possible.
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\14\ Both DEA and FDA released this letter on Aug. 1, 2023. It
is available at: <a href="https://www.dea.gov/sites/default/files/2023-08/DEA%20and%20FDA%20Issue%20Joint%20Letter%20to%20the%20Public.pdf">https://www.dea.gov/sites/default/files/2023-08/DEA%20and%20FDA%20Issue%20Joint%20Letter%20to%20the%20Public.pdf</a>.
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In particular, DEA continues to seek additional information that
will assist the agency to more accurately forecast export requirements,
especially for those substances controlled domestically in schedule I
or II that are not controlled internationally. DEA understands that
manufacturers have contractual obligations that dictate business
decisions regarding the quantities of finished dosage forms they will
produce under a single DEA-issued quota, which applies to products
manufactured with an active ingredient, whether for domestic or foreign
markets. DEA has purchased third-party data to improve its
understanding of the dynamic changes in foreign markets. In February
2024, DEA began utilizing IQVIA's foreign (non-U.S.) sales tracking
[[Page 78777]]
data module, MIDAS (Multi International Data Analysis System), which
provides valuable insight into the growing export markets for schedule
II stimulants. Building off the recently issued quota management
rule,\15\ DEA also intends to add new subcategories to individual
manufacturing quotas and procurement quotas, to distinguish between
domestic requirements and export requirements.
---------------------------------------------------------------------------
\15\ Management of Quotas for Controlled Substances and List I
Chemicals, 88 FR 60,117 (Aug. 31, 2023) (effective Nov. 29, 2023).
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As part of DEA's continuing effort to prevent shortages and be more
nimble in its administration of the quota program, DEA intends to
continue to allocate procurement quotas to DEA-registered manufacturers
of schedule II controlled substances on a semi-annual basis for the
2025 quota year, except that it will continue to allocate procurement
quotas relating to injectable drug products containing schedule II
controlled substances on an annual basis. DEA announced this change in
a letter to DEA-registered manufacturers on April 29, 2024. No further
change is being implemented at this time. DEA remains committed to
ensuring that all patients with legitimate medical need can access
appropriately prescribed medications.
The Administrator, therefore, proposes to establish the 2025 APQ
for certain schedule I and II controlled substances and AAN for the
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
expressed in grams of anhydrous acid or base, as follows:
------------------------------------------------------------------------
Proposed 2025
Basic class quotas (g)
------------------------------------------------------------------------
Schedule I
------------------------------------------------------------------------
-[1-(2-Thienyl)cyclohexyl]pyrrolidine.................. 20
1-(1-Phenylcyclohexyl)pyrrolidine...................... 30
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine......... 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)...... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)..... 30
1-[1-(2-Thienyl)cyclohexyl]piperidine.................. 15
2'-fluoro 2-fluorofentanyl............................. 30
1-Benzylpiperazine..................................... 25
1-Methyl-4-phenyl-4-propionoxypiperidine............... 10
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)....... 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)...... 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)...... 30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P).... 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)............... 100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
Cimbi-36).............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)...... 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25
methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
Cimbi-82).............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)........ 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 30
methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
Cimbi-5)..............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET)................ 25
2,5-Dimethoxy-4-n-propylthiophenethylamine............. 25
2,5-Dimethoxyamphetamine............................... 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 30
2)....................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)..................................................
3,4,5-Trimethoxyamphetamine............................ 30
2-Methyl AP-237........................................ 30
3,4-Methylenedioxyamphetamine (MDA).................... 12,000
3,4-Methylenedioxymethamphetamine (MDMA)............... 12,000
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)........... 40
3,4-Methylenedioxy-N-methylcathinone (methylone)....... 5,200
3,4-Methylenedioxypyrovalerone (MDPV).................. 35
3-FMC; 3-Fluoro-N-methylcathinone...................... 25
3-Methylfentanyl....................................... 30
3-Methylmethcathinone.................................. 30
3-Methylthiofentanyl................................... 30
4,4'-Dimethylaminorex.................................. 30
4-Bromo-2,5-dimethoxyamphetamine (DOB)................. 30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)............. 5,100
4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha- 25
PVP)..................................................
4-CN-Cumyl-Butinaca.................................... 25
4-Fluoroisobutyryl fentanyl............................ 30
4F-MDMB-BINACA......................................... 30
4-FMC; Flephedrone..................................... 25
4-MEC; 4-Methyl-N-ethylcathinone....................... 25
4-Methoxyamphetamine................................... 150
4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one 30
(alpha-PiHP)..........................................
4-Methyl-2,5-dimethoxyamphetamine (DOM)................ 25
4-Methylaminorex....................................... 25
4-Methyl-N-methylcathinone (mephedrone)................ 45
4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)........ 25
4-Methyl-alpha-pyrrolidinohexiophenone (MPHP).......... 25
[[Page 78778]]
4'-Methyl acetyl fentanyl.............................. 30
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).... 25
4F-MDMB-BUTICA......................................... 30
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 50
phenol................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40
phenol (cannabicyclohexanol or CP-47,497 C8-homolog)..
5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide...............
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H- 25
indazole-3-carboxamido)-3,3-dimethylbutanoate)........
5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2- 25
yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide............
5F-CUMYL-PINACA........................................ 25
5F-EDMB-PICA........................................... 30
5F-EDMB-PINACA......................................... 25
5F-MDMB-PICA........................................... 25
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 25
carboxamido)-3-methylbutanoate).......................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5- 25
fluoropentyl)-1H-indazole-3-carboxamide)..............
5-Fluoro-PB-22; 5F-PB-22............................... 25
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3- 25
yl](2,2,3,3-tetramethylcyclopropyl)methanone..........
5-Methoxy-3,4-methylenedioxyamphetamine................ 25
5-Methoxy-N,N-diisopropyltryptamine.................... 25
5-Methoxy-N,N-dimethyltryptamine....................... 11,000
AB-CHMINACA............................................ 30
AB-FUBINACA............................................ 50
AB-PINACA.............................................. 30
ADB-BUTINACA........................................... 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 30
1-(4-fluorobenzyl)-1H-indazole-3-carboxamide).........
Acetorphine............................................ 25
Acetyl Fentanyl........................................ 100
Acetyl-alpha-methylfentanyl............................ 30
Acetyldihydrocodeine................................... 30
Acetylmethadol......................................... 25
Acryl Fentanyl......................................... 25
ADB-4en-PINACA......................................... 30
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 50
pentyl-1H-indazole-3-carboxamide).....................
AH-7921................................................ 30
All other tetrahydrocannabinol......................... 1,166,130
Allylprodine........................................... 25
Alphacetylmethadol..................................... 25
alpha-Ethyltryptamine.................................. 25
Alphameprodine......................................... 25
Alphamethadol.......................................... 25
alpha-Methylfentanyl................................... 30
alpha-Methylthiofentanyl............................... 30
alpha-Methyltryptamine (AMT)........................... 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)............ 25
alpha-pyrrolidinoheptaphenone (PV8).................... 25
alpha-pyrrolidinohexabophenone (alpha-PHP)............. 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)........... 25
Amineptine............................................. 30
Aminorex............................................... 25
Anileridine............................................ 20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3- 25
carboxamide)..........................................
Benzethidine........................................... 25
Benzylmorphine......................................... 30
Betacetylmethadol...................................... 25
beta-Hydroxy-3-methylfentanyl.......................... 30
beta-Hydroxyfentanyl................................... 30
beta-Hydroxythiofentanyl............................... 30
beta-Methyl fentanyl................................... 30
beta'-Phenyl fentanyl.................................. 30
Betameprodine.......................................... 25
Betamethadol........................................... 4
Betaprodine............................................ 25
Brorphine.............................................. 30
Bufotenine............................................. 15
Butonitazene........................................... 30
Butylone............................................... 25
Butyryl fentanyl....................................... 30
Cathinone.............................................. 40
Clonazolam............................................. 30
Clonitazene............................................ 25
Codeine methylbromide.................................. 30
Codeine-N-oxide........................................ 192
Crotonyl Fentanyl...................................... 25
[[Page 78779]]
CUMYL-PEGACLONE........................................ 30
Cyclopentyl Fentanyl................................... 30
Cyclopropyl Fentanyl................................... 20
Cyprenorphine.......................................... 25
d-9-THC................................................ 1,523,040
Desomorphine........................................... 25
Dextromoramide......................................... 25
Diapromide............................................. 20
Diclazepam............................................. 30
Diethylthiambutene..................................... 20
Diethyltryptamine...................................... 25
Difenoxin.............................................. 9,300
Dihydromorphine........................................ 639,954
Dimenoxadol............................................ 25
Dimepheptanol.......................................... 25
Dimethylthiambutene.................................... 20
Dimethyltryptamine..................................... 11,000
Dioxyaphetyl butyrate.................................. 25
Dipipanone............................................. 25
Drotebanol............................................. 25
Ethylmethylthiambutene................................. 25
Ethylone............................................... 25
Etizolam............................................... 30
Etodesnitazene......................................... 30
Etonitazene............................................ 25
Etorphine.............................................. 30
Etoxeridine............................................ 25
Eutylone............................................... 30
Fenethylline........................................... 30
Fentanyl carbamate..................................... 30
Fentanyl related substances............................ 600
Flualprazolam.......................................... 30
Flubromazolam.......................................... 30
Flunitazene............................................ 30
FUB-144................................................ 25
FUB-AKB48.............................................. 25
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca.................... 25
Furanyl fentanyl....................................... 30
Furethidine............................................ 25
gamma-Hydroxybutyric acid.............................. 49,675,266
Heroin................................................. 150
Hydromorphinol......................................... 40
Hydroxypethidine....................................... 25
Ibogaine............................................... 210
Isobutyryl Fentanyl.................................... 25
Isotonitazine.......................................... 25
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)..... 35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)................ 45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)................ 45
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole).... 30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)...... 30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 35
naphthoyl)indole).....................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)...... 30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)..... 30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)...... 30
Ketobemidone........................................... 30
Levomoramide........................................... 25
Levophenyacylmorphan................................... 25
Lysergic acid diethylamide (LSD)....................... 1,200
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1- 30
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide)..........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1- 30
(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
dimethylbutanoate)....................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole- 30
3-carboxamido)-3,3-dimethylbutanoate).................
MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)- 25
1H-indole-3-carboxamido)-3-methylbutanoate............
Marijuana.............................................. 6,675,000
Marijuana extract...................................... 1,000,000
MDMB-4en-PINACA........................................ 30
MMB-FUBICA............................................. 30
Mecloqualone........................................... 30
Mescaline.............................................. 1,200
Mesocarb............................................... 30
Methaqualone........................................... 60
[[Page 78780]]
Methcathinone.......................................... 25
Methiopropamine........................................ 30
Methoxetamine.......................................... 30
Methoxyacetyl fentanyl................................. 30
Methyldesorphine....................................... 5
Methyldihydromorphine.................................. 25
Metodesnitazene........................................ 30
Metonitazene........................................... 30
Morpheridine........................................... 25
Morphine methylbromide................................. 5
Morphine methylsulfonate............................... 5
Morphine-N-oxide....................................... 150
MT-45.................................................. 30
Myrophine.............................................. 25
NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3- 25
carboxylate...........................................
N,N-Dimethylamphetamine................................ 25
Naphyrone.............................................. 25
N-Desethyl isotonitazene............................... 30
N-Ethyl-1-phenylcyclohexylamine........................ 25
N-Ethyl-3-piperidyl benzilate.......................... 10
N-Ethylamphetamine..................................... 24
N-Ethylhexedrone....................................... 25
N-Ethylpentylone, ephylone............................. 30
N-Hydroxy-3,4-methylenedioxyamphetamine................ 24
Nicocodeine............................................ 25
Nicomorphine........................................... 25
N-methyl-3-piperidyl benzilate......................... 30
N-piperidinyl etonitazene.............................. 30
N-Pyrrolidino Etonitazene.............................. 30
Noracymethadol......................................... 25
Norlevorphanol......................................... 2,550
Normethadone........................................... 25
Normorphine............................................ 40
Norpipanone............................................ 25
Ocfentanil............................................. 25
ortho-Fluoroacryl fentanyl............................. 30
ortho-Fluorobutyryl fentanyl........................... 30
Ortho-Fluorofentanyl,2-Fluorofentanyl.................. 30
ortho-Fluoroisobutyryl fentanyl........................ 30
ortho-Methyl acetylfentanyl............................ 30
ortho-Methyl methoxyacetyl fentanyl.................... 30
Para-Chlorisobutyrl fentanyl........................... 30
Para-flourobutyryl fentanyl............................ 25
Para-fluorofentanyl.................................... 25
para-Fluoro furanyl fentanyl........................... 30
Para-Methoxybutyrl fentanyl............................ 30
Para-methoxymethamphetamine............................ 30
para-Methylfentanyl.................................... 30
Parahexyl.............................................. 5
PB-22; QUPIC........................................... 20
Pentedrone............................................. 25
Pentylone.............................................. 25
Phenadoxone............................................ 25
Phenampromide.......................................... 25
Phenomorphan........................................... 25
Phenoperidine.......................................... 25
Phenyl fentanyl........................................ 30
Pholcodine............................................. 5
Piritramide............................................ 25
Proheptazine........................................... 25
Properidine............................................ 25
Propiram............................................... 25
Protonitazene.......................................... 30
Psilocybin............................................. 30,000
Psilocin............................................... 36,000
Racemoramide........................................... 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole)...........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)- 30
benzoyl]indole).......................................
Tetrahydrofuranyl fentanyl............................. 15
Thebacon............................................... 25
Thiafentanil........................................... 25
Thiofentanyl........................................... 25
[[Page 78781]]
Thiofuranyl fentanyl................................... 30
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3- 30
yl](naphthalen-1-yl)methanone)........................
Tilidine............................................... 25
Trimeperidine.......................................... 25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3- 25
tetramethylcyclopropyl)methanone......................
U-47700................................................ 30
Valeryl fentanyl....................................... 25
Zipeprol............................................... 30
------------------------------------------------------------------------
Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine................................ 15
1-Piperidinocyclohexanecarbonitrile.................... 25
4-Anilino-N-phenethyl-4-piperidine (ANPP).............. 937,874
Alfentanil............................................. 5,000
Alphaprodine........................................... 25
Amobarbital............................................ 20,100
Bezitramide............................................ 25
Carfentanil............................................ 20
Cocaine................................................ 60,492
Codeine (for conversion)............................... 942,452
Codeine (for sale)..................................... 19,262,957
d-amphetamine (for sale)............................... 21,200,000
d,l-amphetamine........................................ 21,200,000
d-amphetamine (for conversion)......................... 23,688,235
Dexmethylphenidate (for sale).......................... 6,200,000
Dexmethylphenidate (for conversion).................... 5,374,683
Dextropropoxyphene..................................... 35
Dihydrocodeine......................................... 115,227
Dihydroetorphine....................................... 25
Diphenoxylate (for conversion)......................... 14,100
Diphenoxylate (for sale)............................... 770,800
Ecgonine............................................... 60,492
Ethylmorphine.......................................... 30
Etorphine hydrochloride................................ 32
Fentanyl............................................... 731,341
Glutethimide........................................... 25
Hydrocodone (for conversion)........................... 1,250
Hydrocodone (for sale)................................. 27,121,498
Hydromorphone.......................................... 1,951,508
Isomethadone........................................... 30
L-amphetamine.......................................... 30
Levo-alphacetylmethadol (LAAM)......................... 25
Levomethorphan......................................... 30
Levorphanol............................................ 20,000
Lisdexamfetamine....................................... 32,736,000
Meperidine............................................. 681,184
Meperidine Intermediate-A.............................. 30
Meperidine Intermediate-B.............................. 30
Meperidine Intermediate-C.............................. 30
Metazocine............................................. 15
Methadone (for sale)................................... 25,619,700
Methadone Intermediate................................. 27,673,600
d,l-Methamphetamine.................................... 150
d-methamphetamine (for conversion)..................... 485,020
d-methamphetamine (for sale)........................... 47,000
l-methamphetamine...................................... 587,229
Methylphenidate (for sale)............................. 53,283,000
Methylphenidate (for conversion)....................... 19,975,468
Metopon................................................ 25
Moramide-intermediate.................................. 25
Morphine (for conversion).............................. 2,393,200
Morphine (for sale).................................... 20,805,957
Nabilone............................................... 62,000
Norfentanyl............................................ 25
Noroxymorphone (for conversion)........................ 24,756,979
Noroxymorphone (for sale).............................. 1,000
Oliceridine............................................ 25,100
Opium (powder)......................................... 250,000
Opium (tincture)....................................... 530,837
Oripavine.............................................. 37,721,950
Oxycodone (for conversion)............................. 437,827
[[Page 78782]]
Oxycodone (for sale)................................... 53,584,449
Oxymorphone (for conversion)........................... 31,773,105
Oxymorphone (for sale)................................. 464,464
Pentobarbital.......................................... 40,000,000
Phenazocine............................................ 25
Phencyclidine.......................................... 35
Phenmetrazine.......................................... 25
Phenylacetone.......................................... 100
Piminodine............................................. 25
Racemethorphan......................................... 5
Racemorphan............................................ 5
Remifentanil........................................... 3,000
Secobarbital........................................... 172,100
Sufentanil............................................. 4,000
Tapentadol............................................. 10,390,226
Thebaine............................................... 57,137,944
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)............................. 41,100
Ephedrine (for sale)................................... 3,933,336
Phenylpropanolamine (for conversion)................... 14,878,320
Phenylpropanolamine (for sale)......................... 7,990,000
Pseudoephedrine (for conversion)....................... 1,000
Pseudoephedrine (for sale)............................. 186,617,466
------------------------------------------------------------------------
The Administrator further proposes that the APQ for all other
schedule I and II controlled substances included in 21 CFR 1308.11 and
1308.12 remain at zero.
These proposed 2025 quotas reflect the quantities that DEA believes
are necessary to meet the estimated medical, scientific, research, and
industrial needs of the United States, lawful export requirements; and
the establishment and maintenance of reserve stocks.
In accordance with 21 CFR 1303.13 and 1315.13, upon consideration
of the relevant factors, the Administrator may adjust the 2025 APQ and
AAN as needed.
Conclusion
After consideration of any comments or objections, or after a
hearing, if one is held, the Administrator will issue and publish in
the Federal Register a final order establishing the 2025 APQ for
controlled substances in schedules I and II and establishing an AAN for
the list I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine, as directed by 21 CFR 1303.11(c) and 1315.11(f).
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 20, 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. 2024-21962 Filed 9-20-24; 4:15 pm]
BILLING CODE 4410-09-P
</pre></body>
</html>Indexed from Federal Register on September 25, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.