Notice2023-24282
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 2024
Primary source
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Published
November 2, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) proposes to establish the 2024 aggregate production quotas (APQ) for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. For the 2024 quota year, DEA intends to allocate procurement quotas to DEA-registered manufacturers of schedule II controlled substances on a quarterly basis. In order to address domestic drug shortages of controlled substances, procurement quota allocations will be divided between quantities authorized for domestic sales and quantities authorized for export sales.
Full Text
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<title>Federal Register, Volume 88 Issue 211 (Thursday, November 2, 2023)</title>
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[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75312-75323]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24282]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1228P]
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 2024
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 2024 aggregate production quotas (APQ) for controlled
substances in schedules I and II of the Controlled Substances Act (CSA)
and the assessment of annual needs (AAN) for the list I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine. For the 2024 quota
year, DEA intends to allocate procurement quotas to DEA-registered
manufacturers of schedule II controlled substances on a quarterly
basis. In order to address domestic drug shortages of controlled
substances, procurement quota allocations will be divided between
quantities authorized for domestic sales and quantities authorized for
export sales.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before December 4, 2023. Interested persons may
file written comments on this notice in accordance with 21 CFR
1303.11(c) and 1315.11(d). 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 2024
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.
[[Page 75313]]
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-1228P'' 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: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone: (571) 776-3882.
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 2024 Aggregate Production Quotas and Assessment
of Annual Needs
The proposed 2024 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 (U.S.) in 2024 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 2024 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 2023
and from the states in April 2023, 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
[[Page 75314]]
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 2021, 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 2024 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 five following 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 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 2024 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 2024 will decline on average 7.9
percent from calendar year 2023 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 has ended, pursuant to 21 CFR 1303.11(b)(7), in developing
the proposed 2024 APQ.
FDA predicted an average of a 3.1 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 from patients for specific ADHD medications
containing methylphenidate and amphetamine. FDA's stated reasons for
these specific shortages include increased prescribing potentially
related to the growth in telemedicine, supply chain issues,
manufacturing and quality issues, and business decisions of
manufacturers. DEA considered FDA's concerns when determining the APQ
for these substances. DEA believes that manufacturers will be able to
meet the increase in domestic medical need 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.
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DEA Projected Trends for Certain Schedule I Controlled Substances
There has been a significant increase in the use of schedule I
hallucinogenic controlled substances for research and clinical trial
purposes. DEA has received and subsequently approved new registration
applications for schedule I researchers and new applications for
registration from manufacturers to grow, synthesize, extract, and
prepare dosage forms containing specific schedule I hallucinogenic
substances for research and clinical trial purposes. DEA supports
regulated research with schedule I controlled substances, as evidenced
by the higher APQ proposed for 2024 as compared with APQ for these
substances in 2023. Further, DEA published the final rule, ``Controls
to Enhance the Cultivation of Marihuana for Research in the United
States'' in December 2020, and the Medical Marijuana and Cannabidiol
Research Expansion Act (Pub. L. 117-215) was enacted in December 2022.
The agency continues to review and approve applications for schedule I
manufacturers of marihuana that conform to the federal requirements
contained in the CSA. See 21 CFR part 1318.
Thus, DEA is proposing APQ for ibogaine, psilocyn, psilocybin,
delta-9-tetrahydrocannabinol (d-9-THC), and all other
tetrahydrocannabinols to support manufacturing activities related to
the increased level of research and clinical trials with these schedule
I controlled substances. Additionally, DEA proposes APQs for d-9-THC
and all other tetrahydrocannabinols for 2024 to reflect the relocation
of manufacturing of these controlled substances from abroad to the
United States.
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 the 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.\3\ Diversion is defined
as all distribution, dispensing, or other use of controlled substances
for other than legitimate medical purposes. In order to
[[Page 75315]]
consider the extent of diversion, DEA analyzed reports of diversion of
controlled substances from 2022 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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\3\ 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 2024 APQ, DEA also considered 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 public health emergency.
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 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.'' \4\
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\4\ 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 2023, 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 2020-2022. 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.\5\ 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.\6\
Certain state regulations now include red flag circumstances as
potential indicators of illegitimate prescriptions, and thus of
potential abuse and diversion of controlled substances.\7\ See 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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\5\ 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.
\6\ The Medicine Shoppe, 79 FR 59504, 59507, 59512-13 (2014);
Holiday CVS, L.L.C., d/b/a CVS Pharmacy Nos. 219 and 5195, 77 FR
62316 (Oct. 12, 2012).
\7\ 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,
2023. 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.
Thirty states and two territories provided DEA with summarized PDMP
data between May 3, and June 15, 2023, utilizing the standardized
report developed by NASCSA.\8\ See Table 1a below.
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\8\ 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
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State/territory
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1. Alabama
2. Alaska
3. Arizona
4. Arkansas
5. Connecticut
6. Delaware
7. District of Columbia
8. Hawaii
9. Idaho
10. Indiana
11. Iowa
12. Kansas
13. Kentucky
14. Louisiana
15. Maine
16. Maryland
17. Michigan
18. Minnesota
19. Mississippi
20. Montana
21. Nevada
22. New Jersey
23. North Carolina
24. North Dakota
25. Ohio
26. Oklahoma
27. Puerto Rico
28. Rhode Island
29. South Carolina
30. South Dakota
31. Texas
32. Utah
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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
[[Page 75316]]
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.\9\
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\9\ Frank's Corner Pharmacy, 60 FR 17574 (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.\10\ States also provided the number of prescriptions
paid entirely with cash as a percentage 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.\11\
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\10\ This total does not include insurance co-payments made with
cash.
\11\ Suntree Pharmacy and Suntree Medical Equipment, LLC, 85 FR
73753 (2018) (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 150.7 million people, which is
approximately 45 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 adjust 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 2020-2022. 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 2020-2022, 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 2024.
DEA also reviewed aggregate sales data for each of the covered
controlled substances, which it extracted from IQVIA's National Sales
Perspective.\12\ 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 2020--April 2023, in order to predict the
estimated national sales for 2024.
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\12\ 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 2024 by the forecasted sales data
from IQVIA for 2024. 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 2024 Based on State PDMP Data for
Covered Controlled Substances From 2020-2022
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl................................................ 18
Hydrocodone............................................. 83,823
Hydromorphone........................................... 356
Oxycodone............................................... 150,684
Oxymorphone............................................. 0
------------------------------------------------------------------------
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................................................ 74
Hydrocodone............................................. 12,454
Hydromorphone........................................... 481
Oxycodone............................................... 31,698
Oxymorphone............................................. 252
------------------------------------------------------------------------
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. DEA reduced the APQ for each covered
controlled substance by the quantities listed in Table 3.
Table 3--Total Estimates of Diversion for Covered Controlled Substances
To Be Applied to the 2024 APQs
------------------------------------------------------------------------
Controlled substance (g)
------------------------------------------------------------------------
Fentanyl................................................ 92
Hydrocodone............................................. 96,277
Hydromorphone........................................... 838
[[Page 75317]]
Oxycodone............................................... 182,382
Oxymorphone............................................. 252
------------------------------------------------------------------------
Forthcoming Regulatory Changes and Administration of Individual Quotas
for 2024
DEA is committed to ensuring that all Americans can access
appropriately prescribed medications. As part of this commitment, DEA
undertook work to understand the supply chain dynamics for controlled
substances subject to quotas over the last year and a half, especially
in highly genericized markets. Based on that review, DEA observed
various challenges in the quota allocation process stemming from the
lack of real-time inventory and sales data accessible to DEA, the lack
of information on manufacturers' production lead times, and issues of
timeliness in ARCOS reporting.
Relatedly, 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 their
open letter,\13\ we remain committed to doing all we can to prevent
stimulant drug shortages, limit their impact, and resolve them as
quickly as possible.
---------------------------------------------------------------------------
\13\ 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>.
---------------------------------------------------------------------------
DEA commissioned two reports by IQVIA \14\ in order to understand
the demographic shifts impacting the prescribing of schedule II
stimulants. The reports provided valuable insights. Chief among those
insights was the observed increase in prescriptions dispensed for
mixed-salt amphetamine products to adults between the ages of 31-40
years, particularly women, and older patients (71-80 years old),
particularly during the COVID-19 pandemic (i.e. 2020 and 2021). In
contrast, during 2022, dispensed prescriptions for products containing
methylphenidate HCl and dexmethylphenidate HCl had a higher annual
increase in 2022 (than in 2021) as compared to mixed-salt amphetamine
products which may be indicative of product switching from amphetamine
to methylphenidate and dexmethylphendiate. Neither DEA nor FDA
anticipated these changes.
---------------------------------------------------------------------------
\14\ Both reports are available at: <a href="https://www.deadiversion.usdoj.gov/drug_chem_info/stimulants/">https://www.deadiversion.usdoj.gov/drug_chem_info/stimulants/</a>.
---------------------------------------------------------------------------
In addition to these demographic shifts in prescribing, DEA also
evaluated inventory, manufacturing, and sales data submitted by
manufacturers through ARCOS and through reports submitted to DEA's
Quota Management System. That analysis revealed that dosage
manufacturers of amphetamine did not utilize the full extent of their
authorized quotas. DEA authorized amphetamine medication dosage form
manufacturers across the entire market to purchase and use 38,418
kilograms of amphetamine but those manufacturers initially \15\
reported the purchase of only 31,539 kg. Of that quantity, dosage
manufacturers only shipped 26,953 kg of amphetamine medications.
---------------------------------------------------------------------------
\15\ In July 2023, several manufacturers who--according to their
reporting to DEA--had failed to use their full amphetamine
procurement quotas in 2022 received correspondence from DEA and FDA
asking them to confirm that they would use their full 2023
procurement quotas. Upon receiving that correspondence--
approximately seven months after the close of calendar year 2022--
one such manufacturer then revised its 2022 reporting to DEA to
reflect that it had, in fact, used nearly all of its 2022
amphetamine procurement quota.
---------------------------------------------------------------------------
This ongoing work has led DEA to conclude that changes to its
regulations likely will be useful in developing more precise quotas
that will provide for the estimated medical, scientific, research, and
industrial needs of the United States, for lawful export requirements,
and for the establishment and maintenance of reserve stocks, while also
reducing opportunities for diversion. For instance, DEA believes that
changes to reporting requirements are necessary to improve both the
type of data collected and the timeliness of that data, allowing DEA to
be more nimble in its administration of the quota program. Future
regulatory changes may seek to address the lack of real-time inventory
and sales data accessible to DEA, the lack of information on production
lead times, and issues of timeliness in ARCOS reporting, by
considering, for example, requiring manufacturers to provide
anticipated production timelines and monthly ARCOS reporting. DEA is
not seeking comments on these concepts through this notice, but will
publish detailed proposals for comment in the future.
DEA also will seek additional information that will assist the
agency to more accurately forecast export requirements, especially for
those substances that are not controlled internationally.\16\ 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 also is exploring the purchase of
third-party data to improve its understanding of the dynamic changes in
foreign markets. Building off the recently issued quota management
rule,\17\ DEA also intends to add new subcategories to individual
manufacturing quotas and procurement quotas, to distinguish between
domestic requirements and export requirements.
---------------------------------------------------------------------------
\16\ While amphetamine and methylphenidate are currently
recognized as schedule II controlled substances under the Convention
on Psychotropic Substances of 1971, lisdexamfetamine is not.
Additional details may be found at: <a href="https://www.incb.org/incb/en/psychotropics/1971_convention.html">https://www.incb.org/incb/en/psychotropics/1971_convention.html</a>.
\17\ Management of Quotas for Controlled Substances and List I
Chemicals, 88 FR 60117 (Aug. 31, 2023) (effective Nov. 29, 2023).
---------------------------------------------------------------------------
DEA also is considering methods by which it might increase
transparency in its quota setting process. Future regulatory proposals
may define additional steps, including such concepts as public
notification and an opportunity for public input when prescribing rates
for controlled substances deviate substantially from FDA's estimate of
future use. Furthermore, DEA is considering regulatory changes which
will authorize it to reduce a manufacturer's individual manufacturing
or procurement quota in order to apportion it to another manufacturer.
As with the regulatory changes mentioned above, DEA will welcome
comment on detailed proposals in the future, and is not requesting
comment on these general concepts in this notice.
The abovementioned regulatory changes will take time. In the
meantime, for the 2024 quota year, DEA intends to allocate procurement
quotas to DEA-registered manufacturers of schedule II controlled
substances on a quarterly basis. In order to address domestic drug
shortages of controlled substances, procurement quota allocations for
schedule II controlled substances will be divided between quantities
authorized for domestic sales and quantities authorized for export
sales. DEA will be sending a letter to each manufacturer with
instructions on the data that will be necessary to allow DEA to process
subsequent quarterly procurement quota allocations. DEA may publish or
post how many companies have been allocated quota in
[[Page 75318]]
a given calendar year, and how many of those companies have utilized
their allocated quota. Further, DEA may publish or post the names of
the companies that have been allocated quota.
The Administrator, therefore, proposes to establish the 2024 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 2024
quotas
Basic class ---------------
(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-2) 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C- 30
T-4)...................................................
3,4,5-Trimethoxyamphetamine............................. 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-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-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
4'-Methyl acetyl fentanyl............................... 30
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..... 25
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-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
[[Page 75319]]
5-Methoxy-N,N-diisopropyltryptamine..................... 25
5-Methoxy-N,N-dimethyltryptamine........................ 11,000
AB-CHMINACA............................................. 30
AB-FUBINACA............................................. 50
AB-PINACA............................................... 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 30
(4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetorphine............................................. 25
Acetyl Fentanyl......................................... 100
Acetyl-alpha-methylfentanyl............................. 30
Acetyldihydrocodeine.................................... 30
Acetylmethadol.......................................... 25
Acryl Fentanyl.......................................... 25
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.......................... 790,010
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
Clonitazene............................................. 25
Codeine methylbromide................................... 30
Codeine-N-oxide......................................... 192
Crotonyl Fentanyl....................................... 25
Cyclopentyl Fentanyl.................................... 30
Cyclopropyl Fentanyl.................................... 20
Cyprenorphine........................................... 25
d-9-THC................................................. 900,610
Desomorphine............................................ 25
Dextromoramide.......................................... 25
Diapromide.............................................. 20
Diethylthiambutene...................................... 20
Diethyltryptamine....................................... 25
Difenoxin............................................... 9,300
Dihydromorphine......................................... 639,954
Dimenoxadol............................................. 25
Dimepheptanol........................................... 25
Dimethylthiambutene..................................... 20
Dimethyltryptamine...................................... 3,000
Dioxyaphetyl butyrate................................... 25
Dipipanone.............................................. 25
Drotebanol.............................................. 25
Ethylmethylthiambutene.................................. 25
[[Page 75320]]
Ethylone................................................ 25
Etodesnitazene.......................................... 30
Etonitazene............................................. 25
Etorphine............................................... 30
Etoxeridine............................................. 25
Eutylone................................................ 30
Fenethylline............................................ 30
Fentanyl carbamate...................................... 30
Fentanyl related substances............................. 600
Flunitazene............................................. 30
FUB-144................................................. 25
FUB-AKB48............................................... 25
Fub-AMB, MMB-Fubinaca, AMB-Fubinaca..................... 25
Furanyl fentanyl........................................ 30
Furethidine............................................. 25
gamma-Hydroxybutyric acid............................... 29,417,000
Heroin.................................................. 150
Hydromorphinol.......................................... 40
Hydroxypethidine........................................ 25
Ibogaine................................................ 150
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-(cyclohexylmethyl)- 30
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.............
Mesocarb................................................ 30
Metodesnitazene......................................... 30
Metonitazene............................................ 30
Marijuana............................................... 6,675,000
Marijuana extract....................................... 1,000,000
Mecloqualone............................................ 30
Mescaline............................................... 1,200
Methaqualone............................................ 60
Methcathinone........................................... 25
Methiopropamine......................................... 30
Methoxetamine........................................... 30
Methoxyacetyl fentanyl.................................. 30
Methyldesorphine........................................ 5
Methyldihydromorphine................................... 25
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-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
[[Page 75321]]
N-methyl-3-piperidyl benzilate.......................... 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.............................................. 15,000
Psilocyn................................................ 24,000
Racemoramide............................................ 25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2- 45
methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30
Tetrahydrofuranyl fentanyl.............................. 15
Thebacon................................................ 25
Thiafentanil............................................ 25
Thiofentanyl............................................ 25
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)............... 866,746
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).......................... 20,000,000
Dexmethylphenidate (for sale)........................... 6,200,000
[[Page 75322]]
Dexmethylphenidate (for conversion)..................... 4,200,000
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................................................ 676,062
Glutethimide............................................ 25
Hydrocodone (for conversion)............................ 1,250
Hydrocodone (for sale).................................. 27,143,545
Hydromorphone........................................... 1,951,801
Isomethadone............................................ 30
L-amphetamine........................................... 30
Levo-alphacetylmethadol (LAAM).......................... 25
Levomethorphan.......................................... 30
Levorphanol............................................. 20,000
Lisdexamfetamine........................................ 26,500,000
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)......................... 22,044,741
Noroxymorphone (for sale)............................... 1,000
Oliceridine............................................. 25,100
Opium (powder).......................................... 250,000
Opium (tincture)........................................ 530,837
Oripavine............................................... 33,010,750
Oxycodone (for conversion).............................. 437,827
Oxycodone (for sale).................................... 53,658,226
Oxymorphone (for conversion)............................ 28,204,371
Oxymorphone (for sale).................................. 464,464
Pentobarbital........................................... 33,843,337
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).............................. 170,360,314
------------------------------------------------------------------------
[[Page 75323]]
The Administrator further proposes that aggregate production quotas
for all other schedule I and II controlled substances included in 21
CFR 1308.11 and 1308.12 remain at zero.
These proposed 2024 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. DEA remains
committed to conducting continuous surveillance on the supply of
schedule II controlled substances and list I chemicals necessary to
treat patients with COVID-19, and, pursuant to her authority, the
Administrator will move swiftly and decisively to increase any 2024 APQ
that she determines is necessary to address an unforeseen increase in
demand, should that occur.
In accordance with 21 CFR 1303.13 and 1315.13, upon consideration
of the relevant factors, the Administrator may adjust the 2024 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 2024 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
October 30, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-24282 Filed 11-1-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on November 2, 2023.
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.