Established Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024, 407-418 [2023-28962]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 89, Number 2 (Wednesday, January 3, 2024)]
[Notices]
[Pages 407-418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28962]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1228E]


Established Aggregate Production Quotas for Schedule I and II 
Controlled Substances and Assessment of Annual Needs for the List I 
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the initial 2024 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act and the assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: This Notice is effective January 3, 2024.

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

SUPPLEMENTARY INFORMATION:

I. Legal Authority

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

II. Background

    The 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 that may be manufactured in the United States in 
2024, in order to provide for the estimated medical, scientific, 
research, and industrial needs of the U.S., lawful export requirements, 
and the establishment and maintenance of reserve stocks. These quotas 
include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, 
but do not include imports of controlled substances for use in 
industrial processes.
    On November 2, 2023, a notice titled ``Proposed Aggregate 
Production Quotas for Schedule I and II Controlled Substances and 
Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2024'' was published in 
the Federal Register. 88 FR 75312. This notice proposed the 2024 APQ 
for each basic class of controlled substance listed in schedules I and 
II and the 2024 AAN for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine. All interested persons were 
invited to comment on or object to the proposed APQ and the proposed 
AAN on or before December 4, 2023.

III. Comments Received

    Within the public comment period, DEA received 4,699 comments from 
DEA registrants, people with chronic pain, patients with attention 
deficit/hyperactivity disorder (ADHD), pain advocacy associations, U.S. 
professional associations, U.S. nurses, the Royal Australian and New 
Zealand College of Psychiatrists, the Australian ADHD Professionals 
Association, the ADHD Foundation Australia, and others. The comments 
included concerns about potential domestic opioid drug shortages due to 
further quota reductions; stimulant drug shortages in the United States 
and Australia; concerns that medical professionals might be impeded 
from exercising their medical expertise regarding opioid prescriptions; 
two requests for a public hearing; concerns with the implementation of 
quarterly quota allotments, and comments not pertaining to DEA 
regulated activities. DEA restricted seven comments from public view 
due to confidential business information and/or confidential personal 
identifying information.

Opioid Adequacy

    Issue (Medication Out of Stock at Pharmacy Level): Commenters 
questioned whether the 2024 proposed APQs for Schedule II opioids will 
be adequate to meet legitimate medical needs of patients. Commenters 
said that because of decreases in aggregate production quotas for 
specific opioids, they have had difficulty filling legitimate 
prescriptions at pharmacies.

[[Page 408]]

These issues have negatively impacted their quality of life and caused 
mental health-related issues, possibly leading to suicide.
    DEA Response: DEA is committed to ensuring an adequate and 
uninterrupted supply of controlled substances in order to meet 
legitimate medical, scientific, and export needs of the United States. 
DEA sets the APQs for controlled substances based on the available data 
and information received at that specific point in time set by the 
regulations, however, subsequent factors and manufacturers' business 
practices may arise afterwards and potentially contribute to a 
temporary lack of inventory of controlled substances at the point of 
dispensation. In recent years, this has included labor shortages and a 
lack of production capacity. In such circumstances, DEA, in 
coordination with the Food and Drug Administration (FDA), can utilize 
tools under the CSA to prevent or alleviate drug shortages and ensure 
that patients are able to fill legitimate prescriptions for controlled 
substances without undue delay. Additionally, if a patient is faced 
with a delay in receiving their medications, the patient may request a 
one-time transfer of initial dispensing of an electronic prescription 
for Schedules II-V controlled substances from one retail pharmacy to 
another retail pharmacy. If the medication is a controlled substance in 
Schedules III-V and includes authorized refills, the refills can also 
be transferred with the initial prescription to the receiving pharmacy.
    Issue (Nationwide Shortages): Some commenters stated that there is 
a nationwide shortage of opioid medication because their local 
pharmacies were often out of stock. One commenter also stated that the 
American Society of Health-System Pharmacists (ASHP) has warned about 
shortages of immediate release oxycodone and hydrocodone medications, 
but shortages have not been publicly acknowledged by DEA or FDA.
    DEA Response: DEA utilizes the available, reliable data and 
information received by the agency at the time APQs are proposed and 
proactively monitors drug production, distribution and supply during 
the year. However, drug shortages may occur subsequently due to factors 
outside of DEA control such as manufacturing and quality problems, 
processing delays, supply chain disruptions, or discontinuations. In 
such circumstances, if the drug manufacturer notifies the FDA Drug 
Shortage Staff, FDA will coordinate with DEA to address and minimize 
the impact of drug shortages if both agencies believe action is 
warranted. Currently, FDA has not issued any nationwide shortages of 
oxycodone and hydrocodone products.
    Issue (Patients Switching to Illicit Fentanyl or Medications 
Obtained from Illegal Sources): Several commenters expressed concerns 
that because of DEA's reduction of quotas for pain relieving controlled 
substances, patients with chronic pain who were unable to fill their 
legitimate prescriptions eventually turned to illegal fentanyl or 
medications obtained from illegitimate sources as a substitute relief 
that could increase the risk of overdose death. These commenters stated 
that overdose deaths in the United States continue to rise because of 
illegal fentanyl or illegitimate medications, not from pharmaceutical 
medications prescribed to patients with chronic pain.
    DEA Response: In proposing and establishing APQs for opioids, DEA 
considers rates of overdose deaths. Congress, in 21 U.S.C. 826(i), 
mandates DEA to estimate diversion for five controlled substances--
fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone. This 
estimation must consider the rates of overdose deaths, among other 
factors. While overdose deaths may occur as a result of use of illicit 
substances, DEA's quotas help prevent misuse and diversion of 
pharmaceutical controlled substances. In this way, these quotas can 
reduce the occurrence of overdose and death from the use of legitimate 
controlled substances. Patients should work closely with their 
providers to utilize other FDA-approved medications for their 
conditions and fill their prescriptions only from DEA-registered 
pharmacies. The only safe medications are ones prescribed by a trusted, 
DEA-registered medical professional and dispensed by a licensed 
pharmacist at a DEA-registered pharmacy. The medications received from 
unregistered internet sources may, in fact, be manufactured or laced 
with illicit substances including illicit fentanyl, which contributes 
to rates of overdose deaths.
    Issue (Prescribing Hesitancy): Many commenters, mostly self-
identified patients with chronic pain patients, expressed that the goal 
of the 2016 Centers for Disease Control and Prevention (CDC) Guidelines 
was to decrease opioid overdoses, but instead there has been an 
increase in overdoses nationwide of over 400 percent due to illegal 
fentanyl or illegally manufactured pain pills. Commenters stated that 
many patients with chronic pain patients have been harmed, and some 
have died by suicide, due to the inability to get prescriptions because 
of the APQ reductions made by DEA. Many commenters also stated that 
restrictions imposed by DEA have caused opioid medications to be under-
prescribed due to fear of prosecution. Commenters said doctors should 
have latitude in making treatment decisions to prescribe opioid pain 
medications based on individual patient needs.
    DEA Response: Pursuant to the Substance Use-Disorder Prevention 
that Promotes Opioid Recovery and Treatment for Patients and 
Communities (SUPPORT) Act, DEA is mandated to estimate diversion for 5 
controlled substances--fentanyl, hydrocodone, hydromorphone, oxycodone 
and oxymorphone, and this estimation includes the consideration of 
rates of overdose deaths. While overdose deaths may occur as a result 
of the use of illegal fentanyl or illegally manufactured pain 
medications, quotas are being set by the DEA to prevent misuse and 
diversion of pharmaceutical controlled substances, and thus reducing 
the occurrence of overdose and death from the use of legitimate 
controlled substances. Additionally, DEA's regulations do not impose 
restrictions on the amount and the type of medication that licensed 
practitioners can prescribe. DEA has consistently emphasized and 
supported the authority of individual practitioners under the CSA to 
administer, dispense, and prescribe controlled substances for the 
legitimate treatment of pain within acceptable medical standards, as 
outlined in DEA's policy statement published in the Federal Register on 
September 6, 2006, titled Dispensing Controlled Substances for the 
Treatment of Pain. 71 FR 52716.

Attention Deficit/Hyperactivity Disorder Medications Medication 
Shortages

    Issue: DEA received comments expressing general concerns regarding 
the ongoing shortages experienced with ADHD medications produced from 
amphetamine and methylphenidate.
    DEA Response: DEA is committed to ensuring an adequate and 
uninterrupted supply of controlled substances in order to meet the 
estimated legitimate medical, scientific, research, and industrial 
needs of the United States, for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. DEA sets the APQs to 
provide for all legitimate medical purposes and for anticipated foreign 
demand. Additionally, DEA and FDA coordinate efforts to prevent or 
alleviate drug shortages. Such efforts may include the adjustment of 
the APQs and individual domestic manufacturers' quotas, FDA's approval 
of additional

[[Page 409]]

market competitors, and coordination between the agencies to allow 
importation of foreign-manufactured drug products that meet FDA 
approval. Based on the data DEA considers in setting the APQs, 
including any new FDA approved drug products, as well as manufacturing 
issues that DEA considers under 21 CFR 1303.11(b)(7), DEA determined 
that the proposed APQs for amphetamine, lisdexamfetamine and 
methylphenidate are sufficient to supply legitimate medical needs, 
reserve stocks, and export requirements for 2024. If the actual 
prescribing rates of these substances are significantly higher than the 
2024 estimates of medical needs, the Administrator has the authority to 
increase the aggregate production quota at any time. 21 CFR 1303.13(a). 
For example, in 2023, DEA adjusted the methylphenidate (for sale) APQ 
to address shortages of methylphenidate HCL extended release tablets 
upon consideration of the criteria in accordance with 21 CFR 1303.13. 
Adjustment of Aggregate Production Quota for Methylphenidate (for sale) 
for 2023, 88 FR 68147 (October 3, 2023).
    Issue (Lisdexamfetamine Shortages in Australia): DEA received 
comments from The ADHD Foundation Australia, Australian ADHD 
Professionals Association and the Royal Australian and New Zealand 
College of Psychiatrists. The ADHD Foundation Australia stated that the 
Australian Therapeutic Goods Administration (TGA) has advised of 
current shortages of lisdexamfetamine, with more shortages predicted 
into 2024, under the current production quotas. This commenter also 
asserted that Australia's domestic prescriptions of lisdexamfetamine 
have increased by over 150% from 2020-2022 due to increased awareness 
and diagnosis of ADHD. The Royal Australian and New Zealand College of 
Psychiatrists commented that they endorse the guidelines from the 
Australian ADHD Professionals Association. Both the ADHD Foundation 
Australia and Australian ADHD Professionals Association stated that 
Vyvanse (lisdexamfetamine) and methylphenidate are the only two 
extended-release medications approved by the TGA to treat ADHD in 
Australia. Although Vyvanse's patent expired in August 2023 in the 
United States, Vyvanse remains under patent in Australia and generic 
lisdexamfetamine products will not be available. The commenters are 
concerned that the proposed 2024 lisdexamfetamine APQ has not been 
increased from 2023 levels despite reports of shortages in both the 
United States and Australia. They are also concerned that any U.S. 
production quotas allocated for production of Vyvanse will decrease as 
U.S. production quotas will instead be allotted to manufacture domestic 
generic products instead. The commenters requested that DEA consider 
increasing 2024 lisdexamfetamine APQ to resolve shortages in Australia 
and Aotearoa New Zealand.
    DEA Responses: DEA considered the comments, additional export data, 
recent domestic consumption data, and determined that the proposed APQ 
for lisdexamfetamine will remain at the level proposed based on its 
belief that inventory of bulk active pharmaceutical ingredient (API) 
and the quantities which will be produced in 2024 will be sufficient to 
meet the growing medical usage in domestic and foreign markets. DEA is 
closely monitoring manufacturing and distribution data from 
manufacturers of FDA-approved drug products as reported by the company, 
Automation of Reports and Consolidated Orders System (ARCOS) reports, 
prescription dispensing data from IQVIA, and estimated and actual 
inventories to ensure that there is an adequate and uninterrupted 
supply. In addition, DEA is pursuing the purchase of additional third-
party data to better understand market penetration and demand in 
foreign countries--such as Australia--where American-made API and/or 
pharmaceutical preparations are dispensed.

Market Entry of Generic Lisdexamfetamine Products

    Issue: DEA received comments from one association representing 
manufacturers and one dosage form manufacturer. They stated that DEA 
generally allocates procurement quotas using a company's historical 
sales of a drug. They asserted that this practice denies greater quota 
allocation to generic drug manufacturers who are entering the market 
following the expiration of a patent, due to the fact that new entrants 
do not have an established sales history. The association claimed that 
DEA's application process does not solicit information tailored to this 
situation. The association said that DEA's practice hindered the 
competition of generic lisdexamfetamine products, with the patent 
holder of Vyvanse holding onto a high share of the market.
    DEA Response: DEA typically grants individual commercial 
manufacturing procurement quotas based on the sales history of the drug 
as reported by the company, ARCOS and IQVIA data, inventory estimated 
and actual, inventory allowed by regulation, and manufacturing process 
loss of existing manufacturers. DEA has always been cognizant that new 
manufacturers entering the market for the first time would not have any 
established sales history, and thus the manufacturer's past sales 
history is not a factor when determining the amount of quota needed to 
launch a new product. Instead, DEA considers other data including the 
historic timelines of the shift in prescribing from a branded product 
to a generic product(s) for controlled substances. For example, when 
the patent for Vyvanse expired in August 2023, DEA solicited additional 
information from each FDA-approved manufacturer and considered the 
following factors to determine the amount of quota a dosage form 
manufacturer needed to launch a new generic lisdexamfetamine product: 
(1) the overall patient utilization for the branded product for the 
past 3 years, (2) the current estimated patient utilization for the 
current year, (3) the remaining months in the current year needed to 
meet patient needs, (4) the amount of quota previously granted for 
saleable validation, (5) current inventory of finished goods, in-
process material and API, and (6) the amount of finished goods already 
shipped into the distribution chain.
    The assertion that DEA's practice allowed the patent holder of 
Vyvanse to hold onto a higher share of the market is incorrect. 
However, DEA did consider that the current year (2023) would only allow 
for 4 months of brand erosion when allocating quota necessary to launch 
the generic lisdexamfetamine products. Some manufacturers were denied 
additional quota because their current inventory of saleable products 
was sufficient for a product launch during the remaining four months of 
the calendar year.

Diversion Estimates

    Issue (Impact of Diversion Estimate on Opioids): Several commenters 
stated that the APQs of prescription opioids should not be reduced from 
calendar year 2023 APQ levels, given that less than 1 percent of 
prescription opioids are diverted.
    DEA Response: DEA not only considers the extent of diversion, but 
it also considers other factors, as required by regulation, when 
determining the APQ. 21 U.S.C. 826(a), 21 CFR 1303.11(b). These factors 
include total net disposal of the class by all manufacturers during the 
current and 2 preceding years, trends in the national

[[Page 410]]

rate of net disposal of the class, total actual or estimated 
inventories of the class and of all substances manufactured from the 
class, information obtained from the Food and Drug Administration, and 
changes in the currently accepted medical use in treatment. Additional 
factors considered can be found in 21 CFR 1303.11(b). After considering 
all of the relevant factors, DEA has determined that the APQs of 
prescription opioids should be reduced from calendar year 2023 APQ 
levels and they are sufficient to meet the forecasted domestic and 
foreign medical needs.
    Issue (Underestimation of Opioid Diversion): One pharmaceutical 
company suggested that DEA underestimated actual diversion of opioids. 
The commenter said nonmedical use of prescription opioids is not a 
legitimate medical purpose, but DEA rejected this point in calculating 
diversion, and thus the 2024 APQ must be reduced for nonmedical use of 
prescription opioids. The commenter also asserted that the estimate is 
incomplete because a number of states did not provide Prescription Drug 
Monitoring Program (PDMP) data for the five covered controlled 
substances. Additionally, the commenter asserted that DEA rejected CDC 
guidelines of not prescribing greater than 90 morphine milligram 
equivalence (MME) daily and used 240 MME to calculate diversion.
    DEA Response: The cited 2016 report \1\ provides insightful 
information regarding the relationship between nonmedical prescription-
opioid use and heroin use. However, it does not provide data in a form 
which DEA could utilize to modify its nationwide estimate for the 
diversion of oxycodone. Additionally, as stated in the published 2024 
Proposed APQ, DEA used available data at wholesale distribution and 
retail dispensing channels, i.e., DEA's Theft/Loss Reports and 
available individual state PDMP data.
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    \1\ Compton WM, Jones CM, Baldwin J. Relationship between 
nonmedical prescription-opioid use and heroin use. N Engl J Med. 
2016;374(2):154-63, accessed from https://www.nejm.org/doi/full/10.1056/NEJMra1508490.
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    The state PDMP data submitted was adequate to allow DEA to draw 
reliable inferences regarding the state and U.S. population. The sample 
is large enough to allow DEA to accurately generalize the data to the 
whole population of the United States for use in the calculation of 
estimated national levels of diversion of the covered controlled 
substances.
    The 2022 CDC Clinical Practice Guideline includes information that 
updates and replaces the 2016 CDC Guideline for Prescribing Opioids for 
Chronic Pain. The 2022 CDC guidelines no longer set rigid dosage 
thresholds or duration of opioid therapy. Although DEA accepts CDC 
guidelines for prescribing opioids, DEA believes that higher dosages 
place individuals at higher risk of overdose and death, and 
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.
    Issue (Use of Diversion Estimate for all Controlled Substances): 
One commenter questioned why diversion estimates were not considered 
for the stimulants when proposing the initial 2024 APQ.
    DEA Response: Pursuant to 21 CFR 1303.11(b)(5), DEA considered the 
extent of diversion of the basic class as a factor in setting each APQ 
for each respective basic class, as well as the extent of diversion for 
all other schedule I and II controlled substances in proposing the 
estimated APQ. Under 21 U.S.C. 826(i)(A), DEA is only required to 
publish the diversion estimates for 5 specific opioids.

Data Collection and Analysis

    Issue (Data Accuracy): Several commenters stated FDA's estimation 
of medical needs and DEA's data collection process are flawed and 
inaccurate.
    DEA Response: FDA utilizes a variety of data sources in developing 
its estimates of domestic medical needs. When determining the 2024 
APQs, DEA considered the estimation of domestic medical needs data 
provided by FDA, and also considered other data sources including 
prescriptions dispensed in prior and current years reported in IQVIA, 
research and clinical trials information from DEA-registered 
researchers and manufacturers, information provided in quota 
applications from DEA-registered manufacturers, as well as historic and 
current year export data and future estimations of export requirements. 
DEA is actively reevaluating and improving the data collection process 
to ensure the APQs are set at an adequate level to meet legitimate 
medical, scientific, research, and export needs while establishing and 
maintaining reserve stocks.
    Issue (Lack of Real-Time Data): One commenter opined that DEA lacks 
real-time data on opioid production and distribution. The lack of real-
time data makes it difficult to accurately assess legitimate medical 
needs of patients and ensure adequate supply of opioid pain 
medications.
    DEA Response: DEA has access to sales data provided by 
manufacturers from the Quota and Year-end Reporting Management System 
(QMS), ARCOS reports, and monthly IQVIA data when determining 
legitimate medical needs to ensure an adequate supply of medications 
containing schedule II controlled substances. Additionally, DEA is 
considering regulatory changes to gain access to more real-time data 
such as requiring manufacturers and distributors to report sales data 
into the ARCOS database on a monthly basis to improve the timeliness 
and accuracy of data points being used to estimate legitimate medical 
needs.
    Issue (Lack of Data Transparency): Two commenters stated that there 
is a lack of transparency in the quota setting process.
    DEA Response: DEA is considering methods that might increase 
transparency in its quota setting process. Future regulatory proposals 
may include steps such as public notification and an opportunity for 
public input when prescribing rates for controlled substances 
substantially deviate from FDA's estimate of medical needs. DEA must 
strike a balance between increasing transparency and complying with 
laws and regulations aimed at protecting confidential business and 
patient information.

Schedule I Controlled Substances

    Issue (Religious Use of Schedule I Substances): Two commenters 
requested that DEA increase APQs for certain schedule I controlled 
substances, including: psilocin, psilocybin, mescaline, ibogaine, 
lysergic acid diethylamide (LSD), 2-(4-Iodo-2,5-
dimethoxyphenyl)ethanamine (2CI), dimethyltryptamine (DMT), 5-methoxy-
N,N-dimethyltryptamine (5-MeO-DMT) for religious use. They also 
commented that the APQ for mescaline should be increased in order to 
allow access to members of the Native American Church, as well as 
replanting into the wild because of shortages. They opined that DEA has 
disregarded their legal religious use of psychedelics as a factor when 
setting the production quotas of these substances. They also requested 
a hearing with the Administrator if DEA does not take their freedom of 
religion into consideration.
    DEA Response: In the past, DEA held discussions with 
representatives of indigenous communities when requested and continued 
to welcome further engagement and input. The APQs are determined in 
part by the individual manufacturing quota requests submitted by DEA-
registered manufacturers of these substances. DEA

[[Page 411]]

received quota applications from DEA-registered manufacturers for 5-
MeO-DMT, psilocin, psilocybin, mescaline, LSD, 2CI, DMT and 5-MeO-DMT. 
DEA has considered these applications, along with the factors listed in 
21 CFR 1303.11 (b) when determining the aggregate production quotas.
    Issue: Two commenters commented that the APQs should include 
fruiting bodies containing psilocybin and psilocin and peyote buttons 
containing mescaline, rather than pure chemicals only.
    DEA Response: Psilocybin and psilocin are schedule I controlled 
substances naturally occurring in psychedelic mushrooms, while 
mescaline is the schedule I controlled substance naturally occurring in 
peyote. Because the CSA controls psilocybin and psilocin specifically, 
DEA will continue to establish APQ for those two substances. The APQs 
apply to psilocybin and psilocin that is manufactured synthetically as 
well as to substances that are derived naturally. Peyote is controlled 
under 21 U.S.C. 812(e) Schedule I (c) as a separate controlled 
substance from mescaline. As noted below, the APQ for peyote was 
proposed and is established at zero

Comments and Quota Applications From DEA-Registered Manufacturers

    Issue: DEA received comments from three DEA-registered 
manufacturers regarding 3 different schedule I and II controlled 
substances, requesting that the proposed APQ for dexmethylphenidate 
(for conversion), lisdexamfetamine, and psilocybin be established at 
sufficient levels to allow for manufacturers to meet medical and 
scientific needs. DEA also received additional or revised quota 
applications for 4-Anilino-N-phenethyl-4-piperidine (4-ANPP), all other 
tetrahydrocannabinol, delta-9-tetrahydrocannabinol, dimethyltryptamine, 
fentanyl and pentobarbital.
    DEA Response: DEA considered the comments and quota applications 
from the DEA-registered manufacturers and determined that DEA's 
proposed APQs will be increased for the abovementioned controlled 
substances, except lisdexamfetamine. The increases are reflected below 
in the section titled Determination of 2024 Aggregate Production Quotas 
and Assessment of Annual Needs.

List 1 Chemical (Pseudoephedrine)

    Issue: Several pharmaceutical companies and healthcare 
organizations asserted that at a recent advisory meeting convened by 
the FDA, the advisory committee voted that phenylephrine, a common 
ingredient found in many over-the counter (OTC) cold and cough 
medications, is a safe but is ineffective as a decongestant at the 10 
mg dose. According to FDA's website,\2\ FDA has yet to make a final 
decision on the status of phenylephrine. In light of this information, 
the commenters suggested that DEA should re-evaluate whether the 2024 
pseudoephedrine (for sale) AAN is adequate given potential 
repercussions on the supply of and demand for phenylephrine-containing 
products, should FDA no longer designate phenylephrine as ``generally 
recognized as safe and effective'' (GRASE).
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    \2\ FDA clarifies results of recent advisory committee meeting 
on oral phenylephrine [verbar] FDA.
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    DEA Response: DEA considered the comments and consulted with the 
FDA and determined that an increase of the 2024 pseudoephedrine (for 
sale) AAN from its proposed value currently is appropriate, and will 
continue to monitor inventory and use to ensure that there will be 
sufficient supply to address a potential increase in consumer demand 
for pseudoephedrine products should FDA determine that products 
containing phenylephrine are ineffective. The increase finalized herein 
will ensure that there is sufficient pseudoephedrine API for the 
manufacturing of OTC medications that are commonly used to treat 
congestion from cold, flu, allergy and COVID.

Quarterly Quota Allotment Implementation

    Issue: DEA received comments from DEA-registered manufacturers and 
an association representing manufacturers regarding how DEA will 
implement quarterly quota allotment. They expressed concerns that DEA 
did not give sufficient notice of this significant change to adjust 
their business planning and schedules. They also believe that the 
quarterly quota allotment will cause a bottleneck and exacerbate 
shortages of medications.
    DEA Response: As part of its commitment to ensure that all 
Americans have access to appropriately prescribed medications, DEA 
studied the supply chain dynamics for controlled substances subject to 
quotas, especially for those schedule II controlled substances in 
shortage. Beyond the lack of real-time data and gaps in its 
understanding of production lead times which DEA is seeking to resolve 
in forthcoming proposed regulatory changes, DEA also concluded that its 
existing quota allocation model did not allow it to remain nimble when 
patent exclusivity for Vyvanse expired and FDA authorized fourteen (14) 
generic manufacturers to begin marketing. DEA's challenges with its 
existing allocation model were exacerbated because the loss of patent 
exclusivity occurred late in the quota year, a time when DEA had 
already allocated significant authority to the manufacturer of Vyvanse 
and due to the Food and Drug Administration's (FDA) decision that it 
would not provide 6-months of patent exclusivity to the first applicant 
who files a substantially complete abbreviated new drug application 
(commonly referred to as ``first filer exclusivity'').
    With regard to comments that quarterly quotas will create 
bottlenecks and exacerbate drug shortages, DEA disagrees. There are 
several reasons why manufacturers of drugs containing controlled 
substances subject to quotas either gain (or lose) market share in any 
given calendar year for which a quota applies and include: changes in 
demand and a manufacturer's ability to adjust to those changes relative 
to its competitors; inflationary pressures which impact a 
manufacturer's profit margin and subsequent decisions to either 
continue (or discontinue) marketing; labor shortages in certain 
geographic areas; and supply chain difficulties which impact access to 
API, excipients, equipment and packaging material. In order for DEA to 
ensure an adequate and uninterrupted supply of schedule II controlled 
substances necessary to meet legitimate medical, commercial, and 
scientific needs, DEA believes that changes in its approach to 
allocating procurement quotas will ensure that it is best positioned to 
respond appropriately to changes in market demand. Along similar lines, 
DEA does not believe that applying these changes to schedule II drugs 
only after they enter shortage would be sufficient, as DEA would then 
need to gather data and information for those drugs, a process which 
would delay DEA's efforts to address shortages and potentially 
exacerbate them.
    DEA has elected to make these changes at the beginning of the 2024 
quota year and will be providing guidance to manufacturers. Information 
gained from its approach will inform rulemaking which it is currently 
pursuing.

Administrative Procedures Act

    Issue: DEA received comments from DEA-Registered manufacturers, an 
association representing manufacturers and the generic public that the 
quarterly quota allotment implementation did not go through a notice-
and-comment

[[Page 412]]

rulemaking procedure as required by the Administrative Procedure Act.
    DEA Response: DEA has elected to make changes at the beginning of 
the 2024 quota year as it believes that information gained from its 
approach will inform rulemaking which is currently being pursued. In 
addition, as discussed above, DEA is undertaking these changes for the 
2024 quota year to allow it to more quickly and nimbly respond to fast-
changing market trends, including potential shortages, with respect to 
medications subject to quotas. While these changes to the quota 
allotment process will impact the adjudication of individual quota 
applications, they do not affect any APQs set pursuant to this final 
order.

Request for Public Hearing

    Issue: One pharmaceutical company requested a public hearing prior 
to publishing the Final Order to establish the initial 2024 APQ. This 
company requested a public hearing ``to correct the omissions and 
inaccurate diversion calculation in the 2023 oxycodone Quota.'' The 
company asserted that these omissions led to an inaccurate diversion 
calculation for oxycodone and that the 2024 APQ requires a significant 
reduction from the 2023 APQ.
    DEA Response: The decision whether to grant a hearing on the issues 
raised by the commenter lies solely within the discretion of the 
Administrator. 21 CFR 1303.11(c). While hearings are required when 
requested by states in certain situations, this commenter is not a 
state. This request does not present any evidence that would lead to 
the conclusion that a hearing is necessary or warranted. DEA has 
addressed specific points raised by the commenter in Issues and 
Responses above.

Out of Scope Comments

    DEA received comments that are outside the scope of this order. The 
comments were general in nature and raised issues with respect to 
specific medical illnesses, medical treatments and medication costs. 
These comments do not impact the analysis involved in establishing the 
2024 APQ.

IV. Determination of 2024 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the established 2024 aggregate production quotas and 
assessment of annual needs, DEA has considered the above comments along 
with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in 
accordance with 21 U.S.C. 826(a). These factors include, but are not 
limited to, the 2023 manufacturing quotas, current 2023 sales and 
inventories, anticipated 2024 export requirements, industrial use, 
additional applications for 2024 quotas, and information on research 
and product development requirements.
    On July 19, 2023, DEA published a temporary scheduling order 
placing Etizolam, Flualprazolam, Clonazolam, Flubromazolam, and 
Diclazepam in schedule I of the CSA (88 FR 48112), making all 
regulatory controls pertaining to schedule I controlled substances 
applicable to the manufacture of these substances, including the 
requirement to establish an aggregate production quota pursuant to 21 
U.S.C. 826 and 21 CFR part 1303.
    On December 12, 2023, DEA published a temporary scheduling order 
placing 4F-MDMB-BUTICA, 5F-EDMB-PICA, ADB-4en-PINACA, CUMYL-PEGACLONE, 
MDMB-4en-PINACA, MMB-FUBICA in schedule I of the CSA (88 FR 86040), 
making all regulatory controls pertaining to schedule I controlled 
substances applicable to the manufacture of these substances, including 
the requirement to establish an aggregate production quota pursuant to 
21 U.S.C. 826 and 21 CFR part 1303.
    On December 13, 2023, DEA published a final rule placing N-(1-
amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H-indazole-3-carboxamide 
(ADB-BUTINACA), 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one 
([alpha]-PiHP or alpha-PiHP), and 2-(methylamino)-1-(3-
methylphenyl)propan-1-one (3-MMC or 3-methylmethcathinone) in schedule 
I of the Controlled Substances Act (CSA) (88 FR 86266), making all 
regulatory controls pertaining to schedule I controlled substances 
applicable to the manufacture of these substances, including the 
requirement to establish an aggregate production quota pursuant to 21 
U.S.C. 826 and 21 CFR part 1303. Based on all of the above, the 
Administrator is establishing the 2024 APQs for Etizolam, 
Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam, 4F-MDMB-
BUTICA, 5F-EDMB-PICA, ADB-4en-PINACA, CUMYL-PEGACLONE, MDMB-4en-PINACA, 
MMB-FUBICA, N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-butyl-1H-
indazole-3-carboxamide (ADB-BUTINACA), 4-methyl-1-phenyl-2-(pyrrolidin-
1-yl)pentan-1-one (a-PiHP or alpha-PiHP), and 2-(methylamino)-1-(3-
methylphenyl)propan-1-one (3-MMC or 3-methylmethcathinone) at greater 
than zero; and 4-Anilino-N-phenethyl-4-piperidine (4-ANPP), all other 
tetrahydrocannabinol, dexmethylphenidate (for conversion), delta-9-
tetrahydrocannabinol, dimethyltryptamine, fentanyl, pentobarbital and 
psilocybin at higher levels than previously proposed.
    The Administrator establishes the 2024 AAN for pseudoephedrine (for 
sale) at a higher level than was proposed.

Estimates of Diversion Pursuant to the SUPPORT Act

    As specified in the proposal, and as required by 21 U.S.C. 826(i), 
DEA calculated a national diversion estimate for each of the covered 
controlled substances.
    This data, which remains unchanged, was published in the Proposed 
Aggregate Production Quotas for Schedule I and II Controlled Substances 
and Assessment of Annual Needs for the List I Chemicals Ephedrine, 
Pseudoephedrine, and Phenylpropanolamine for 2024. 88 FR 75312 
(November 2, 2023).
    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2024 APQ for the 
following schedule I and II controlled substances and the 2024 AAN for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, expressed in grams of anhydrous acid or base, as 
follows:

------------------------------------------------------------------------
                                                            Established
                       Basic class                          2024 quotas
                                                                (g)
------------------------------------------------------------------------
             New Temporary Controlled Schedule I Substances
------------------------------------------------------------------------
4F-MDMB-BUTICA..........................................              30
5F-EDMB-PICA............................................              30
ADB-4en-PINACA..........................................              30
Clonazolam..............................................              30
CUMYL-PEGACLONE.........................................              30
diclazepam..............................................              30

[[Page 413]]

 
etizolam................................................              30
flualprazolam...........................................              30
flubromazolam...........................................              30
MDMB-4en-PINACA.........................................              30
MMB-FUBICA..............................................              30
------------------------------------------------------------------------
                               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-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 (alpha-             30
 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
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...........

[[Page 414]]

 
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)-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..........................       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
Clonitazene.............................................              25
Codeine methylbromide...................................              30
Codeine-N-oxide.........................................             192
Crotonyl Fentanyl.......................................              25
Cyclopentyl Fentanyl....................................              30
Cyclopropyl Fentanyl....................................              20
Cyprenorphine...........................................              25
d-9-THC.................................................       1,523,040
Desomorphine............................................              25
Dextromoramide..........................................              25
Diapromide..............................................              20
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

[[Page 415]]

 
Ethylmethylthiambutene..................................              25
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 416]]

 
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..............................................          20,000
Psilocin................................................          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)...............         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)..........................      20,000,000
Dexmethylphenidate (for sale)...........................       6,200,000
Dexmethylphenidate (for conversion).....................       5,374,683

[[Page 417]]

 
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................................................         731,360
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...........................................      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
------------------------------------------------------------------------


[[Page 418]]

    The Administrator also establishes APQ for all other schedule I and 
II controlled substances included in 21 CFR 1308.11 and 1308.12 at 
zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon 
consideration of the relevant factors, the Administrator may adjust the 
2024 APQ and AAN as needed.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
December 28, 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. 2023-28962 Filed 12-29-23; 8:45 am]
BILLING CODE 4410-09-P