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 Department of Justice Drug Enforcement Administration [Docket No. DEA-1228P]
 AGENCY: Drug Enforcement Administration, Department of Justice.
 ACTION: Notice with request for comments.
 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.
 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 
                        *http://www.regulations.gov*
                         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 
                        *Regulations.gov.*
                         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 
                    *http://www.regulations.gov.*
                     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 
                    *http://www.regulations.gov*
                     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 
                    *http://www.regulations.gov*
                     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 
                    ( print 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). 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. 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 
                    ( print 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). 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] 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). 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. Table 1
                        a
                        —States/Territories That Responded to DEA's Data Request
State/territory1. Alabama2. Alaska3. Arizona4. Arkansas5. Connecticut6. Delaware7. District of Columbia8. Hawaii9. Idaho10. Indiana11. Iowa12. Kansas13. Kentucky14. Louisiana15. Maine16. Maryland17. Michigan18. Minnesota19. Mississippi20. Montana21. Nevada22. New Jersey23. North Carolina24. North Dakota25. Ohio26. Oklahoma27. Puerto Rico28. Rhode Island29. South Carolina30. South Dakota31. Texas32. Utah
 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: 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( print 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] 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.
                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] 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. 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
18Hydrocodone
83,823Hydromorphone
356Oxycodone
150,684Oxymorphone
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
74Hydrocodone
12,454Hydromorphone
481Oxycodone
31,698Oxymorphone
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
92Hydrocodone
96,277Hydromorphone
838( print page 75317)Oxycodone
182,382Oxymorphone
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. 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. 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. 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. 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 
                    ( print 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: Basic class
Proposed 2024 quotas(g)**Schedule I**-[1-(2-Thienyl)cyclohexyl]pyrrolidine
201-(1-Phenylcyclohexyl)pyrrolidine
301-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine
101-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
301-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
301-[1-(2-Thienyl)cyclohexyl]piperidine
152′-fluoro 2-fluorofentanyl
301-Benzylpiperazine
251-Methyl-4-phenyl-4-propionoxypiperidine
102-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)
302-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)
302-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
302-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)
302-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
1002-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
302-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)
302-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
252-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)
302-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
302,5-Dimethoxy-4-ethylamphetamine (DOET)
252,5-Dimethoxy-4-n-propylthiophenethylamine
252,5-Dimethoxyamphetamine
252-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)
302-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)
303,4,5-Trimethoxyamphetamine
303,4-Methylenedioxyamphetamine (MDA)
12,0003,4-Methylenedioxymethamphetamine (MDMA)
12,0003,4-Methylenedioxy-N-ethylamphetamine (MDEA)
403,4-Methylenedioxy-N-methylcathinone (methylone)
5,2003,4-Methylenedioxypyrovalerone (MDPV)
353-FMC; 3-Fluoro-N-methylcathinone
253-Methylfentanyl
303-Methylthiofentanyl
304,4′-Dimethylaminorex
304-Bromo-2,5-dimethoxyamphetamine (DOB)
304-Bromo-2,5-dimethoxyphenethylamine (2-CB)
5,1004-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP)
254-CN-Cumyl-Butinaca
254-Fluoroisobutyryl fentanyl
304F-MDMB-BINACA
304-FMC; Flephedrone
254-MEC; 4-Methyl-N-ethylcathinone
254-Methoxyamphetamine
1504-Methyl-2,5-dimethoxyamphetamine (DOM)
254-Methylaminorex
254-Methyl-N-methylcathinone (mephedrone)
454-Methyl-alpha-ethylaminopentiophenone (4-MEAP)
254-Methyl-alpha-pyrrolidinohexiophenone (MPHP)
254′-Methyl acetyl fentanyl
304-Methyl-α-pyrrolidinopropiophenone (4-MePPP)
255-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
505-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
405F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
255F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
255F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide
255F-CUMYL-PINACA
255F-EDMB-PINACA
255F-MDMB-PICA
255F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)
255F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)
255-Fluoro-PB-22; 5F-PB-22
255-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
255-Methoxy-3,4-methylenedioxyamphetamine
25( print page 75319)5-Methoxy-N,N-diisopropyltryptamine
255-Methoxy-N,N-dimethyltryptamine
11,000AB-CHMINACA
30AB-FUBINACA
50AB-PINACA
30ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)
30Acetorphine
25Acetyl Fentanyl
100Acetyl-alpha-methylfentanyl
30Acetyldihydrocodeine
30Acetylmethadol
25Acryl Fentanyl
25ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)
50AH-7921
30All other tetrahydrocannabinol
790,010Allylprodine
25Alphacetylmethadol
25alpha-Ethyltryptamine
25Alphameprodine
25Alphamethadol
25alpha-Methylfentanyl
30alpha-Methylthiofentanyl
30alpha-Methyltryptamine (AMT)
25alpha-Pyrrolidinobutiophenone (α-PBP)
25alpha-pyrrolidinoheptaphenone (PV8)
25alpha-pyrrolidinohexabophenone (alpha-PHP)
25alpha-Pyrrolidinopentiophenone (α-PVP)
25Amineptine
30Aminorex
25Anileridine
20APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide)
25Benzethidine
25Benzylmorphine
30Betacetylmethadol
25beta-Hydroxy-3-methylfentanyl
30beta-Hydroxyfentanyl
30beta-Hydroxythiofentanyl
30beta-Methyl fentanyl
30beta′-Phenyl fentanyl
30Betameprodine
25Betamethadol
4Betaprodine
25Brorphine
30Bufotenine
15Butonitazene
30Butylone
25Butyryl fentanyl
30Cathinone
40Clonitazene
25Codeine methylbromide
30Codeine-N-oxide
192Crotonyl Fentanyl
25Cyclopentyl Fentanyl
30Cyclopropyl Fentanyl
20Cyprenorphine
25d-9-THC
900,610Desomorphine
25Dextromoramide
25Diapromide
20Diethylthiambutene
20Diethyltryptamine
25Difenoxin
9,300Dihydromorphine
639,954Dimenoxadol
25Dimepheptanol
25Dimethylthiambutene
20Dimethyltryptamine
3,000Dioxyaphetyl butyrate
25Dipipanone
25Drotebanol
25Ethylmethylthiambutene
25( print page 75320)Ethylone
25Etodesnitazene
30Etonitazene
25Etorphine
30Etoxeridine
25Eutylone
30Fenethylline
30Fentanyl carbamate
30Fentanyl related substances
600Flunitazene
30FUB-144
25FUB-AKB48
25Fub-AMB, MMB-Fubinaca, AMB-Fubinaca
25Furanyl fentanyl
30Furethidine
25gamma-Hydroxybutyric acid
29,417,000Heroin
150Hydromorphinol
40Hydroxypethidine
25Ibogaine
150Isobutyryl Fentanyl
25Isotonitazine
25JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)
35JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
45JWH-073 (1-Butyl-3-(1-naphthoyl)indole)
45JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)
30JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)
30JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)
35JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)
30JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)
30JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)
30Ketobemidone
30Levomoramide
25Levophenyacylmorphan
25Lysergic acid diethylamide (LSD)
1,200MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide)
30MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate)
30MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
30MMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate
25Mesocarb
30Metodesnitazene
30Metonitazene
30Marijuana
6,675,000Marijuana extract
1,000,000Mecloqualone
30Mescaline
1,200Methaqualone
60Methcathinone
25Methiopropamine
30Methoxetamine
30Methoxyacetyl fentanyl
30Methyldesorphine
5Methyldihydromorphine
25Morpheridine
25Morphine methylbromide
5Morphine methylsulfonate
5Morphine-N-oxide
150MT-45
30Myrophine
25NM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate
25N,N-Dimethylamphetamine
25Naphyrone
25N-Ethyl-1-phenylcyclohexylamine
25N-Ethyl-3-piperidyl benzilate
10N-Ethylamphetamine
24N-Ethylhexedrone
25N-Ethylpentylone, ephylone
30N-Hydroxy-3,4-methylenedioxyamphetamine
24Nicocodeine
25Nicomorphine
25( print page 75321)N-methyl-3-piperidyl benzilate
30N-Pyrrolidino Etonitazene
30Noracymethadol
25Norlevorphanol
2,550Normethadone
25Normorphine
40Norpipanone
25Ocfentanil
25ortho-Fluoroacryl fentanyl
30ortho-Fluorobutyryl fentanyl
30Ortho-Fluorofentanyl,2-Fluorofentanyl
30ortho-Fluoroisobutyryl fentanyl
30ortho-Methyl acetylfentanyl
30ortho-Methyl methoxyacetyl fentanyl
30Para-Chlorisobutyrl fentanyl
30Para-flourobutyryl fentanyl
25Para-fluorofentanyl
25para-Fluoro furanyl fentanyl
30Para-Methoxybutyrl fentanyl
30Para-methoxymethamphetamine
30para-Methylfentanyl
30Parahexyl
5PB-22; QUPIC
20Pentedrone
25Pentylone
25Phenadoxone
25Phenampromide
25Phenomorphan
25Phenoperidine
25Phenyl fentanyl
30Pholcodine
5Piritramide
25Proheptazine
25Properidine
25Propiram
25Protonitazene
30Psilocybin
15,000Psilocyn
24,000Racemoramide
25SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)
45SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)
30Tetrahydrofuranyl fentanyl
15Thebacon
25Thiafentanil
25Thiofentanyl
25Thiofuranyl fentanyl
30THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30Tilidine
25Trimeperidine
25UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25U-47700
30Valeryl fentanyl
25Zipeprol
30**Schedule II**1-Phenylcyclohexylamine
151-Piperidinocyclohexanecarbonitrile
254-Anilino-N-phenethyl-4-piperidine (ANPP)
866,746Alfentanil
5,000Alphaprodine
25Amobarbital
20,100Bezitramide
25Carfentanil
20Cocaine
60,492Codeine (for conversion)
942,452Codeine (for sale)
19,262,957d-amphetamine (for sale)
21,200,000d,l-amphetamine
21,200,000d-amphetamine (for conversion)
20,000,000Dexmethylphenidate (for sale)
6,200,000( print page 75322)Dexmethylphenidate (for conversion)
4,200,000Dextropropoxyphene
35Dihydrocodeine
115,227Dihydroetorphine
25Diphenoxylate (for conversion)
14,100Diphenoxylate (for sale)
770,800Ecgonine
60,492Ethylmorphine
30Etorphine hydrochloride
32Fentanyl
676,062Glutethimide
25Hydrocodone (for conversion)
1,250Hydrocodone (for sale)
27,143,545Hydromorphone
1,951,801Isomethadone
30L-amphetamine
30Levo-alphacetylmethadol (LAAM)
25Levomethorphan
30Levorphanol
20,000Lisdexamfetamine
26,500,000Meperidine
681,184Meperidine Intermediate-A
30Meperidine Intermediate-B
30Meperidine Intermediate-C
30Metazocine
15Methadone (for sale)
25,619,700Methadone Intermediate
27,673,600d,l-Methamphetamine
150d-methamphetamine (for conversion)
485,020d-methamphetamine (for sale)
47,000l-methamphetamine
587,229Methylphenidate (for sale)
53,283,000Methylphenidate (for conversion)
19,975,468Metopon
25Moramide-intermediate
25Morphine (for conversion)
2,393,200Morphine (for sale)
20,805,957Nabilone
62,000Norfentanyl
25Noroxymorphone (for conversion)
22,044,741Noroxymorphone (for sale)
1,000Oliceridine
25,100Opium (powder)
250,000Opium (tincture)
530,837Oripavine
33,010,750Oxycodone (for conversion)
437,827Oxycodone (for sale)
53,658,226Oxymorphone (for conversion)
28,204,371Oxymorphone (for sale)
464,464Pentobarbital
33,843,337Phenazocine
25Phencyclidine
35Phenmetrazine
25Phenylacetone
100Piminodine
25Racemethorphan
5Racemorphan
5Remifentanil
3,000Secobarbital
172,100Sufentanil
4,000Tapentadol
10,390,226Thebaine
57,137,944**List I Chemicals**Ephedrine (for conversion)
41,100Ephedrine (for sale)
3,933,336Phenylpropanolamine (for conversion)
14,878,320Phenylpropanolamine (for sale)
7,990,000Pseudoephedrine (for conversion)
1,000Pseudoephedrine (for sale)
170,360,314
 
 
 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.


# Footnotes

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). Back to Citation
 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. Back to Citation
 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. Back to Citation
 4.
    
                         21 U.S.C. 826(i)(1)(C). Back to Citation
 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.* Back to Citation
 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). Back to Citation
 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. Back to Citation
 8.
    
                         NASCSA formatted DEA's request into an analytics model developed by one of its associates, Appriss Inc. Back to Citation
 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). Back to Citation
 10.
    
                         This total does not include insurance co-payments made with cash. Back to Citation
 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). Back to Citation
 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. Back to Citation
 13.
    
                         Both DEA and FDA released this letter on Aug. 1, 2023. It is available at: 
                        *https://www.dea.gov/​sites/​default/​files/​2023-08/​DEA%20and%20FDA%20Issue%20Joint%20Letter%20to%20the%20Public.pdf.* Back to Citation
 14.
    
                         Both reports are available at: 
                        *https://www.deadiversion.usdoj.gov/​drug_​chem_​info/​stimulants/​.* Back to Citation
 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. Back to Citation
 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: 
                        *https://www.incb.org/​incb/​en/​psychotropics/​1971_​convention.html.* Back to Citation
 17.
    
                         Management of Quotas for Controlled Substances and List I Chemicals, 88 FR 60117 (Aug. 31, 2023) (effective Nov. 29, 2023). Back to Citation


[FR Doc. 2023-24282 Filed 11-1-23; 8:45 am] BILLING CODE P