Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Justice Drug Enforcement Administration [Docket No. DEA-1228A]
 AGENCY: Drug Enforcement Administration, Department of Justice.
 ACTION: Notice with request for comments.
 SUMMARY: The Drug Enforcement Administration proposes to adjust the 2024 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act. Additionally, as DEA announced in an April 29, 2024 letter to DEA-registered manufacturers, procurement quotas for commercial manufacturing of a schedule II controlled substance will be calculated on a semi-annual basis, except for injectable drug products containing schedule II controlled substances, which will be calculated on an annual basis.
 DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before October 25, 2024. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in her sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the 
                            **Federal Register**
                            . After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the 
                            **Federal Register**
                             a final order establishing the 2024 adjusted aggregate production quotas for schedule I and II controlled substances, and an adjusted assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, as relevant.
 ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-1228A” 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/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
 FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: 571-776-3882.


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 and Background Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas (APQ) for each basic class of controlled substance 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. DEA established the 2024 APQ for substances in schedules I and II and the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on January 3, 2024.[1]
                        
                         That order stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all APQ and AAN are subject to adjustment. DEA published a Final Order revising the 2024 lisdexamfetamine and d-amphetamine (for conversion) APQ on September 5, 2024.[2] 
 
 Analysis for Proposed Adjusted 2024 Aggregate Production Quotas and Assessment of Annual Needs DEA proposes to adjust the established 2024 APQ for certain schedule I and II controlled substances and the AAN for certain list I chemicals to be manufactured in the United States in 2024 to 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. These quotas do not include imports of controlled substances for use in industrial processes. Factors for Determining the Proposed Adjustments In determining the proposed adjustments, the Administrator has taken into account the factors in 21 CFR 1303.13 (adjustment of APQ for controlled substances) and 21 CFR 1315.13 (adjustment of the AAN for ephedrine, pseudoephedrine, and phenylpropanolamine). The Administrator is authorized to increase or reduce the APQ and the AAN at any time.[3] DEA determined whether to propose an adjustment of the APQ for 2024 by considering the factors found at 21 CFR 1303.13(b): (1) Changes in the demand for that class, changes in the national rate of net disposal of the class, changes in the rate of net disposal of the class by registrants holding individual manufacturing quotas for that class, and changes in the extent of any diversion in the class; (2) Whether any increased demand for that class, the national and/or individual rates of net disposal of that class are temporary, short term, or long term; (3) Whether any increased demand for that class can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to [21 CFR] 1303.24(b); (4) Whether any decreased demand for that class will result in excessive inventory accumulation by all persons registered to handle that class (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to [21 CFR] 1303.24(b) or abandoned pursuant to [21 CFR] 1303.27; (5) 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 which are 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. DEA also considered updated information obtained from 2023 year-end inventories, 2023 disposition data submitted by quota applicants, changes in estimates of the medical needs of the United States, export requirements, and other information made available to DEA after the initial APQ and AAN had been established. Additional factors the Administrator considered in calculating the APQ, but not the AAN, include product development requirements of both bulk and finished dosage form manufacturers. After considering the changes in the extent of diversion of all controlled substances, as required by 21 CFR 1303.13(b)(1), DEA has determined that any changes from the initial calculations are slight and not statistically significant from the estimates of diversion that DEA applied to the initial APQ valuations. DEA determined whether to propose an adjustment of the AAN for 2024 by considering the factors found at 21 CFR 1315.13(b) and summarized below: (1) Changes in the demand for that chemical, changes in the national rate of net disposal of the chemical, and changes in the rate of net disposal of the chemical by registrants holding individual manufacturing or import quotas for that chemical; (2) Whether any increased demand for that chemical, the national and/or changes in individual rates of net disposal of that chemical are temporary, short term, or long term; (3) Whether any increased demand for that chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the assessment of annual needs, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to [21 CFR] 1315.24(b); (4) Whether any decreased demand for that chemical will result in excessive inventory accumulation by all persons registered to handle that chemical (including manufacturers, distributors, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to [21 CFR] 1315.24(b) or abandoned pursuant to [21 CFR] 1315.27; (5) Other factors affecting medical, scientific, research, industrial, and importation needs in the United States, lawful export requirements, and reserve stocks, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the chemical or the substances that are 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. In evaluating whether there is a need for adjustment of the 2024 AAN for list I chemicals, DEA used the calculation methodology previously described in the 2010 and 2011 AAN.[4]
                        
                         DEA considered the total net disposals of the list I chemicals for the current and preceding two years, actual and estimated inventories, projected demand, industrial use, and export requirements from data provided by DEA registered manufacturers and importers on the relevant quota application forms.[5] Additional Considerations Applicable to Covered Controlled Substances When setting APQ, the Administrator must estimate the amount of diversion of any substance that is considered a “covered controlled substance.” [6]
                        
                         The covered controlled substances are fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.[7]
                        
                         DEA is required to “make appropriate quota reductions, as determined by the [Administrator], from the quota the [Administrator] would have otherwise established had such diversion not been considered.” [8]
                        
                         When estimating diversion, the Administrator “shall consider information” that she, in consultation with the Secretary of Health and Human Services, “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 “may take into consideration” whatever other sources of information she determines reliable.[9] DEA sent letters to the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the states in March, April, and May 2024 requesting overdose death and overprescribing data that could be considered in estimating diversion. DEA received information from the CDC in May 2024, the FDA in June 2024, and has begun receiving Prescription Data Monitoring Program 
                        ( print page 78766)
                        (PDMP) data from the states. DEA considered this information in developing the estimates of diversion for the five covered controlled substances for this proposed adjustment. DEA also aggregated data for each covered controlled substance from Drug Theft and Loss Reports to determine the estimates of diversion. DEA gathered data involving employee theft, break-ins, armed robberies, and material lost in transit. DEA calculated the metric weight in grams of each active pharmaceutical ingredient (API) of the controlled substances being diverted as identified in these reports. In calculating the estimates of diversion, DEA utilized the same methodology as 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.[10]
                        
                         Below, DEA provides an updated chart showing estimations of diversion for each of the covered controlled substances. Diversion Estimates for 2024 (
                            g
                            )
Fentanyl
112Hydrocodone
124,170Hydromorphone
1,137Oxycodone
263,236Oxymorphone
165
 Implementation of Semi-Annual Quota Allotment For the 2024 quota year, DEA announced that it intended to allocate procurement quotas to DEA-registered manufacturers of schedule II controlled substances on a quarterly basis, in order to help DEA prevent shortages and be more nimble in its administration of the quota program. After the announcement, DEA met with several manufacturers to discuss the impact of that change. Numerous manufacturers asked DEA to consider allocating quotas semi-annually to assist with production planning and execution. DEA understands and appreciates the complexities of the supply chain. In light of the discussions with manufacturers, as well as meetings with FDA discussing their statutory obligations for drug availability to meet legitimate patients' needs, input from health associations in foreign countries, and consideration of the continuing issues with the supply chain in the aftermath of the COVID-19 pandemic, DEA determined that it would and will allocate procurement quotas for schedule II controlled substances on a semi-annual basis, except that it would and will allocate procurement quotas for injectable drug products containing schedule II controlled substances on an annual basis. DEA announced this change in a letter to DEA-registered manufacturers on April 29, 2024. No further change is being implemented at this time. DEA remains committed to ensuring that all patients with legitimate medical need can access appropriately prescribed medications that are manufactured domestically. Proposed Adjustments for the 2024 Aggregate Production Quotas and Assessment of Annual Needs DEA is proposing increases to the APQ for the following schedule I substances: psilocybin and psilocyn. These proposed increases are to support research and clinical trials by DEA-registered schedule I researchers. These proposed increases demonstrate DEA's support for research with schedule I controlled substances. The proposed increases reflect research and development needs as part of the process for seeking the FDA approval of new drug products. DEA is proposing increases to the APQ for the following schedule II substances: noroxymorphone (for conversion), oripavine, and oxymorphone (for conversion). These proposed increases are necessary to meet manufacturing needs and increased consumption of naloxone products as standard treatment for opioid overdose. These substances are part of the synthesis pathway to manufacture naloxone products. On March 13, 2024, the “White House Challenge to Save Lives from Overdose” was announced in support of the Administration's Unity Agenda efforts to address the opioid overdose crisis.[11]
                        
                         The challenge is a nationwide initiative to increase training, awareness, and access to lifesaving opioid overdose reversal medications. The FDA has approved two over the counter (OTC) naloxone products for the emergency treatment of opioid overdose.[12]
                        
                         As a result of the White House Challenge and efforts by the Department of Health and Human Services to help recipients of State and Tribal Opioid Response Grants increase distribution of opioid overdose reversal agents, DEA is expecting medical usage of naloxone to continue to rise in 2024. The proposed increase to the APQ of noroxymorphone (for conversion), oripavine and oxymorphone (for conversion) reflects this increasing medical usage of naloxone. DEA is proposing decreases to the following APQ: fentanyl, hydrocodone (for sale), hydromorphone, and oxycodone (for sale). These proposed decreases are based on adjustments to the diversion estimates for calendar year 2024. DEA established the 2024 APQ for substances in schedules I and II on January 3, 2024.[13]
                        
                         Subsequent to that publication, DEA published in the 
                        **Federal Register**
                         a final rule to permanently schedule 2-methyl AP-237 under the CSA.[14]
                        
                         As a result, this substance is subject to CSA schedule I controls and DEA is proposing to assign an individual APQ for this substance pursuant to 21 U.S.C. 826 and 21 CFR part 1303. The Administrator, therefore, proposes to adjust the 2024 APQ for the schedule I and II controlled substances noroxymorphone (for conversion), oripavine, oxymorphone (for conversion), psilocybin, psilocyn, and 2-methyl AP-237. The proposed adjusted APQ and AAN, as expressed in grams of anhydrous acid or base, are as follows: Basic class
Established
                                 2024 quotas 
                                 (g)
Proposed
                                 revised 2024 
                                 quotas 
                                 (g)**New Temporary Controlled Schedule I Substances**4F-MDMB-BUTICA
30
no change( print page 78767)5F-EDMB-PICA
30
no changeADB-4en-PINACA
30
no changeClonazolam
30
no changeCUMYL-PEGACLONE
30
no changeDiclazepam
30
no changeEtizolam
30
no changeFlualprazolam
30
no changeFlubromazolam
30
no changeMDMB-4en-PINACA
30
no changeMMB-FUBICA
30
no change**Schedule I**-[1-(2-Thienyl)cyclohexyl]pyrrolidine
20
no change1-(1-Phenylcyclohexyl)pyrrolidine
30
no change1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine
10
no change1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
30
no change1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
30
no change1-[1-(2-Thienyl)cyclohexyl]piperidine
15
no change2′-fluoro 2-fluorofentanyl
30
no change1-Benzylpiperazine
25
no change1-Methyl-4-phenyl-4-propionoxypiperidine
10
no change2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)
30
no change2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)
30
no change2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
30
no change2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)
30
no change2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
100
no change2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
30
no change2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)
30
no change2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
25
no change2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)
30
no change2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
30
no change2,5-Dimethoxy-4-ethylamphetamine (DOET)
25
no change2,5-Dimethoxy-4-n-propylthiophenethylamine
25
no change2,5-Dimethoxyamphetamine
25
no change2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)
30
no change2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)
30
no change2-Methyl AP-237
0
303,4,5-Trimethoxyamphetamine
30
no change3,4-Methylenedioxyamphetamine (MDA)
12,000
no change3,4-Methylenedioxymethamphetamine (MDMA)
12,000
no change3,4-Methylenedioxy-N-ethylamphetamine (MDEA)
40
no change3,4-Methylenedioxy-N-methylcathinone (methylone)
5,200
no change3,4-Methylenedioxypyrovalerone (MDPV)
35
no change3-FMC; 3-Fluoro-N-methylcathinone
25
no change3-Methylfentanyl
30
no change3-Methylmethcathinone
30
no change3-Methylthiofentanyl
30
no change4,4′-Dimethylaminorex
30
no change4-Bromo-2,5-dimethoxyamphetamine (DOB)
30
no change4-Bromo-2,5-dimethoxyphenethylamine (2-CB)
5,100
no change4-Chloro-alpha-pyrrolidinovalerophenone (4-chloro-alpha-PVP)
25
no change4-CN-Cumyl-Butinaca
25
no change4-Fluoroisobutyryl fentanyl
30
no change4F-MDMB-BINACA
30
no change4-FMC; Flephedrone
25
no change4-MEC; 4-Methyl-N-ethylcathinone
25
no change4-Methoxyamphetamine
150
no change4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one (alpha-PiHP)
30
no change4-Methyl-2,5-dimethoxyamphetamine (DOM)
25
no change4-Methylaminorex
25
no change4-Methyl-N-methylcathinone (mephedrone)
45
no change4-Methyl-alpha-ethylaminopentiophenone (4-MEAP)
25
no change4-Methyl-alpha-pyrrolidinohexiophenone (MPHP)
25
no change4′-Methyl acetyl fentanyl
30
no change4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)
25
no change5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
50
no change5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
40
no change5F-AB-PINACA; (1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
25
no change( print page 78768)5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
25
no change5F-CUMYL-P7AICA; 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide
25
no change5F-CUMYL-PINACA
25
no change5F-EDMB-PINACA
25
no change5F-MDMB-PICA
25
no change5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)
25
no change5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)
25
no change5-Fluoro-PB-22; 5F-PB-22
25
no change5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
25
no change5-Methoxy-3,4-methylenedioxyamphetamine
25
no change5-Methoxy-N,N-diisopropyltryptamine
25
no change5-Methoxy-N,N-dimethyltryptamine
11,000
no changeAB-CHMINACA
30
no changeAB-FUBINACA
50
no changeAB-PINACA
30
no changeADB-BUTINACA
30
no changeADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)
30
no changeAcetorphine
25
no changeAcetyl Fentanyl
100
no changeAcetyl-alpha-methylfentanyl
30
no changeAcetyldihydrocodeine
30
no changeAcetylmethadol
25
no changeAcryl Fentanyl
25
no changeADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)
50
no changeAH-7921
30
no changeAll other tetrahydrocannabinol
1,166,130
no changeAllylprodine
25
no changeAlphacetylmethadol
25
no changealpha-Ethyltryptamine
25
no changeAlphameprodine
25
no changeAlphamethadol
25
no changealpha-Methylfentanyl
30
no changealpha-Methylthiofentanyl
30
no changealpha-Methyltryptamine (AMT)
25
no changealpha-Pyrrolidinobutiophenone (α-PBP)
25
no changealpha-pyrrolidinoheptaphenone (PV8)
25
no changealpha-pyrrolidinohexabophenone (alpha-PHP)
25
no changealpha-Pyrrolidinopentiophenone (α-PVP)
25
no changeAmineptine
30
no changeAminorex
25
no changeAnileridine
20
no changeAPINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide)
25
no changeBenzethidine
25
no changeBenzylmorphine
30
no changeBetacetylmethadol
25
no changebeta-Hydroxy-3-methylfentanyl
30
no changebeta-Hydroxyfentanyl
30
no changebeta-Hydroxythiofentanyl
30
no changebeta-Methyl fentanyl
30
no changebeta′-Phenyl fentanyl
30
no changeBetameprodine
25
no changeBetamethadol
4
no changeBetaprodine
25
no changeBrorphine
30
no changeBufotenine
15
no changeButonitazene
30
no changeButylone
25
no changeButyryl fentanyl
30
no changeCathinone
40
no changeClonitazene
25
no changeCodeine methylbromide
30
no changeCodeine-N-oxide
192
no changeCrotonyl Fentanyl
25
no changeCyclopentyl Fentanyl
30
no changeCyclopropyl Fentanyl
20
no changeCyprenorphine
25
no changed-9-THC
1,523,040
no changeDesomorphine
25
no changeDextromoramide
25
no changeDiapromide
20
no changeDiethylthiambutene
20
no change( print page 78769)Diethyltryptamine
25
no changeDifenoxin
9,300
no changeDihydromorphine
639,954
no changeDimenoxadol
25
no changeDimepheptanol
25
no changeDimethylthiambutene
20
no changeDimethyltryptamine
11,000
no changeDioxyaphetyl butyrate
25
no changeDipipanone
25
no changeDrotebanol
25
no changeEthylmethylthiambutene
25
no changeEthylone
25
no changeEtodesnitazene
30
no changeEtonitazene
25
no changeEtorphine
30
no changeEtoxeridine
25
no changeEutylone
30
no changeFenethylline
30
no changeFentanyl carbamate
30
no changeFentanyl related substances
600
no changeFlunitazene
30
no changeFUB-144
25
no changeFUB-AKB48
25
no changeFub-AMB, MMB-Fubinaca, AMB-Fubinaca
25
no changeFuranyl fentanyl
30
no changeFurethidine
25
no changegamma-Hydroxybutyric acid
29,417,000
no changeHeroin
150
no changeHydromorphinol
40
no changeHydroxypethidine
25
no changeIbogaine
150
no changeIsobutyryl Fentanyl
25
no changeIsotonitazine
25
no changeJWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)
35
no changeJWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
45
no changeJWH-073 (1-Butyl-3-(1-naphthoyl)indole)
45
no changeJWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)
30
no changeJWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)
30
no changeJWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)
35
no changeJWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)
30
no changeJWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)
30
no changeJWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)
30
no changeKetobemidone
30
no changeLevomoramide
25
no changeLevophenyacylmorphan
25
no changeLysergic acid diethylamide (LSD)
1,200
no changeMAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide)
30
no changeMDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate)
30
no changeMDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
30
no changeMMB-CHMICA-(AMB-CHIMCA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate
25
no changeMarijuana
6,675,000
no changeMarijuana extract
1,000,000
no changeMecloqualone
30
no changeMescaline
1,200
no changeMesocarb
30
no changeMethaqualone
60
no changeMethcathinone
25
no changeMethiopropamine
30
no changeMethoxetamine
30
no changeMethoxyacetyl fentanyl
30
no changeMethyldesorphine
5
no changeMethyldihydromorphine
25
no changeMetodesnitazene
30
no changeMetonitazene
30
no changeMorpheridine
25
no changeMorphine methylbromide
5
no changeMorphine methylsulfonate
5
no changeMorphine-N-oxide
150
no changeMT-45
30
no change( print page 78770)Myrophine
25
no changeNM2201: Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate
25
no changeN,N-Dimethylamphetamine
25
no changeNaphyrone
25
no changeN-Ethyl-1-phenylcyclohexylamine
25
no changeN-Ethyl-3-piperidyl benzilate
10
no changeN-Ethylamphetamine
24
no changeN-Ethylhexedrone
25
no changeN-Ethylpentylone, ephylone
30
no changeN-Hydroxy-3,4-methylenedioxyamphetamine
24
no changeNicocodeine
25
no changeNicomorphine
25
no changeN-methyl-3-piperidyl benzilate
30
no changeN-Pyrrolidino Etonitazene
30
no changeNoracymethadol
25
no changeNorlevorphanol
2,550
no changeNormethadone
25
no changeNormorphine
40
no changeNorpipanone
25
no changeOcfentanil
25
no changeortho-Fluoroacryl fentanyl
30
no changeortho-Fluorobutyryl fentanyl
30
no changeOrtho-Fluorofentanyl,2-Fluorofentanyl
30
no changeortho-Fluoroisobutyryl fentanyl
30
no changeortho-Methyl acetylfentanyl
30
no changeortho-Methyl methoxyacetyl fentanyl
30
no changePara-Chlorisobutyrl fentanyl
30
no changePara-flourobutyryl fentanyl
25
no changePara-fluorofentanyl
25
no changepara-Fluoro furanyl fentanyl
30
no changePara-Methoxybutyrl fentanyl
30
no changePara-methoxymethamphetamine
30
no changepara-Methylfentanyl
30
no changeParahexyl
5
no changePB-22; QUPIC
20
no changePentedrone
25
no changePentylone
25
no changePhenadoxone
25
no changePhenampromide
25
no changePhenomorphan
25
no changePhenoperidine
25
no changePhenyl fentanyl
30
no changePholcodine
5
no changePiritramide
25
no changeProheptazine
25
no changeProperidine
25
no changePropiram
25
no changeProtonitazene
30
no changePsilocybin
20,000
30,000Psilocyn
24,000
36,000Racemoramide
25
no changeSR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)
45
no changeSR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)
30
no changeTetrahydrofuranyl fentanyl
15
no changeThebacon
25
no changeThiafentanil
25
no changeThiofentanyl
25
no changeThiofuranyl fentanyl
30
no changeTHJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30
no changeTilidine
25
no changeTrimeperidine
25
no changeUR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25
no changeU-47700
30
no changeValeryl fentanyl
25
no changeZipeprol
30
no change**Schedule II**1-Phenylcyclohexylamine
15
no change1-Piperidinocyclohexanecarbonitrile
25
no change4-Anilino-N-phenethyl-4-piperidine (ANPP)
937,874
no change( print page 78771)Alfentanil
5,000
no changeAlphaprodine
25
no changeAmobarbital
20,100
no changeBezitramide
25
no changeCarfentanil
20
no changeCocaine
60,492
no changeCodeine (for conversion)
942,452
no changeCodeine (for sale)
19,262,957
no changed-amphetamine (for sale)
21,200,000
no changed,l-amphetamine
21,200,000
no changed-amphetamine (for conversion)
23,688,235
no changeDexmethylphenidate (for sale)
6,200,000
no changeDexmethylphenidate (for conversion)
5,374,683
no changeDextropropoxyphene
35
no changeDihydrocodeine
115,227
no changeDihydroetorphine
25
no changeDiphenoxylate (for conversion)
14,100
no changeDiphenoxylate (for sale)
770,800
no changeEcgonine
60,492
no changeEthylmorphine
30
no changeEtorphine hydrochloride
32
no changeFentanyl
731,360
731,341Glutethimide
25
no changeHydrocodone (for conversion)
1,250
no changeHydrocodone (for sale)
27,143,545
27,121,498Hydromorphone
1,951,801
1,951,508Isomethadone
30
no changeL-amphetamine
30
no changeLevo-alphacetylmethadol (LAAM)
25
no changeLevomethorphan
30
no changeLevorphanol
20,000
no changeLisdexamfetamine
32,736,000
no changeMeperidine
681,184
no changeMeperidine Intermediate-A
30
no changeMeperidine Intermediate-B
30
no changeMeperidine Intermediate-C
30
no changeMetazocine
15
no changeMethadone (for sale)
25,619,700
no changeMethadone Intermediate
27,673,600
no changed,l-Methamphetamine
150
no changed-methamphetamine (for conversion)
485,020
no changed-methamphetamine (for sale)
47,000
no changel-methamphetamine
587,229
no changeMethylphenidate (for sale)
53,283,000
no changeMethylphenidate (for conversion)
19,975,468
no changeMetopon
25
no changeMoramide-intermediate
25
no changeMorphine (for conversion)
2,393,200
no changeMorphine (for sale)
20,805,957
no changeNabilone
62,000
no changeNorfentanyl
25
no changeNoroxymorphone (for conversion)
22,044,741
24,756,979Noroxymorphone (for sale)
1,000
no changeOliceridine
25,100
no changeOpium (powder)
250,000
no changeOpium (tincture)
530,837
no changeOripavine
33,010,750
37,721,950Oxycodone (for conversion)
437,827
no changeOxycodone (for sale)
53,658,226
53,584,449Oxymorphone (for conversion)
28,204,371
31,773,105Oxymorphone (for sale)
464,464
no changePentobarbital
40,000,000
no changePhenazocine
25
no changePhencyclidine
35
no changePhenmetrazine
25
no changePhenylacetone
100
no changePiminodine
25
no changeRacemethorphan
5
no changeRacemorphan
5
no changeRemifentanil
3,000
no changeSecobarbital
172,100
no change( print page 78772)Sufentanil
4,000
no changeTapentadol
10,390,226
no changeThebaine
57,137,944
no change**List I Chemicals**Ephedrine (for conversion)
41,100
no changeEphedrine (for sale)
3,933,336
no changePhenylpropanolamine (for conversion)
14,878,320
no changePhenylpropanolamine (for sale)
7,990,000
no changePseudoephedrine (for conversion)
1,000
no changePseudoephedrine (for sale)
186,617,466
no change
 The Administrator further proposes that the APQ for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. 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. 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 any adjustment of the 2024 APQ for each basic class of controlled substances in schedules I and II and AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.[15] Signing Authority This document of the Drug Enforcement Administration was signed on September 20, 2024, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the 
                        **Federal Register**
                        . Heather Achbach, Federal Register Liaison Officer, Drug Enforcement Administration.


# Footnotes

1.
    
                             89 FR 407. Back to Citation
 2.
    
                             Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR 72424 (Sept. 5, 2024). Back to Citation
 3.
    
                             21 CFR 1303.13(a), 1315.13(a). Back to Citation
 4.
    
                             74 FR 60294 (Nov. 20, 2009); 75 FR 79407 (Dec. 20, 2010). Back to Citation
 5.
    
                             74 FR 60294 (Nov. 20, 2009); 75 FR 79407 (Dec. 20, 2010). Back to Citation
 6.
    
                             21 U.S.C. 826(i)(1)(A). Back to Citation
 7.
    
                             21 U.S.C. 826(i)(1). Back to Citation
 8.
    
                             All functions vested in the Attorney General by the CSA have been delegated to the Administrator of DEA. 28 CFR 0.100(b); 21 U.S.C. 826(i)(1)(C). Back to Citation
 9.
    
                             21 U.S.C. 826(i)(1)(B). Back to Citation
 10.
    
                             88 FR 75312 (November 2, 2023). Back to Citation
 11.
    
                             
                            *https://www.whitehouse.gov/​briefing-room/​statements-releases/​2024/​03/​13/​fact-sheet-biden-harris-administration-launches-the-white-house-challenge-to-save-lives-from-overdose/​.* Back to Citation
 12.
    
                             
                            *https://www.fda.gov/​news-events/​press-announcements/​fda-approves-second-over-counter-naloxone-nasal-spray-product*. Back to Citation
 13.
    
                             89 FR 407. Back to Citation
 14.
    
                             89 FR 18793 (March, 15, 2024). Back to Citation
 15.
    
                             21 CFR 1303.13(c) and 1315.13(c). Back to Citation


[FR Doc. 2024-21960 Filed 9-20-24; 4:15 pm] BILLING CODE P