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###### Department of Justice

###### Drug Enforcement Administration

          - [Docket No. DEA-1228F]

# AGENCY:

Drug Enforcement Administration, Department of Justice.

# ACTION:

Final order.

# SUMMARY:

This final order establishes the final adjusted 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 order is effective December 17, 2024.

# 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, VA 22152, Telephone: (571) 362-3261.

# SUPPLEMENTARY INFORMATION:

## Legal Authority

Section 306 of the Controlled Substances Act (CSA) (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 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.

## Background

                        DEA published the 2024 established aggregate production quotas (APQs) for controlled substances in schedules I and II and for the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the                         **Federal Register**                         (FR) on January 3, 2024.[1]                                                  This notice stated that the Administrator would adjust, as needed, the established APQ in 2024 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. DEA is committed to preventing and limiting diversion by enforcing laws and regulations regarding controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, while meeting the legitimate medical, scientific, and export needs of the United States.                    

                        The 2024 proposed adjusted APQ for controlled substances in schedules I and II and AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the                         **Federal Register**                         on September 25, 2024 [2]                                                  after consideration of the criteria outlined in that notice. All interested persons were invited to comment on or object to the proposed APQs and AANs on or before October 25, 2024. Prior to this notice, DEA also published a final order to increase the 2024 APQ for lisdexamfetamine and d-amphetamine (for conversion).[3]                                                  Therefore, DEA proposed no additional changes for those substances.                    

## Comments Received

                        DEA received 20 timely comments in response to the September                         **Federal Register**                         notice, from chronic pain patients and DEA-registered entities. The comments included requests to ensure sufficient availability in the APQ for select schedule I and schedule II controlled substances including increasing specific APQs if necessary; requests that DEA utilize its regulatory authority in additional ways; opioid shortage concerns; and comments outside the scope of this final order. DEA restricted three comments from public view due to confidential business information and/or confidential personal identifying information.                    

### DEA's Regulatory Authority

*Issue:*                         DEA-registered manufacturers requested the APQs for 4-Anilino-N-Phenethyl-4-Piperidine, fentanyl, hydromorphone, morphine (for conversion), oxymorphone (for conversion), and sufentanil be reviewed for sufficiency and adjusted if necessary.                    

*DEA Response:*                         DEA sets the APQs in a manner to meet the estimated medical, scientific, research, industrial needs of the United States, lawful export requirements, and for the establishment and maintenance of reserve stocks. As of the date the comment period closed for the proposed adjusted 2024 APQ and AAN, DEA believes that the proposed adjusted 2024 APQs are sufficient to meet the current estimated 2024 legitimate medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and to provide for adequate reserve stock.                    

*Issue:*                         A DEA-registered manufacturer suggested several changes that it believes are necessary to deter companies from using the quota process to gain competitive advantage and to ensure that quota is available when supply chain circumstances change. Among these, the commenter suggested that DEA needs to obtain authority to reallocate manufacturing quota from one registered bulk manufacturer to another in the event that a finished dosage form manufacturer wishes, midyear, to procure bulk material from a different bulk manufacturer than originally planned.                    

*DEA Response:*                         This comment is outside the scope of the current action, but DEA notes the commenter's suggestion for future consideration. DEA currently can reallocate or revoke quotas in specific circumstances as discussed in 21 CFR 1303.26 and 1303.36.                    

*Issue:*                         The same commenter who raised the immediately preceding issue also suggested that DEA should change the procurement quota application form (DEA Form 250) so that applicants can specify multiple suppliers from which they may procure a basic class of bulk controlled substance, as well as the estimated timeframe for receipt of the basic class from each supplier.                    

*DEA Response:*                         The current procurement quota application form (DEA Form 250) allows for the applicants to specify multiple suppliers from which they may procure a basic class of bulk controlled substance, as well as the estimated timeframe for receipt of the basic class from each supplier.                    

*Issue:*                         The same commenter who raised the two immediately preceding issues suggested that DEA specify, when granting quota, to which specific finished dosage forms the quota is to be applied and the proportion of the authorized amount that is to be used toward each identified dosage form. The manufacturer further requested that DEA verify during DEA inspections the manufacturer's compliance with the details specified in the quota grant.                    

*DEA Response:*                         In 21 U.S.C. 826(a)(2), Congress granted DEA the authority to delineate quota by pharmaceutical dosage form (tablets, capsules, oral                               ( print page 102639)                            liquids, etc.) if DEA determines it will assist in avoiding overproduction, shortages, or diversion of a controlled substance. DEA currently believes the designation of quota by dosage forms at the bulk manufacturing level could lead to unforeseen circumstances such as interference with production schedules or hindrance of the supply chain. Moreover, in compliance with Congress's directive, DEA would need to consider whether the application of such detail to quotas would assist in avoiding overproduction, shortages, or diversion.                    

                        When a manufacturer has several customers that use the same active pharmaceutical ingredient (API) to manufacture similar dosage forms (                        *i.e.*                         brand and generic formulations), the terms of the contractual agreements govern the transaction in normal circumstances. DEA does not grant quota to fulfill specific business contracts between registrants; rather, DEA grants quota to meet the legitimate medical, scientific, research, and export requirements while ensuring the ability to maintain adequate reserve stock.                    

*Issue:*                         The same commenter who raised the three immediately preceding issues suggested that DEA assess “quota usage” on a quarterly or semi-annual basis to verify that manufacturers timely distribute materials that they are authorized under quota to manufacture, and to require companies to surrender unused quotas so that those unused amounts can be reassigned to others who can then supply the market.                    

*DEA Response:*                         DEA has in the past and will continue to ask manufacturers to surrender quota that they will not be able to utilize in a timely manner (                        *e.g.,*                         due to production scheduling issues, malfunctioning of manufacturing lines, etc.). While DEA will note for potential future consideration the commenter's suggestion that DEA periodically assess quota usage, in a series of meetings held in the spring of 2024, numerous API and dosage form manufacturers informed DEA that a requirement to utilize quota quarterly would not be feasible because of limited capacity of production lines and manufacturers' strict adherence to production schedules. As a result of the discussion, DEA is allotting commercial manufacturing procurement quotas for Schedule II non-injectable products on a semi-annual basis.                    

### Opioid Shortage Concerns

*Issue:*                         Nine commenters expressed general concerns regarding a perceived nationwide shortage of opioid medication due to patients experiencing intermittent out-of-stock or back-ordered situations at pharmacies while attempting to fill their prescriptions.                    

*DEA Response:*                         DEA utilizes the available, reliable data and information received by the agency in advance of publication; however drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations. In such circumstances, if the drug manufacturer notifies the U.S. Food and Drug Administration (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 notice of any nationwide shortages of the type of opioid medications mentioned by these commenters.                    

*Out of Scope Comments:*                         DEA received other comments that were general in nature and raised issues with respect to specific medical illnesses and medical treatments. All of the issues raised are outside of the scope of this final order for 2024 and do not impact the analysis involved in finalizing the 2024 APQs.                    

## Analysis for Final Adjusted 2024 Aggregate Production Quotas and Assessment of Annual Needs

In determining the final adjusted 2024 APQs and AANs, DEA has considered the above comments relevant to this final order for calendar year 2024, along with the factors set forth in 21 CFR 1303.13 and 21 CFR 1315.13, in accordance with 21 U.S.C. 826(a). DEA has also considered other relevant factors, including the 2023 year-end inventories, initial 2024 manufacturing and import quotas, 2024 export requirements, actual and projected 2024 sales, research and product development requirements, additional applications received, and the extent of any diversion of the controlled substance in the class. Based on all of the above, the Administrator is finalizing the adjusted APQs in the same amounts as proposed.

                        On July 29, 2024, DEA published a temporary scheduling order placing N-desethyl isotonitazene and N-piperidinyl etonitazene in schedule I of the CSA,[4]                                                  and on October 25, 2024, DEA published a final rule placing ethylphenidate in schedule I of the CSA,[5]                                                  making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an APQ pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This final order establishes an APQ for these substances for the first time.                    

Pursuant to the above, the Administrator hereby finalizes the 2024 APQs for the following schedule I and II controlled substances and the 2024 AANs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:
      ( print page 102640)          ( print page 102641)          ( print page 102642)          ( print page 102643)          ( print page 102644)          ( print page 102645)          ( print page 102646)          ( print page 102647)          ( print page 102648)    
                        The Administrator also establishes that APQs for all other schedule I and II controlled substances included in 21                               ( print page 102649)                            CFR 1308.11 and 1308.12 remain at zero.                    

## Signing Authority

                        This document of the Drug Enforcement Administration was signed on December 13, 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.                                 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, 89 FR 407.                        
        Back to Citation      

2.                                 Proposed Adjustments to the 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, 89 FR 78764 (September 25, 2024).                        
        Back to Citation      

3.                                 Adjustment to the Aggregate Production Quota for Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR 72424 (Sept. 5, 2024).                        
        Back to Citation      

4.                                 Schedules of Controlled Substances: Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule I, 89 FR 60817.                        
        Back to Citation      

5.                                 Schedules of Controlled Substances: Placement of Ethylphenidate in Schedule I, 89 FR 84281.                        
        Back to Citation      

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[FR Doc. 2024-30019 Filed 12-16-24; 8:45 am]

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