`[Federal Register Volume 89, Number 242 (Tuesday, December 17, 2024)]
[Notices]
[Pages 102638-102649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30019]



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Vol. 89

Tuesday,

No. 242

December 17, 2024

Part IX





Department of Justice





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Drug Enforcement Administration





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Final Adjusted 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; 
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 2025; 
Notices

  Federal Register / Vol. 89 , No. 242 / Tuesday, December 17, 2024 / 
Notices  

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1228F]


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the 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.
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    \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.
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    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.
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    \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).
    \3\ Adjustment to the Aggregate Production Quota for 
Lisdexamfetamine and d-Amphetamine (for Conversion) for 2024, 89 FR 
72424 (Sept. 5, 2024).
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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

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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.
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    \4\ Schedules of Controlled Substances: Temporary Placement of 
N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule 
I, 89 FR 60817.
    \5\ Schedules of Controlled Substances: Placement of 
Ethylphenidate in Schedule I, 89 FR 84281.
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    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:
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BILLING CODE 4410-C
    The Administrator also establishes that APQs for all other schedule 
I and II controlled substances included in 21

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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.
[FR Doc. 2024-30019 Filed 12-16-24; 8:45 am]
BILLING CODE 4410-09-P`