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DOJ/DEA RIN: 1117-AB86 Publication ID: Spring 2024 
Title: ●Revision of Application for Manufacturing Quota 
Abstract:

The Drug Enforcement Administration (DEA) proposes to revise existing regulations that manage the quotas for schedule I and II controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, to be utilized by DEA-registered manufacturers. This rule is being proposed to: restructure DEA's manufacturing and procurement quota regulations for more clarity and consistency; clarify which use-specific subcategories for quotas should be used for controlled substances that will be sold domestically and controlled substances that will be exported and revise the applications for individual manufacturing and procurement quota. These revisions would apply to both bulk and dosage-form manufacturers. The changes are necessary to ensure clarity, provide transparency into the manufacturing process, and to ensure enough schedule I and II controlled substances and three List I chemicals are available in America to meet estimated scientific, medical, lawful export, and inventory needs.

 
Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 1303    21 CFR 1303.04    21 CFR 1303.13 to 15    21 CFR 1303.17 to 18    21 CFR 1303.22    21 CFR 1315.22    21 CFR 1315.32    21 CFR 1315.35    21 CFR 1315.37 to 38   
Legal Authority: 21 U.S.C. 802    21 U.S.C. 821    21 U.S.C. 826    21 U.S.C. 871   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2024 
Additional Information: DEA Docket Number 1278
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Scott A. Brinks
Section Chief, Regulatory Drafting and Support Section, Diversion Control Division
Department of Justice
Drug Enforcement Administration
8701 Morrissette Drive,
Springfield, VA 22152
Phone:571 362-8209
Email: scott.a.brinks@dea.gov