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DOJ/DEA RIN: 1117-AB49 Publication ID: Fall 2019 
Title: Management of Quotas for Controlled Substances and List I Chemicals 
Abstract:

The Drug Enforcement Administration proposes to revise and amend existing regulations to reduce overall inventories held by DEA-registered manufacturers and other registrants; to create use-specific subcategories for procurement quotas; and to clarify the current language and ensure that both manufacturers and distributors are required to obtain certification of a buyer’s quota for the requested schedules I and II controlled substances, as well as list I chemicals.  These changes are necessary, in light of the increasingly complex controlled substances manufacturing business practices, to reduce the potential for the diversion of certain controlled substances. Due to this evolution of complexity in the pharmaceutical industry and the inflexible nature of the regulations by which DEA must calculate inventory allowances for manufacturers of controlled substances, the current inventory allowances provide opportunity for the accumulation of controlled substance surpluses to occur. These proposed regulations will rectify a situation where DEA’s ability to strike an appropriate balance between ensuring the availability of controlled substances to industry and the risk to public health and safety has been hindered and resulted in an overproduction of controlled substances inventories available for diversion.

 
Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: 21 CFR 1303    21 CFR 1315   
Legal Authority: 21 U.S.C. 821    21 U.S.C. 826    21 U.S.C. 871(b)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Public Comment URL: www.regulations.gov/  
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:202 598-6812
Fax:202 353-1263