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DOJ/DEA RIN: 1117-AA19 Publication ID: Fall 2005 
Title: Definition and Registration of Reverse Distributors 
Abstract: In years past, most pharmaceutical manufacturers and wholesalers, as a service to their customers, accepted returns of outdated/damaged merchandise. Also, agencies such as DEA and State Boards of Pharmacy accepted surrendered drugs or witnessed their disposal by controlled substance registrants. Over the past several years, environmental concerns and regulations have eliminated many of the disposal options that had been available. As a result, drug producers and government agencies alike are increasingly reluctant to be involved in the disposal process. Due to these factors and the time and resources expended by DEA and manufacturers, DEA is establishing this essential link in the legitimate distribution chain. 
Agency: Department of Justice(DOJ)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1301   
Legal Authority: 21 USC 821    21 USC 822    21 USC 823    21 USC 824    21 USC 871(b)    21 USC 875    21 USC 877   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/23/1995  60 FR 43732   
NPRM Comment Period End  10/23/1995    
Interim Final Rule  07/11/2003  68 FR 41222   
Interim Final Rule Effective  08/11/2003    
Interim Final Rule Comment Period End  09/09/2003    
Final Action  05/02/2005  70 FR 22591   
Final Action Effective  05/02/2005    
Additional Information: DEA-108
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Patricia M. Good
Chief, Liaison and Policy Section
Department of Justice
Drug Enforcement Administration
Office of Diversion Control,
Washington, DC 20537
Phone:202 307-7297