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EPA/SWER RIN: 2050-AG39 Publication ID: Spring 2015 
Title: Management Standards for Hazardous Waste Pharmaceuticals 

Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act when discarded. Health-care (and associated) facilities that generate hazardous waste pharmaceuticals have reported having difficulties complying with the manufacturing-oriented framework of the subtitle C hazardous waste regulations for a number of reasons. First, under the current hazardous waste regulatory scheme, health-care workers, whose primary focus is to provide care for patients, are often responsible for the implementation of the regulations. Second, a health-care facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are stringently regulated even in small amounts. To facilitate compliance and to respond to these concerns, the EPA is proposing to revise the regulations to improve management and disposal of hazardous waste pharmaceuticals. The revisions are also intended to clarify regulation of a major mechanism used by health-care facilities for management of unused and/or expired pharmaceuticals, which is known as reverse distribution. In 2008, the Agency proposed to address pharmaceutical hazardous waste management issues by adding them to the Universal Waste rule. However, in order to address the adverse comments received on the 2008 proposal, the EPA is now considering re-proposing health-care facility-specific regulations for the management of hazardous waste pharmaceuticals in order to provide a regulatory scheme that is adapted to the unique issues that hospitals, pharmacies and other health-related facilities face.

Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 40 CFR 260    40 CFR 261    40 CFR 262    40 CFR 264    40 CFR 265    40 CFR 266    40 CFR 268    40 CFR 270   
Legal Authority: 42 U.S.C. 6912(a)    42 U.S.C. 6921 to 6939   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/02/2008  73 FR 73520   
NPRM Comment Period Extended  01/30/2009  74 FR 5633   
Second NPRM  07/00/2015 
Additional Information: Docket #:EPA-HQ-RCRA-2007-0932. Includes Retrospective Review under Executive Order 13563.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, Local, State, Tribal 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL:   Public Comment URL:!docketDetail;D=EPA-HQ-RCRA-2007-0932  
Sectors Affected: 446110 Pharmacies and Drug Stores; 541940 Veterinary Services; 562111 Solid Waste Collection; 562112 Hazardous Waste Collection; 562119 Other Waste Collection; 562211 Hazardous Waste Treatment and Disposal; 562212 Solid Waste Landfill; 562213 Solid Waste Combustors and Incinerators; 562219 Other Nonhazardous Waste Treatment and Disposal; 622110 General Medical and Surgical Hospitals 
RIN Data Printed in the FR: No 
Agency Contact:
Mary Jackson
Environmental Protection Agency
Solid Waste and Emergency Response
1200 Pennsylvania Avenue NW, Mail Code 5304P,
Washington, DC 20460
Phone:703 308-8453

Kristin Fitzgerald
Environmental Protection Agency
Solid Waste and Emergency Response
1200 Pennsylvania Avenue NW, Mail Code 5304P,
Washington, DC 20460
Phone:703 308-8286
Fax:703 308-0514