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EPA/SWER RIN: 2050-AG39 Publication ID: 2012 
Title: Management Standards for Hazardous Waste Pharmaceuticals 
Abstract: A small portion of pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act when discarded. Healthcare (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, healthcare workers, whose primary focus is to provide care for patients, are often involved in the implementation of the regulations. Second, a healthcare 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, 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 healthcare facilities for management of unused and/or expired pharmaceuticals, 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, EPA is now considering re-proposing healthcare 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 healthcare-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: Undetermined 
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 USC 6912(a)    42 USC 6921-6939   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/02/2008  73 FR 73520   
NPRM Comment Period Extended  01/30/2009  74 FR 5633   
Second NPRM  08/00/2013 
Additional Information: Docket #:EPA-HQ-RCRA-2007-0932. NPRM: http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.pdf; NPRM Extension of Comment Period: http://www.epa.gov/fedrgstr/EPA-WASTE/2009/January/Day-30/f2035.pdf; Docket: http://www.regulations.gov/#!docketDetail;D=EPA-HQ-RCRA-2007-0932. This action includes retrospective review under EO 13563; see: http://www.epa.gov/regdarrt/retrospective/history.html.
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Information URL: http://www.epa.gov/wastes/hazard/wastetypes/universal/pharm.htm  
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:
Lisa Lauer
Environmental Protection Agency
Solid Waste and Emergency Response
5304P,
Washington, DC 20460
Phone:703 308-7418
Fax:703 308-0514
Email: Lauer.Lisa@epa.gov

Jessica Young
Environmental Protection Agency
Solid Waste and Emergency Response
1200 Pennsylvania Avenue NW, Mail Code 5304T,
Washington, DC 20460
Phone:202 566-0522
Email: young.jessica@epa.gov