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EPA/OLEM RIN: 2050-AG39 Publication ID: Spring 2018 
Title: Management Standards for Hazardous Waste Pharmaceuticals 
Abstract:

Some 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 responsible for 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, the EPA is considering a final rule that will 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.

 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
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
Timetable:
Action Date FR Cite
NPRM  12/02/2008  73 FR 73520   
NPRM Comment Period Extended  01/30/2009  74 FR 5633   
Second NPRM  09/25/2015  80 FR 58013   
NPRM Comment Period Extended  11/05/2015  80 FR 68491   
Final Rule  10/00/2018 
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: http://www.epa.gov/hwgenerators/management-pharmaceutical-hazardous-waste   Public Comment URL: https://www.regulations.gov/document?D=EPA-HQ-RCRA-2007-0932-0150  
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:
Kristin Fitzgerald
Environmental Protection Agency
Office of Land and Emergency Management
1200 Pennsylvania Avenue NW, Mail Code 5304P,
Washington, DC 20460
Phone:703 308-8286
Fax:703 308-0514
Email: fitzgerald.kristin@epa.gov

Tiffany Kollar
Environmental Protection Agency
Office of Land and Emergency Management
1200 Pennsylvania Avenue NW, Mail Code 5304P,
Washington, DC 20460
Phone:703 308-8675
Fax:703 308-0514
Email: kollar.tiffany@epa.gov