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| EPA/SWER | RIN: 2050-AG39 | Publication ID: Fall 2013 |
| 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 | |
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Legal Deadline:
None |
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Timetable:
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| Additional Information: Docket #:EPA-HQ-RCRA-2007-0932 | |
| Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: Undetermined |
| Federalism: Undetermined | |
| Included in the Regulatory Plan: No | |
| RIN Information URL: http://www.epa.gov/waste/hazard/generation/pharmaceuticals.htm | Public Comment URL: NPRM: http://www.epa.gov/fedrgstr/EPA-WASTE/2008/December/Day-02/f28161.pdf |
| 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 | |
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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 Email: jackson.mary@epa.gov 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 Email: fitzgerald.kristin@epa.gov |
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