Environmental Protection Agency
Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the Subtitle C hazardous waste regulations for a number of reasons. First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but 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 regulated in small amounts. To facilitate compliance and to respond to these concerns, the U.S. Environmental Protection Agency (EPA or the Agency) is proposing to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare- related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Environmental Protection Agency 40 CFR Parts 261, 262, 266, 268, and 273 [EPA-HQ-RCRA-2007-0932; FRL-9924-08-OSWER] RIN 2050-AG39 AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the Subtitle C hazardous waste regulations for a number of reasons. First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but 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 regulated in small amounts. To facilitate compliance and to respond to these concerns, the U.S. Environmental Protection Agency (EPA or the Agency) is proposing to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthca…
Other Federal Register documents from the same docket.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Management Standards for Hazardous Waste Pharmaceuticals (Renewal)
Agency Information Collection Activities; Proposed Collection; Comment Request; Management Standards for Hazardous Waste Pharmaceuticals Title of ICR, EPA ICR No. 2486.03, OMB Control No. 2050-0212
Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine
Management Standards for Hazardous Waste Pharmaceuticals
Amendment to the Universal Waste Rule: Addition of Pharmaceuticals; Extension of Comment Period
Citation: 80 FR 58014
