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 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 health care facilities for management of unused and/or expired pharmaceuticals, known as reverse distribution.