Regulation of Pharmaceutical Waste
Updated: Aug 29
Since the passage of the Resource Conservation and Recovery Act (RCRA) in 1976, the U.S. EPA has not used its clearly defined authority to determine whether certain pharmaceuticals should be classified as hazardous waste. EPA hasn’t even established a process for the regular identification and review of pharmaceuticals that may qualify for regulation as hazardous waste. The closest EPA has come to using its authority was in 2008, when an amendment to the Universal Waste Rule (UWR) was proposed, which would address pharmaceutical wastes. However, due to substantial negative feedback after the public comment period ended, EPA decided not to move forward with the proposed rule.
EPA defines hazardous waste under RCRA according to its characteristics which include ignitability, corrosivity, reactivity, and toxicity. The EPA definition of a pharmaceutical chemical or compound includes any “chemical product, vaccine, or allergenic, not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in humans or animals”. Additionally, facilities such as hospitals and other health care facilities that generate more than 220 pounds of hazardous waste per month, or greater than 2.2 pounds of acute hazardous waste per month, are subject to RCRA hazardous waste regulations.
Proper disposal of pharmaceutical waste is confusing and unclear, which is one of the main reasons it remains unregulated. In a recent report on pharmaceutical waste, EPA indicated that health care workers, pharmacy employees, and other pharmaceutical generators are often unfamiliar with or confused by RCRA hazardous waste management requirements, resulting in the improper disposal of hazardous pharmaceuticals as municipal or bulk wastes. EPA’s report also stated that many health care facilities, namely hospitals, are not even aware of what RCRA regulations are, let alone how they’re applicable. Some form of regulation of pharmaceutical wastes is clearly needed, as demonstrated by the results of a 2000 water quality study by the United States Geologic Survey (USGS). The USGS studied 139 streams across the country and found that 80 percent contained some type of pharmaceutical chemical or compound. This is the purpose behind EPA’s development of a revised proposal for the specific regulation of hazardous waste pharmaceuticals at healthcare facilities. EPA anticipates the proposal will be available for public comment in spring 2013.
Check EPA’s pharmaceutical waste web page at http://www.epa.gov/osw/hazard/wastetypes/universal/pharm.htm. Also follow the EES Blog for further updates to the proposed rules covering pharmaceutical wastes.