EPA Proposes Rule Governing Disposal of Hazardous Waste Pharmaceuticals

Members | October 19, 2015

The U.S. Environmental Protection Agency (EPA) recently published a proposed rule that would impose stringent regulations regarding how healthcare facilities, including long-term care facilities, dispose of pharmaceuticals classified as hazardous waste. Presently, while pharmaceutical hazardous waste in long-term care facilities is regulated by the agency, it is subject to the agency’s less-stringent household hazardous waste standard. In the proposed rule, however, the EPA argues that long-term care facilities more closely resemble hospitals and thus should be subject to more stringent requirements.

The U.S. Environmental Protection Agency (EPA) recently published a proposed rule that would impose stringent regulations regarding how healthcare facilities, including long-term care facilities, dispose of pharmaceuticals classified as hazardous waste.  

Presently, while pharmaceutical hazardous waste in long-term care facilities is regulated by the agency, it is subject to the agency’s less-stringent household hazardous waste standard.  

In the proposed rule, however, the EPA argues that long-term care facilities more closely resemble hospitals and thus should be subject to more stringent requirements.  

A long-term care facility is defined under the proposed rule as a “licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility.”  

The rule states that it applies, but is not limited, to assisted living facilities, hospices, nursing homes, skilled nursing facilities, and the assisted living and skilled nursing care portions of continuing care retirement facilities.  

The agency is seeking public input on the definition, the overall appropriateness of classifying long-term care facilities as health care facilities rather than households, and the extent to which long-term care facilities will pass the cost of compliance on to their “customers.”

Specifically, the proposed rule seeks to:

  • Prohibit long-term care facilities (among others) from disposing of hazardous waste pharmaceuticals by flushing them down the toilet or into a drain. 
  • Subject long-term care facilities to more stringent requirements regarding on-site management of “creditable” (i.e., those medications for which the provider is eligible to receive manufacturer’s credit for return to reverse distributors) and “non-creditable” hazardous waste pharmaceuticals.    
  • Impose new tracking requirements for shipping of creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors.. 
  • Regulate the disposal of hazardous waste pharmaceutical residues remaining in containers after use. 

Comments on the proposed rule are due no later than Nov. 24, 2015.  

LeadingAge is working with an informal coalition of providers and other stakeholders on a collaborative approach to the comments.  We welcome member input on the proposed rule and ask members to provide any comments to Jennifer Hilliard, jhilliard@leadingage.org, no later than Nov. 10, 2015.