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Publications | September 3, 2015
2 minute read

Proposed Regulation and Ban on Flushing of Pharmaceutical Waste Watched Closely by Healthcare Industry

New waste rules, proposed by the EPA, are expected to create requirements for healthcare facilities regarding generation, handling and disposal of pharmaceuticals.

The implications of the proposed rules are broad and, if finalized, will lead to significant changes regarding how pharmaceutical wastes are managed by hospitals, pharmacies, nursing homes and other healthcare industries:

  • The proposed rule would require healthcare facilities to determine the hazardous waste status of all pharmaceuticals that they discard.
  • EPA proposes a complete ban on disposing of hazardous waste pharmaceuticals via sinks, toilets and sewers. According to EPA, more than 6,400 tons are flushed annually, eventually entering water supplies and posing risks to the public and wildlife.
  • EPA seeks to revise certain aspects of the Resource Conservation and Recovery Act (RCRA) to implement new containment, labeling, tracking and disposal requirements for pharmaceuticals that qualify as hazardous waste. This will be a complex process for any healthcare facility that uses multiple pharmaceuticals.
  • The new rule distinguishes between pharmaceuticals that are returned to reverse distributors for credit and those that aren’t. “Potentially creditable” pharmaceuticals are subject to simpler, more streamlined requirements. 

The EPA will accept public comment on the proposals for 60 days following publication in the Federal Register. The rule is expected to be finalized in 2016 and will be effective at the federal level six months after promulgation. Until then, the proposed rule serves as guidance to help the healthcare industry meet current RCRA requirements applicable to pharmaceuticals. 

Details on these proposed rules are available online.

Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule

Hazardous Waste Generator Improvements Proposed Rule

If you are interested in providing public comment to EPA in relation to the proposed rules, or have any questions, contact any member of our Environmental or Health Law Groups