Proposed Rule: Management Standards for Hazardous Waste Pharmaceuticals

Rule Summary

The EPA Administrator signed the proposed Management Standards for Hazardous Waste Pharmaceuticals Rule on August 31, 2015, and it was published in the Federal Register (FR) on September 25, 2015.

EPA received a number of requests to extend the comment period and in response provided a 30-day extension. A notice announcing this extension was published in the Federal Register on November 5, 2015.  

This rule proposes a tailored, sector-specific set of regulations for the management of hazardous waste pharmaceuticals by healthcare facilities (including pharmacies) and reverse distributors. It will provide standards to ensure the management of hazardous waste pharmaceuticals is safe and workable within the healthcare setting.

In addition, the proposed pharmaceutical rule will make our drinking and surface water safer and healthier by reducing the amount of pharmaceuticals entering our waterways. Our proposal is projected to prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually by banning healthcare facilities from flushing hazardous waste pharmaceuticals down the sink and toilet. 

Through this proposal, EPA strives to improve the management hazardous waste pharmaceuticals at healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors in order to improve environmental protection.

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Commenting on the Proposed Rule

The comment period for this rule closed on December 24, 2015.

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Rule History

In 2008, EPA proposed to add pharmaceuticals to the types of hazardous wastes that could be managed as Universal Wastes (73 FR 73520, December 2, 2008).  Although commenters supported the idea of new regulations for the management of pharmaceuticals, there were numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport pharmaceutical “universal wastes” as well as for the lack of tracking requirements for the shipment of these wastes. Therefore, the Agency decided to not finalize the 2008 proposed rule, but rather develop another proposal for new standards for the management and disposal of pharmaceutical hazardous waste that are generated by healthcare-related facilities.

With the new rule, the concerns raised by the public comments regarding notification and tracking issues can be more fully addressed as well as other pharmaceutical hazardous waste management issues that are more specific to healthcare facilities. This new proposed rulemaking will only pertain to those pharmaceutical wastes the meet the current definition of a Resource Conservation and Recovery Act (RCRA) hazardous waste and that are generated by healthcare-related facilities.

Several of the proposed provisions are also responsive to the Notice of Data Availability (79 FR 8926, February 14, 2014) that EPA issued on the retail sector asking for comment on hazardous waste management practices in that sector and on challenges they face in complying with RCRA. 

After consolidating the feedback from these two sources, the regulated community, states and other stakeholders, EPA developed this proposal to improve the management of hazardous waste pharmaceuticals to strengthen environmental protection while ensuring businesses have the flexibility and certainty they need to successfully operate.

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Additional Resources

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