Management of Hazardous Waste Pharmaceuticals

2013 Proposal to Address the Management of Hazardous Waste Pharmaceuticals

The Agency is in the process of developing a new proposal to establish appropriate standards for the management and disposal of hazardous waste pharmaceuticals generated by healthcare facilities. This most recent effort is a continuation of the December 2, 2008 proposal to add hazardous waste pharmaceuticals to the Universal Waste Program. Public comment on the December 2008 proposal revealed numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport “universal waste” pharmaceuticals 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 hazardous waste pharmaceuticals 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 hazardous waste pharmaceutical 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 RCRA hazardous waste and that are generated by healthcare-related facilities.

2013 Proposal Status

The new proposal for healthcare facility-specific management standards for hazardous waste pharmaceuticals is currently under development. We anticipate that the proposed rule will be published and available for public comment in August 2013. For information on the development of regulations, please see: The Basics of the Regulatory Process.

How Are Hazardous Waste Pharmaceuticals Currently Regulated?

Until the newly proposed rule is finalized and adopted by authorized states, healthcare facilities and other business entities that generate hazardous waste pharmaceuticals must manage these wastes in accordance with the RCRA Subtitle C generator requirements.

Hazardous Waste Pharmaceutical Resources

Guidance Documents

Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States; revised August 2008.

Guidance Memos and Letters

Healthcare Environmental Resource Center

Pollution prevention and compliance assistance information for the healthcare industry

Pharmaceutical Collection Programs and Events

Pharmaceutical collection programs and events FAQs

2008 Universal Waste Proposal

On December 2, 2008, EPA proposed to add hazardous waste pharmaceuticals to the Universal Waste Program in order to facilitate their proper management and disposal. However, due to the adverse public comments received regarding the lack of notification and tracking requirements under the Universal Waste program, the Agency has decided not to finalize the 2008 proposal. Instead EPA is utilizing the comments received on the 2008 proposal to re-focus its efforts by proposing new healthcare facility-specific standards for the management of hazardous waste pharmaceuticals.

For historical purposes, please see the following links for the Federal Register notices for the December 2, 2008 proposal to add hazardous waste pharmaceuticals to the federal Universal Waste program and the notice for the extension of the comment period.

Federal Register Notice | PDF Version (26 pp, 345K, about PDF) - Proposed Rule - December 2, 2008
Federal Register Notice | PDF Version (1 pg, 61K, about PDF) - Extension of the Comment Period - January 30, 2009

To use Regulations.gov:

Select Docket Search
Select "Environmental Protection Agency" from the Agency drop-down menu
In the Docket ID box, type in the docket number (EPA-HQ-RCRA-2007-0932) and press the "Submit" button to receive search results

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