EPA Considers New Pharmaceutical Waste Rules

Date: May 2, 2012

Source: News Room

The EPA is now considering healthcare facility-specific regulations for managing hazardous pharmaceutical waste rather than regulate them under its universal waste program as proposed in Dec. 2008. The action follows criticism from states and the healthcare industry that its original approach would fail to address improper disposal of the waste.

EPA's 2008 proposed rule aimed to facilitate better management of pharmaceutical wastes by streamlining generator requirements and encouraging generators of hazardous pharmaceutical wastes to manage them under the provisions of the Universal Waste Rule, which is generally less stringent than federal rules for hazardous waste. The proposed rule was intended to facilitate take-back programs by removing Resource Conservation & Recovery Act (RCRA) barriers, according to the rule's preamble. The Environmental Council of the States,representing state environmental regulators, wrote that EPA's proposed rule was unlikely to divert pharmaceuticals from sewer systems because of DEA's witnessed destruction requirements and because reverse distributors cannot accept most pharmaceutical wastes generated outside the pharmacy. States want the agency to take a more holistic approach to dealing with pharmaceutical waste, by working with other federal agencies, like the DEA and the FDA, on the issue.


Status Update

As a result from comments received in response to the December 2, 2008 Proposed Rule, the Agency has decided to develop another proposal for healthcare facility-specific regulations for the management of hazardous pharmaceutical wastes in order to provide a regulatory scheme that addresses the unique issues that hospitals, pharmacies and other healthcare-related facilities face. It is anticipated that the proposal will be available for public comment in Spring 2013.

To learn more, visit: www.epa.gov/osw/hazard/wastetypes/universal/pharm-rule.htm.