Management Standards for Hazardous Waste Pharmaceuticals

On August 31, 2015, the Environmental Protection Agency (“EPA”) Administrator signed the proposed rule titled “Management Standards for Hazardous Waste Pharmaceuticals” (the “Rule”), which will be published in the Federal Register in the coming weeks. The Rule proposes a set of regulations for the management of hazardous waste pharmaceuticals by healthcare facilities, including hospitals, physicians’ offices, nursing care facilities, pharmacies, continuing care retirement communities, and outpatient care centers.

Currently, some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (“RCRA”) when discarded. A number of healthcare facilities have reported difficulties complying with the RCRA regulations when discarding pharmaceuticals regulated as hazardous waste. In response to these reported difficulties, the EPA will release the Rule, which proposes to revise the RCRA regulations to improve the management and disposal of hazardous waste pharmaceuticals and to tailor the regulations to address the specific issues reported by hospitals, pharmacies, and other healthcare facilities.

More specifically, via the Rule, the EPA proposes the following:

  • to prohibit healthcare facilities from disposing of hazardous waste pharmaceuticals down the toilet or drain (i.e, flushed or sewered);
  • that hazardous waste pharmaceuticals managed under the proposed rule will not be counted toward calculating the site’s generator category (i.e., Large Quantity Generator, Small Quantity Generator or Conditionally Exempt Small Quantity Generator);
  • a conditional exemption for hazardous waste pharmaceuticals that are also DEA controlled substances; and
  • management standards for hazardous waste pharmaceutical residues remaining in containers.

As mentioned, the EPA intends to publish the Rule in the Federal Register in the coming weeks. The EPA will accept public comments on the Rule for sixty days following its publication.

General information on the Rule is available here.

This News Alert has been prepared for informational purposes only and should not be construed as, and does not constitute, legal advice on any specific matter. For more information, please see the disclaimer.