January 9, 2019 Sweetnam and Schwartz

The focus on pharmaceutical waste is increasing at the Federal and state levels. The United States Environmental Protection Agency (“EPA”) has announced that it will develop a new rule to address the management and disposal of hazardous waste pharmaceuticals generated by healthcare facilities. The new rule would only apply to pharmaceutical waste within the definition of “hazardous waste” under the Resource Conservation and Recovery Act (“RCRA”) and is anticipated to be published for public comment in August 2013.

EPA currently regulates the disposal of pharmaceuticals from healthcare facilities under RCRA’s hazardous waste generator regulations. Therefore, healthcare facilities, including pharmacies, hospitals and retail stores with pharmacies, that dispose of hazardous waste pharmaceuticals may be regulated hazardous waste generators. EPA has posted guidance regarding the management of hazardous waste pharmaceuticals. Many healthcare facilities have had difficulty maintaining compliance with these requirements because of the large variety, but relatively small amount of pharmaceutical waste generated at various locations. Nonetheless, until the new rule is promulgated, healthcare facilities are still required to comply with RCRA generator regulations when disposing of hazardous pharmaceutical waste and may be subject to federal or state enforcement if they fail to comply. Meantime, in the absence of a final federal rule, some states have enacted their own regulations to alleviate some of this burden on health care facilities. It is uncertain how the EPA’s proposed new rule may impact these state regulations.

We can be of assistance if you need to know more about the new proposal for healthcare facility-specific management standards for hazardous waste pharmaceuticals, or to determine your compliance status under currently applicable regulations.

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