New Management Standards for Hazardous Waste Pharmaceuticals Expected by July 2018

Even in an era of extensive regulatory scrutiny, the EPA proposes to issue a final rulemaking for hazardous waste pharmaceuticals in July 2018 (Fall Regulatory Agenda, December 14, 2017). The comment period for the proposed regulations closed in 2015.

Handling discarded pharmaceuticals

Many pharmaceutical products, when discarded, meet the definition of a hazardous waste and must be handled under stringent management and disposal requirements. Almost every level of pharmaceutical sales and marketing is impacted by changes to the hazardous waste management program.

The EPA has recognized that health care facilities such as pharmacies, veterinary clinics, doctor offices, clinics, and retail operations do not have the expertise and training to consistently meet the hazardous waste generator requirements.

Simplifying the process

The proposed regulations build on existing reverse logistics and take-back programs now in use but aim to simplify management standards for discarded and waste pharmaceutical products. As an addition to old rules, the new regulation also aims to prohibit the disposal of pharmaceutical wastes to sewer. If you would like more information on the specific changes the rule proposes, visit the EPA’s proposed rule page.

The EPA has committed to keep working with retail groups prior to finalizing the regulations, and we here at Antea Group will be tracking the progress of these regulations and their potential impacts on the large group of affected facilities. If the EPA continues the course set in 2015, the maximum benefit will fall to facilities that make some operational adjustments and implement new notification, training, recordkeeping, and reporting methods.

What’s next?

Even though the changes won’t be published until July, we can still help with your existing hazardous waste generator program. For low-risk healthcare and retail facilities we offer a fit-for-purpose service called RiskRight EHS® -- a suite of EHS programs including training, policy and procedure development, preparing and assisting with notification documents, classifying wastes, and more.

We are ready and willing to assist you with evaluating requirements and developing programs to maintain compliance in the future, and will work to keep you updated with the most recent changes to any relevant regulations.

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