On September 25, 2015, the EPA published in the Federal Register the long awaited proposed rule to manage hazardous waste pharmaceuticals generated by healthcare facilities (including hospitals, clinics, and retail stores with pharmacies) and reverse distributors. The new rule will only pertain to those pharmaceutical wastes that meet the current definition of a Resource Conservation and Recovery Act (RCRA) hazardous waste and that are generated by healthcare-related facilities.

EPA’s goals

The EPA emphasizes that the proposed hazardous waste pharmaceutical rule will make drinking and surface water safer and healthier by reducing the amount of pharmaceuticals entering U.S. waterways. The EPA projects that its proposed rule will:

• Prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually by banning healthcare facilities from flushing hazardous waste pharmaceuticals down the sink and toilet
• Reduce the regulatory burden on healthcare workers and pharmacists working in healthcare facilities by creating a specific set of regulations for these facilities that provide greater flexibility in how facilities and employees manage their hazardous waste and make the regulations easier to understand.

Key points

Facilities that generate hazardous pharmaceutical waste will manage such wastes under new Subpart P of 40 CFR 266 instead of under 40 CFR 262. The EPA states that compared to the hazardous waste generator regulations, healthcare facilities operating under the new standards will have the following benefits:

• A healthcare facility will not become a hazardous waste large quantity generator (LQG), with all the associated requirements, when it generates more than 1 kg of acute hazardous waste pharmaceuticals in a month;
• A healthcare facility will not have to comply with the satellite accumulation area regulations, which are a poor fit for healthcare facilities;
• A facility will not need to specify hazardous waste codes on manifests;
• A facility will be able to accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days, an increase of 275 days over the current generator regulations; and
• Facilities will now have basic training requirements.

Comment period and effective date

The EPA will accept comments for 60 days following publication of the rule in the Federal Register. The Agency anticipates that the rule will be finalized in 2016 and will be effective at the federal level 6 months after promulgation.

The proposal was published in the Federal Register on September 25, 2015.