Part 1: New EPA Rule Explained

New EPA Rule

The Environmental Protection Agency (EPA) released a Proposed Rule on the Management Standards for Hazardous Waste Pharmaceuticals (HWP) in September 2015. The proposed rule streamlines hazardous pharmaceutical waste management standards for healthcare facilities operating in the United States, including pharmacies, veterinary clinics, physicians’ offices, dentists’ offices, outpatient care centers, chiropractors, hospitals, nursing care facilities, pharmaceutical reverse distributors and medical examiners and coroners’ offices.

The proposed rule adds a new section to the hazardous waste regulations, subpart P to 40 CFR Part 266, to address HWPs that are generated by healthcare facilities. One of the goals of the rule is to impose controls on the current practice of sending expired and unused HWPs to reverse distributors. The rule would segregate these HWPs into either “potentially creditable” or “non-creditable” pharmaceuticals and incorporates new procedures to manage these pharmaceuticals through the proper channels for compliant disposal. Another goal of the rule is to reduce the amount of HWPs disposed of in the sewer system, through flushing down toilets. Studies have found many forms of medicine in the nation’s waterways, which threaten the safety of drinking and surface water. According to the EPA, this proposal could prevent more than 6,400 tons of hazardous pharmaceuticals from being flushed down sinks and toilets by healthcare facilities each year.

It is difficult to manage hazardous waste pharmaceuticals under the current RCRA rules because hazardous waste generation and management at healthcare facilities differ from that at industrial facilities. Generally, many different kinds of pharmaceutical waste are generated in small quantities at many different places throughout a healthcare facility. By comparison, most industrial generators usually generate large quantities of fewer types of waste at a small number of locations. RCRA hazardous waste regulations are often confusing to healthcare employees, resulting in HWPs being managed and disposed of incorrectly. The intent of this proposed rule would be to simplify how these HWPs are currently managed.

This EPA highly anticipated proposed rule is intended to sweep aside many of the burdensome Resource Conservation and Recovery Act (RCRA) requirements that have long been a thorn in the side of healthcare systems. The proposal aims to make compliance easier and less costly for facilities that already have robust programs in place. It will streamline the process of storing and discarding hazardous drug waste and simplify requirements for creating manifests and shipping hazardous drug waste to disposal facilities. The EPA expects that the rulemaking process will be finalized in 2016 after public comments are reviewed, and the rule will take effect at the federal level six months later.

Our next post will explore how this new rule with affect long-term care facilities.

Joe Jordan

Joe Jordan

Director of Hazardous Waste Solutions at Sharps Compliance
Joe Jordan has a Bachelors of Arts degree in Chemistry from Washington and Jefferson College. He is certified in RCRA & DOT, as well as 40 Hour HAZWOPER certified. Joe has been in the hazardous waste industry since 1990 and has managed industrial, healthcare, retail & governmental clients both large & small.
Joe Jordan

Author: Joe Jordan

Joe Jordan has a Bachelors of Arts degree in Chemistry from Washington and Jefferson College. He is certified in RCRA & DOT, as well as 40 Hour HAZWOPER certified. Joe has been in the hazardous waste industry since 1990 and has managed industrial, healthcare, retail & governmental clients both large & small.