Citing “widespread noncompliance in the health care industry,” the U.S. Environmental Protection Agency’s Office of Inspector General recently issued a report criticizing the agency for its failure to properly regulate discarded pharmaceutical waste as hazardous waste. While for many years EPA has banned the improper disposal of a variety of pharmaceutical wastes from hospitals, pharmacies, physicians’ and dentists’ offices, outpatient care centers, residential care facilities and the like, the report concludes that many health care facilities are unaware of the hazardous waste regulations covering pharmaceutical wastes. This lack of compliance, coupled with recent studies identifying the prevalence of pharmaceuticals in drinking water supplies and water bodies due to flushing pharmaceuticals down the drain or toilet, is shedding light on an issue that some would say environmental regulators have overlooked.
When a final decision is made to dispose pharmaceutical products (potentially including empty containers that may contain only residues), federal and state hazardous waste laws may classify the materials as a “listed” hazardous waste due to concerns with toxicity. EPA estimates that hospitals and reverse distributors generate about 15,000 tons of hazardous waste pharmaceuticals every year.
Health care facilities should expect increased inspections and enforcement activities as EPA reacts to the Inspector General’s report through more aggressive enforcement of its current regulations and by broadening the scope of its regulatory reach to cover additional pharmaceuticals.
EPA’s actions also come on the heels on increased enforcement by the States as well. The State of California, for example, recently entered into a $13.75 million settlement with a well-known national retail drugstore chain and a $3.6 million settlement with a nationally recognized wholesale membership warehouse for improper disposal of pharmaceutical waste and other household products. Other states such as Minnesota and Washington have conducted related enforcement and outreach activities, and there are signs that other states in the Midwest are increasing inspections and enforcement as well.
If you have any questions about the recent developments regarding regulatory enforcement of pharmaceutical wastes, how these developments may impact your business, and how to structure your operations to avoid pitfalls with the regulatory requirements, please contact Drew Brought in our firm’s Environmental Practice Group or any member of the firm’s Health Care Practice Group.