In response to recent studies showing that substantial levels of pharmaceutical waste are present in the nation’s water supply, USEPA (or the "Agency") has begun to focus on discharges by health care facilities. This means hospitals, clinics and physicians’ offices need to be prepared for possible inspections and information requests.

Although extensive regulations mandate special handling of certain kinds of pharmaceutical waste, the disposal of most categories of pharmaceutical waste has, until recently, remained essentially unexamined and unregulated. Yet virtually all health care facilities, including hospitals, clinics, dental offices, long-term care facilities and veterinary clinics must dispose of unused pharmaceuticals. Until recently, most facilities were advised that flushing unused pharmaceuticals down the drain was the preferred method of disposal. For example, the Controlled Substances Act actually encourages flushing unused controlled substances down a drain or toilet. Moreover, the advantages of this simple method of pharmaceutical disposal are obvious: it is convenient and entails no monetary outlay. The same is often not true of alternatives.

When data began to show substantial amounts of unused pharmaceuticals were passing through publicly owned wastewater treatment works, which are not designed to remove pharmaceuticals from wastewater, the USEPA initiated a study to evaluate the extent of the problem. According to USEPA, its study identified more than 160 pharmaceutical compounds in discernable concentrations in the nation’s water supply. The USEPA’s preliminary study was completed in August 2008, and a month later, the biennial Effluent Guidelines were published in the Federal Register. Although the 2008 Effluent Guidelines establish no new requirements, they reveal the Agency's planning processes and priorities, and make clear that USEPA intends to continue its focus on the health care sector’s disposal of pharmaceuticals over the next two years. In other words, it is now clear that the disposal of unused pharmaceuticals has been targeted for regulatory changes.

So what’s next? During 2009 and 2010, USEPA will focus more intently on the management of unused pharmaceuticals within the health services industry, and will conduct a nationwide survey of hospitals, long-term care facilities, hospices and veterinary facilities, including in-person Agency visits to discover how facilities are managing, tracking and disposing of their unused pharmaceuticals. The types of facilities to be studied include dental offices and clinics; doctors and mental health practitioners; nursing and long-term care facilities; hospitals, hospices, and clinics; medical laboratories and diagnostic centers; and veterinary care services. In light of these developments, health care facilities are urged to review their disposal practices to ensure that pharmaceutical substances already regulated as hazardous waste are not being improperly disposed of, and to make certain that all federal, state and local regulations are followed with respect to disposal practices generally.

When the EPA “focuses” on a sector of the economy, it gathers information in several ways, including showing up at the door for inspections and sending information requests. The ancipated increase in Agency visits to health care facilities in 2009 makes this a good time for facilities to take stock and ensure that their environmental compliance procedures are up to date, and that all necessary permits and records are organized and available for inspection upon demand. Those facilities that have not yet implemented an Environmental Management System (“EMS”) would be well-advised to make plans to put an EMS in place as soon as is practicable.

Hinshaw and Culbertson LLP’s Environmental Specialty Group provides advice and help with managing the complexities of environmental regulation and compliance, as well as assistance to those facing enforcement actions.

For further information concerning disposal of unused pharmaceuticals, please contact: Charles F. Helsten, Nicola Nelson or your regular Hinshaw attorney.

This alert has been prepared by Hinshaw & Culbertson LLP to provide information on recent legal developments of interest to our readers. It is not intended to provide legal advice for a specific situation or to create an attorney-client relationship.