Disposal of Controlled Substances by Long Term Care Facilities

The Secure and Responsible Drug Disposal Act of 2010

The Drug Enforcement Administration (DEA) is currently developing regulations for the surrender of unused controlled substances by individuals and by LTC facilities on behalf of their residents, pursuant to new authority granted by the Secure and Responsible Drug Disposal Act of 2010 (SRDDA). 

Under the DEA’s current regulations, LTC facilities are prohibited from sending unused controlled substances off-site for disposal. This stems from the fact that, prior to the enactment of the SRDDA, the Controlled Substances Act (CSA) required the DEA to restrict transfers of controlled substances within a "closed system" of facilities or persons that are registered with the DEA. Because LTC facilities are not eligible to be registered entities, they are not allowed to send controlled substances off-site for disposal and therefore are not able to take advantage of off-site disposal methods designed to minimize environmental contamination.

The SRDDA seeks to address this issue by authorizing, but not requiring, the Attorney General, acting through the DEA, to promulgate regulations to establish a process under which LTC facilities (which still are not eligible to be DEA-registrants) would collect their residents unused controlled substances and return them to a DEA-registered entity for disposal. The SRDDA leaves the details of such a process to the discretion of the Attorney General, other than requiring that it comply with the CSA.

The SRDDA also includes an increased criminal penalty for convictions of a drug offense in the abuse of regulations surrounding these programs.

DEA Hosts Public Forum on Controlled Substance Disposal in LTCFs | January 2011

Following enactment of the SRDDA, the DEA hosted a public meeting to discuss the development of regulations for the disposal of unused controlled substances by LTC facilities. Various stakeholders, including government agencies, industry trade associations, and advocacy organizations, presented their views on the manner in which the DEA should implement its new authority under the SRDDA. Representatives of LTCPA and its members attended this meeting.  

LTCPA Asks the DEA:

  • To promulgate regulations that allow, but do not require, LTC pharmacy providers to receive unused controlled substances from LTC facilities for processing and ultimate disposal.
  • To coordinate the development of these new regulations with state regulations that control the return, reuse and disposal of unused pharmaceuticals.

EPA Issues Draft Guidance on Unused Pharmaceuticals | September 2010

In addition to the actions being taken by the DEA, the Environmental Protection Agency's (EPA) Office of Water issued Draft Guidance entitled “Best Management Practices for Unused Pharmaceuticals at Health Care Facilities,” which describes:

  • Techniques for reducing or avoiding pharmaceutical waste
  • Practices for identifying and managing types of unused drugs
  • Applicable disposal regulations

This guidance was developed following a two-year study of drug disposal practices at health care facilities that identified "near-universal interest from stakeholders to better manage unused pharmaceuticals.” The draft guidance targets hospitals, medical clinics, doctors’ offices, LTC facilities, and veterinary facilities. EPA expects that this document will help reduce the amount of pharmaceuticals discharged to water bodies.

LTCPA met with the EPA to discuss its concerns with the draft guidance and subsequently submitted written comments.