About the Rule

  • On September 9, 2014 the U.S. Drug Enforcement Agency (“DEA”) published new regulations that will allow retail pharmacies, hospitals, long term care facilities, and other authorized persons to collect unused medications from the public. The new DEA regulations take effect on October 9, 2014 and implement the Secure and Responsible Drug Disposal Act of 2010.
  • This Act allows ultimate end users to deliver controlled substances to authorized collectors for the purpose of disposal.
  • The regulations give ultimate end users three voluntary options for disposal: (1) take-back events, (2) mail-back programs, and (3) collection receptacles.
  • Authorized collectors may operate (1) a collection receptacle at their registered location(s), (2) collection receptacles at long-term care facilities (if the collector is a retail pharmacy or hospital/clinic with an on-site pharmacy); and/or (3) a mail-back program (if the location can destroy the drugs on-site).

Environmental Compliance Implications

  • On-site Destruction Requirement – Collectors who conduct mail-back programs are required to have and utilize an on-site method of destruction to destroy returned packages. This on-site destruction requirement could subject the collector to onerous EPA or state environmental regulations applicable to treatment, storage, and disposal facilities (“TSDF”).
  • Comingled Substances – The regulations allow all pharmaceutical controlled substances collected through take-back events, mail-back programs, and collection receptacles to be comingled with non-controlled substances. If hazardous waste pharmaceuticals are commingled with nonhazardous waste pharmaceuticals, then all of the contents of the mail-back package or receptacle will likely be subjected to federal and/or state hazardous waste regulations.
  • Collectors as “Generators” – Collectors could possibly be considered “generators” of any hazardous waste pharmaceuticals that are collected. Pharmaceuticals that are collected directly from ultimate users via mail-back programs or collection receptacles may fall under RCRA’s Household Hazardous Waste Exemption. However, some states do not recognize this exemption. Current rules do not address how collectors should attempt to preserve the household hazardous waste exemption when collection receptacles are accessible in commercial areas. The environmental responsibilities of the collector will depend on this issue.

For further guidance on these issues, please contact Troutman Sanders attorneys: Greg Blount or Hahnah Gaines.