DEA Releases Final Rule On Disposal Of Controlled Substances

On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010 (the "Disposal Act"), and according to the DEA, "generally expands the options available to collect controlled substances from ultimate users for the purpose of disposal."1 The Final Rule will go into effect on October 9, 2014, but affected entities and individuals may want to start preparing their policies and procedures now.

Background — The Disposal Act

The Disposal Act provides the legislative authority for the Final Rule. The Disposal Act was enacted in 2010 and was designed to address a gap in the Controlled Substances Act (the "CSA") concerning the disposal of controlled substances. Specifically, the CSA permitted only ultimate users2 of controlled substances to dispose of controlled substances in very limited ways. As noted by the DEA, this "resulted in the accumulation of pharmaceutical controlled substances in household medicine cabinets that were available for abuse, misuse, diversion, and accidental ingestion."3

The Disposal Act sought to remedy this problem by providing expanded alternatives for the disposal of controlled substances, including the ability to deliver controlled substances to another person for purposes of disposal. Thus, the goal of the Disposal Act—and of the Final Rule—"is to set parameters for controlled substance diversion prevention that will encourage public and private entities to develop a variety of methods for collecting and destroying pharmaceutical controlled substances in a secure, convenient, and responsible manner."4

Key Provisions of the Final Rule

Three New Voluntary Disposal Options

The Final Rule has several key provisions that generally provide ultimate users with three additional voluntary options for disposal of their controlled substances: (1) take-back events, (2) mail-back programs or (3) collection receptacles. It is not mandatory for ultimate users to use these three options, and ultimate users are not prohibited from using existing lawful methods for the disposal of controlled substances.5

Take-back Events.6 Ultimate users or persons entitled to dispose of an ultimate user decedent's property will be permitted to dispose of their lawfully possessed controlled substances listed in Schedules II-V during a take-back event. Law enforcement will...