The Department of Justice (DOJ), Drug Enforcement Administration (DEA) released a final rule that implements the Secure and Responsible Drug Disposal Act of 2010, also referred to as the “Disposal Act.” The new regulations take effect on October 9, 2014. They provide additional options for ultimate users to dispose of controlled substances, and create a voluntary role for industry registrants, i.e. “collectors,” which are entities that ultimate users can transfer controlled substances to for disposal.
An “ultimate user” includes a person a controlled substance is prescribed to; any member of that person’s household; and individuals lawfully entitled to dispose of that person’s property upon their decease. Prior to the Disposal Act, ultimate users who wanted to dispose of unused, unwanted, or expired controlled substances had limited options. They were only permitted to:
- Destroy the substances themselves (e.g. flushing the substances),
- Surrender them to law enforcement, or
- Seek assistance from the DEA.
Under the Disposal Act, their options are expanded to include:
- Mail-back programs,
- Collection receptacles, and
- Take-back events.
Under the Disposal Act regulations, law enforcement agencies may facilitate any of the disposal pathways. Manufacturers, narcotic treatment programs (NTPs), distributors, reverse distributors, hospitals and clinics with on-site pharmacies and retail pharmacies can amend their DEA registrations to become “collectors,” enabling them to operate mail back programs and maintain collection receptacles for controlled substances. Authorized hospitals/clinics and retail pharmacies can also maintain collection receptacles at long-term care facilities.
Collectors are authorized to receive schedule II-V controlled substances for the purpose of destruction. If a collector operates a mail-back program the collector is required to destroy the drugs onsite, which can make a mail-back program quite costly for a collector. If a collector operates a take-back program, the collector can install and manage a collection receptacle and either destroy the substances onsite or transfer them to a reverse distributor. DEA chose not to define “destruction;” DEA only requires that the controlled substances are rendered “non-retrievable,” meaning “the condition or state . . . following a process that permanently alters that controlled substance’s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes.” Once a controlled substance is rendered non-retrievable, the controlled substance is no longer subject to DEA regulation.
Pharmacies and law enforcement agencies are not required to establish controlled substance take-back locations, but those that do become authorized collectors are allowed to receive both controlled and non-controlled substances. Controlled substances can be co-mingled with other consumer medications, meaning that consumers may place all leftover medicines into one collection box or one mail-back envelope without identifying the medicines. If substances are co-mingled, it appears that all substances collected in a mail-back program will have to be rendered “non-retrievable,” further increasing potential costs.
While most state and local drug take-back programs have been unable to accept controlled substances to date, these programs can now be expanded by law enforcement or collectors under the Disposal Act regulations to accept schedule II-V controlled substances. If the challenged Alameda and King County drug take-back programs are upheld, those programs—which are mandatory for drug producers selling in the county—are expected to also expand to encompass controlled substances, thereby increasing the burden on industry.