Hoping to further curtail diversion of controlled substances, DEA has expanded the options for their collection
The Drug Enforcement Administration (DEA) published its notice of proposed rulemaking (the Proposed Rule) late last year in connection with disposal of controlled substances. The Proposed Rule is a coordinated effort to implement the Secure and Responsible Drug Disposal Act of 2010. Stakeholders continue to wait for final regulations.
The Proposed Rule is intended to provide a pathway for the secure disposal of controlled substances by DEA registrants and “ultimate users” of the medications. By expanding the options for collection of controlled substances, DEA hopes to further curtail any potential diversion of controlled substances. Some methods to be used under the Proposed Rule include take-back events, mail-back programs, and collection-box locations.
The Proposed Rule seeks to provide a definition of “collector” that would include those types of entities permitted to collect and dispose of controlled substances.
At present this function is limited to law enforcement and entities connected with reverse distribution. Under the Proposed Rule, law enforcement and reverse distributors would continue to be allowed to undertake collection activities. However, manufacturers, distributors, and retail pharmacies would also be allowed to administer mail-back programs as well as to maintain collection boxes.
Of interest, the Proposed Rule also allows retail pharmacies to place collection boxes in long-term-care facilities for the purpose of disposing of controlled substances on behalf of both current and former residents of that facility. This would alleviate a recurring problem in facilities with respect to controlled substances that are not currently returnable, except through limited channels.
Despite the inclusion of more types of entities eligible to participate in the disposal of controlled substances, there are still requirements for record-keeping and accounting under the Proposed Rule.
For example, the Proposed Rule describes requirements for the packaging of medications sent through the mails, contains provisions for security at the collection site, and specifies timing requirements related to the disposal of controlled substances.
The Proposed Rule also requires participants in any controlled-substance disposal program to provide for a mechanism by which liners and packages containing the controlled substances can be tracked and audited.
In addition to describing what types of entities will be allowed to oversee the disposal of controlled substances, the Proposed Rule also places restrictions on which individuals will be allowed oversight privileges.
The DEA has expressed concern in the Proposed Rule over the participation of certain individuals. Specifically, the Proposed Rule does not permit participation in the disposal process by an individual who has been convicted of any felony offense related to controlled substances or any individual who has had an application for DEA registration revoked or suspended.
Furthermore, if an individual has ever surrendered a DEA registration for cause, that person would be excluded from the disposal program.
Finally, DEA has set forth requirements in the Proposed Rule relating to how a controlled substance may be destroyed.
Specifically, the manner of destruction must be such that the controlled substance be placed in a “nonretrievable” state. The intended result is to render the controlled substance into a condition ensuring that it is no longer at risk for diversion.
Although DEA is not requiring any particular form of destruction, examples provided in the Proposed Rule include chemical digestion or incineration. Neither flushing nor mixing of controlled substances with coffee grounds or kitty litter meets the “nonretrievable” standard, according to DEA.