Disposal of Controlled Substances

On December 21, 2012, the Drug Enforcement Agency (DEA) published a notice of proposed rulemaking (77 FR 75784-75817) for the creation of regulations for the secure disposal of controlled substances by both DEA registrants and ultimate users.  DEA is proposing three options for the collection of controlled substances from ultimate users for the purpose of disposal/destruction: (1) Take-Back Events; (2) Mail-Back Programs; and Collection Receptacles.  The proposed regulations allow law enforcement agencies to continue conducting take-back events and to allow law enforcement agencies, authorized manufacturers, distributors, reverse distributors, and retail pharmacies to administer mail-back programs and maintain collection receptacles.  Long-term care facilities with pharmacies on-site would also be allowed to maintain collection receptacles at the facility.

The proposed rule would amend the definition of reverse distributor and would amend the current time frame that a reverse distributor could be in possession of a controlled substance.

The proposed rule includes specific standards for mail-back programs and packages, take-back programs, and collection receptacles.

The presentation would consist of a review and discussion of the proposed regulations or the final rule if it becomes a final rule prior to the conference.