Updated Controlled Substances Disposal Requirements: Effective October 9, 2014

Historically, under the Controlled Substance Act (CSA), patients could only dispose of unused controlled substances themselves or deliver the controlled substances to law enforcement officials.

In October 2010, the Secure and Responsible Drug Disposal Act (Disposal Act) of 2010 was enacted with the goal of facilitating more convenient and secure disposal options. The Disposal Act amended the CSA and authorized “ultimate users” or persons who have  “lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or a member of his household,” to deliver their controlled substances to a broader range of entities for disposal in accordance with the requirements of the Drug Enforcement Agency (DEA).

Earlier this month, the DEA published a rule which broadens the range of permissible collection and disposal methods for unused, unwanted, or expired controlled pharmaceutical substances while also further clarifying the roles of “collectors” and “reverse distributors.”

Authorized Collectors. The new rule allows authorized collectors, or those entities who have submitted a written request to the DEA Registration Unit, to conduct mail-back collection programs and maintain collection receptacles at authorized collection locations. Under the rule, hospitals and clinics with on-site pharmacies may register as collators.

Reverse Distributors. As defined by the rule, reverse distributors can acquire controlled substances from another DEA registrant or law enforcement for the purpose of destruction or return to the registered manufacturer or an entity authorized to accept returns on a registered manufacturer’s behalf. All controlled substances must be stored securely at the reverse distributor’s location until destruction or return to the registered manufacturer.

Disposal. Under the Rule, all controlled substances must be destroyed and rendered non-retrievable under all Federal, State, tribal and local regulations. A controlled substance is deemed to be non-retrievable when it cannot be transformed into a physical or chemical condition or state as a controlled substance or controlled substance analogue. While the method of destruction is not specified, any registered entity that destroys controlled substances must (1) maintain a complete and accurate record of all destroyed substances on a DEA Form 41 and (2) include the signature of two employees who witnessed the controlled substance distraction.

Again, the updated Controlled Substances Disposal Requirements become effective on October 9, 2014.