21 CFR 1304.02 - Definitions.

This rule proposes requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users. These regulations would implement the Secure and Responsible Drug Disposal Act of 2010 (Pub. L. 111-273) by expanding the options available to collect controlled substances from ultimate users for purposes of disposal to include: Take-back events, mail-back programs, and collection receptacle locations. These proposed regulations contain specific language to continue to allow law enforcement agencies to voluntarily conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations propose to allow authorized manufacturers, distributors, reverse distributors, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this proposed rule expands the authority of authorized retail pharmacies to voluntarily maintain collection receptacles at long term care facilities. This proposed rule also reorganizes and consolidates existing regulations on disposal, including the role of reverse distributors.