Fed Regist. 2014 Sep 9;79(174):53519-70.
This rule governs the secure disposal of controlled substances by registrants and ultimate users. These regulations will implement the Secure and Responsible Drug Disposal Act of 2010 by expanding the options available to collect controlled substances from ultimate users for the purpose of disposal, including: Take-back events, mail-back programs, and collection receptacle locations. These regulations contain specific language allowing law enforcement to voluntarily continue to conduct take-back events, administer mail-back programs, and maintain collection receptacles. These regulations will allow authorized manufacturers, distributors, reverse distributors, narcotic treatment programs (NTPs), hospitals/clinics with an on-site pharmacy, and retail pharmacies to voluntarily administer mail-back programs and maintain collection receptacles. In addition, this rule expands the authority of authorized hospitals/clinics and retail pharmacies to voluntarily maintain collection receptacles at long-term care facilities. This rule also reorganizes and consolidates previously existing regulations on disposal, including the role of reverse distributors.
本规则规定了注册者和最终使用者对管制物质的安全处置。这些法规将通过扩大从最终使用者处收集管制物质以进行处置的可用选项来实施2010年《安全和负责任的药物处置法》，包括：回收活动、邮寄返还计划和收集容器地点。这些法规包含特定条款，允许执法部门自愿继续开展回收活动、管理邮寄返还计划并维护收集容器。这些法规将允许授权的制造商、经销商、逆向经销商、麻醉药品治疗项目（NTPs）、设有现场药房的医院/诊所和零售药房自愿管理邮寄返还计划并维护收集容器。此外，本规则扩大了授权医院/诊所和零售药房在长期护理机构自愿维护收集容器的权限。本规则还对先前存在的处置法规进行了重组和整合，包括逆向经销商的作用。
