AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
SUMMARY: 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.
DATES: Effective Date: This rule is effective October 9, 2014.
Compliance Date: All Memoranda of Agreement (MOAs) and Memoranda of Understanding (MOUs) issued pursuant to current 21 CFR 1307.21 will not be effective after October 9, 2014. Registrants may consult § 1317.05(a)(5) for information on requesting new MOAs and MOUs for disposal of controlled substances.
FOR FURTHER INFORMATION CONTACT:
Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.