DEA Proposed Rule for Disposal of Controlled Substances

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If you have any questions about this policy proposal, please send an email to govaff@ascp.com.

A growing prescription drug abuse epidemic in the United States prompted the passage of The Secure and Responsible Drug Disposal Act of 2010 (PDF). The law amends the Controlled Substances Act (CSA) and authorizes the Drug Enforcement Administration (DEA) to implement regulations establishing mail-back programs, take-back events, and the use of secured on-site disposal receptacles for the safe disposal of controlled substances dispensed but not consumed by ultimate users. DEA released a notice of proposed rulemaking (NPRM) on December 21, 2012 with public comments due February 19, 2013.

In addition to proposing regulations for establishing community mail-back programs and take-back events, DEA proposes regulations for long-term care facilities (LTCF) that would allow the placement of onsite receptacles for disposal of controlled substances. Only retail and/or LTC pharmacy services providers would be authorized to manage receptacles at LTCFs, and they must be registered "collectors" through modification of their DEA registration. The placement of a receptacle in an LTCF by a retail/LTC pharmacy services provider would be voluntary, and the receptacle design would have to meet certain specifications. LTCF staff would not be authorized to handle or remove the contents of the receptacle. Pharmacies or reverse distributors are authorized to handle the removal and transport of controlled substance waste, however the removal of a receptacle’s contents at an LTCF must be performed or witnessed by two retail/pharmacy services provider "authorized employees." In the absence of the voluntary placement of a receptacle, DEA's proposal explicitly prohibits LTCFs from handling disposal of controlled substances dispensed but not consumed by residents. The proposal states that residents or their responsible party would have to dispose of any unused controlled substances through mail-back programs or take-back events.

This resource page contains information and background on DEA's proposal and ASCP's position and comments. For additional information on pharmaceutical waste, visit our Pharmaceutical Waste Practice Resource Center.

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February 2013

  • Comments to DEA on NPRM for the Disposal of Controlled Substances:

December 2012

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ASCP Submits Comments to DEA on the Disposal of Controlled Substances in LTCFs

ASCP submitted comments (PDF) February 19, 2013 to the Drug Enforcement Administration (DEA) in response to a request for public comments on its proposed rule for the disposal of controlled substances. The proposal would establish regulations implementing amendments to the Controlled Substances Act (CSA) set forth through the passage of the Secure and Responsible Drug Disposal Act of 2010 (PDF). The proposed regulations, if finalized, would establish mail-back programs, take-back events, and the use of secured onsite disposal receptacles for the safe disposal of controlled substances dispensed but not consumed by ultimate users. The proposed regulations provide specific rules for the use of on-site receptacles within long-term care facilities (LTCFs).

ASCP is supportive of the voluntary program proposed by DEA as an option available to LTCFs. However most LTCFs and LTC pharmacies will have difficulty implementing the voluntary receptacle program as outlined by DEA. In comments submitted to DEA, ASCP expressed concerns over the cost prohibitive nature of the voluntary program, which requires specific types of receptacles and limits management and handling of receptacles to pharmacy personnel. The proposed rule also presents challenges for compliance with existing regulations for the transport and disposal of hazardous and medical wastes. In the absence of a voluntary receptacle program, LTCFs are prohibited from handling disposal of controlled substances on behalf of ultimate users, which could potentially open new avenues for misuse, abuse, or diversion. ASCP recommends DEA explore additional options, such as allowing LTCFs to render controlled substance waste "non-retrievable," or allow LTCF participation in mail-back programs.

DEA Releases Controlled Drug Disposal Proposed Rule

The Drug Enforcement Administration (DEA) announced in a December 21, 2012 Federal Register notice a long-awaited proposed rule for controlled substance disposal. The proposed rule provides guidance for DEA registrants, law enforcement agencies, ultimate users of medication and long-term care facilities. It is intended to ensure the secure disposal of controlled medications through mail-back programs, take-back events, and secured onsite receptacles. The proposed rule recommends that long-term care facilities dispose of accumulated controlled medications through onsite receptacles provided and managed voluntarily by a retail pharmacy. If implemented as proposed, long-term care facilities would not be allowed to use reverse distributors or other third parties for the disposal of controlled substances. The rule, if finalized, is voluntary and does not provide a regulatory framework for disposal of controlled medications accumulated in long-term care facilities if a retail pharmacy does not provide an onsite receptacle. ASCP plans to analyze this proposed rule and submit comments to the docket by the February 19, 2013 deadline.

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