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On September 9, 2014, the Drug Enforcement Administration (DEA) published their final rule regarding the disposal of controlled substances. This resource page contains information and background on DEA's regulation and ASCP's position. For additional information on pharmaceutical waste, visit our Pharmaceutical Waste Practice Resource Center
A growing prescription drug abuse epidemic in the United States prompted the passage of The Secure and Responsible Drug Disposal Act of 2010. The law amends the Controlled Substances Act (CSA) and authorizes 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. The intent of the regulation is to prevent serious injury and death as a result of unauthorized use of controlled substances, and to prevent the accumulation of unwanted controlled substances.
The disposal options outlined in the final rule are voluntary. Long-term care facilities (LTCFs) may continue to use current disposal practices, provided they are legal within existing state and federal regulations. LTCFs and LTC provider pharmacies that opt to utilize these options must do so within the parameters of the rule, which is effective October 9, 2014.
ASCP is still evaluating the impact this new voluntary program will have on LTC pharmacy operations and their LTCF customers. It is recommended that pharmacies and LTCFs review current processes for handling destruction of controlled substances and evaluate process changes that would be needed in order to implement one of the new disposal options. Pharmacies and LTCFs should seek guidance from legal counsel or risk management experts to select the option that meets their needs and reduces the risk of unauthorized use of controlled substances.
ASCP has and will continue to track/analyze this regulation and work with other stakeholders to truly understand the impact this rule will have on pharmacies and LTCFs. To date ASCP has undertaken the following initiatives related to the rule:
ASCP’s Policy and Advocacy staff are in the process of evaluating the finer details of the rule before determining the Society’s next steps. A full summary of the rule will be provided to the membership as soon as possible, which will outline the details on how this rule will affect the professions of consultant and senior care pharmacy.
ASCP understands and appreciates your desire to stay informed and to get directly involved in ASCP’s next steps. To receive regular updates and to receive instructions on how to get involved, join ASCP’s Grassroots Network (members only).
On September 8, 2014, the Drug Enforcement Administration (DEA) released their final rule regarding the disposal of controlled substances. ASCP’s Policy and Advocacy staff have been anticipating this final rule since the publication of a notice of proposed rulemaking on December 21, 2012. ASCP submitted comments opposing the proposal citing potential new avenues for diversion and the logistical impracticality of applying the regulations. Staff are reviewing the details of the final rule to determine the impact it will have on the long-term care setting and will make an analysis available as soon as possible. Continue to check our Advocacy Center for updates.
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.
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.