There are a number of legislative and administrative initiatives at the federal level aimed at reducing the environmental and safety risks associated with leftover medicines. The following information summarizes current and proposed policies.
The Controlled Substances Act and the 2010 Secure and Responsible Drug Disposal Act
The Controlled Substances Act (CSA) was passed in 1970 to limit drug abuse and addiction in the U.S. by regulating how certain substances are managed. Ironically, the CSA’s strict restrictions on the handling of controlled substances (e.g., OxyContin®, Percocet®, and Adderall®), made it challenging to establish convenient options for drug take-back programs, which are also very important for keeping drugs out of the hands of abusers. The CSA mandates that only law enforcement officers can accept expired or unused controlled substances from households. PSI worked with a diverse group of stakeholders to advocate for changes to the CSA that would allow residents to dispose of these controlled substances in other safe and convenient ways. The October 2010 passage of the Secure and Responsible Drug Disposal Act, which amends the CSA by requiring that the Drug Enforcement Administration (DEA) make drug disposal easier for consumers, marked the first achievement toward that goal. In January 2011, PSI provided testimony endorsed by more than 120 parties from around the country at the DEA’s public hearing in preparation for proposing rules to implement the Act.
DEA’s Final Rule Regarding Disposal of Controlled Substances
The DEA’s final rule on the collection and disposal of controlled substances, such as Oxycontin®, Percocet®, and Vicodin®—released September 9, 2014—will eventually give consumers much greater flexibility as to when, where, and how they can dispose of their unwanted medication. The rule allows manufacturers, distributors, reverse distributors, narcotic treatment programs, retail pharmacies, and hospitals/clinics with an on-site pharmacy to voluntarily apply for authorization and maintain on-site drug collection receptacles and provide mail-back programs. Law enforcement agencies may also continue to collect controlled substances, and may also now offer mail-back programs. Although the rule goes into effect October 9, 2014, state and municipal governments, local law enforcement agencies, state boards of pharmacy, pharmacy retailers, manufacturers, reverse distributors, and a host of other stakeholders will need to take a number of steps to comply with and carry out the rule before then.
PSI is committed to providing technical support for stakeholders who modify an existing program or launch a new drug take-back initiative. Secure medicine take-back programs are the safe and environmentally sound method of disposing of leftover and expired medicines, but they are not yet available in all communities, in large part due to a lack of sustainable financing. While the new DEA rule allows for the implementation of the Secure and Responsible Drug Disposal Act, it does not address the issue of sustainable financing.
In response to the DEA’s proposed rule – released in December 2012 – PSI’s letter submitted to the DEA, was developed with input from our government members and corporate partners.
DEA National Prescription Drug Take-Back Days
Since October 2010, the DEA has held eight National Prescription Drug Take-Back Days in partnership with local law enforcement and other community groups. Through these one-day pharmaceutical collection events, which take place in counties and municipalities across the country, the DEA has collected over 4.1 million pounds of unused and unwanted medicines, including controlled substances. However, the DEA announced that its September 27, 2014 national collection event will be the last now that the rule regarding the disposal of controlled substances is finalized.
Although the final rule expands collection options, ending the DEA-sponsored one-day events will likely have a negative impact on many existing drug take-back programs where law enforcement took advantage of the free disposal option offered through the DEA’s events. In the absence of these national drug take-back days, organizers of collection programs will need to find – and pay for – another safe disposal option.
U.S. Pharmaceutical Stewardship Act
In 2011, U.S. Congresswoman Louise Slaughter (D-NY) introduced the Pharmaceutical Stewardship Act (H.R. 2939). This bill calls for the creation of a manufacturer-financed nonprofit organization that would operate safe, environmentally responsible drug take-back programs in every state. Rep. Slaughter plans to reintroduce a similar bill in an upcoming legislative session.
For federal agencies that promote take-backs for pharmaceutical waste, click here.