Information for Retail Pharmacies and Hospitals/Clinics that Have or Want to Install Take-back Kiosks
On this page:
- How the Resource Conservation and Recovery Act Applies
- How the Drug Enforcement Administration Regulates this Collection and Disposal
- Becoming an Authorized DEA-Authorized Drug Collector
How RCRA Applies to the Disposal of Pharmaceuticals Collected in Take-back Kiosks
DEA regulations allow retail pharmacies and hospitals/clinics with on-site pharmacies to install collection receptacles (often referred to as take-back kiosks) for the collection of household pharmaceuticals. Participating pharmacies must register with DEA (i.e., DEA registrants) and must amend their DEA registrations to become DEA authorized collectors.
Under the RCRA regulations in 40 Code of Federal Regulations, part 266 subpart P, EPA continues to consider collected household pharmaceuticals exempt from RCRA hazardous waste regulation under the household hazardous waste exclusion. However, 40 CFR section 266.506 of part 266 subpart P requires that household pharmaceuticals collected in take-back kiosks at hospital and retail pharmacies must:
- Not be disposed of down the drain (i.e., flushed or put down the sink).
- Be managed in compliance with all applicable DEA regulations.
- Be destroyed either by:
- Being combusted in:
- Hazardous waste combustors.
- Large and small municipal waste combustors.
- Hospital, medical, and infectious waste incinerators.
- Commercial and industrial solid waste incinerators.
- Another method that DEA has publicly deemed in writing to meet their non-retrievable standard.
- Being combusted in:
Note that DEA stated publicly that incineration is currently the only method of destruction that meets the DEA’s non-retrievable standard. So, at this time, incineration is the only option available to meet the conditional exemption for the handful of RCRA hazardous waste pharmaceuticals that are also DEA controlled substances.
EPA’s conditional exemption at 40 CFR section 266.506 is self-implementing. If and when DEA determines that a technology other than incineration meets their non-retrievable standard, it will automatically satisfy the EPA conditional exemption with no action required by EPA. EPA built flexibility into the conditional exemption to allow for future innovation without changes to 40 CFR section 266.506.
How DEA Regulates the Collection and Disposal of Pharmaceuticals Collected in Take-back Kiosks
DEA regulations require DEA-authorized collectors to use opaque liners inside the take-back kiosks. When DEA-authorized collectors purchase those liners, they typically include pre-paid, pre-addressed outer packaging that is Department of Transportation compliant, allowing them to be shipped to a DEA-registered reverse distributor. Approximately 35 DEA-registered reverse distributors are authorized by DEA to accept shipments of collected household pharmaceuticals. Note that the list of DEA-registered reverse distributors varies over time. Contact the DEA at ODLP@dea.usdoj.gov for an up-to-date list of DEA-registered reverse distributors.
For additional details about the DEA regulations pertaining to pharmaceutical take-backs, read volume 79 of the September 9, 2014 Federal Register on page 53520 and 21 CFR parts 1301-1317.
Becoming an Authorized DEA Drug Collector
For information about amending your DEA registration to become an authorized DEA collector and installing a take-back kiosk for collecting unwanted household medicines, read the following websites:
- The DEA Registrant Drug Disposal section on their Drug Disposal Information webpage.
- Product Stewardship Institute’s How-to Guide for Drug Take-back (pdf)(1.851 MB).