DEA Controlled Substance Disposal Guidelines
Background: The Drug Enforcement Agency's (DEA) Office of Diversion Control (see in 21 CFR 1304, www.deadiversion.usdoj.gov) regulates the disposal of DEA controlled substances. This Office's primary goal is to eliminate the diversion of legitimately manufactured (or used) controlled substances into the illicit drug traffic. DEA controlled substances may only be obtained by those personnel or organizations that complete DEA's registration process. An individual Researcher (i.e. PI) or Department may register with the DEA as a 'Researcher'. This registration grants the PI or Department the authority to purchase and use, for research purposes, DEA controlled substances. Once a PI or Department obtains a DEA controlled substance, they have the responsibility (under DEA regulations 21 CFR 1304) to track the use, security and disposition of these substances. DEA enforcement personnel may ask a PI or Department to account for DEA controlled substances listed in their registration. It is important to maintain all waste disposal records to allow for the accurate accounting of your DEA controlled substances.
A PI or Department that intends on disposing DEA substances have two disposal options. Harvard's EH&S Department will assist PI's and Departments with these options:
OPTION 1: Destruction ('Witness Burn') - This involves the transport of the DEA waste substances to a DEA-approved incinerator. Here, the DEA waste substances must be destroyed in the presence of the PI (or a representative), a federal official (typically U.S. Marshall's office) and local law enforcement official. This option is presently not widely used by the research community.
OPTION 2: Reverse Distribution Registrant - This options transfers ownership of the DEA waste substance to a DEA-approved Pharmaceutical Returns Processor for re-use, re-sale or destruction. This process involves the completion of various forms and paperwork including, but not limited to, completing DEA Form 222 (for Schedule I and II) or Form 41 (for Schedule III, IV, V substances). In order to accurately complete these forms, the PI or Department must have the original registration information for each DEA substance. Copies of Form 222 and 41 (other shipping documentation vendor, shipping receipts) must be maintained by the PI or Department for two years.
The process for Option 2 is outlined below:
- Lab representative gathers and writes down information about the DEA waste substance to assist with necessary paperwork including: Manufacturer, Substance name (as it appears on label), Form (Ample, 1ml/1 pouch/50 mg tablet, etc. % purity), actual amount, container size, Lot#, CAS# and National Drug Code (NDC)#.
- Lab representative contacts the EH&S Hazardous Waste Services Line 6-3322 or https://www.uos.harvard.edu/cgi-bin/ehs/ehs-bin/hw_services.pl to initiate disposal process for DEA waste substance(s). Although EH&S cannot physically remove the substance from the lab, EH&S assists lab personnel to coordinate removal of the substance via a 3rd party waste contractor (e.g. Triumvirate Environmental Inc.(TEI)/Clean Harbors) who have established business relationships with DEA-approved Pharmaceutical Returns Processors.
- EH&S will coordinate contact between lab representative and 3rd party waste vendor.
- Waste vendor works with lab represenative to complete necessary paperwork and any communications necessary with DEA and/or Pharmaceutical Returns Processor.
- Waste vendor assists lab represenative with packaging substances and coordinating waste shipment removal. Waste vendor & disposal services will be paid directly by lab.
- Lab representative retains DEA forms and associated paperwork for a minimum of two years.
Please Note:
1. DEA controlled substances are listed on five separate DEA lists (Schedules I, II, III, IV, V). Designation on one of these Schedules is based primarily by the substances propensity to become addictive (i.e. Schedule I contain substances that are highly addictive in nature, Schedule V the least addictive).
2. "Orphaned" DEA Substances: In situations when "orphaned" or abandoned DEA substances are discovered during lab clean-outs, transfers, etc, a concerted effort must be made by Department to determine how these substances were originally obtained. The original PI or Department that obtained these DEA substances are responsible for its disposal. If the original PI or Department are unknown or not available, disposal of these substances can be difficult and is treated by DEA on a case-by case basis. In some cases, resolution requires the Department to submit a letter(explaining circumstances) to the DEA and requesting the transfer of ownership of these materials to an active PI or Department registration or permission to denature the DEA substance with a solvent (or other substance) to render it unrecoverable.
