Does your organization perform research with the use of controlled substances? Controlled Substances are materials that are regulated by the Drug Enforcement Agency (DEA) due to their potential for abuse. They are listed in Title 21 of the Code of Federal Regulations, Section 1308 (21 CFR 1308), organized into five “schedules” (Schedule I – V) based on the potential for abuse. Ketamine, testosterone and diazepam are examples of controlled substances that are widely used in research and development.
Possession and use of controlled substances is regulated by the DEA and when an organization has unused controlled substances that are expired or no longer needed, the organization must go through the proper outlet to dispose of the hazardous materials and comply with DEA requirements. ACTenviro is that outlet!
The process is different for Schedule I and II substances, which are more tightly-regulated than Schedule III, IV and V substances. In general, though, we will need an exact inventory, including container size, whether it is opened or un-opened, quantity remaining in the container and the national drug code (usually printed on the container). We will also need a copy of the organization’s active DEA license. ACTenviro personnel will usually come to the site to collect this information, because it is so important.
Once we have this information, we will complete any required documentation (such as DEA form 222 for Schedule I/II substances) and submit to an appropriate disposal facility or reverse distributor. Note that review and approval of DEA form 222 by the disposal facility may require 2-3 weeks and disposal cannot proceed until the approved form is received by the customer. ACTenviro will coordinate all aspects of the shipment of the controlled substances to the disposal facility using an express carrier (e.g. FedEx or UPS), including packaging of the materials, delivery to the carrier and tracking of the package in transit. Once the disposal facility
receives the package, it will provide documentation (such as DEA form 41) that customers can retain as documentation of proper disposal.
Note that these procedures only apply to unused controlled substances. There are separate procedures to account for breakage or spillage of unused controlled substances, and once the controlled substances are used for their intended purposes (based on the DEA permit), they are no longer subject to DEA regulation and any associated wastes will be evaluated with respect to hazardous waste criteria.
Disposal of controlled substances can be very complicated, and improper disposal can put a facility’s license at risk. ACTenviro is always available to help, so please contact us with any controlled substance, hazardous waste or other disposal needs!
– Nicole R. Martinez, Account Manager