Controlled substance disposal process
The disposal of controlled substances is the responsibility of the licensed registrant. Controlled substance registrants have two disposal options available for expired or waste controlled substances.
To minimize waste, DEA registrants must only purchase quantities they intend to use. Damaged, expired, unwanted, unusable, or non-returnable controlled substances must be accounted for, retained, and disposed of in accordance with applicable state and federal regulations. The Indiana Professional Licensing Agency and the United States Drug Enforcement Administration (DEA) have determined that expired controlled substances must be discarded within 30 days following the date of expiration. Failure to dispose of expired medications within this time limit may result in the issuance of a warning or citation during an on-site inspection.
The Registrant Record of Controlled Substances Destroyed, DEA Form 41, is necessary to document proper disposal.
A copy of DEA Form 41 must be retained on file following disposal of any DEA controlled substance. It must be retained by the registrant for at least two years.
Disposal records must contain:
- DEA number, name, and address (if applicable).
- The reverse distributor’s DEA number, name, and address.
- The number of units (in finished forms and/or commercial containers) disposed of in any manner, including the manner of disposal.
The disposal record must be dated to reflect when the products were sent for destruction and removed from inventory.
The following are disposal options for expired or unwanted controlled substances. IUEHS must be contacted to help determine the correct disposal method.