DEA Pharmaceutical Wastage
The DEA (Drug Enforcement Agency) regulates the disposal of DEA controlled substances for DEA registrants.
Often, a common question from healthcare facilities and pharmacies is “How do we properly dispose of our controlled substances”? To which I reply “That depends”. According to the DEA, controlled substances and their subsequent disposal falls into two types. Those two types being “Inventory” and “Pharmaceutical Wastage”. Compliant disposal entails determining what type of DEA control you have and then managing that disposal accordingly. In the below summary, I’ve outlined the major differences along with the recommended disposal methods. Note, this guidance is related to DEA federal regulations. State and local regulations may be stricter so check with them before implementing any plan.
INVENTORY
- Definition – DEA controlled substances that are part of your current inventory or stock that have not been dispensed.
- Examples – Undispensed Fentanyl that is still on your pharmacy shelf. Undispensed Ketamine that is expired and destined for a reverse distributor for potential credit.
- Recommended Disposal – Send to a DEA registered reverse distributor for disposal. Make sure they are Drug Distributor Accredited through NABP. We can provide assistance if needed.
- Note – DEA’s non-retrievable standard applies. Therefore, never use medicine disposal devices to dispose of any DEA controls that are considered in INVENTORY.
PHARMACEUTICAL WASTAGE
- Definition – Per a DEA letter to Practitioner, it is the remaining DEA controlled substance left over after being dispensed out of your INVENTORY and administered to a patient.
- Examples – Diazepam solution that is left in the syringe after being administered to a patient. Left over Ketamine that has been dispensed from inventory but not fully administered to a patient.
- Recommended Disposal – Use a medicine disposal device, such as PAC-RX™ for the temporary storage of DEA controls prior to being sent to an incinerator for disposal. Properly document by two witnesses the DEA controlled substances going into the PAC-RX™ medicine disposal device. Never place used medicine disposal devices directly in the trash as this is likely a violation of federal, local, state or landfill regulations.
- Note – DEA’s non-retrievable does not apply. There are no specific DEA regulations for disposal, however, DEA recommends implementing procedures to prevent diversion. For security and recordkeeping refer to CFR Title 21 Section 1304.22(c). Lastly, once a drug has been deemed pharmaceutical wastage, it can no longer be placed back into inventory.
It is also important to point out that some DEA controlled substances are also RCRA hazardous waste by the EPA. This adds yet another layer of complexity to the issue of compliant DEA control disposal. The recommended disposal procedures could vary depending on several variables such as what state you are in, the adoption of EPA’s Subpart P and the reverse distributor’s disposal method. Contact us directly for additional guidance in this area.
This article was meant to provide a brief informational overview of the sometimes complex area of DEA control disposal. It is not meant to be all encompassing legal advice. Seek professional legal advice for that. For here, you get what you pay for.