1. Request DEA authorization to destroy damaged, outdated, and/or unwanted controlled substances
Once per calendar year for retail pharmacies through the nearest DEA Division Field Office
Complete DEA Form 41 (Registrant’s Inventory of Drugs Surrendered)
Write a letter to the DEA to request permission to destroy, including: date and method of destruction, names of 2 people who will be witnesses (physician, pharmacist, physician assistant, nurse practitioner, nurse or law enforcement officer)
Send letter and DEA Form 41 at least 2 weeks prior to proposed destruction date and await written decision
Once destroyed, signed and completed copies of DEA Form 41 must be forwarded to the DEA
Exception to prior authorization: If a member of a state law enforcement authority or regulatory agency witnesses the destruction, then prior authorization from the nearest DEA Diversion Field Office or local DEA Special Agent in Charge is not required
Copies of a DEA Form 41 or state controlled substance destruction form must be forwarded to the local DEA Diversion Field Office after the destruction
2. Forward controlled substances to a DEA registered distributor who handles the disposal of drugs
Can be done at anytime
Local DEA Division Field Office can provide an updated list of distributors
The distributor must issue a DEA Form 222 to the pharmacy if CII medications are included
For CIII-CV, the pharmacy should document drug name, dose form, strength, quantity and date transferred in writing
The DEA registered distributor who will destroy the controlled substances is then responsible for submitting DEA Form 41 to the local DEA Diversion Office
Must keep records of dispensing, destruction, disposal including:
Patient name with date of birth or medical record number as second identifier
Drug name, dose and dose form
Prescriber
Name of individual that dispenses
Name of individual that administers
Date and time of administration
Name of witness observing disposal of unused drug
“Blanket Authorization”
Issued on a very limited basis for registrants associated with hospitals, clinics or others needing to dispose of used needles, syringes and other injectable objects only
Granted due to the contamination by hazardous body fluids
Requests for ”blanket authorization” are based on:
Frequency of destruction and volume involved
Method of destruction – must be incinerated or other method involving complete destruction
Registrant’s history
Security at the pharmacy or registered location
Name and title of the person responsible for destruction