DEA Form 106: Theft or Loss of Controlled Substances

Discovering a Theft of Controlled Substances

Must contact the nearest DEA Diversion Field Office upon discovery

Notify local police

Complete DEA Form 106 Report of Theft or Loss of Controlled Substances 

If review shows no actual controlled substance loss, then Form 106 is not needed.  Inform DEA in writing to close the initial report. 

Link to PDF of DEA Form 106: https://www.deadiversion.usdoj.gov/21cfr_reports/theft/DEA_Form_106.pdf

Federal Investigation of Pharmaceutical Theft or Robbery

A Federal Investigation occurs if any one or more of the following:

Replacement cost of controlled substances is ≥ $500

Someone is killed or suffers significant injury

Interstate or foreign commerce is involved in planning or executing the crime  

In-transit Loss

If an in-transit loss occurs, the supplier is responsible for reporting the loss.  

The pharmacy is only responsible after signing for the shipment.

Pharmacy Employment Practices

Pharmacy must not employ anyone with a controlled substance felony on record or anyone who has had a DEA registration denied, revoked or suspended.

A waiver may be approved in certain situations but will only be considered for approval if diversion is unlikely to occur.

DEA Form 41: Destruction of Controlled Substances

Two Methods:

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 Request DEA authorization to destroy damaged, outdated, and/or unwanted controlled substances 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

Hospital/Institution Pharmacy Controlled Substances

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

Must still complete a DEA Form 41

Source: deadiversion.usdoj.gov

Link to DEA Form 41: https://www.deadiversion.usdoj.gov/21cfr_reports/surrend/41_form.pdf

DEA Applications and Forms

The DEA applications, renewals and forms were on every MPJE I have taken in one way or another.

Over the next several weeks we will do a deeper dive into each type of application and renewal or form to learn the details.

Basics

What is the DEA?

Stands for Drug Enforcement Administration

Part of the United States Department of Justice

Responsible for the Controlled Substances Act

Those who are authorized to possess controlled substances must be registered by the DEA. 

Pharmacists typically do not need to register individually with the DEA if they are working in a registered organization.