Significant Loss

How does the DEA define significant loss? That is a question many of you who oversee controlled substances have asked over the years. I have asked myself this same question. I recently listened to a webinar by a DEA Diversion Investigator. He reminded the audience that anytime you see a Code of Federal Regulations (CFR) statement, the DEA expects you to conform to the regulation. He specifically referenced 21 CFR 1301.76b which states:

The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.

He stated, “If you have a theft or significant loss, within 24 hours, one business day, you are required to fill out that DEA form 106. That’s it.” He then went on to pose the question on all our minds, “So, what is significant loss?” And his answer, “For the DEA, it is everything. If you lose one pill, it’s significant to us.” What?! He then went on to acknowledge that each place of business may see it a bit differently, so the DEA allows us to define what is significant at our place of business, within reason, of course. They allow us to make the determination, submit the 106 Form on whatever loss is significant for our business with the “understanding that at some point in time if the DEA comes in and conducts an audit and we see that you’re 100 pills short, we’re going to ask questions.”

Have we come full circle? Bottom line, the DEA cares about every single controlled substance. They also recognize that the “small” amounts of loss happen so they allow for an individualized definition of significant loss that takes several things into account. See my previous post, What is Considered Significant Loss, for a list of these considerations. A word of caution though, don’t be too liberal with your definition as it may find you in the hot seat with the DEA should they come calling!

Terri Vidals
Terri Vidals

Terri has been a pharmacist for over 30 years and is a drug diversion mitigation and monitoring subject matter expert. Her years of experience in various roles within hospital pharmacy have given her real-world insight into risk, compliance, and regulatory requirements, as well as best practices for medication and patient safety.

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