Factors to Consider when Determining the Significance of a Loss of Controlled Substances during Registration

When determining whether a loss of controlled substances is significant, a registrant should consider the following factors:

The actual quantity of controlled substances lost in relation to the type of businessThe specific controlled substances lostWhether the loss can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substancesA pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts to resolve the lossesWhether the specific controlled substances are likely candidates for diversionLocal trends (if known) and other indicators of the diversion potential of the missing controlled substance

When determining whether a loss of controlled substances is significant, a registrant should consider the following factors:

1. The actual quantity of the substance lost: The amount lost will be a significant determinant in deciding the magnitude of the loss. A large amount lost will be more significant than a small amount.

2. The type of controlled substance involved: Some controlled substances, such as highly addictive opioids or stimulants, have a higher potential for abuse and diversion than others. Losing these substances may be considered more significant.

3. The specific circumstances surrounding the loss: How the substance was lost can also play a part in determining the significance of the loss. For example, if the substance was stolen, this could be considered a significant loss.

4. The potential harm or danger that could result from the loss: If the loss could lead to a potential danger to public health or safety, it would be considered more significant.

5. The registrant’s compliance history: A registrant’s past compliance history could play a role in determining the significance of a loss. If the registrant has a history of noncompliance, the loss may be considered a more significant violation.

Overall, the above factors should be taken into consideration in evaluating whether a loss of controlled substances is significant. The DEA may investigate and take appropriate action against a registrant who fails to report a significant loss of controlled substances.

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