Posted Sept.15, 2005
To clarify existing regulations, the Drug Enforcement Administration has made several amendments, which were effective Sept. 12, to the Code of Federal Regulations. Registered practitioners are now responsible for notifying their local Field Division Office, in writing, of any theft or substantial loss of any controlled substances within one business day of discovering the theft or loss. Practitioners should also complete, and submit to the office, DEA Form 106 regarding the theft or loss. Finally, practitioners should consider six factors—at the minimum—when determining whether a loss is substantial.
Previously, the regulation required practitioners to notify the DEA "upon discovery" of theft or substantial loss. There was confusion within the industry as to the exact meaning of the phrase "upon discovery," and the DEA proposed inserting the word "immediately" before the phrase to clarify the point. After receiving comments in response to the notice of proposed rule making that was posted July 8, 2003, the DEA amended the rule to read "within one business day."
Following the initial written notification to the DEA and when the circumstances surrounding the theft or loss are clear, the practitioner should submit DEA Form 106. Updates should be provided to the DEA if the investigation takes more than two months.
After posting the notice of proposed rule making, the DEA received suggestions on how to make DEA Form 106 a more useful report. In response, the administration has scheduled a revision of the form within the next year.
Along with "upon discovery," the regulation's original phrase "significant loss" also created confusion within the industry. The DEA recognized there is no single objective standard that can be applied to all registrants; what constitutes a substantial loss for one registrant may be insignificant for another. Any unexplained loss or discrepancy must be reviewed within the context of a registrant's business activity and environment. The DEA added a list of factors to consider when determining whether a loss is substantial.
A practitioner should—at the minimum—consider the following factors:
- the actual quantity of controlled substances lost in relation to the type of business
- the specific controlled substances lost
- whether the loss of the controlled substances 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 substances
- a pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses
- if known, whether the specific controlled substances are likely candidates for diversion
- local trends and other indicators of the diversion potential of the missing controlled substances
The DEA distinguished breakage and spillage from theft or substantial loss. Substances that are broken or spilled are not considered lost because the practitioner can account for them. Additional guidance on record keeping and disposal can be found in the DEA's notice of proposed rule making at the Office of Diversion Control's Web site, www.deadiversion.usdoj.gov/fed_regs/rules/2003/fr0708.htm.
For further information on the amendments, log on and click on "Reports by Registrants of Theft or Significant Loss of Controlled Substances." The DEA Form 106 may be found at the office's main Web site.