The Drug Enforcement Administration’s Final Rule on Theft and Significant Loss Reporting: We Can See More Clearly Now

April 1, 2006

The pharmacist in charge of Kilgoban Pharmacy is conducting a routine inventory. When comparing the actual on-hand quantity of schedule II drugs with a computergenerated printout of the theoretical count, the pharmacist finds that the oxycodone 40 mg. tablet counts do not match. In fact, the audit shows a possible shortage of about 100 tablets. The pharmacist knows that something has to be done; after all, a schedule II drug may be missing, but what?

To comply with federal requirements, the hypothetical pharmacist must understand DEA’s rule on controlled substance theft and significant loss reporting. The failure to report, or even reporting in what DEA determines is an untimely manner, could lead to the agency pursuing civil or administrative action against the pharmacy or its DEA registration. DEA recently amended its rule on controlled substance theft and significant loss reporting, making important substantive changes and providing guidance on loss reporting. This article analyzes DEA’s new rule and what it means for pharmacies and other DEA registrants.