Pharmaceutical manufacturers and distributors have the responsibility to design & operate a system to disclose suspicious orders of controlled substances to the DEA.  Over the past three years, there have been numerous cases of DEA sanctions resulting from non-compliance with “DEA 21 CFR 1301.74 b: Suspicious Order Monitoring”.

In April 2007, the DEA orders AmerisourceBergen to suspend shipments from its Orlando distribution center.  The distribution center did not reopen until August 25, 2007.  http://www.contractormisconduct.org/ass/contractors/7/cases/576/629/amerisourcebergen-dea-lax-controls_pr.pdf

In late 2007, Cardinal Health had 4 distribution centers suspended.  The DEA charged that Cardinal was distributing excessive amounts of controlled substances to pharmacies that were then selling the products illicitly.   As a result of these suspensions, in 2008 Cardinal paid a $34-million “settlement” without admitting any wrongdoing.  http://www.pharmaceuticalcommerce.com/frontEnd/main.php?idSeccion=972

The DEA requires REGISTRANTS TO DESIGN AND OPERATE SYSTEMS TO DISCLOSE SUSPICIOUS ORDERS OF CONTROLLED SUBSTANCES.
» Read more: Pharmaceutical Suppliers: How are you handling DEA requirements for “Suspicious Order Monitoring”?