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.
This DEA mandate describes Suspicious Orders as having a significant deviation in;
• Order Size (Quantity)
• Order Frequency
• Order Pattern
e-SupplyLink is currently building a “Suspicious Order Management” system for a pharmaceutical supplier in South Carolina: www.e-supplylink.com/som.htm. We are looking for input. How are pharmaceutical suppliers handling the DEA requirement for “Suspicious Order Monitoring”?
