Who Must Comply?

Beginning in 2007 and continuing throughout 2008, the DEA made high profile examples of the "Big Three" in a renewed effort to bring Controlled Substance Registrants into compliance with Suspicious Order Monitoring (CFR 21 1301.74b). The DEA imposed strict sanctions and significant fines on Cardinal, McKesson, and AmerisourceBergen.



Business Wire; Apr 25, 2007
AmerisourceBergen Receives DEA Order to Temporarily Halt Distribution of Controlled Substances from Its Orlando, Florida Facility.

U.S. Newswire; Oct 2, 2008
Cardinal Health Inc., Agrees to Pay $34 Million to Settle Claims That it Failed to Report Suspicious Sales of Widely-Abused Controlled Substances

U.S. Newswire; May 2, 2008
McKesson Corporation Agrees to Pay More Than $13 Million to Settle Claims That It Failed to Report Suspicious Sales of Prescription Medications



More recently, the DEA has instituted a shift in their enforcement of SOM Compliance away from the "Big Three" to small and medium size business.

Unfortunately, Masters Pharmaceutical, Harvard Drug Group, and Sunrise Wholesale Inc. have all been targeted by the DEA for noncompliance with anti-diversion mandates in DEA 21 CFR 1301.74b. In some cases the investigations continue, as does the press coverage.

What is Suspicious Order Monitoring and DEA 21 CFR 1301.74b?

The SOMLink™ Solution

SOMLink™ is a suite of analytic and order management tools designed to automate suppliers' compliance with DEA 21 CFR 1301.74b

Features and Benefits Overview