A New Standard For Suspicious Order Monitoring: Part 1
By Kenneth Weinstein, Crystal Pike and Nicholas Van Niel ( August 21, 2017, 5:40 PM EDT) -- As the opioid crisis continues to be a top public health priority, the "Suspicious Order Monitoring (SOM) requirement" has become an increasingly important enforcement tool for the U.S. Drug Enforcement Agency. In the past year alone, several significant settlements and court decisions have resulted from enforcement of this requirement, a regulatory clause that dates back to changes to the 1970 Controlled Substances Act (CSA) enacted in 1971. These recent developments point to enhanced DEA expectations for compliance and escalated penalties for noncompliance throughout the prescription opioid distribution chain. Two recent enforcement resolutions are the D.C. Court of Appeal's upholding of the DEA's decision to revoke Masters Pharmaceuticals controlled substance registration and the DOJ/DEA settlement with Mallinckrodt....
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