Suspicious Order Reports

The Chronicles welcomes guest blogger Katea Ravega, a Q&B Health Law attorney.

In a 308-page decision dated September 8, 2015, the new Acting Administrator of the DEA, Chuck Rosenberg, issued an Order revoking the DEA registration of wholesale distributor Masters Pharmaceuticals, Inc. (“Masters”). In doing so, the Administrator rejected the recommendation from DEA’s

Just when you thought it was safe to have a robust order monitoring program to detect and report suspicious orders, DEA has moved the goal post.  In previous posts (here and here), we’ve talked about DEA’s “extra-regulatory” guidance on both suspicious orders and “due diligence”.  In late February-early March, the DEA held a

…to infinity and beyond! For years manufacturers and distributors have searched for the holy grail of DEA compliance – specific guidance from DEA on what actually constitutes a suspicious order.  The obvious source of assistance and the sole legal basis establishing the requirement to detect and report suspicious orders is found in DEA’s own regulations.