DEA’s recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.
On February 29, the U.S. District Court for the District of Columbia lifted a temporary restraining order preventing the enforcement of an Immediate Suspension Order (ISO) issued by the U.S. Drug Enforcement Administration (DEA). The ISO suspending Cardinal Health Inc.’s (Cardinal’s) controlled substance distribution license for its Lakeland, Florida, facility can now be enforced. In issuing its decision, the court agreed with DEA’s assertion that drug distributors have an affirmative obligation to monitor for and investigate evidence of diversion. The decision has implications for both distributors and pharmacies, as DEA’s position expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.
DEA investigated Cardinal’s Lakeland, Florida, facility and two pharmacies run by a major national pharmacy chain as part of its ongoing efforts to combat Florida’s prescription drug abuse epidemic. On February 2 and 3, DEA served an ISO to Cardinal, alleging that the distributor failed to implement controls to monitor for and detect diversion. For instance, the DEA investigation found that Cardinal shipped 50 times as much oxycodone to its four top pharmacies in Florida as it did to its other retail customers.
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