'Know your customer's customer' is the advice for controlled-substances distribution


Cegedim meeting focuses on compliance issues in pharma distribution

A new spate of counterfeit drugs showing up in US clinics; a major wholesaler in trouble with DEA; and ongoing legislative debates over wholesaler licensure and inspections are all pointing to an intensified focus on pharma distribution. So, the timing of the 15th Annual Controlled Substances, PDMA and State Conference (April 18-20, National Harbor, MD) from Cegedim Compliance Solutions (Richmond, VA) couldn’t be better.

Ron Buzzeo, chief compliance officer at Cegedim Compliance Solutions, says that DEA is intensifying its focus on drug distributors, due primarily to the ongoing epidemic of abuse of opioids—but manufacturers (of all controlled substances, not just opioids) need to be on guard. “The law in this area has been clear—everyone involved must monitor where these drugs are going, and to verify the monitoring systems of your trading partners. In other words, ‘Know your customer’s customers.’” And while there are a variety of dedicated IT systems available to provide this monitoring, Buzzeo says that the process can’t be left to an automated system. “The system is only as good as the people who are operating it,” he says. “Training is critical, and establishing a comprehensive set of business rules, and then applying them consistently, is key.”

Besides DEA compliance, the meeting will feature sessions on the Verified Authorized Wholesaler Distributor (VAWD) program—the inspection process for which has become more complex in recent months; sample accountability programs regulated under the Prescription Drug Marketing Act (PDMA); and aggregate-spending compliance rules under the Physician’s Sunshine Act. Conference details are available here.

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