DEA Launches Improved System for Registered Drug Manufacturers, Distributors to Combat Opioid Epidemic

DEA Launches Improved System for Registered Drug Manufacturers, Distributors to Combat Opioid Epidemic

DEA regulations require distributors to know their customers and develop a system to identify and report orders that seem suspicious. This new tool will help manufacturers and distributors make informed choices about whether new customers are purchasing disproportionate amounts of controlled substances.

The Drug Enforcement Administration announced Tuesday the launch of an improved system to help more than 1,500 registered drug manufacturers and distributors in the U.S. more effectively identify potential illicit drug diversion and work against the opioid epidemic.

In October, President Trump signed into law the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act.” A provision in the bill requires the DEA to give drug manufacturers and distributors access to anonymized information via the Automated Reports and Consolidated Orders System (ARCOS) to help them identify, report, and stop suspicious orders of opioids and reduce the rate of diversions.

ARCOS is an extensive drug reporting system that monitors the distribution of controlled substances from the point of manufacture through commercial drug supply chain channels to the point of sale to the retail level. ARCOS neither collects nor contains any data on sales to the ultimate users of the substance, i.e. patients.

Last February, DEA launched a new tool in the ARCOS Online Reporting System to help drug manufacturers and distributors fulfill their regulatory obligations under the Controlled Substances Act. The new requirement in the SUPPORT Act improves upon this tool and the administration is releasing a further enhancement to the ARCOS Online Reporting System.

The new enhancement will allow manufacturers and distributors registered with the DEA to view and download the number of distributors and the amount (anonymized data in grams and dosage units) each distributor sold to a prospective customer in the last available six months of data. The resource is part of DEA’s work to collaborate with its 1.8 million registrants to combat the ongoing opioid epidemic in the U.S.

DEA regulations require distributors to know their customers and develop a system to identify and report orders that seem suspicious. This new tool will help manufacturers and distributors make informed choices about whether new customers are purchasing disproportionate amounts of controlled substances by providing valuable information for distributors to consider as part of their assessment.

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