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U.S. Department of Justice announces new opioid diversion rule

by Mary McNitt | Jul 20, 2018

In a step to combat the opioid epidemic, the United States Department of Justice (DOJ) recently announced final adoption and publication of a new rule related to drug diversion and opioid production limits. Under the adopted final rule, the Drug Enforcement Administration (DEA) must now take into consideration the extent of a drug’s diversion in the system when it sets the annual production limit for that specific drug.

The rule will give the DEA leeway to reduce the amount of the drug that can be produced by the manufacturer in a given year if the agency believes a particular opioid has a high rate of diversion for misuse. The goal is to reduce the amount of a drug available in the marketplace to decrease diversion and to make the manufacturer aware of the drug’s misuse and diversion. It is believed this will help create better vigilance among stakeholders and protect Americans from potentially dangerous and addictive drugs.

The rule also requires the DEA to share notices of proposed production quotas and final production quota orders with the state attorneys general. It also calls for greater input from the U.S. Department of Health and Human Services, the Food and Drug Administration, the Centers for Disease Control, the Centers for Medicare and Medicaid Services as well as the states when developing and administering the production quotas. 

Details of the DOJ report can be viewed here.

Our Government Affairs Team continues to track opioid policy development at the federal and state levels. If you have questions regarding this or any other policy, please contact us at AskGovtAffairs@optum.com.


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