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Regulatory Focus™ > News Articles > 8 > DOJ, DEA Seek 10% Reduction in Opioid Manufacturing

DOJ, DEA Seek 10% Reduction in Opioid Manufacturing

Posted 16 August 2018 | By Zachary Brennan 

DOJ, DEA Seek 10% Reduction in Opioid Manufacturing

The Department of Justice (DOJ) and US Drug Enforcement Administration (DEA) on Thursday announced they are seeking a 10% reduction in manufacturing for the six frequently misused opioids for 2019.

The proposal would impact the manufacturing of more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. DEA said the quota was set in consultation with the US Food and Drug Administration and other data and forecasts.

Once the aggregate quota is set, DEA said that it allocates individual manufacturing and procurement quotas to companies that apply. DEA may revise a quota if there is an increase or decrease in sales or if there are new exports or manufacturers entering the market, new product developments or recalls. 


“Ultimately, revised limits will encourage vigilance on the part of opioid manufacturers, help DEA respond to the changing drug threat environment, and protect the American people from potential addictive drugs while ensuring that the country has enough opioids for legitimate medical, scientific, research, and industrial needs,” the agencies said in a joint statement.

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