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Saturday, March 25, 2023

DEA Takes Additional Steps to Allow Increased Production of Controlled Substances Used in COVID-19 Care

The Drug Enforcement Administration announced today that it is increasing Aggregate Production Quotas available to pharmaceutical manufacturers for the production of controlled substance medications that are in high demand due to the coronavirus (COVID-19) pandemic.  DEA will also approve increases in imports of medications necessary for patients on ventilators.

“DEA is committed to ensuring an adequate and uninterrupted supply of critical medications during this public health emergency,” said Acting Administrator Uttam Dhillon.  “This will ensure that manufacturers can increase production of these important drugs, should the need arise.”

Aggregate Production Quotas for the schedule II controlled substances increased today represent the total amount necessary to meet the country’s medical, scientific, research and industrial needs, lawful export requirements, and for the establishment and maintenance of reserve stocks.  DEA has issued a final order to increase the 2020 APQ by 15 percent for certain substances needed for the treatment of COVID-19, including fentanyl, morphine, hydromorphone, codeine, ephedrine, pseudoephedrine, and certain controlled substance intermediates which are essential to their production.  DEA will also increase the APQ for methadone to ensure that opioid treatment programs have sufficient supplies to treat patients suffering from opioid use disorder.

In addition, DEA is increasing the authorized amounts of certain schedule III and IV controlled substances that may be imported into the United States, including ketamine, diazepam, midazolam, lorazepam, and phenobarbital, which are also necessary to treat patients on ventilators.

These increases apply to controlled substances identified by the U.S. Department of Health and Human Services as impacted by COVID-19.  After the health emergency recedes, DEA will reevaluate demand and adjust APQ levels as needed.

Since the beginning of the pandemic, DEA has been implementing measures aimed at improving access and reducing barriers to controlled substances for patients in need.  DEA continues to work closely with its federal partners, DEA registrants, and their respective associations to monitor the supply of controlled substances and medications in the United States.  Last week, DEA issued a temporary exception to its regulations so that manufacturers can increase their inventory of schedule II controlled substances, which will help to ensure that production and distribution are not interrupted.  In addition, DEA proactively reached out to manufacturers and has been expediting individual requests for quota to meet production needs.

Read more at DEA

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