Quotas Increased For Controlled Substances Which Treat COVID-19 Patients
Since the beginning of the COVID-19 pandemic, the US Drug Enforcement Administration (DEA) has been implementing measures aimed at improving access and reducing barriers to controlled substances for patients in need.
To prevent potential inventory constraints, the DEA announced on April 7, 2020, that it is increasing Aggregate Production Quotas (APQ) available to pharmaceutical manufacturers for the production of controlled substance medications that are in high-demand due to the coronavirus (COVID-19) pandemic.
The DEA 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.
The APQ 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 will also increase the APQ for methadone for opioid treatment programs and 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 the production of these important drugs, should the need arise.”
Last week, the 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.
The DEA’s mission is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.
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