The Drug Enforcement Administration (DEA) has announced a change to its annual aggregate production quota (APQ) allocation for Schedule II controlled substances, rolling back its recent implementation of a quarterly allocation process. In November 2023, DEA proposed shifting APQ allocation from an annual to a quarterly basis. The agency argued that this was necessary to enable a more timely response to demand shifts and to ease excess quota allocation to manufacturers with capacity. ASHP raised concerns regarding this approach, but DEA moved ahead with the quarterly APQ allocation in January 2024.
Unfortunately, the quarterly allocation process had unintended adverse consequences, including delaying delivery of APQ allocations, which consequently delayed production and limited manufacturers from planning the production of CII products, including sterile injectables.
Given the long history of shortages in the CII space, particularly for sterile injectable products, ASHP immediately raised concerns with policymakers regarding the potential for the new APQ process to hinder production and create shortages. In response, DEA has announced to manufacturers that APQ allocation will return to an annual schedule for sterile injectable products and a semi-annual schedule for non-injectable products.
“We applaud DEA for its responsiveness to clinical concerns around the APQ allocation process,” said Tom Kraus, ASHP vice president of government relations. “While this shift isn’t a magic bullet for shortages, it does remove one significant threat to CII supply. However, we remain extremely concerned that some manufacturers have yet to receive a quota for this quarter.”
ASHP will continue to update members as DEA makes additional information available. For questions or concerns about the DEA change or drug shortages, please contact Jillanne Schulte Wall.
