DEA’s finalized annual aggregate production quotas (APQs) for 2018 mandate a 20% reduction in the amount of opiate and opioid medication—including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine, and fentanyl—that may be manufactured in 2018. Quotas are aimed at preventing a diversion while simultaneously satisfying annual needs.
APQs establish the total amount of opioids and other controlled substances necessary to meet the estimated medical, scientific, research, industrial, and export needs for 2018 and to maintain adequate reserve stocks. DEA says 2018’s cuts are a response to reduced demand.
Quotas may be appealed at any time during the year on the basis of increased sales or exports, new manufacturers entering the market, new product development, or product recalls.
Critics of DEA’s decision have expressed concerns that the reduced quota could lead to drug shortages and negatively affect pain management patients’ access to treatment.
Last year, the agency removed a 25% buffer for almost every Schedule II opiate and opioid medication. The buffer was implemented in 2013 to help address shortages. Although DEA stated at that time that its October 2016 final order was based on reduced demand, its decision was consistent with the views of several U.S. senators who called for DEA to limit opioid production and sales as another mechanism to combat the opioid epidemic.