DEA plans reduction in opioid manufacturing for 2019
This would mark the third straight year of reductions
According to an August 20 with request for comments, DEA is planning to cut opioid production quotas next year for six commonly prescribed opioids and other schedule I and II controlled substances. The proposal decreases the U.S. production quotas by approximately 10% in 2019 for oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. This would mark the third straight year of proposed reductions, which DEA said are aimed at preventing a diversion while simultaneously satisfying annual production needs.
Aggregate productions quotas (APQs) are published annually in the Federal Register and reflect the total amount of controlled substances necessary to meet the country’s estimated medical, scientific, research, industrial, and export needs for the year. Notably, in July 2018, DEA expanded the factors it uses to set APQs and assess annual needs to include the extent of any diversion of the controlled substance in the class, as well as relevant information from the Department of Health and Human Services and states. The APQs in the notice reflect DEA’s application of this new policy.
DEA said that once the APQ is set, they can allocate individual manufacturing and procurement quotas to those manufacturers that apply for them. The agency may also revise a company’s quotas at any time during the year if change is warranted because of an increase or decrease in sales or exports, new manufacturers entering the market, and new products being developed, or recalled, according to a DEA press release.