DEA Proposes Cut in Controlled Substance Manufacturing for 2018

DEA proposes 20% decrease in the amount of controlled substances to be manufactured in the U.S.
DEA proposes 20% decrease in the amount of controlled substances to be manufactured in the U.S.

The Drug Enforcement Administration (DEA) has proposed a 20% decrease in the amount of controlled substances to be manufactured in the U.S. in 2018 compared to 2017. The proposed notice will be published in the Federal Register on August 7, 2017.

The Centers for Disease Control and Prevention (CDC) released guidelines in 2016 recommending a decrease in opioid prescribing for chronic pain. Since then, the DEA and partners have made efforts to increase awareness among practitioners, manufacturers, pharmacists, and the public about the harms of opioid misuse and the importance of appropriate prescribing.

The DEA's manufacturing reduction applies to commonly prescribed Schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine, and fentanyl. Sales data from IMS Health have indicated a drop in demand for these opioid painkillers. The Proposed Aggregate Production Quotas (APQ) for Schedule I and II controlled substances generally represent the total amount of controlled substances required to meet the national demand for legitimate medical, scientific, research, industrial, and export needs for the year, as well as the amount to maintain reserve stocks. The quotas serve to maintain adequate supply for medical needs of Schedule I and II controlled substances while controlling the amounts available to prevent diversion.

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The APQs are determined for over 250 controlled substances and are based on data from the FDA, retail consumption data, manufacturers' history and projections, as well as internal tracking data. The DEA allocates manufacturing and procurement quotas to the specific manufacturers that are affected. If a change is warranted during the year, the DEA may revise a company's quota.

“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” said Acting Administrator Chuck Rosenberg. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”

For more information visit FederalRegister.gov.