WASHINGTON, D.C. – The U.S. Drug Enforcement Administration is proposing a reduction for controlled substances that may be manufactured in the U.S. next year by 20 percent as compared to 2017, per the proposed notice published in the Federal Register on August 7, 2017 and available now for public inspection.
The DEA has proposed to reduce more commonly prescribed schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, meperidine and fentanyl.
Demand for these opioid medicines has dropped, according to sales data obtained by DEA from IMS Health, a company that provides insurance companies with data on prescriptions written and prescription medications sold in America.
“Physicians, pharmacists, and patients must recognize the inherent risks of these powerful medications, especially for long-term use,” Acting Administrator Chuck Rosenberg said. “More states are mandating use of prescription drug monitoring programs, which is good, and that has prompted a decrease in opioid prescriptions.”
The “Proposed Aggregate Production Quotas for Schedule I and II” controlled substances now published in the Federal Register reflects the total amount of controlled substances needed to meet the country’s legitimate medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks.
In 2016, the Centers for Disease Control and Prevention issued guidelines to practitioners recommending a reduction in prescribing opioid medications for chronic pain.
DEA and its federal partners have increased efforts in the last several years to educate practitioners, pharmacists, manufacturers, and the public about the dangers associated with the misuse of opioid medications and the importance of properly prescribing.
When Congress passed the Controlled Substances Act, the quota system was intended to reduce or eliminate diversion from “legitimate channels of trade” by controlling the quantities of the basic ingredients needed for the manufacture of controlled substances. The purpose of quotas is to provide for an adequate and uninterrupted supply for legitimate medical need of schedule I and schedule II controlled substances, which have a high potential for abuse, while limiting the amounts available to prevent diversion.
DEA must balance the production of what is needed for legitimate use against the production of an excessive amount of these potentially harmful substances. DEA establishes an APQ for more than 250 schedule I and II controlled substances annually.
In setting the APQ, DEA considers data from many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturers’ disposition history and forecasts; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories.
Once the aggregate quota is set, DEA allocates individual manufacturing and procurement quotas to those manufacturers that apply for them. DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls.
The Federal Register notice is available here.