September 11, 2019
WASHINGTON – The U.S. Drug Enforcement Administration is proposing to reduce the manufacturing of five Schedule II opioid controlled substances in the United States next year. The Notice of Proposed Rulemaking being published in the Federal Register for public inspection and comment.
DEA proposes to reduce the amount of fentanyl produced by 31%, hydrocodone by 19%, hydromorphone by 25%, oxycodone by 9% and oxymorphone by 55%. Combined with morphine, the proposed quota would be a 53% decrease in the amount produced over that which was produced in 2016. All this in the face of shortages reported by hospitals and clinics around the nation, some of which have had to cut back on elective surgeries in order to deal with the shortages. Such steps by some hospitals are done so that critical shortages can be used to address urgent and emergent medical conditions and accidents.
At the same time the DEA proposes to increase the amount of marijuana that can be produced for research by almost a third over 2019’s level, from 2,450 kilograms to 3,200 kilograms, which is almost triple what it was in 2018. This will meet the need created by the increase in the amount of approved research involving marijuana. Over the last two years, the total number of individuals registered by DEA to conduct research with marijuana, marijuana extracts, derivatives and delta-9-tetrahydrocannabinol (THC) has increased by more than 40 percent, from 384 in January 2017 to 542 in January 2019.
In setting the quota, 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 internal system for tracking controlled substance transactions; and past quota histories. As a result of new laws and regulations that took effect in 2018, the number of factors that DEA considers in setting the quota has increased. Information on these factors and how they were assessed appears in the Notice.
The five opioid substances targeted are subject to special scrutiny following the enactment of last years Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which requires DEA to “estimate the amount of diversion of the covered substance that occurs in the United States” and “make appropriate quota reductions. DEA’s estimates of the amount of diversion that took place for each of these five opioid substances and how those estimates were calculated appear in the Notice.