United States Drug Enforcement Administration

WASHINGTON – In an effort to reduce the availability of deadly illegal fentanyl in America, the U.S. Drug Enforcement Administration has proposed to control three substances used by operators of clandestine laboratories to illicitly manufacture the deadly Schedule II controlled substance.

Two Notices of Proposed Rulemaking were published in the Federal Register recently.  On Friday, Sept. 13, 2019, DEA proposed that benzylfentanyl and 4-anilinopiperidine be controlled as list I chemicals under the Controlled Substances Act. Today, DEA proposes to designate norfentanyl as an immediate precursor (i.e., a substance from which another is formed) for fentanyl and to make it a Schedule II controlled substance under the CSA.

Both Notices are based on findings that these substances are important precursors used in the illegal production of fentanyl.  

In recent years, the distribution of illegally produced fentanyl has been linked to an unprecedented outbreak of overdose deaths in the United States. Provisional data available from the Centers for Disease Control and Prevention for 2018 suggest that overdose deaths from synthetic opioids like fentanyl and its related compounds will continue to increase by as much as eight percent from their record-setting 2017 levels when the country lost 28,400 persons from fentanyl and its related compounds.

These substances are much more potent than heroin, and in many parts of the United States, much cheaper on the street. Fentanyl is approximately 100 times more potent than morphine and 50 times more potent than heroin. Two milligrams of fentanyl (equivalent to a few grains of table salt) can cause breathing to stop in more than 95 percent of the American public.  

DEA is working expeditiously to combat fentanyl trafficking in a variety of ways. Besides placing temporary (emergency) controls on many fentanyl-related substances and their chemical intermediates, beginning in January 2018, DEA created six new heroin-fentanyl enforcement teams to combat trafficking in heroin, fentanyl and fentanyl analogues in those regions of our country that have been hardest hit by the opioid epidemic. DEA is also working with the United States Congress to develop legislation to make permanent Schedule I controls on fentanyl-related substances while also ensuring that research on these substances can continue here in the United States.    

These Notices provide industry and others the opportunity to provide information on any legitimate uses of these substances. Stakeholders may submit public comments on the proposals within 30 days after publication. If finalized as proposed, benzylfentanyl and 4-anilinopiperidine will become subject to the chemical regulatory provisions of the CSA and its implementing regulations, and norfentanyl will become subject to all the regulatory controls and administrative, civil and criminal sanctions applicable to a Schedule II controlled substance. Both actions will help to prevent, curtail or limit the manufacture of fentanyl.

Follow the links to see the two Federal Register Notices, 21 CFR Part 1310  and 21 CFR Part 1308.  

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