On Tuesday the Drug Enforcement Administration (DEA) released a temporary amendment and scheduling order adding seven synthetic opioids to Schedule I of the Controlled Substances Act. The two-year placements were carried out “to avoid imminent hazard to the public safety,” per the agency.
The specific substances at issue are Butonitazene, Etodesnitazene, Flunitazene, Metodesnitazene, Metonitazene, N-Pyrrolidino etonitazene, and Protonitazene as well as derivatives.
Typically placement of a drug or synthetic drug into schedule I requires compliance with 21 U.S.C. 811(b), including testing, scientific review, and other requirements which can take time to process. However, the Controlled Substances Act permits placement in schedule I for two years if the administrator finds that such action is necessary to avoid an imminent hazard to the public safety. Specifically, the administrator must consider the substance’s history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health, per the statute.
The notice specifically stated that the substances in this order have similar pharmacological profiles to known abused opioids, that the synthetic opioids have been detected in 44 toxicology and post mortem cases in the country between November 2020 and July 2021, and have been seized from the scene of many drug enforcement actions, indicating a widespread use and availability of the substances. Finally, the agency noted that it is not aware of any currently accepted medical uses for these substances in the United States, meaning that the primary use is that of abuse and non-compliance with current federal law.
Placement of the synthetic opioids raises the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, and possession of, and engagement in research and conduct of instructional activities or chemical analysis with, schedule I controlled substances.
