DEA Finalizes Schedule I Placement of Five Designer Benzodiazepines
- The DEA has permanently placed clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam into Schedule I of the Controlled Substances Act, enforcing strict federal controls.
- This final rule, published in the Federal Register on March 2, 2026, makes permanent a temporary scheduling order initially issued in July 2023 to comply with the 1971 Convention on Psychotropic Substances.
- The DEA determined all five substances have high abuse potential, no accepted medical use in the U.S., and lack accepted medical safety; none are FDA-approved for marketing or medical use.
- Schedule I status restricts manufacture, distribution, and retail sales, though academic research is allowed with DEA registration; the rule becomes effective 30 days after publication.
The U.S. Drug Enforcement Administration has issued a final rule permanently placing clonazolam, diclazepam, etizolam, flualprazolam and flubromazolam into Schedule I of the Controlled Substances Act, solidifying federal restrictions on the five substances. According to the Federal Register notice scheduled for publication March 2, 2026, the rule makes permanent the temporary scheduling order first issued in July 2023 and later extended through July 26, 2026. The agency states that the action ensures the United States meets its obligations under the 1971 Convention on Psychotropic Substances.
DEA concluded that each of the five substances has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The agency noted that none of the substances has an FDA-approved marketing application, and no New Drug Applications are in effect.
Although some commenters pointed out that etizolam is prescribed in other countries, DEA said the Department of Health and Human Services determined that it does not have a currently accepted medical use in the U.S. The agency also emphasized that Schedule I status does not preclude academic research, though researchers must obtain DEA registration to handle the substances.
With the final rule, the five compounds — including their salts, isomers and salts of isomers — are added to 21 CFR 1308.11 as Schedule I depressants. As Schedule I substances, they are subject to the strictest federal controls, including registration requirements for manufacturing, distribution, research, import and export. Retail sales to the general public remain prohibited.
The rule takes effect 30 days after publication in the Federal Register.