H.R. 5032 — Nitazene Control Act

This section states congressional findings on nitazenes, a class of synthetic opioids first synthesized in the 1950s that exhibit extreme potency at the mu-opioid receptor (with some analogs exceeding fentanyl's potency). The findings recognize Drug Enforcement Administration scheduling of multiple nitazene compounds as Schedule I controlled substances due to high abuse potential and lack of accepted medical use; note their emergence in the illicit drug supply contributing to U.S. overdoses and fatalities; and conclude that class-wide permanent scheduling is necessary to address new analogs, streamline enforcement, and protect public health.

This section classifies benzimidazole-opioids, commonly referred to as nitazenes—defined chemically as substances with a benzimidazole core substituted at the 2-position with a benzyl or substituted benzyl group, a basic nitrogen-containing side chain at the 1-position, and mu-opioid receptor agonist activity (including but not limited to etonitazene, clonitazene, metonitazene, isotonitazene, protonitazene, butonitazene, etodesnitazene, flunitazene, N-pyrrolidino etonitazene, N-desethyl isotonitazene, and N-piperidinyl etonitazene)—as Schedule I controlled substances under the Controlled Substances Act (CSA). (As background, Schedule I substances have high potential for abuse, no currently accepted medical use in treatment in the United States, and lack of accepted safety for use under medical supervision; thus, this placement prohibits their manufacture, distribution, dispensing, or possession other than for authorized research.) The section (1) deems any such nitazenes previously temporarily scheduled under CSA section 201(h) as permanently scheduled in Schedule I; (2) authorizes the Attorney General, in consultation with the Secretary of Health and Human Services, to issue rules clarifying the nitazene class definition for enforcement purposes; and (3) exempts from new Schedule I registration requirements, for up to 18 months, researchers conducting ongoing pre-enactment studies on previously unscheduled nitazenes under an active FDA/DEA-recognized IND or exemption and IRB approval, provided they notify the Attorney General within 90 days of enactment and expeditiously apply for registration (with no authorization for new research without registration).