International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments
The Federal Register notice requests comments on international drug scheduling recommendations for several substances, including clobromazolam, cychlorphine, desalkylgidazepam, ethylbromazolam, etomethazene, spirochlorphine, etomidate, and medetomidine. This could lead to future U.S. scheduling changes under the Controlled Substances Act.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on August 26, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Low urgency. Manufacturers, importers, and distributors of the listed substances; pharmaceutical companies with products containing these substances; compounding pharmacies. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comments are due by October 26, 2026 (60 days after publication).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The notice announces international scheduling recommendations and requests public comments. No immediate regulatory changes are in effect; future U.S. scheduling actions may follow.
Who it affects
Manufacturers, importers, and distributors of the listed substances; pharmaceutical companies with products containing these substances; compounding pharmacies.
What you must do
Review the notice and consider submitting comments by the deadline if the substances are relevant to your operations.
Deadline
Comments are due by October 26, 2026 (60 days after publication).
Never miss a change like this again
Aforeworn watches Pharmaceutical Manufacturing (FDA/DEA) around the clock and alerts you the moment a rule moves — with a plain-English brief on what to do.
Start your free trialRelated changes in Pharmaceutical Manufacturing (FDA/DEA)
- Guidance: Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities
- FDA to require diversity plan for clinical trials - nature.com
- Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661
- FDA Issues Final Rule Clarifying Evidence of Off-Lab... - Dechert
- Schedules of Controlled Substances: Temporary Placement of 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule I of the Controlled Substances Act