DEA Places New ADHD Drug Centanafadine in Schedule III
Published Date: 10/30/2026
Rule
Summary
The DEA is officially putting the new ADHD medicine centanafadine (brand name Simtriyo) into Schedule III, meaning it’s recognized as having some potential for abuse but also accepted medical use. This change starts October 30, 2026, and affects patients, doctors, and pharmacies handling the drug. You’ve got until November 30, 2026, to share your thoughts or request a hearing about this decision.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
Centanafadine placed in Schedule III
The Drug Enforcement Administration placed centanafadine (Simtriyo) into Schedule III of the Controlled Substances Act effective October 30, 2026. The drug was approved by FDA on July 24, 2026 for ADHD in adults and pediatric patients aged 6 years and older weighing at least 20 kg. The scheduling recognizes both medical use and some abuse potential and applies to centanafadine including its salts and isomers.
DEA registration and handling rules for centanafadine
Anyone who handles centanafadine (manufacture, distribute, dispense, import, export, research, possess, or conduct instructional activities) must be registered with DEA in accordance with 21 U.S.C. and 21 CFR. Registrants must take an initial inventory on the date they first handle controlled substances and then inventory all controlled substances every two years, meet schedule III-V security and employee screening rules, maintain records and reports, follow labeling/packaging rules, and ensure prescriptions comply with 21 U.S.C. 829 and 21 CFR parts 1306 and 1311. Persons unwilling or unable to obtain DEA registration must surrender or transfer held centanafadine stocks; patients possessing centanafadine under a lawful prescription are not required to register.
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