2026-22208·DEPARTMENT OF JUSTICE

Schedules of Controlled Substances: Placement of Centanafadine in Schedule III

Final RuleEffectiveComments open

Published: Oct 30, 2026
Effective: Oct 30, 2026
Comments close: Nov 30, 2026
Citation: 91 FR 68470
Docket: Docket No. DEA-1743
Agencies: DEPARTMENT OF JUSTICE, Drug Enforcement Administration

Interim final rule; request for comments.

Summary

The rule adds the medication centanafadine (brand name Simtriyo) to Schedule III of the Controlled Substances Act. By placing the drug in this schedule, the government aims to balance the need for access to a newly approved treatment for attention‑deficit/hyperactivity disorder with safeguards against potential abuse, diversion, or illegal trafficking. The rule is issued by the Drug Enforcement Administration (DEA), an agency within the Department of Justice, acting on a scheduling recommendation from the Department of Health and Human Services after the FDA approved the drug on July 24, 2026. It applies to anyone who manufactures, distributes, prescribes, dispenses, or possesses centanafadine and its chemically related forms—such as salts and isomers—including pharmaceutical companies, pharmacies, health‑care providers, and patients. The interim final rule takes effect on October 30, 2026, the same day it was published in the Federal Register (91 FR 68470). The public may submit comments on the rule until November 30, 2026. After the comment period, the DEA will review feedback and may issue a final rule that could adjust or confirm the Schedule III placement, after which the drug will be subject to the prescribing, record‑keeping, and security requirements that apply to Schedule III substances.

AI-generated summary — verify against the Federal Register text.

Official abstract

On July 24, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder in adults and pediatric patients aged 6 years and older, weighing at least 20 kg. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place centanafadine, chemically known as (1R,5S)-1- (naphthalen-2-yl)-3-azabicyclo[3.1.0]hexane, in schedule III of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing centanafadine, including its salts, isomers (whether optical, positional, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible in schedule III of the CSA.