DEA Places Centanafadine (Simtriyo) in Schedule III; Comments Due November 30, 2026

What this means for your practice

This classification is a critical development for any healthcare practice, including telehealth providers, medspas, and general practitioners, that may prescribe or dispense medications for Attention-Deficit/Hyperactivity Disorder (ADHD). The immediate effectiveness of this interim final rule means that centanafadine (Sintriyo) is now subject to all federal regulatory controls applicable to Schedule III substances under the Controlled Substances Act (CSA). Practices must ensure their internal protocols, including inventory management, secure storage, recordkeeping, and prescribing practices, are fully compliant with these new requirements. For telehealth, specifically, the prescription of controlled substances via telemedicine requires adherence to both federal and state-specific regulations, which may vary. Non-compliance with DEA regulations carries significant risks, including fines, license suspension, and potential criminal charges. All relevant staff should be immediately informed of this change and trained on the appropriate handling and documentation procedures for Schedule III substances to maintain regulatory integrity and avoid enforcement actions.

The Drug Enforcement Administration (DEA) has issued an interim final rule placing centanafadine in Schedule III of the Controlled Substances Act (CSA). The rule was published in the Federal Register on October 30, 2026 (91 FR 68470, Docket No. DEA-1743) and took effect the same day. It covers centanafadine's salts, isomers (optical, positional or geometric) and salts of those isomers wherever they can exist.

What happened

On July 24, 2026, the Food and Drug Administration (FDA) approved a new drug application for Simtriyo (centanafadine) for attention-deficit/hyperactivity disorder in adults and in pediatric patients aged 6 years and older who weigh at least 20 kg. The Department of Health and Human Services (HHS) then sent DEA a recommendation to place centanafadine in Schedule III. DEA issued the interim final rule under the CSA as amended by the Improving Regulatory Transparency for New Medical Therapies Act.

The rule describes centanafadine as a central nervous system stimulant. It says both FDA and DEA concluded that its abuse potential is lower than that of Schedule II stimulants, but high enough to warrant control.

What Schedule III control requires

The rule lists the Schedule III controls that now apply to anyone who handles centanafadine:

• Registration: anyone who manufactures, distributes, dispenses, imports, exports, researches or possesses it must hold a DEA registration (patients with a lawful prescription are exempt).
• Security: Schedule III-V security requirements under 21 CFR 1301.71-1301.77.
• Inventory: an initial inventory and a biennial inventory under 21 CFR 1304.11.
• Records and reports: under 21 CFR parts 1304, 1312 and 1317.
• Prescriptions: every prescription must comply with 21 U.S.C. 829 and 21 CFR parts 1306 and 1311, subpart C (electronic prescriptions for controlled substances).
• Disposal: anyone who cannot or will not register must surrender or transfer existing stock, and disposal follows 21 CFR part 1317.

The telehealth point

Because centanafadine is now a controlled substance, prescribing it by telemedicine without a prior in-person medical evaluation falls under the Ryan Haight Act, which, subject to certain exceptions, requires at least one in-person medical evaluation before a practitioner prescribes a controlled substance remotely. Prescribing without that visit generally relies on the DEA and HHS temporary telemedicine flexibilities. Their fourth extension runs through December 31, 2026 (90 FR 61301, FR Doc. 2025-24123). Telehealth programs that plan to prescribe Simtriyo to patients they have not seen in person should plan for the end of those flexibilities, and should check the controlled-substance rules of each state where their patients are located.

Comment deadline

The rule is effective now, but DEA is taking comments on Docket No. DEA-1743. Comments must be submitted electronically or postmarked on or before November 30, 2026. The federal docket system will not accept electronic comments after 11:59 p.m. Eastern Time that day. Requests for a hearing, and waivers of a hearing, must be received by DEA on or before the same date.

Key facts

Frequently asked questions

What is Simtriyo?

Simtriyo is the brand name of centanafadine, which FDA approved on July 24, 2026 for ADHD in adults and in children 6 and older who weigh at least 20 kg.

When did the Schedule III control start?

On October 30, 2026, the day the interim final rule was published.

Can a telehealth clinician prescribe it without an in-person visit?

Outside the Ryan Haight Act's limited exceptions, only under the DEA and HHS temporary telemedicine flexibilities, which run through December 31, 2026 (90 FR 61301), and only where state law also allows it.

How do I comment?

Submit comments on Docket No. DEA-1743 at regulations.gov, or by mail postmarked, on or before November 30, 2026.

Sources: Federal Register, Schedules of Controlled Substances: Placement of Centanafadine in Schedule III (2026-22208) · Federal Register, Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities (2025-24123)