DEA Places Cipepofol (Cypsedo) in Schedule IV of the Controlled Substances Act

What this means for your practice

For healthcare businesses, including telehealth providers, medspas, and dental practices that may administer or prescribe medications for surgical or procedural settings, the scheduling of cipepofol (Cypsedo) as a Schedule IV controlled substance carries significant compliance implications. Any practice that utilizes Cypsedo will now be subject to federal regulations governing Schedule IV substances, which include stringent requirements for prescribing, dispensing, record-keeping, inventory, and physical security. Practitioners must ensure their DEA registration is active and appropriate for controlled substances, and all staff involved in handling the drug must be aware of and adhere to these new regulatory mandates. This emphasizes the need for robust internal compliance protocols and ongoing training to avoid potential violations.

Washington, D.C. — The Drug Enforcement Administration (DEA), a component of the Department of Justice, has officially moved to place cipepofol, identified by its brand name Cypsedo, into Schedule IV of the Controlled Substances Act (CSA). This regulatory action, formalized through an interim final rule (IFR), became effective on August 27, 2026, and mandates new federal controls for the drug.

Background on Scheduling Action

The DEA's decision follows a comprehensive process initiated by the recent approval of Cypsedo by the United States Food and Drug Administration (FDA). On May 29, 2026, the FDA granted approval for Cypsedo (cipepofol) for its intended use in the induction of general anesthesia in adult patients undergoing surgical procedures. Following this approval, the Department of Health and Human Services (HHS) conducted its own evaluation of cipepofol and subsequently provided a formal scheduling recommendation to the DEA. This recommendation advised the placement of cipepofol, chemically known as 2-[(1 R )-1-cyclopropylethyl]-6-isopropylphenol, into Schedule IV of the CSA.

In accordance with the mandates of the CSA, as specifically amended by the Improving Regulatory Transparency for New Medical Therapies Act, the DEA is obligated to issue this interim final rule. This legislative amendment streamlines the process for scheduling new medications following FDA approval and HHS recommendation, ensuring timely regulatory oversight of substances with abuse potential.

Immediate Effect and Public Comment Period

The interim final rule for cipepofol's Schedule IV placement is effective as of August 27, 2026. This means that all federal regulations pertaining to Schedule IV controlled substances apply to cipepofol immediately upon this date. Healthcare providers, pharmacies, and manufacturers must comply with these regulations without delay.

Recognizing the importance of public input, the DEA has opened a comment period for this rulemaking. Interested parties, including healthcare professionals, researchers, and the public, are invited to submit written comments on the rule. Comments must be submitted electronically via the Federal eRulemaking Portal at www.regulations.gov or postmarked by September 28, 2026. The electronic system will not accept comments after 11:59 p.m. Eastern Time on the final day of the comment period. When submitting comments, it is crucial to reference "Docket No. DEA1713" to ensure proper categorization and review.

Requesting a Hearing

In addition to written comments, individuals or entities desiring a hearing on the matters of fact and law asserted in this rulemaking must submit their requests, along with a written statement of position, on or before September 28, 2026. These requests should be directed to the DEA Administrator at the provided address. A courtesy copy of such requests should also be sent to the DEA's Hearing Clerk and the Federal Register Representative.

Implications of Schedule IV Classification

The placement of cipepofol in Schedule IV signifies that the federal government recognizes the drug's accepted medical use, but also its potential for abuse, albeit lower than substances in Schedules I, II, or III. Drugs in Schedule IV typically have a limited potential for physical or psychological dependence.

For medical practices and healthcare operators, the Schedule IV designation means adherence to a distinct set of regulatory requirements under the CSA. These requirements include, but are not limited to:

• Prescribing: Prescriptions for Schedule IV substances generally require a valid practitioner-patient relationship and must meet specific formatting and content requirements. Telehealth providers, in particular, must ensure their prescribing practices align with both federal and state regulations for controlled substances dispensed via telemedicine.
• Dispensing: Pharmacies and dispensing practitioners must maintain meticulous records of all Schedule IV substances received, dispensed, or disposed of.
• Record-keeping: Detailed records of acquisition, inventory, and disposition must be kept for a minimum of two years, readily available for inspection by the DEA. This includes maintaining perpetual inventory logs where required.
• Security: Schedule IV controlled substances must be stored securely to prevent diversion. This typically involves storing them in a securely locked cabinet or dispersing them throughout the non-controlled substance stock to deter theft.
• Inventory: Healthcare practices holding a DEA registration must conduct initial and biennial inventories of all controlled substances, including cipepofol, in their possession.

Addressing Public Comments and Future Actions

The DEA considers all comments received in response to this docket as part of the public record. Comments, including any personal or business identifying information voluntarily submitted, will generally be made available for public inspection online at www.regulations.gov. Commenters who wish to submit confidential or proprietary business information must follow specific instructions for marking and submitting two copies of their comments, one clearly marked as confidential.

This interim final rule underscores the DEA's ongoing commitment to regulating controlled substances effectively, ensuring patient safety while facilitating access to necessary medical therapies. The public comment period provides a critical opportunity for stakeholders to contribute to the regulatory process and inform any potential future modifications to this rule.

Key Facts

| Detail | Value | |---|---| | Drug Name | Cipepofol (Brand name: Cypsedo) | | Regulatory Action | Interim Final Rule placing cipepofol in Schedule IV of the Controlled Substances Act (CSA) | | Effective Date | August 27, 2026 | | Comment Deadline | September 28, 2026 | | Docket Number | DEA1713 | | Approving Agency | United States Food and Drug Administration (FDA) approved Cypsedo on May 29, 2026 |

Frequently Asked Questions

What is the effective date for cipepofol being classified as a Schedule IV controlled substance?

This rule is effective August 27, 2026.

What is the deadline for submitting comments on this interim final rule?

Comments must be submitted electronically or postmarked on or before September 28, 2026. Electronic submissions will not be accepted after 11:59 p.m. Eastern Time on that day.

How can I submit comments to the DEA regarding this rule?

The DEA encourages electronic submissions through the Federal eRulemaking Portal at https://www.regulations.gov. Paper comments can be mailed to the Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, VA 22152.

What is the chemical name for cipepofol?

Cipepofol is chemically known as 2-[(1 R )-1-cyclopropylethyl]-6-isopropylphenol.

What should I reference on my correspondence when submitting comments?

You should reference “Docket No. DEA1713” on all correspondence, including any attachments, to ensure proper handling of your comments.

Source: DEA — Rule: Schedules of Controlled Substances: Placement of Cipepofol in Schedule IV · 2026-08-27