2025-19542Rule

DEA Slaps Seven Deadly Opioids into Schedule I Lockdown

Published Date: 10/15/2025

Rule

Summary

Starting October 15, 2025, the DEA is temporarily putting seven powerful new opioids into Schedule I, meaning they’re considered very dangerous with no accepted medical use. This affects anyone who makes, sells, studies, or even possesses these drugs, who will now face strict rules and penalties. The temporary ban lasts two years, giving the government time to keep people safe while deciding what’s next.

Analyzed Economic Effects

6 provisions identified: 0 benefits, 6 costs, 0 mixed.

Seven Nitazenes Placed in Schedule I

Starting October 15, 2025, DEA temporarily places seven benzimidazole-opioids (ethyleneoxynitazene; methylenedioxynitazene; 5-methyl etodesnitazene; N-desethyl etonitazene; N-desethyl protonitazene; N,N-dimethylamino etonitazene; and N-pyrrolidino isotonitazene) in Schedule I through October 15, 2027 (with a possible one-year extension). Schedule I means these substances are treated as having high potential for abuse and no accepted medical use and are subject to Schedule I controls and sanctions.

Unauthorized Possession and Retail Sales Outlawed

Possessing any quantity of these seven substances in a manner not authorized by the Controlled Substances Act on or after October 15, 2025 is unlawful and may subject you to administrative, civil, and criminal sanctions; retail sales of Schedule I controlled substances to the general public are not allowed under the CSA.

Registration Required to Handle These Drugs

As of October 15, 2025, anyone who handles (manufactures, distributes, imports/exports, researches, analyzes, or possesses) these seven substances must be registered with DEA under 21 U.S.C. 822, 823, 957, and 958 and 21 CFR parts 1301 and 1312. Persons currently handling these substances who are not registered must submit an application and may not continue to handle them unless DEA approves the registration.

Surrender or Dispose Stocks If Not Registered

If you possess any of these seven substances and do not want or cannot obtain a Schedule I registration, you must surrender all currently held quantities; you may not continue to lawfully hold them after October 15, 2025. The temporary order requires disposal or surrender of stocks by persons who will not be registered.

Immediate Security, Labeling, Inventory, and Reporting Rules

Beginning October 15, 2025, registrants handling these substances must meet Schedule I security requirements (21 CFR 1301.71-1301.93), labeling and packaging rules, take required inventories (initial inventory and biennial thereafter), maintain records, and submit reports and order forms as specified in 21 U.S.C. and 21 CFR parts (with current registrants given 30 calendar days from October 15, 2025 to comply with labeling, inventory, and recordkeeping requirements).

Manufacture Limited to DEA-Registered Quota Holders

Only DEA-registered manufacturers may lawfully manufacture these seven substances, and manufacturing is limited to quotas assigned under 21 U.S.C. 826 and 21 CFR part 1303, effective October 15, 2025. Manufacturers must comply with quota, order form, import/export, and reporting requirements.

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Key Dates

Published Date
Rule Effective
10/15/2025
10/15/2025

Department and Agencies

Department
Independent Agency
Agency
Justice Department
Drug Enforcement Administration
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