DEAFinal Rule

Schedules of Controlled Substances: Temporary Placement of N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in Schedule I

HealthcareOther

Summary

The DEA is temporarily classifying two synthetic drugs called N-pyrrolidino metonitazene and N-pyrrolidino protonitazene as Schedule I controlled substances, meaning they are now illegal to make, sell, or possess. This action was taken because these drugs are dangerous opioids that have been appearing on the illegal drug market and pose a serious public health threat.

Key Points

  • 1Two new synthetic opioid drugs are now classified as Schedule I, the most restrictive category under federal drug law, making them illegal to manufacture, distribute, or possess without a DEA license
  • 2This is a temporary emergency measure that allows the government to act quickly against dangerous drugs before completing the lengthy permanent scheduling process
  • 3These drugs are designer opioids similar to fentanyl that have caused overdoses and deaths, prompting federal action to get them off the streets
  • 4People found with these substances face federal criminal penalties including fines and imprisonment
  • 5Drug manufacturers, distributors, and law enforcement agencies must immediately comply with the new restrictions and report any existing supplies to the DEA

Impact Assessment

If you are a pharmaceutical manufacturer or importer, this means you cannot legally produce, import, or distribute N-pyrrolidino metonitazene or N-pyrrolidino protonitazene, and any existing inventory must be ceased or surrendered.

Impact Level
Moderate
Geographic Scope

National

Compliance Cost

Minimal

Who is Affected
Healthcare ProvidersManufacturersImporters/Exporters

Key Dates

Published

August 15, 2025

Regulatory Connections

Amends CFR Sections
21 CFR Part 1308
Other Documents in This Rulemaking (DEA-2024-0118)

This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.