DEA Proposes Permanent Schedule I Placement for Five Designer Benzodiazepines
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The Drug Enforcement Administration (DEA) has announced a proposed rule to place five substances—clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam—in Schedule I of the Controlled Substances Act (CSA). The proposal includes each substance and its salts, isomers, and salts of isomers.
These substances were temporarily placed in Schedule I on July 26, 2023, due to concerns about an imminent hazard to public safety. The temporary order was later extended to July 26, 2026. If this proposed rule is finalized, it will make these controls permanent.
Why Are These Substances Being Scheduled?
According to the DEA, these five substances have a high potential for abuse. They are chemically and pharmacologically similar to classical benzodiazepines, like diazepam and alprazolam. These classical drugs are widely abused and can cause dependence.
The DEA and the Department of Health and Human Services (HHS) reviewed scientific and medical evidence about these substances. The review found that:
- They are not approved for any medical use in the United States.
- There are no accepted safety standards for their use under medical supervision.
- They have been linked to abuse, dependence, and serious health risks.
Evidence and Data
No legitimate sources, such as approved medicines, exist for these five substances in the United States. They are not used or manufactured legally and are mostly obtained from illegal sources or foreign countries.
The DEA and HHS collected the following data:
- Over 50,000 encounters of these substances by law enforcement, from every state and Washington, DC.
- Evidence from U.S. poison centers and toxicology programs showing hundreds of cases involving these drugs, including deadly overdoses.
- Studies and user reports showing these drugs can cause strong sedative effects, impaired driving, and physical dependence. Some are more potent than known prescription benzodiazepines.
Risks to Public Health
The five substances act as strong depressants on the central nervous system. They can cause drowsiness, confusion, poor coordination, and breathing trouble. People have died from overdoses involving these drugs, especially when mixed with other substances like opioids.
Reports show that people of all adult ages, and both sexes, have been harmed. Often, these drugs are used alone or with other dangerous drugs like fentanyl or stimulants.
Legal and International Obligations
The United States is required by the United Nations Convention on Psychotropic Substances (1971) to control these substances because other countries voted to add them to international lists.
What Will Happen Under Permanent Scheduling?
If permanently placed in Schedule I:
- It will be illegal to manufacture, distribute, import, export, or possess these substances except for DEA-approved research.
- They will be subject to strict storage and recordkeeping rules.
- Only DEA-registered persons will be allowed to handle these substances.
- Penalties for unauthorized activity would include criminal, civil, and administrative actions.
Public Input and Comments
The public can comment on this proposed rule until August 25, 2025. Comments can be made electronically at regulations.gov or mailed to the DEA office.
People who want a hearing must ask before the same deadline.
Small Business Impact
DEA states that very few suppliers or researchers use these substances for legal research. The rule is not expected to impact a significant number of small businesses.
How the Rule Changes Regulations
If the rule becomes final, it will remove the substances from the temporary list and add them to the permanent list of Schedule I controlled substances under 21 CFR 1308.11(e).
Contact Information
For more information, contact Dr. Terrence L. Boos at the DEA, phone: (571) 362-3249.
Conclusion
The DEA’s proposal aims to keep U.S. laws in line with international treaties and protect public health. Clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam will remain closely controlled due to the dangers they pose. The public is invited to review and comment before the rule is finalized.
Legal Disclaimer
This article includes content collected from the Federal Register (federalregister.gov). The content is not an official government publication. This article is for informational purposes only and does not constitute legal advice. For case-specific consultation, please contact us. Read our full Legal Disclaimer, which also includes information on translation accuracy.
