
DEA Proposes New Rule: Propionyl Chloride To Become a Controlled Chemical
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The Drug Enforcement Administration (DEA) is planning to make a new rule about propionyl chloride. This chemical is often used to make fentanyl and related dangerous drugs. The proposed rule would list propionyl chloride as a List I chemical. This means it will be controlled under the Controlled Substances Act (CSA).
Why Is Propionyl Chloride Being Controlled?
Propionyl chloride is used by illegal labs to make fentanyl, fentanyl analogues, and fentanyl-like substances. These drugs have caused many overdose deaths in the United States. Fentanyl is a powerful synthetic opioid. A small amount can be deadly. The DEA says propionyl chloride is important in making these drugs because it replaces another controlled chemical, propionic anhydride, during the process.
What Will Happen If the Rule Is Finalized?
- Everyone who makes, sells, imports, or exports propionyl chloride will have to follow CSA rules.
- There will not be a threshold amount. This means any amount of propionyl chloride, even a tiny amount, will be regulated.
- Chemical mixtures that contain any propionyl chloride will also be regulated, no matter the concentration.
- No automatic exemptions will be given, but companies can apply for an exemption.
Comment Period Open Until July 3, 2025
The DEA is asking for comments from the public about this rule. Comments need to be sent in by July 3, 2025. People can comment online at www.regulations.gov or by mail. All comments become part of the public record, so personal information could be seen by others.
How Does Propionyl Chloride Make Fentanyl?
Fentanyl and related drugs are not found in nature. They are made from chemicals. Propionyl chloride is used in several steps of different methods for making fentanyl. These methods include the “Janssen,” “Siegfried,” and “Gupta” processes. In these, propionyl chloride reacts with other chemicals to make important fentanyl building blocks.
Illegal labs use propionyl chloride because it is easy to get and is not currently regulated. Making it a List I chemical will make it harder for illegal labs to get the chemical.
Information Gathered by the DEA
The DEA got six public comments about this action. Three comments supported the rule. Three others mentioned possible problems. Some said that propionyl chloride can also be used in research labs or in making pharmaceutical or agricultural products. Some worried that controlling this chemical would make it harder and more expensive for researchers to get. Others said most people who use it already have the paperwork to buy it.
What Will Be Required If the Rule Takes Effect?
- Registration: Anyone making, selling, importing, or exporting propionyl chloride (or mixtures with it) must register with the DEA.
- Records and Reports: Records of transactions must be kept for two years. Any odd transactions, losses, or thefts must be reported.
- Shipping: Importing or exporting must follow DEA rules.
- Security: Companies must provide strong controls to prevent theft or misuse.
- Inspections: The DEA can inspect businesses handling this chemical.
- Legal Risk: Doing anything with propionyl chloride that is not allowed by law is a crime.
There will be a temporary 30-day exemption for people already handling propionyl chloride. During this time, they must apply for registration or exemption.
Economic and Legal Effects
The DEA does not expect this rule to have big costs for companies. The main cost will be registration fees ($3,699 for manufacturers and $1,850 for distributors, importers, and exporters). Companies already making opioid medicines with fentanyl should already have DEA registration. The DEA thinks very few businesses will be impacted.
The rule follows all proper government and legal procedures. It does not interfere with state laws or other government powers.
Next Steps
The DEA is taking comments until July 3, 2025. After that, they will decide if the rule should go into effect.
Contact Information
For more details, contact Terrence L. Boos at the DEA (571) 362-3249.
How To Comment
- Online: www.regulations.gov (Docket No. DEA-1189)
- Mail: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, VA 22152
All comments must be sent or postmarked by July 3, 2025.
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