DEA Eyes a Chemical Precursor Most People Have Never Heard Of
Published Date: 6/3/2025
Proposed Rule
Summary
The DEA wants to officially list propionyl chloride as a controlled chemical because it’s used to make illegal drugs like fentanyl. This means anyone handling it will have to follow strict rules, no matter how much they have or if it’s mixed with other chemicals. If you work with this chemical, get ready for new regulations and make sure to share your thoughts by July 3, 2025!
Analyzed Economic Effects
7 provisions identified: 1 benefits, 4 costs, 2 mixed.
All Propionyl Chloride Transactions Regulated
If finalized, every sale, manufacture, import, or export of propionyl chloride will be regulated under the Controlled Substances Act no matter how small the quantity is. Chemical mixtures that contain any amount of propionyl chloride also would be regulated unless a manufacturer’s exemption is approved by DEA.
DEA Registration Requirement and Annual Fees
Anyone who manufactures, distributes, imports, or exports propionyl chloride (or regulated mixtures) must obtain DEA registration(s). Annual registration fees cited in the proposal are $3,699 for manufacturers and $1,850 for distributors, importers, and exporters; separate registrations are required by activity and by each principal business location.
Recordkeeping and Reporting Obligations
Registered handlers must keep records of regulated transactions for two years and must report to DEA unusual or extraordinary transactions, proposed transactions involving persons DEA has flagged, unusual loss or disappearance, and other suspicious circumstances per 21 U.S.C. 830 and 21 CFR 1310.04–.05. Bulk manufacturers must also submit annual manufacturing, inventory, and use data.
Temporary Registration Exemption Window
DEA would allow a temporary exemption from the registration requirement only for persons who submit a properly completed registration application or application for a mixture exemption on or before 30 days after publication of a final rule. That temporary exemption lasts until DEA approves or denies the application, but all other control requirements (including recordkeeping and reporting) are effective on the final rule's effective date.
Security, Inspections, and Liability Rules Apply
Registered handlers must implement effective security controls against theft and diversion, and facilities where propionyl chloride is held are 'controlled premises' subject to DEA administrative inspections. Any unauthorized activity with propionyl chloride could lead to administrative, civil, or criminal penalties.
Mixture Exemption Application Available
Manufacturers of chemical mixtures can apply under 21 CFR 1310.13 for an exemption so that a mixture containing propionyl chloride would not be regulated. DEA may grant exemption if the mixture is formulated so the listed chemical cannot be readily recovered or used illicitly.
Small Distributor Count and Expected Effects
DEA identified 20 domestic suppliers of propionyl chloride; 3 are already registered and 17 are not registered. DEA estimates that if the rule is finalized, some non-registered distributors may stop selling propionyl chloride rather than pay registration fees, and projects the number of affected small entities would be 17 out of 8,804 firms in the NAICS 424690 industry (about 0.19%).
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Key Dates
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