DEA Designates 4-Piperidone, Used in Illicit Manufacture of Fentanyl, A List I Chemical

In addition to regulating drugs of abuse, the federal Controlled Substances Act (“CSA”) controls the manufacture and distribution of chemicals used in the illicit manufacture of controlled substances.  As the primary agency enforcing the CSA, the Drug Enforcement Administration (“DEA”) previously designated nine chemicals used in the illicit manufacture of fentanyl or its analogues as List I or List II chemicals.  To further address the fentanyl crisis, DEA has issued a final rule designating 4-piperidone a List I chemical after concluding that “the vast majority of, if not all” of that chemical is being used in the illicit manufacture of fentanyl.  Designation of 4-Piperidone as a List I Chemical, 88 Fed. Reg. 21,902, 21,907, 21,909 (to be codified at 21 C.F.R. § 1310.02(a)(38) (Apr. 12, 2023).

The List I designation includes 4-piperidone’s acetals, amides, carbamates, salts and salts of its acetals, amides, and carbamates, and any combination thereof as a List I chemical.  Id. at 21,909 (to be codified at 21 C.F.R. § 1310.12(c)).

The designation subjects 4-piperidone (also called “piperidin-4-one”) manufacturers, distributors, importers, and exporters to DEA registration, recordkeeping and reporting, importation/exportation, and security requirements.  DEA did not establish a threshold for 4-piperidone, so all domestic and international transactions including all chemical mixtures, are regulated transactions.  DEA has assigned chemical code 8330 to 4-piperidone.  Id.

DEA is aware of at least 38 domestic suppliers and 19 foreign suppliers of 4-piperidone and those entities must obtain an agency registration unless exempt, or cease handling the chemical.  Id. at 21,904.  The final rule becomes effective May 12th, and DEA is allowing “continued legitimate commerce” in 4-piperidone by temporarily exempting handlers from required registration as long as it “receives a properly completed application for registration or application for exemption of a chemical mixture” on or before that date.  Id. at 21,906 (to be codified at 21 C.F.R. § 1310.09(s)(1)).

The final rule is attached here.