16 Sept 2019
Import Controls Proposed for Two Fentanyl Precursors
The Drug Enforcement Administration is proposing to designate two fentanyl precursors – N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4-amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), including its amides, carbamates and salts – as list I chemicals under the Controlled Substances Act. Comments are due by 12 November.
If finalised, this rule would subject importers, exporters, manufacturers and distributors of any amount of these substances to all of the regulatory controls (importation and exportation, registration, records and reporting, inspection, etc.) and administrative, civil and criminal actions applicable to the import, export, manufacture and distribution of a list I chemical. This rule would not establish a threshold for domestic and international transactions of these substances, meaning all transactions of chemical mixtures containing these substances would be regulated at any concentration and would be subject to control under the CSA.
While fentanyl is legally prescribed by medical practitioners in the United States for appropriate use in anaesthesia and analgesia, illegal fentanyl use has become an epidemic in the country. The DEA believes that all legitimate U.S. production of fentanyl for prescription purposes uses two precursor chemicals that are now subject to control, including under a United Nations protocol: NPP and ANPP. These two chemicals have been subject to regulation in mainland China since 1 February 2018.
DEA investigators have found that illicit manufacturers of fentanyl are now using other methods in response to the restrictions placed on NPP and ANPP. The DEA noted that benzylfentanyl is “readily available from chemical suppliers and can be converted to the immediate precursor, norfentanyl, in a one-step chemical reaction.” The agency believes there are three suppliers of this chemical in mainland China, as well as one in Canada, one in the United Kingdom and five within the United States.
The DEA also found that 4-anilinopiperidine can be converted to ANPP in a one-step chemical reaction and can then be used as the immediate precursor chemical in the illicit manufacture of fentanyl. The agency has identified 38 U.S. suppliers and 28 foreign suppliers of this chemical, of which 11 are in mainland China and one is in Hong Kong.
While no legitimate uses of either benzylfentanyl or 4-anilinopiperidine have been documented to date by the DEA, the agency is still offering temporary registration for any legitimate users of these chemicals, alone or in a mixture, provided that a properly completed application for registration or exemption is submitted within 30 days from the date of publication of a final rule. The temporary exemption would remain in effect until the DEA takes final action on an application. It would apply only to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would enter into force on the final rule’s effective date.