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1 Health Canada Santé Canada STATUS DECISION OF CONTROLLED AND NON-CONTROLLED SUBSTANCE(S) Substance: Despropionyl fentanyl ** SECONDARY REVIEW ** Based on the current information available to the Office of Controlled Substances, it appears that the above substance is: Controlled X Not Controlled ☐ under the schedules of the Controlled Drugs and Substances Act (CDSA) for the following reason(s): The substance is a metabolite of fentanyl and is captured under item 16(5) of Schedule I to the CDSA. Prepared by: _______________________________________ Vincent Marleau Date: _______________ Verified by: Date: ________________ _______________________________________ Mark Kozlowski Approved by: _______________________________________ Date: ________________ DIRECTOR, OFFICE OF CONTROLLED SUBSTANCES This status was requested by: Benoit Archambault, DAS 1 Drug Status Report Drug: Despropionyl fentanyl Drug Name Status: Despropionyl fentanyl is the common name. Chemical Name: 1-Phenethyl-N-phenylpiperidin-4-amine Other Names: N-phenyl-1-(2-phenylethyl)-4-piperidinamine; N-phenyl-1-(2phenylethyl)piperidin-4-amine; 1-(beta-phenethyl)-4-anilinopiperidine; 4-anilino-Nphenethylpiperidine Chemical structure: Molecular Formula: C19H24N2 CAS-RN: 21409-26-7 Pharmacological class / Application: Fentanyl derivative International status: US: Despropionyl fentanyl is not listed specifically in the Schedules to the US Controlled Substances Act and is not mentioned anywhere on the DEA website. United Nations: The substance is not listed on the Yellow List - List of Narcotic Drugs under International Control, the Green List - List of Psychotropic Substances under International Control, nor the Red List - List of Precursors and Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances under International Control. Canadian Status: Despropionyl fentanyl is not listed specifically in the Schedules to the CDSA. The substance is a metabolite of fentanyl1, which is listed as sub-item 16(5) “Fentanyl (N–(1– phenethyl–4–piperidyl) propionanilide)” in Schedule I to the CDSA under the heading “Fentanyls, their salts, derivatives, and analogues and salts of derivatives and analogues, 1 Clavijo, C.F. et al. (2011). A low blood volume LC-MS/MS assay for the quantification of fentanyl and its major metabolites norfentanyl and despropionyl fentanyl in children. Journal of Separation Science: 34(24); 3568-3577. 3 including:”. As a metabolite of fentanyl, Despropionyl fentanyl is captured by sub-item 16(5) in Schedule I to the CDSA. Recommendation: Despropionyl fentanyl is included in item 16(5) of Schedule I to the CDSA and is a controlled substance. Date: May 15th, 2013.