This publication presents the data and findings of the risk assessment on methyl 2-{[1-(4-fluorobutyl)-1H-indole-3-carbonyl]amino}-3,3-dimethylbutanoate (4F-MDMB-BICA), carried out by the extended Scientific Committee of the EMCDDA on 9 December 2020. On the basis of the Risk Assessment Report, on 12 March 2021, the Commission decided that 4F-MDMB-BICA should be included in the definition of 'drug', in the Annex to Framework Decision 2004/757/JHA.