Drug Product Law and Legal Definition

Drug product means “a finished dosage form, for example, tablet, capsule, or solution that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.” [21 CFR 314.3; Title 21-Food And Drugs; Chapter I-Food And Drug Administration, Department Of Health And Human Services; Subchapter D-Drugs For Human Use; Part 314-Applications For Fda Approval To Market A New Drug; Subpart A-General Provisions]