Drug Substance Law and Legal Definition

Drug substance means “an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient.” [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]