Animal Drug Product [Food and Drugs] Law and Legal Definition

Pursuant to (b) (16) 21 CFR 60.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter A General; Part 60 Patent Term Restoration; Subpart A General Provisions], Animal Drug Product means “the active ingredient of a new animal drug (as that term is used in the Act) that is not primarily manufactured using recombinant deoxyribonucleic acid (DNA), recombinant ribonucleic acid (RNA), hybridoma technology, or other processes involving site-specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.”