Bulk Drug Substance [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 207.3 (4) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter C Drugs: General; Part 207 Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution; Subpart A General], Bulk Drug Substance means “any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.”