Prescription Drug [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 203.3 (y) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter C Drugs: General; Part 203 Prescription Drug Marketing; Subpart A General Provisions], the term Prescription Drug means “any drug (including any biological product, except for blood and blood components intended for transfusion or biological products that are also medical devices) required by Federal law (including Federal regulation) to be dispensed only by a prescription, including finished dosage forms and bulk drug substances subject to section 503(b) of the act.”