be clearly distinguishing and differentiating from any name recognized in an official compendium. O'fficial preparations (a drug product, a dietary supplement including nutritional supplements, or a finished device) may contain additional suitable ingredients. Drugs USP's goal is to have substance and preparation (product) monographs in USP- NF for all FDA-approved drugs, including biologics, and their ingredients. USP also develops monographs for therapeutic products not approved by FDA, e.g., pre-1938 drugs, dietary supplements, and compounded preparations. Although submission of information needed to develop a monograph by the Council of Experts is voluntary, compliance with a USP-NF h. if available, is mandatory