Drug products are colored for a variety of reason and there are different types of color additives that can be used in these products. However, all color additives must be pre-approved by the FDA and listed in Title 21 of the Code of Federal Regulations before they may be used in drugs and other FDA-regulated products. This webinar will give you an overview of FDA’s regulation and enforcement of color additives in drugs, including certified and certification exempt color additives, and how the certification process works. In addition, you will learn about why color is added to drug products, the different types of color additives, the color additive petition process, and how a color additive is listed for use in drugs. Finally, we will discuss labeling requirements for color additives in drug products and how FDA enforces these regulations.