U.S. FDA Registration & Labeling Compliance Assistance

FDA Drug Color Additives Requirement

All drug color additives must be FDA approved for their specific intended use and formulation. Drug colors additives must be either FDA certified colors (on a batch basis), or exempted from FDA color certification. Batch Certification is a process by which FDA evaluates the composition of all colors used in drug formulation. To obtain the color additive batch certification, drug manufacturers must submit a sample of the color additive for each batch used in the product formulation along with the batch-specific documents. After proper examinations U.S. FDA will certify the color additive if the analysis of the batch sample meets the FDA requirements.

Color additive violations are amongst most common reasons for FDA import detentions and refusals. FDA Listing Inc. assists drug manufacturers in demonstrating to FDA that color additives contained in the imported products are certified, and properly declared on the product label. Our experts we will assist you to initially determine if a batch certification needed for your used color additive and next walk you through filling for batch certifications and approval. For assistance regarding drug color additive review and certification click the start button.