D&C Blue No. 1
Excipient (pharmacologically inactive substance)
What is it?
FDA has regulatory review for color additives used in foods, drugs, cosmetics, and medical devices. D&C Blue No. 1 is not listed as a FDA-approved colorant; however FD&C Blue No. 1 is listed. FD&C colors are the colors certified for use by the U.S. FDA in the food, drug, and cosmetic industry. FD&C indicates that the colorant is approved for use in food, drugs and cosmetics, and D&C indicates it is approved for use in drugs and cosmetics. It appears that D&C Blue No. 1 would fall under the same regulations as FD&C Blue No. 1.
 Electronic Code of Federal Registers. Title 21: Food and Drugs. Part 74. Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices. Accessed online 8/19/2012. http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditiveInventories/ucm115641.htm#table1A
 U.S. Food and Drug Administration. Color Additives: FDA's Regulatory Process and Historical Perspectives. Accessed April 13, 2012. http://www.fda.gov/ForIndustry/ColorAdditives/RegulatoryProcessHistoricalPerspectives/default.htm