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D&C Blue No. 1

Excipient (pharmacologically inactive substance)

Medically reviewed by Drugs.com. Last updated on Apr 13, 2020.

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.[1][2] 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.

[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

[2] 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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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