Mr. Erickson is director of professional affairs at Gallipot Inc.
Where can I obtain powdered food coloring for use in compounding?
Food coloring as a descriptive class is not approved for use in pharmaceutical compounding; however, drug and cosmetic (D&C) and food, drug, and cosmetic (FD&C) dyes are allowed. Colorants are unique compounds from a legislative and regulatory standpoint: most countries maintain positive lists of colorants suitable for use in food, drugs, cosmetics, or in more than 1 of these classes.
Following are several examples of FD&C colorants approved for use in the United States. Please note: Where the words Alum Lake are used, the dye is insoluble; in compounded preparations it is used most often as an excipient in capsule formulations as a visual aid to verify uniformity. The other dyes are water-soluble. Either type can be used to make a preparation more appealing to the patient and hence improve adherence.
Examples of Approved Colorants
*Tartrazine-containing prescription drugs for human use are required to bear the statement: "This product contains FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons."
The incidence of this sensitivity in the general population is low, but aspirin-sensitive patients seem most likely to exhibit tartrazine hypersensitivity.
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One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs