compounding HOTLINE

FEBRUARY 01, 2008
Martin A. Erickson III, RPh

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

  • FD&C Blue #1 (Brilliant Blue FCF) Alum Lake
  • FD&C Blue #1 CI 42090
  • FD&C Blue #2 (Indigotine) CI 73015
  • FD&C Green #3 (Fast Green FCF) CI 42053
  • FD&C Red #3 (erythrosine) CI 45430
  • FD&C Yellow #5 Alum Lake
  • FD&C Yellow #5 (tartrazine*) CI 19140
  • FD&C Yellow #6 (Sunset Yellow FCF) Alum Lake (looks orange)
  • FD&C Yellow #6 CI 15985 (looks orange)

*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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