Drug Industry Gets FDA Guidance on Color Additives in Medicines

The FDA issued Thursday recommendations for replacing color additives in approved or marketed drug products, reminding the pharmaceutical industry that additives must conform to the agency’s regulations.

The guidance describes considerations for replacing a color additive in drug products, regardless of the reason for the change, according to the Food and Drug Administration’s notice in the Federal Register. This includes ensuring the selected color additive conforms with the requirements under the federal Food, Drug, and Cosmetic Act; updating information on labeling, composition statements, and master batch records; and documenting information to support the change.

If the FDA deems the color additive unsafe, the color additive must be removed or replaced. Color additives can also be replaced for other reasons, such as business decisions, according to the FDA.

The guidance recommends that new drug application and abbreviated new drug application holders submit information to support color additive replacements in changes being effected in 30 days (CBE-30) supplements.

“In many cases, replacing a color additive with one that is listed in the color additive regulations is unlikely to adversely affect the identity, strength, quality, purity, or potency of the drug product. Therefore, this draft guidance recommends a CBE-30 for such a change,” the FDA wrote.

The recommendations don’t apply to drug products in which a color additive is the active pharmaceutical ingredient, such as methylene blue. The recommendations also don’t apply to drugs that would create a different product if the color additive was replaced.

Given biological products rarely include color additives, the recommendations don’t apply to products that have an approved biologics license application, according to the FDA.