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# Drug Product Color Additive Replacement Guide
- URL: https://www.fdaweb.com/drug-product-color-additive-replacement-guide/
- Published: 2025-05-29T12:00:00.000Z
- Updated: 2026-09-14T15:13:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159270

FDA has published a draft guidance, *Replacing Color Additives in Approved or Marketed Drug Products*, describing considerations for replacing a color additive. The [document](https://www.fda.gov/media/186692/download?ref=fdaweb.com) says if a color additive is used in a drug product, the additive must conform to the agency’s color additive regulations.

“If FDA deems the color additive unsafe and repeals the color additive regulation, the color additive must be removed or replaced,” the draft says.

Considerations listed in the guidance for replacing a color additive are:

- ensuring that the selected color additive conforms with the color additive requirements;
- updating information, including labeling, composition statements, master batch records, and drug product specifications (as applicable);
- documenting information to support the change, including maintaining appropriate records at the manufacturing site; and
- submitting information to support the change in a supplement (for application products).

The guidance says its recommendations apply both to applicants and manufacturers.