The FDA has issued a draft guidance providing drug manufacturers with recommendations on replacing color additives in drugs.
This draft guidance provides recommendations regarding the documentation that should be generated to support a color additive replacement. It also recommends that new drug application (NDA) and abbreviated new drug application (ANDA) holders submit color additive replacements in changes being effected in 30 days (CBE-30) supplements. Drug product manufacturers should retain information to support the change at the manufacturing facility.
On January 15, FDA amended its color additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a color additive petition. Drug manufacturers who use FD&C Red No. 3 in ingested drugs will have until January 18, 2028, to reformulate their products. The draft guidance being issued today is not specific to reformulating products containing FD&C Red No. 3. Replacing a color additive with one that is listed in FDA’s color additive regulations is unlikely to adversely affect the identity, strength, quality, purity, or potency of the drug.
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