Reformulating Drug Products That Contain Carbomers Manufactured with Benzene

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Today, FDA issued a new guidance to help drug manufacturers limit consumers’ and patients’ exposure to unacceptable levels of benzene in drug products.

In 2020, FDA identified the potential for unacceptable levels of benzene in certain carbomers (which may be used as thickening agents in drugs) based on the allowable limits in current Carbomer United States Pharmacopeia (USP) monographs. USP has issued a Notice of Intent to Revise, stating its intent to remove five benzene-containing carbomer monographs with a target effective date of August 1, 2025

Today’s guidance provides manufacturers with recommendations for testing and documentation related to reformulation of drug products that use carbomers manufactured with benzene, taking into consideration the various routes of administration and dosage forms of affected drug products. For application holders, this guidance also recommends appropriate submission types to notify the agency of such changes.

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