Reformulating Drugs Containing Carbomers

FDA has published an immediately effective guidance, Reformulating Drug Products That Contain Carbomers Manufactured With Benzene, with recommendations for applicants and manufacturers on the tests that should be performed and the documentation that should be submitted or available to FDA to support the reformulation of drug products that use carbomers manufactured with benzene. The document recommendations take into account the various routes of administration and dosage forms of affected drug products, FDA says.

The guidance does not address toxicological considerations related to the unavoidable use of benzene in drug products, drug substances, or inactive ingredients.

The agency says it is implementing the guidance without prior public comment “because benzene is a known human carcinogen. By providing recommendations on how applicants and manufacturers can reformulate certain drug products, the agency seeks to facilitate the transition away from using carbomers manufactured with high levels of benzene. Publishing this guidance without prior public comment addresses the immediate public health need to expedite the discontinuation of these carbomers and provides a less burdensome risk-based approach to applicant submissions….”