Reformulating Drug Products That Contain Carbomers Manufactured With Benzene; Guidance for Industry; Availability

Zusammenfassung

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Reformulating Drug Products That Contain Carbomers Manufactured With Benzene." The purpose of this guidance is to provide recommendations to applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to support the reformulation of drug products that use carbomers manufactured with benzene. Certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, which raises safety concerns. FDA has requested that the USP omit (or remove) these monographs, and applicants and manufacturers may need to reformulate their drug products to avoid use of these carbomers. This guidance provides recommendations for tests and documentation related to reformulation based on various routes of administration and dosage forms of affected drug products, and provides recommendations for application holders on the appropriate submission types to notify the Agency of reformulation changes. The intended effect of this guidance is to, as appropriate, provide a less burdensome risk-b