FDA Issues New Guidance to Tackle Benzene Levels in Drug Products
In a significant move, the U.S. Food and Drug Administration (FDA) has issued new guidance aimed at aiding drug manufacturers in reducing consumers’ and patients’ exposure to unacceptable levels of benzene in various drug products.
The FDA’s decision was prompted by its identification, in 2020, of the potential for unacceptable levels of benzene in certain carbomers, commonly used as thickening agents in pharmaceuticals. This assessment was based on the permissible limits outlined in the current Carbomer United States Pharmacopeia (USP) monographs. Responding to this concern, the USP has announced its intent to revise by issuing a Notice of Intent, with a target effective date of August 1, 2025, to remove five benzene-containing carbomer monographs.
The newly released guidance provides manufacturers with essential recommendations for testing and documentation related to the reformulation of drug products utilizing carbomers manufactured with benzene. It takes into consideration the diverse routes of administration and dosage forms of the affected drug products. For application holders, the guidance also advises on appropriate submission types to notify the FDA of reformulation changes. Given the high priority for public health, the FDA has implemented this guidance to become immediately effective without prior comment, emphasizing the urgency of the situation.
Dr. Sarah McMullen, PhD, Country Director of the FDA’s India Office, emphasized the importance of the guidance, stating, “This is a proactive step to address potential health risks associated with benzene exposure in drug products. We urge manufacturers to swiftly implement these guidelines to ensure the safety of consumers.”
This guidance not only signifies the FDA’s commitment to maintaining pharmaceutical safety standards but also underscores its rapid response to emerging concerns within the drug supply chain. Stakeholders, including manufacturers and healthcare professionals, are encouraged to familiarize themselves with the guidance and take prompt action to address benzene exposure in drug products
This development marks a pivotal effort by the FDA to uphold the integrity of the nation’s drug supply and protect public health.
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