Reformulating drug products that contain carbomers manufactures with benzene

The FDA document provides guidance for industry on reformulating drug products using carbomers produced with benzene. The document outlines the risks associated with benzene, a known human carcinogen, and recommends testing and documentation for reformulating products. It covers various drug forms like semisolid, solid oral, and suspensions, emphasizing the importance of compliance with good manufacturing practices and regulatory submissions.
The guidance is intended to ensure safety and efficacy in drug products, particularly addressing changes in drug composition due to the reformulation process.
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https://medgate.vn/wp-content/uploads/2024/02/Reformulating-Drug-Products-That-Contain-Carbomers-Manufactured-with-Benzene.pdf