FDA Guidance Aimed at Reducing Benzene in Drugs

The FDA has issued a direct-to-final guidance on testing for benzene in drug manufacture.

The 13-page benzene guidance, “Reformulating Drug Products That Contain Carbomers Manufactured with Benzene,” explains that certain United States Pharmacopeia (USP) carbomer monographs currently allow for unacceptable levels of benzene, a known human carcinogen. The FDA has requested that the USP omit (or remove) these monographs. Consequently, applicants and manufacturers may need to reformulate their drug products to avoid using these carbomers. 

The guidance, which the FDA issued without inviting public comment due to “the immediate public health need to expedite the discontinuation of the use of these carbomers,” provides recommendations for testing and documentation related to reformulation, taking into consideration the various routes of administration and dosage forms of affected drug products.

Read the guidance here.

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