FDA finalizes guidance over benzene carcinogen in drugs

In final guidance that takes effect immediately, FDA restricted manufacturers from using benzene in new and existing prescription drugs as well as nonprescription interventions.

Benzene is a known carcinogen. Certain hand sanitizers and aerosol drug products have been recalled due to benzene contamination.

Levels of benzene as high as 100 parts per million (ppm) or greater were considered acceptable before FDA’s new rule. However, FDA, warned in December 2022 and again 1 year later that any drug containing more than 2 ppm of benzene would be deemed adulterated and should be recalled.

FDA is urging pharmaceutical companies to take action as soon as possible to reformulate drug products that use inactive ingredients made with benzene. The official guidance includes reporting categories and documentation needed to reformulate with immediate-release solid oral, topically applied liquid and semisolid, modified-release solid oral, and oral suspension dosage forms.