The US Food and Drug Administration (FDA) recently finalized a guidance to expedite the reformulation of drug products that use inactive ingredients manufactured with benzene, which the agency called a “known carcinogen.”
The guidance applies to new drug applications and abbreviated new drug applications (ANDAs) as well as marketed drugs, and nonprescription drugs. It covers topically applied liquid and semisolid dosage forms such as creams, gels, lotions, and ointments; immediate-release solid oral dosage forms; modified-release solid oral dosage forms and oral suspensions.
In an announcement, FDA said it “encourages manufacturers to implement reformulation as soon as possible. Given the high priority for public health, FDA is issuing this guidance to become immediately effective without prior comment.”…
