The US Food and Drug Administration compared the United States Pharmacopeia’s two recommended limits on benzene levels in production of certain types of OTC and Rx drugs and advises firms to immediately switch to the lower one.
US FDA Recommends Tests, Documentation To Show Benzene No Higher Than 2PPM In Drugs
CDER says guidance needed to help facilitate and expedite reformulating drug products which use carbomers manufactured with benzene, a human carcinogen, so that no more than 2 parts per million of the substance is present.
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