FDA published a discussion on MedWatch reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products. There were multiple complaints raising concerns that displaying the strength per milliliter in larger, more prominent font, instead of the strength per total volume, may lead to confusion about how much drug is in the container. FDA issued a draft guidance in April 2013, which applies to marketed prescription drugs and CDER-regulated biological products, that states: “For small volume parenteral products, the strength per total volume should be the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per milliliter enclosed by parentheses.”
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