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Tag: Pharmaceutical development

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What is the FDA Definition of Overage?

5 min read
According to regulatory guidance and industry standards, overage is the intentional addition of an ingredient in excess of the label claim during manufacturing. Understanding the precise FDA definition of overage is crucial for manufacturers to ensure product safety, efficacy, and labeling accuracy. This practice is carefully regulated and depends heavily on the product category and the reason for its use, such as compensating for manufacturing losses or potential degradation.