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Regulatory Focus™ > News Articles > Quality & Compliance: Combination Product Labeling

Quality & Compliance: Combination Product Labeling

Posted 01 October 2009

This article, the fourth in a series2 on US Food and Drug Administration (FDA) regulation of combination products, considers the topic of combination product labeling. Section 201(m) of the Federal Food, Drug, and Cosmetic Act defines "label" as "…written, printed or graphic matter upon any article or any of its content or wrappers or accompanying such article…" In this article, "labeling" is distinguished from the label affixed to a drug product and/or its packaging, and refers mainly to directions for use (i.e., prescribing information and instructions for use (IFU)). Instructional, storage-related, or precautionary statements on the primary label may also be considered to be labeling. This article does not cover regulation of combination product advertising and promotional materials, which also fall within the definition of labeling.

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