FDA Guidance for Industry

Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products

Over-the-Counter (OTC) Dosage Delivery Devices

On May 4, 2011, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry with the Agency’s recommendations for improving dosage delivery devices, such as cups and droppers, for over-the-counter (OTC) (i.e., non-prescription) orally ingested liquid drug products.

This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, syrups) that are packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, spoons).

Because written, printed, or graphic matter appearing on dosage delivery devices packaged with aTC liquid drug products is considered labeling, such markings on these devices must not be false or misleading and must be clear and consistent with the drug product’s directions for use.

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Download “Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products” UCM188992.pdf – Downloaded 453 times – 595 KB

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