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.
- See sections 201 the Federal (m), 502(a) and 502(f)(1) of Food, Drug, and Cosmetic Act.)