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  1. Medication Errors Related to CDER-Regulated Drug Products

Over-the-Counter (OTC) Dosage Delivery Devices

Medicine Cup with tsp Markings and Red LiquidOn 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. The intent of this guidance is to suggest ways manufacturers can improve their labeling in order to minimize the risk of accidental overdose. 

 

 
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