Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products

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.  The intent of this guidance is to suggest ways manufacturers can improve their labeling in order to minimize the risk of accidental overdose. 

The following questions and answers provide background on accidental overdose of OTC liquid drug products and describe the steps manufacturers and consumers can take to reduce medication dosing errors.

Q1. What are over-the-counter (OTC) orally ingested liquid drug products?

Q2. What are dosage delivery devices?

Q3. Why is FDA concerned about over-the-counter (OTC) dosage delivery devices?

Q4. Why did FDA issue a guidance for industry on dosage delivery devices?

Q5. What are the main points of the guidance?

Q6. How will FDA determine if this guidance is effective in minimizing the risk of accidental overdose of over-the-counter (OTC) orally ingested liquid drug products?

Q7. What can consumers do to help assure the safe use of over-the-counter (OTC) orally ingested liquid drug products?

ten tips for patients, parents, and caregivers who are administering over-the-counter (OTC) liquid oral drug products to children.