FDA sets standards for liquid OTC dosage devices

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.

"Accidental medication overdose in young children is an increasingly common, but preventable public health problem," stated Karen Weiss, program director for the Center for Drug Evaluation and Research's Safe Use Initiative.

Key recommendations in the guidance include:

  • Dosage delivery devices should be included for all orally ingested OTC liquid drug products;

  • Devices should be marked with calibrated units of liquid measurement (e.g., teaspoon, tablespoon or milliliter) that are the same as the units of liquid measure specified in the directions for the product and there should not be any unnecessary markings;

  • Manufacturers should ensure that dosage delivery devices only are used with the accompanying products; and

  • Liquid measure markings on dosage delivery devices clearly should be visible and not obscured when the liquid product is added to the device.