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FDA Releases Final Guidance for OTC Dosage Delivery Devices
To address concerns about the risk of accidental overdoses with OTC medications, especially in children, FDA has released a final draft guidance for industry regarding the manufacture of dosage delivery devices. The document “Guidance for Industry Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products” (PDF) provides to firms that are manufacturing, marketing, or distributing orally ingested OTC liquid drug products recommendations for making liquid dosage delivery devices that are easier for consumers to use and understand. FDA notes that better measuring devices for OTC liquid drug products will help patients, parents, and other caregivers use the right amount of these medications, especially when administering liquid drug products to children. The guidance also recommends that dosage devices are marked with calibrated units of liquid measurement (eg, teaspoon, tablespoon, or milliliter) that are the same as the units of liquid measurement specified in the labeled dosage directions on the product packaging and in any written instructions. More information about this guidance is available on the FDA Web site.
