Final Guidance from FDA on Dispensing Devices Sold with OTC Drugs

The US Food and Drug Administration has published final guidance targeting over-the-counter drug products packaged with syringes, droppers and other dispensing devices.

Dispensing devices can minimize the risk of accidental overdoses, according to the guidance; the agency issued the guidance to address concerns over unclear or inconsistently marked dosage delivery devices.

The guidance’s specific recommendations for manufacturers include:

• Inclusion of dispensing devices with all orally ingestible OTC liquid drugs
• Marking of devices with the same calibrated measurement units as those specified in product directions
• Ensuring that dispensing devices are used only with the products with which they’re packaged
• Ensuring that liquid measure markings on dispensing devices remain clearly visible when liquids are added to those devices