United States medical device QA/RA blog

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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

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