To amend the Federal Food, Drug, and Cosmetic Act to ensure accurate, intelligible information on dosage delivery devices packaged with liquid over-the-counter medications.
Protecting Our Kids' Medicine Act - Amends the Federal Food, Drug, and Cosmetic Act to require a liquid formulation of an over-the-counter drug to be packaged with a dosage delivery device meeting specified requirements. Defines "dosage delivery device" as an object that is designed to measure the dosage of a drug in liquid form and deliver that drug to an individual and includes calibrated cups, droppers, syringes, and spoons.
Sets forth requirements for such a dosage delivery device, which include that such device: (1) is calibrated in units of measure specified in the dosage directions on the outside packaging of the drug, the bottle, or written instructions on the label; (2) uses the same abbreviations as the directions and conforms to international or national standards for abbreviations; (3) has clearly printed decimals or fractions; (4) contains leading zeros before decimal points to avoid tenfold dosing errors; (5) has smaller font sizes for numerals in fractions compared to the size of the font used for numerals not in fractions; (6) contains no extraneous or unnecessary markings that may be confusing to consumers; and (7) uses markings that are clearly visible when the drug is added to the device.
Deems a drug to be misbranded if it does not meet the requirements of this Act.
Makes this Act effective one year after enactment.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
checking server…
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line