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H.R. 338

BillFederalHouseIn Committee
Protecting Our Kids' Medicine Act
About This Bill
Committee
Latest Action · February 1, 2011
Referred to the Subcommittee on Health.
Congress
112th (2011–2013)
Introduced
January 19, 2011
Cosponsors (0)
None
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Summary

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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.

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