US HB338 | 2011-2012 | 112th Congress

US Congress House Bill 338 (Prior Session Legislation)

Status

Sponsorship: Partisan Bill (Democrat 1)
Status: Introduced on January 19 2011 - 25% progression, died in committee
Action: 2011-02-01 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Summary

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.