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H.R.338 / 112th Congress

Protecting Our Kids' Medicine Act

Referred to the Subcommittee on Health.

Official summary

Version 00 · Introduced in House · Jan 19, 2011

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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Who introduced it

Rep. Israel, Steve [D-NY-2] · D–NY

Committees

  • Energy and Commerce Committee
0 cosponsorship records, including any withdrawals

    Actions

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    1. Referred to the Subcommittee on Health.

    2. Referred to the House Committee on Energy and Commerce.

    3. Introduced in House

    4. Introduced in House

    Bill text & related measures

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    Related bills identified by Congress.gov

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    Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.

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