3.0.0 338 2023-01-11T13:20:58Z 2023-01-11T13:20:58Z House H HR 2011-01-19 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. ISRAEL:H.R. 338.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I, Section 8, Clause 3 and Article I,Section 18 of the United States Constitution.[Page H356]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2011-02-01T21:39:26Z Referred to 2011-01-19T15:03:10Z 2011-02-01 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2011-01-19 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2011-01-19 Introduced in House IntroReferral Intro-H 9 Library of Congress 2011-01-19 Introduced in House IntroReferral 1000 9 Library of Congress I000057 Rep. Israel, Steve [D-NY-2] STEVE ISRAEL D NY 2 N Health Consumer affairs Drug safety, medical device, and laboratory regulation Health

00 2011-01-19 Introduced in House 2011-02-14T21:04:43Z 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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Display Title Official Title as Introduced Introduced in House IH Short Titles as Introduced Introduced in House 2011-01-19T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr338ih/xml/BILLS-112hr338ih.xml 2011-02-01 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.