[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 338 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 338

 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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 19, 2011

  Mr. Israel introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protecting Our Kids' Medicine Act''.

SEC. 2. REQUIREMENT OF ACCURATE DOSAGE DELIVERY DEVICES FOR LIQUID OTC 
              DRUGS.

    (a) Clarification of Treatment of Dosage Delivery Devices.--Section 
502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 
amended by adding at the end the following new subsection:
    ``(aa) If it is a liquid formulation of a drug that is not subject 
to section 503(b) and--
            ``(1) it is not packaged with a dosage delivery device; or
            ``(2) it is packaged with a dosage delivery device and--
                    ``(A) the calibrated units of measure marked on the 
                dosage delivery device (such as `teaspoon', 
                `tablespoon', or `milliliter') are not the same as the 
                units of measure specified in the dosage directions--
                            ``(i) on the outside packaging or bottle 
                        for the drug; or
                            ``(ii) contained in any other written 
                        instructions that are included in the labeling 
                        of the drug;
                    ``(B) if any units of measure on the dosage 
                delivery device are abbreviated on the dosage delivery 
                device and--
                            ``(i) the abbreviation used on the dosage 
                        delivery device is not the same as the 
                        abbreviation used in the dosage directions 
                        described under subparagraph (A);
                            ``(ii) international or national standards 
                        for abbreviations for units of measure are not 
                        used on the dosage delivery device;
                            ``(iii) nonstandard or uncommon 
                        abbreviations for units of measure are used on 
                        the dosage delivery device; or
                            ``(iv) the abbreviations for units of 
                        measure that are used on the dosage delivery 
                        device are not defined on such device or in the 
                        dosage directions described under subparagraph 
                        (B);
                    ``(C) decimals or fractions on the dosage delivery 
                device are not printed clearly (as determined by the 
                Secretary);
                    ``(D) leading zeros are not used before decimal 
                points printed on the dosage delivery device for 
                purposes of avoiding tenfold dosing errors;
                    ``(E) smaller font sizes are not used for numerals 
                in fractions printed on dosage delivery devices, as 
                compared to the size of the font used for numerals not 
                in fractions;
                    ``(F) the dosage delivery device contains 
                extraneous or unnecessary markings (as determined by 
                the Secretary) that may be confusing to consumers; or
                    ``(G) the markings on the dosage delivery device 
                are not clearly visible or are obscured when the drug 
                is added to the device.
        For purposes of this paragraph, the term `dosage delivery 
        device' means 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.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect at the end of the one-year period beginning on the date of 
the enactment of this Act.
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