[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6259 Introduced in House (IH)]

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114th CONGRESS
  2d Session
                                H. R. 6259

To amend the Federal Food, Drug, and Cosmetic Act to ensure that liquid 
   over-the-counter medications are packaged with appropriate dosage 
   delivery devices and, in the case of such medications labeled for 
  pediatric use, appropriate flow restrictors, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 28, 2016

  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 that liquid 
   over-the-counter medications are packaged with appropriate dosage 
   delivery devices and, in the case of such medications labeled for 
  pediatric use, appropriate flow restrictors, and for other purposes.

    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 of 
2016''.

SEC. 2. DOSAGE DELIVERY DEVICES FOR LIQUID OTC DRUGS AND FLOW 
              RESTRICTORS FOR SUCH DRUGS LABELED FOR PEDIATRIC USE.

    (a) In General.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(dd)(1) If it is a liquid formulation of a drug that is not 
subject to section 503(b) and--
            ``(A) it is not packaged with a dosage delivery device in 
        accordance with specifications to be determined by the 
        Secretary by regulation;
            ``(B) in the case of such a liquid formulation that is 
        labeled for pediatric use, it is not packaged with a dosage 
        delivery device, as described in subparagraph (A), and--
                    ``(i) a flow restrictor; or
                    ``(ii) another mechanism to reduce the frequency 
                and volume of accidental ingestion that provides a 
                level of safety that is equivalent to or greater than 
                the level of safety that would be provided by a flow 
                restrictor, as determined by the Secretary by 
                regulation; or
            ``(C) its labeling is in violation of subparagraph (2).
    ``(2) The Secretary shall require that any measurement in the 
labeling of a liquid formulation of a drug that is not subject to 
section 503(b), including any measurement in the labeling of a dosage 
delivery device packaged with the liquid formulation, be expressed 
exclusively in metric units. The Secretary may waive the requirement in 
the preceding sentence with respect to one or more liquid formulations 
if the Secretary determines that, with respect to such formulations, 
implementation of such requirement would not benefit the public health.
    ``(3) In this paragraph:
            ``(A) The term `dosage delivery device'--
                    ``(i) means an object that is designed to measure 
                the dosage of a drug in liquid form and deliver that 
                drug to an individual; and
                    ``(ii) includes calibrated cups, droppers, 
                syringes, and spoons.
            ``(B) The term `flow restrictor' has such meaning as the 
        Secretary may prescribe by regulation.''.
    (b) Regulations.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall--
            (1) promulgate a final rule implementing the amendment made 
        by subsection (a); and
            (2) include in such rule a definition of the term ``flow 
        restrictor''.
    (c) Applicability.--The amendment made by subsection (a) applies 
beginning on the date that is 1 year after the date of enactment of 
this Act.
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