I 
113TH CONGRESS 
2D SESSION 
H. R. 5613 
To amend the Federal Food, Drug, and Cosmetic Act to ensure that liquid 
over-the-counter medications are packaged with appropriate dosage deliv-
ery 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 18, 2014 
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 pack-
aged 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 Representa-
tives 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 2014’’. 
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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 deter-
mined 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 sub-
paragraph (A), and— 
‘‘(i) a flow restrictor; or 
‘‘(ii) another mechanism to reduce the fre-
quency 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 measure-
ment in the labeling of a liquid formulation of a drug that 
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is not subject to section 503(b), including any measure-
ment 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 liq-
uid formulations if the Secretary determines that, with re-
spect to such formulations, implementation of such re-
quirement 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, sy-
ringes, and spoons. 
‘‘(B) The term ‘flow restrictor’ has such mean-
ing 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’’. 
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(c) APPLICABILITY.—The amendment made by sub-
section (a) applies beginning on the date that is 1 year 
after the date of enactment of this Act. 
Æ 
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