I 
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 deliv-
ery devices packaged with liquid over-the-counter medica-
tions. 
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’’. 
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SEC. 2. REQUIREMENT OF ACCURATE DOSAGE DELIVERY 
DEVICES FOR LIQUID OTC DRUGS. 
(a) CLARIFICATION OF TREATMENT OF DOSAGE DE-
LIVERY 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 de-
vice 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 label-
ing of the drug; 
‘‘(B) if any units of measure on the dosage 
delivery device are abbreviated on the dosage 
delivery device and— 
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‘‘(i) the abbreviation used on the dos-
age delivery device is not the same as the 
abbreviation used in the dosage directions 
described under subparagraph (A); 
‘‘(ii) international or national stand-
ards for abbreviations for units of measure 
are not used on the dosage delivery device; 
‘‘(iii) nonstandard or uncommon ab-
breviations 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 deliv-
ery 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 deter-
mined by the Secretary); 
‘‘(D) leading zeros are not used before dec-
imal points printed on the dosage delivery de-
vice for purposes of avoiding tenfold dosing er-
rors; 
‘‘(E) smaller font sizes are not used for 
numerals in fractions printed on dosage delivery 
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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 deter-
mined 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 de-
liver that drug to an individual and includes cali-
brated 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. 
Æ 
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