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 delivery devices packaged with liquid over-the-counter medications. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protecting Our Kids’ 

5 Medicine Act’’. 


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1 SEC. 2. REQUIREMENT OF ACCURATE DOSAGE DELIVERY 

2 DEVICES FOR LIQUID OTC DRUGS. 

3 (a) CLARIFICATION OF TREATMENT OF DOSAGE DE4 LIVERY DEVICES.—Section 502 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 352) is amended by 

6 adding at the end the following new subsection: 

7 ‘‘(aa) If it is a liquid formulation of a drug that is 

8 not subject to section 503(b) and— 

9 ‘‘(1) it is not packaged with a dosage delivery 

10 device; or 

11 ‘‘(2) it is packaged with a dosage delivery de12 vice and— 

13 ‘‘(A) the calibrated units of measure 

14 marked on the dosage delivery device (such as 

15 ‘teaspoon’, ‘tablespoon’, or ‘milliliter’) are not 

16 the same as the units of measure specified in 

17 the dosage directions— 

18 ‘‘(i) on the outside packaging or bottle 

19 for the drug; or 

20 ‘‘(ii) contained in any other written 

21 instructions that are included in the label22 ing of the drug; 

23 ‘‘(B) if any units of measure on the dosage 

24 delivery device are abbreviated on the dosage 

25 delivery device and— 


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1 ‘‘(i) the abbreviation used on the dos2 age delivery device is not the same as the 

3 abbreviation used in the dosage directions 

4 described under subparagraph (A); 

5 ‘‘(ii) international or national stand6 ards for abbreviations for units of measure 

7 are not used on the dosage delivery device; 

8 ‘‘(iii) nonstandard or uncommon ab9 breviations for units of measure are used 

10 on the dosage delivery device; or 

11 ‘‘(iv) the abbreviations for units of 

12 measure that are used on the dosage deliv13 ery device are not defined on such device 

14 or in the dosage directions described under 

15 subparagraph (B); 

16 ‘‘(C) decimals or fractions on the dosage 

17 delivery device are not printed clearly (as deter18 mined by the Secretary); 

19 ‘‘(D) leading zeros are not used before dec20 imal points printed on the dosage delivery de21 vice for purposes of avoiding tenfold dosing er22 rors; 

23 ‘‘(E) smaller font sizes are not used for 

24 numerals in fractions printed on dosage delivery 


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1 devices, as compared to the size of the font 

2 used for numerals not in fractions; 

3 ‘‘(F) the dosage delivery device contains 

4 extraneous or unnecessary markings (as deter5 mined by the Secretary) that may be confusing 

6 to consumers; or 

7 ‘‘(G) the markings on the dosage delivery 

8 device are not clearly visible or are obscured 

9 when the drug is added to the device. 

10 For purposes of this paragraph, the term ‘dosage 

11 delivery device’ means an object that is designed to 

12 measure the dosage of a drug in liquid form and de13 liver that drug to an individual and includes cali14 brated cups, droppers, syringes, and spoons.’’. 

15 (b) EFFECTIVE DATE.—The amendment made by 

16 subsection (a) shall take effect at the end of the one-year 

17 period beginning on the date of the enactment of this Act. 

Æ 


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