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 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 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 packaged with appropriate dosage delivery devices and, in 

the case of such medications labeled for pediatric use, 

appropriate flow restrictors, and for other purposes. 

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 of 2014’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
2 

•HR 5613 IH

1 SEC. 2. DOSAGE DELIVERY DEVICES FOR LIQUID OTC 

2 DRUGS AND FLOW RESTRICTORS FOR SUCH 

3 DRUGS LABELED FOR PEDIATRIC USE. 

4 (a) IN GENERAL.—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: 

7 ‘‘(dd)(1) If it is a liquid formulation of a drug that 

8 is not subject to section 503(b) and— 

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

10 device in accordance with specifications to be deter11 mined by the Secretary by regulation; 

12 ‘‘(B) in the case of such a liquid formulation 

13 that is labeled for pediatric use, it is not packaged 

14 with a dosage delivery device, as described in sub15 paragraph (A), and— 

16 ‘‘(i) a flow restrictor; or 

17 ‘‘(ii) another mechanism to reduce the fre18 quency and volume of accidental ingestion that 

19 provides a level of safety that is equivalent to 

20 or greater than the level of safety that would be 

21 provided by a flow restrictor, as determined by 

22 the Secretary by regulation; or 

23 ‘‘(C) its labeling is in violation of subparagraph 

24 (2). 

25 ‘‘(2) The Secretary shall require that any measure26 ment in the labeling of a liquid formulation of a drug that 


SSpencer on DSK4SPTVN1PROD with BILLS
3 

•HR 5613 IH

1 is not subject to section 503(b), including any measure2 ment in the labeling of a dosage delivery device packaged 

3 with the liquid formulation, be expressed exclusively in 

4 metric units. The Secretary may waive the requirement 

5 in the preceding sentence with respect to one or more liq6 uid formulations if the Secretary determines that, with re7 spect to such formulations, implementation of such re8 quirement would not benefit the public health. 

9 ‘‘(3) In this paragraph: 

10 ‘‘(A) The term ‘dosage delivery device’— 

11 ‘‘(i) means an object that is designed to 

12 measure the dosage of a drug in liquid form 

13 and deliver that drug to an individual; and 

14 ‘‘(ii) includes calibrated cups, droppers, sy15 ringes, and spoons. 

16 ‘‘(B) The term ‘flow restrictor’ has such mean17 ing as the Secretary may prescribe by regulation.’’. 

18 (b) REGULATIONS.—Not later than 1 year after the 

19 date of enactment of this Act, the Secretary of Health and 

20 Human Services, acting through the Commissioner of 

21 Food and Drugs, shall— 

22 (1) promulgate a final rule implementing the 

23 amendment made by subsection (a); and 

24 (2) include in such rule a definition of the term 

25 ‘‘flow restrictor’’. 


SSpencer on DSK4SPTVN1PROD with BILLS
4 

•HR 5613 IH

1 (c) APPLICABILITY.—The amendment made by sub2 section (a) applies beginning on the date that is 1 year 

3 after the date of enactment of this Act. 

Æ 


SSpencer on DSK4SPTVN1PROD with BILLS