Protecting Our Kids' Medicine Act of 2016

Bill: 114-hr-6259
Sponsor: full_name: Rep. Israel, Steve [D-NY-3]
Introduced: 2016-09-28
Policy area: Health
Subjects: Administrative law and regulatory procedures

Child health

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)
Latest action: action_date: 2016-09-28
text: Referred to the House Committee on Energy and Commerce.

Summaries:
action_date: 2016-09-28
action_desc: Introduced in House
text: <p><b>Protecting Our Kids' Medicine Act of 2016</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. The Food and Drug Administration may waive the requirement for metric units if that requirement would not benefit public health.</p> Over-the-counter liquid drugs labeled for pediatric use may not be sold without a flow restrictor or another mechanism to reduce accidental ingestion.

tv_txt: I 114th CONGRESS 2d Session H. R. 6259 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.

1. Short title This Act may be cited as the Protecting Our Kids’ Medicine Act of 2016 . 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.