3.0.0 1108 2023-01-11T13:35:10Z 2023-01-11T13:35:10Z House HR 2017-02-16 115 [Congressional Record Volume 163, Number 28 (Thursday, February 16, 2017)]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. DeLAURO:H.R. 1108.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 3 in Article I, Section 8,Clause 18 of the United States Constitution[Page H1303]]]> hsif00 Energy and Commerce Committee House Standing hsif17 Innovation, Data, and Commerce Subcommittee Referred to 2017-02-17T18:56:55Z Referred to 2017-02-16T15:02:00Z 2017-02-17 hsif17 Innovation, Data, and Commerce Subcommittee 1 House committee actions Referred to the Subcommittee on Digital Commerce and Consumer Protection. Committee 2017-02-16 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2017-02-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2017-02-16 Introduced in House IntroReferral 1000 9 Library of Congress D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 N R000606 Rep. Raskin, Jamie [D-MD-8] Jamie Raskin D MD 8 2017-03-08 False D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 2017-03-08 False L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2017-03-08 False S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 2017-10-25 False Health Administrative remedies Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Health 00 2017-02-16 Introduced in House 2017-06-28T19:30:39Z Recall Unsafe Drugs Act of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require producers of medications to notify the Food and Drug Administration (FDA) of the identity and location of a medication if the producer has reason to believe: (1) that the medication is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the medication will cause a threat of serious adverse health consequences or death to humans or animals.

The FDA may: (1) request that the distributor of a medication that is in violation of the FFDCA voluntarily recall the medication; (2) require the distributor of a medication that may cause serious adverse health consequences to immediately cease distribution of the medication; (3) recall a medication for which distribution has been ceased after giving the distributor an opportunity for an informal hearing; and (4) immediately recall a medication that presents an imminent threat of serious adverse health consequences. Distributors may appeal these FDA orders.

In the case of a recall, the FDA must notify consumers and state and local health officials to whom the medication was, or may have been, distributed.

Medication distributors must have a recall plan in effect.

]]> Recall Unsafe Drugs Act of 2017 Display Title Recall Unsafe Drugs Act of 2017 Official Title as Introduced To provide for the mandatory recall of drugs regulated by the Food and Drug Administration. Introduced in House IH Short Titles as Introduced Recall Unsafe Drugs Act of 2017 Introduced in House 2017-02-16T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115hr1108ih/xml/BILLS-115hr1108ih.xml 2017-02-17 Referred to the Subcommittee on Digital Commerce and Consumer Protection. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.