3.0.0 5740 2023-01-11T13:21:56Z 2023-01-11T13:21:56Z House H HR 2010-07-14 111 hsif00 Energy and Commerce Committee House Standing Referred to 2010-07-14T14:00:47Z 2010-07-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2010-07-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2010-07-14 Introduced in House IntroReferral 1000 9 Library of Congress T000326 Rep. Towns, Edolphus [D-NY-10] EDOLPHUS TOWNS D NY 10 N C000984 Rep. Cummings, Elijah E. [D-MD-7] ELIJAH CUMMINGS D MD E. 7 2010-09-28 False F000030 Rep. Farr, Sam [D-CA-17] SAM FARR D CA 17 2010-09-29 False K000336 Rep. Kucinich, Dennis J. [D-OH-10] DENNIS KUCINICH D OH J. 10 2010-09-29 False C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2010-11-15 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 2010-07-14 Introduced in House 2010-08-20T21:16:13Z Amends the Federal Food, Drug, and Cosmetic Act to require any registered producer of a drug or device to notify the Secretary of Health and Human Services (HHS), as soon as practicable, of the identity and location of a drug, if such person has reason to believe: (1) that such drug is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the drug will cause a threat of serious adverse health consequences or death to humans or animals.

Authorizes the Secretary to: (1) request that any person who distributes a drug that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of the FFDCA voluntarily recall such drug; (2) issue an order requiring any person who distributes a drug that may cause serious adverse health consequences or death to humans or animals to immediately cease distribution of such drug; (3) amend the order to cease distribution to include a recall of the drug after an opportunity for an informal hearing; and (4) issue an order requiring an immediate recall of a drug if the Secretary has credible evidence or information that a drug subject to a cease distribution or recall order presents an imminent threat of serious adverse health consequences or death to humans or animals. Provides for notice to affected persons.

Prohibits the failure to comply with the notification requirements of, or orders issued pursuant to, this Act.

Requires the Secretary to provide notice of a recall order to consumers to whom the drug was, or may have been, distributed and to appropriate state and local health officials, as necessary.

]]> To provide for the mandatory recall of adulterated or misbranded drugs. Display Title To provide for the mandatory recall of adulterated or misbranded drugs. Official Title as Introduced To provide for the mandatory recall of adulterated or misbranded drugs. Introduced in House IH Introduced in House 2010-07-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr5740ih/xml/BILLS-111hr5740ih.xml 2010-07-14 Referred to the House Committee on Energy and Commerce. 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.