H.R. 5740 · 111th Congress
To provide for the mandatory recall of adulterated or misbranded drugs.
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Never voted on. It didn't reach a floor vote before the 111th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
TownsSponsor4 cosponsors · 4 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · Jul 14, 2010
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To provide for the mandatory recall of adulterated or misbranded drugs.
Latest action (Jul 14, 2010): Referred to the House Committee on Energy and Commerce.
Policy area: Health · Origin: House · Introduced: Jul 14, 2010
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.