PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Mar 17, 2005
Counterfeit Drug Enforcement Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services, upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to: (1) cease distribution of the drug; (2) notify health professionals of the order and instruct such professionals to cease administering or prescribing the drug; and (3) amend the order to include a recall if necessary.
Establishes a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated or misbranded and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated or misbranded. Requires a manufacturer of a drug to notify the Secretary within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred.
Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations.
People & committees
Rep. Israel, Steve [D-NY-2] · D–NY
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 15, 2025. Consult Congress.gov for the current record.
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