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Version 00 · Introduced in House · May 12, 2005
Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug 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, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred.
Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations.
Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible.
Showing the opening paragraphs of the official summary.
Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations.
Requires the Secretary to educate the public and health care professionals on counterfeit drugs.
Directs the Secretary: (1) 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 cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and (2) amend the order to include a recall if necessary.
People & committees
Rep. Israel, Steve [D-NY-2] · D–NY
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Sponsor introductory remarks on measure. (CR E950-951)
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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