Counterfeit Drug Enforcement Act

Summary

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 17 March 2005

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• Introduced in House (PDF)

  Introduced in House · EN · 17 March 2005

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• Introduced in House

  summary · EN · 17 March 2005

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