Tim Fagan's Law

Summary

Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) 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 a 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 Department of Health and Human Services (HHS) 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 using technologies that HHS determines are technically feasible and assist in preventing such violations. Authorizes additional appropriations for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires HHS to educate the public and health care professionals on counterfeit drugs. Directs HHS, upon a finding that a drug intended for human use may constitute a threat to the public health, 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, distributing, selling, or prescribing the drug. Requires HHS, after providing the person with an opportunity for an informal hearing, to amend the order to include a recall, if appropriate. Requires HHS and the Attorney General to establish a procedure through which the FDA is authorized to issue subpoenas.

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Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 11 December 2014

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• Introduced in House (PDF)

  Introduced in House · EN · 11 December 2014

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• Introduced in House

  summary · EN · 11 December 2014

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