H.R. 6679 (112th): Counterfeit Drug Enforcement Act of 2012

Introduced:
Dec 18, 2012 (112th Congress, 2011–2013)
Sponsor:
Rep. Steve Israel [D-NY2]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on December 18, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Dec 18, 2012
Referred to Committee Dec 18, 2012
Cosponsors
none
Committees

House Energy and Commerce

The committee chair determines whether a bill will move past the committee stage.

Full Title

To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes.

Summary

No summaries available.

Text

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Last updated Dec 18, 2012.
10 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

12/18/2012--Introduced.
Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2012 - 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 (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 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.
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 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; and
(2) amend the order to include a recall if necessary.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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