United States · Bill · HR
H.R. 2345 (109th)
Tim Fagan's Law
Introduced
12 May 2005
Last action
23 May 2005 · Referred
Status
Referred to the Subcommittee on Health.
Sponsors
Rep. Israel, Steve [D-NY-3], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Cummings, Elijah E. [D-MD-7], Rep. Watson, Diane E. [D-CA-33], Rep. Jackson Lee, Sheila [D-TX-18], Rep. Ackerman, Gary L. [D-NY-5], Rep. Owens, Major R. [D-NY-11], Rep. Davis, Danny K. [D-IL-7], Rep. Higgins, Brian [D-NY-26], Rep. Pastor, Ed [D-AZ-4], Rep. Waxman, Henry A. [D-CA-33], Rep. Woolsey, Lynn C. [D-CA-6], Rep. Fattah, Chaka [D-PA-2], Rep. Conyers, John, Jr. [D-MI-13], Rep. Lowey, Nita M. [D-NY-17]
Subjects
Healthcare
Source updated
15 August 2025
Summary
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. 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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
12 May 2005
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
12 May 2005
Introduced
Sponsor introductory remarks on measure. (CR E950-951)
Source: IntroReferral
12 May 2005
Introduced
Introduced in House
Source: IntroReferral
12 May 2005
Introduced
Introduced in House
Source: IntroReferral
23 May 2005
Referred
Referred to the Subcommittee on Health.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Introduced in House · 12 May 2005 · Download file
Documents
3 official files
Introduced in House (text)
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Introduced in House (text)
Introduced in House · EN · 12 May 2005
Introduced in House (PDF)
Introduced in House · EN · 12 May 2005
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Introduced in House
summary · EN · 12 May 2005
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Sponsors
- Rep. Israel, Steve [D-NY-3] · D · Sponsor
- Del. Norton, Eleanor Holmes [D-DC-At Large] · D · Cosponsor
- Rep. Cummings, Elijah E. [D-MD-7] · D · Cosponsor
- Rep. Watson, Diane E. [D-CA-33] · D · Cosponsor
- Rep. Jackson Lee, Sheila [D-TX-18] · D · Cosponsor
- Rep. Ackerman, Gary L. [D-NY-5] · D · Cosponsor
- Rep. Owens, Major R. [D-NY-11] · D · Cosponsor
- Rep. Davis, Danny K. [D-IL-7] · D · Cosponsor
- Rep. Higgins, Brian [D-NY-26] · D · Cosponsor
- Rep. Pastor, Ed [D-AZ-4] · D · Cosponsor
- Rep. Waxman, Henry A. [D-CA-33] · D · Cosponsor
- Rep. Woolsey, Lynn C. [D-CA-6] · D · Cosponsor
- Rep. Fattah, Chaka [D-PA-2] · D · Cosponsor
- Rep. Conyers, John, Jr. [D-MI-13] · D · Cosponsor
- Rep. Lowey, Nita M. [D-NY-17] · D · Cosponsor
- · hsif00 · Standing
Related records
- related to → Counterfeit Drug Enforcement Act
- related to ← Tim Fagan's Law
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/109th-congress/house-bill/2345
- Open data entity: https://api.congress.gov/v3/bill/109/hr/2345
- us · 109-hr-2345 · source updated 15 August 2025