United States · Bill · HR
H.R. 1396 (109th)
Counterfeit Drug Enforcement Act
Introduced
17 March 2005
Last action
22 March 2005 · Referred
Status
Referred to the Subcommittee on Health.
Sponsors
Rep. Israel, Steve [D-NY-3]
Subjects
Healthcare
Source updated
15 August 2025
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
17 March 2005
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
17 March 2005
Introduced
Introduced in House
Source: IntroReferral
17 March 2005
Introduced
Introduced in House
Source: IntroReferral
22 March 2005
Referred
Referred to the Subcommittee on Health.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Introduced in House · 17 March 2005 · Download file
Documents
3 official files
Introduced in House (text)
This file cannot be previewed here. Use View or Download.
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in House (text)
Introduced in House · EN · 17 March 2005
Introduced in House (PDF)
Introduced in House · EN · 17 March 2005
ViewDownloadOpen at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Introduced in House
summary · EN · 17 March 2005
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.
Sponsors
- Rep. Israel, Steve [D-NY-3] · D · Sponsor
- · hsif00 · Standing
Related records
- 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/1396
- Open data entity: https://api.congress.gov/v3/bill/109/hr/1396
- us · 109-hr-1396 · source updated 15 August 2025