Summary: H.R.3297 — 108th Congress (2003-2004)All Information (Except Text)

There is one summary for H.R.3297. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (10/15/2003)

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.

Provides a criminal fine and/or imprisonment for a person who knowingly caused a prescription drug to be adulterated or misbranded and sells or trades the drug, or who purchased or traded for the drug knowing or having reason to know that the drug was knowingly adulterated or misbranded.

Provides additional funding for Food and Drug Administration (FDA) inspections and investigations.

Modifies provisions pertaining to criminal penalties for committing certain prohibited acts involving food, drugs, devices, or cosmetics to: (1) make a violation punishable by a fine in accordance with Federal criminal law, imprisonment for not more than one year, or both; (2) make a second violation, or a violation committed with intent to defraud or mislead, punishable by a fine in accordance with Federal criminal law, imprisonment for not more than three years, or both; and (3) make a violation of provisions pertaining to prescription drug marketing punishable by a fine in accordance with Federal criminal law, imprisonment for not more than ten years, or both.