Summary: H.R.6543 — 111th Congress (2009-2010)All Information (Except Text)

There is one summary for H.R.6543. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (12/17/2010)

Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to expand safety and inspection requirements for the manufacture and importation of drugs by: (1) expanding registration requirements for foreign and domestic drug producers; (2) requiring drug manufacturers to have in effect and implement an effective quality system; (3) expanding and equalizing inspection requirements for foreign and domestic drug producers; (4) imposing additional requirements relating to the notification, nondistribution, and recall of adulterated or misbranded drugs; (5) permitting the detention of drugs found to be in violation of drug safety requirements; (6) allowing for the destruction of drugs that pose a significant adverse health effect; (7) providing enhanced civil and criminal penalties and forfeiture for violations of drug safety requirements and enhanced subpoena authority for investigating violations; (8) prohibiting the importation of drugs into the United States lacking documentation of safety; (9) requiring unique identification numbers for drug establishments and importers; and (10) expanding protections for whistleblowers who refuse to violate, or who disclose violations of, this Act.