legislation: 111-hr-6543
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| bill_id | congress | bill_type | bill_number | title | policy_area | introduced_date | latest_action_date | latest_action_text | origin_chamber | sponsor_name | sponsor_state | sponsor_party | sponsor_bioguide_id | cosponsor_count | summary_text | update_date | url |
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| 111-hr-6543 | 111 | hr | 6543 | Drug Safety Enhancement Act of 2011 | Health | 2010-12-17 | 2010-12-17 | Referred to the House Committee on Energy and Commerce. | House | Rep. Dingell, John D. [D-MI-15] | MI | D | D000355 | 3 | 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. | 2023-01-11T13:21:12Z |