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  • Not enacted
    The President has not signed this bill
  • The senate has not voted
  • The house has not voted
      house Committees
      House Committee on Energy and Commerce
      Health
    IntroducedJanuary 28th, 2009

Bill Details

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Title

Food and Drug Administration Globalization Act of 2009

Official Title

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food, drugs, devices, and cosmetics in the global market, and for other purposes.

Summary

Food and Drug Administration Globalization Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth provisions governing food safety, including requiring for each food facility: (1) a hazard analysis of facilities that manufacture, process, pack, transport, or hold food for consumption in the United States; (2) identification and implementation of preventive controls; and (3) a written food safety plan. Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to significantly minimize, prevent, or eliminate the occurrence of such hazards; (2) establish science-based minimum standards for the safe production and harvesting of fruits and vegetables as necessary; (3) establish a risk-based inspection schedule; and (4) establish a program to expedite the movement of certified food through the importation process. Provides for: (1) an accreditation system for food facilities; and (2) certification of laboratories to conduct sampling and testing of food. Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish an active surveillance system for food. Sets forth provisions governing drug and device safety, including: (1) providing for risk-based inspection schedules; (2) requiring quality risk management plans for establishments; (3) requiring country of origin labeling; and (4) providing for the recall of drugs. Sets forth provisions governing cosmetic safety, including requiring cosmetic establishments to: (1) submit to the Secretary a cosmetic and ingredient statement for each cosmetic; (2) report any serious and unexpected adverse event in the United States associated with the use of the cosmetic; and (3) conform with good manufacturing practices. Sets forth provisions governing the Food and Drug Administration (FDA), including provisions: (1) regarding the reorganization of FDA; and (2) authorizing the Commissioner of Food and Drugs to issue subpoenas for any proceeding regarding a violation of the FFDCA.

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