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What is the final rule of the FSMA?

FSMA 204. The FSMA 204 Rule, also known as the FDA Food Traceability Final Rule, requires companies to keep additional records for designated foods to protect public health. The FDAs additional recordkeeping requirements are outlined in the Federal Register Notice.

What does the Food Safety Modernization Act cover?

The Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus to preventing contamination of the food supply, rather than responding to it. The law applies to human food as well as to food for animals, including pets.

What is the Food Safety Modernization Act produce rule?

The Produce Safety Rule, outlined in Section 105 of FSMA, establishes science-based minimum standards for safe production and harvesting of fresh fruits and vegetables. These standards are based on a foundation of Good Agricultural Practices (GAPs).

What is the FSMA final rule for mitigation strategies?

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.

What is the final rule of the FDA intended use?

Under the final rule, a firm would not be regarded as intending an unapproved new use based solely on that firms knowledge that such drug was being prescribed or used by health care providers for such use. ing to FDA, the word solely is used to convey that FDA does not intend to consider a firms knowledge

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What is the final rule of the Food Safety Modernization Act?

The FSMA 204 Rule, also known as the FDA Food Traceability Final Rule, requires companies to keep additional records for designated foods to protect public health. The FDAs additional recordkeeping requirements are outlined in the Federal Register Notice.

What is the rule of the Food and Drug Administration?

The FDA protects the public from unsafe foods to drugs and from medical devices to cosmetics. It also protects the rights and safety of patients in clinical trials of new medical products and monitors the promotional activities of drug and device manufacturers.

What is the difference between FDA final guidance and final rule?

Final regulations are legislative rules that have the force of law. Whereas, guidances do not set new legal standards, impose legal requirements or have the force of law. Instead guidances are issued to help interpret or clarify an existing regulation. FDA certainly understands this difference.

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What is the final rule of the FSMA?

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