2023-20738: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of two additional draft chapters of a multichapter draft guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapters are entitled "Chapter 11--Food Allergen Program" and "Chapter 16-- Acidified Foods." This draft guidance is not final nor is it in effect at this time.
The agency’s own summary, as published.
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