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FDA Releases Two Guidance Documents Regarding Preventive Controls for Animal and Human Food Rules

Monday, October 23, 2017

(North American Meat Institute)

The Food and Drug Administration (FDA) issued two guidance documents intended for facilities that may be subject to the Preventive Controls for Animal Food rule or the Preventive Controls for Human Food rule. The " Guidance for Industry #235: Current Good Manufacturing Practice Requirements for Food for Animals " helps animal food establishments determine if they are subject to the Current Good Manufacturing Practice (CGMP) requirements in the Preventive Controls for Animal Food rule and provides recommendations for meeting the CGMP requirements. The guidance includes a self-assessment tool that facilities may use to evaluate their compliance with the CGMP requirements.

FDA also published draft guidance, " Application of the 'Solely Engaged' Exemptions in Parts 117 and 507 ," which addresses the applicability of the "solely engaged" exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. The draft guidance explains instances when facilities are exempt from CGMP or preventive controls requirements because they are "solely engaged" in certain activities. FDA is currently accepting public comments on the draft guidance.

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