FDA Releases Two FSMA Guidance Documents

Nov 14, 2017 | Amy Chang

The US Food and Drug Administration released 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” provides information on determining if animal food establishments are subject to the Current Good Manufacturing Practice (CGMP) in the Preventative Controls for Animal Food rule.

The Application of the ‘Solely Engaged’ Exemptions in Parts 117 and 507 document provides information on the applicability of the “solely engaged” exemptions for the Preventive Controls for Human Food and Preventive Controls for Animal Food rules. It explains when facilities are exempt from CGMP or preventive controls requirements because they are “solely engaged” in certain activities. The draft guidance also explains that the “solely engaged” exemptions do not apply when a facility is also conducting certain other activities.


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