FDA Releases Draft Guidance Regarding Current Good Manufacturing Practice Requirements for Animal Food

Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry #235, “Current Good Manufacturing Practice Requirements for Food for Animals,” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance contains information designed to help animal food facilities determine whether they need to comply with the animal food current good manufacturing practice (CGMP) requirements in 21 C.F.R. part 507 and, if so, how. Unlike the draft guidance FDA also issued this week on CGMP requirements for human food, this animal food CGMP guidance is not intended to be part of a multi-chapter guidance, but is a stand-alone document. There will, however, be future guidances on other provisions of part 507, including hazard analysis and preventive controls for animal food. This alert highlights key aspects of the draft guidance that will be of interest to industry stakeholders.