FDA CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals

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Current Good Manufacturing Practice Requirements for Food for Animals Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction This guidance is intended for domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug and Cosmetic Act (the FD&C Act) because they manufacture, process, pack, or hold animal food for consumption in the U.S. This guidance contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food established in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015 (80 FR 56170) (the final rule). This guidance also provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping. The CGMP requirements are codified in 21 CFR part 507, subpart B (subpart B), and some related requirements are codified in 21 CFR part 507, subparts A and F (subparts A and F). FDA’s (hereinafter also referred to as “Agency”, “we”, or “our”) guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). This law enables FDA to better protect public health by helping to ensure the safety and security of the animal food supply by focusing on prevention of food safety problems rather than reacting to problems after they occur. As part of our implementation of FSMA, we established risk-based preventive control requirements for the production of animal food by food facilities required to register under section 415 of the FD&C Act (see section 418 of the FD&C Act). At the same time, we established Current Good Manufacturing Practice requirements (CGMPs) for the manufacturing, processing, packing, and holding of animal food under section 402(a)(3) and (4) of the FD&C Act and sections 311, 361, and 368 of the Public Health Service Act.

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