FDA Issues Final Compliance Policy Guide On Food Facility Registration

The U.S. Food and Drug Administration (FDA) announced the availability of “Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food” (the CPG). The CPG provides guidance for FDA staff regarding the enforcement of the food facility registration provisions of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were amended by the FDA Food Safety Modernization Act (FSMA). They include the requirement that certain food facilities register with FDA, the requirement that registered facilities biennially renew their registrations with FDA, and FDA’s authority to suspend a food facility’s registration.

These registration requirements apply to food facilities that manufacture, process, pack, or hold food for human and animal consumption in the United States. The CPG replaces “Compliance Policy Guide Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”

In April 2013, FDA published a draft of the CPG and received two comments, both of which did not recommend significant changes to the draft CPG. No substantive changes were made from the draft to final version of the guide.

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