On August 24, the US Food and Drug Administration (FDA or Agency) issued a final rule (Final Rule) that extends and clarifies the compliance dates for a limited subset of Food Safety Modernization Act (FSMA) requirements in four of the seven foundational rules part of FDA’s FSMA implementation.1 The four rules include
Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (Preventive Control Rules) for Human and Animal Foods;2
Foreign Supplier Verification Programs (FSVP);3 and
The Agency decided to extend the dates to address industry concerns about the practicality of complying with such dates and to better align them with the other FSMA rules. Generally, FDA granted an additional two years to comply.
The below table provides the updated compliance dates for the subset of FSMA requirements. Given the dates’ variability among the four rules, the earliest compliance date is listed.