FDA Posts Draft Guidances on 'Qualified Facility' Exemption From Preventive Controls Regs
The Food and Drug Administration on May 13 released draft guidance documents to help small business “qualified facilities” comply with new regulations on preventive controls for human and animal food, it said (here). Documents include questions and answers on requirements…
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for qualified facilities (here), as well as draft “attestations” of eligibility for qualified facility status for human food (here) and animal food (here), and instructions for how to submit them (here). Small business “qualified facilities” are mostly exempt from upcoming preventive controls requirements for human and animal food (see 1509100021 and 1509100073). In order to obtain qualified facility status, companies subject to human food preventive controls regulations must submit their attestations by Sept. 17, 2018, and companies subject to animal food rules must file them by Sept. 17, 2019, though in each case records must be kept before these dates.