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Part 110 Lives Another Day

Yesterday FDA withdrew its directive to remove and reserve the Current Good Manufacturing Practice (cGMP) for Human Food regulations found in 21 C.F.R. Part 110. This is not groundbreaking as the cGMP requirements in Part 110 were codified into Part 117, Current Good Manufacturing Practices, Hazard Analysis, and Risk Based Preventive Controls for Human Food. See 80 Fed. Reg. 55,908 (Sept. 17, 2015). Essentially, today’s notice removes “instruction 13” of the Final Rule, establishing 21 C.F.R. Part 117, which required Part 110’s cGMP requirements to be removed and reserved on September 17, 2018.

Removal of the directive is necessary because of the extension of compliance dates for certain facilities subject to the modernized cGMP requirements in the Preventive Controls regulation. More specifically, if Part 110 was removed, small and very small facilities, as described in Part 117, would not be subject to any cGMPs until January 28, 2019 and January 27, 2020, respectively. Retaining the cGMP for Human Food regulation will maintain the status quo while these facilities prepare for compliance with the new cGMP and Preventive Controls requirements.

Although this is a Final Rule, FDA is accepting comments until October 12, 2018.

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