Which Current Good Manufacturing Practice (CGMP) regulations apply to a manufacturer of dietary supplements, those in 21 CFR part 111 or those in 21 CFR part 117?

A dietary supplement manufacturer would be required to comply with the CGMP regulations in 21 CFR part 117, subpart B in addition to the regulations in 21 CFR part 111, unless the regulations conflict. To the extent regulations conflict, the manufacturer would comply with the regulation in part 111 (see the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, Response 197; 80 Fed. Reg. 55908 at 55978).