4 replies to this topic

[sarah2014]

people with experience in dietary supplements lets share information about our HACCP plan and our CCPS 

[safefood007]

Kindly share your process flow

[Angus86]

Hi Sarah - I too am in dietary supplements - but ingredients. We do not manufacture finished dietary supplements. I'd love to brainstorm regulatory ideas with you as I'm still learning 21 CFR 111 :)

[sarah2014]

don't hesitate if you have any questions

[workerbee123]

Here is the specific language from 117 that exempts supplement companies:

21 CFR Part 117, Subpart A Exemptions, section (e):

(e) Subparts C and G do not apply to any facility with regard to the manufacturing, processing, packaging, or holding of a dietary supplement that is in compliance with the requirements of part 111 of this chapter (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) and section 761 of the Federal Food, Drug, and Cosmetic Act (Serious Adverse Event Reporting for Dietary Supplements).