FDA 21 CFR Part 111

Controls Used for Manufacturing, Processing, Packing, or Holding Dietary Supplements for FDA 21 CFR Part 111 CGMP Regulations

In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule FDA 21 CFR Part 111. In essence, the final rule requires that the proper controls be in place for dietary supplements during manufacturing, packaging, labeling, and holding operations. The move was in response to concerns about substandard dietary supplement manufacturing practices, as well as mislabeling practices.

Solutions to 21 CFR Part 111 Challenges