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GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 111 - Dietary Supplement handbook


US FDA Title 21 CFR PART 111 -- Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding operations for Dietary Supplements Pocket Guide

In June 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 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.

The 21 CFR 111 ruling addresses the quality of the manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements; nor does it address the safety of the dietary supplement's ingredients, or their effects on health, when proper manufacturing techniques are used. The rule applies to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.

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