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Requesting Exemption from Supplements GMP Rule

06/25/2007

Federal Register Interim final rule: FDA is issuing an interim final rule that sets forth a procedure for requesting an exemption from the requirement in the final rule “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” The manufacturer can conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This interim final rule allows companies to get FDA review of an alternative to the required 100% identity testing of dietary ingredient components, provided certain conditions are met, and establishes a requirement for retention of records relating to the agency's response to an exemption request. To view this interim final rule, click here.

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