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Is pre-clearance necessary if the standards of the OTC monograph are met?

April 26, 2017Met monograph necessary OTC pre-clearance Standards

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Is pre-clearance necessary if the standards of the OTC monograph are met?

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No. Marketing pre-clearance of OTC drug products by the FDA is not required if the standards of the applicable monograph are met. Additional requirements for the marketing of human drug products may be found in Title 21 of the Code of Federal Regulations containing parts 200-299 and 300-499.