OTC Review/Drug Monographs

In 1972, the U.S. Food and Drug Administration (FDA) developed The OTC Review to review the safety and efficacy of OTC ingredients, doses, formulations, and labeling used in medicines available to consumers without a prescription.

The OTC Review process is not yet complete. The current status of an OTC medicine can be viewed by visiting the rulemaking history for OTC drug products section of FDA’s Center for Drug Evaluation and Research’s website. Those ingredients and indications which are not covered by final monographs are in tentative final monographs.

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