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OTC Drug Monograph Compliance & FDA Labeling Support – XPRO America

Over-the-counter (OTC) drugs play a vital role in the U.S. healthcare market, allowing consumers to access safe and effective treatments without a prescription. To ensure public safety, the U.S. Food and Drug Administration (FDA) regulates OTC products under the OTC Drug Monograph system. Compliance with these monographs is mandatory for [...]

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FDA Product Classification: Cosmetic, Drug & OTC Guidance – XPRO America

Correctly determining whether a product is regulated as a cosmetic, drug, or OTC hybrid is one of the most critical steps for companies entering the U.S. market. Misclassification can lead to FDA enforcement actions, product recalls, detentions at ports, and costly re-labeling or reformulation. The U.S. FDA defines cosmetics as [...]

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