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Over-The-Counter Drugs

How We Can Help

Is it a drug? Is it a cosmetic? What is the risk?
We can help you classify your product and ensure compliance with the US FDA monograph or the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. OTC drug monographs are a kind of “recipe book” covering ingredients, doses, formulations, labeling and testing. Products conforming to a monograph may be marketed without FDA pre-approval.

What We Do

  • Review ingredients and substantiate their safety

  • Review claims and labels

  • Ensure compliance with the OTC drug monographs

  • Support toxicological testing requirements for a new ingredient approval (New Drug Application or NDA)

  • Heavy metal testing

  • Microbial quality

  • California Proposition 65 compliance

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