Module 6

04/10/2024

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Each monograph defines…

• Drug substances considered appropriate for OTC use

• Specific labeling requirements ● Indications ● Dosage ● Directions for Use ● Warnings

The Organisation for Professionals in Regulatory Affairs

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OTC Monographs… • How to evaluate products…? ● ADVISORY PANELS formed to decide this

● Three categories: ❑ Category I: GRASE ❑ Category II: Not GRASE ❑ Should not be marketed – as OTC ❑ Category III: Insufficient data ❑ Safe but not yet proven to be effective – need more data

● To be in a monograph… ❑ a product must be Category I

The Organisation for Professionals in Regulatory Affairs

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