Module 6

04/10/2024

What is an OTC monograph?

FDA (2022):

•

• Simply stated, an OTC monograph is a "rule book"

for each therapeutic category establishing

conditions, such as active ingredients, uses

(indications), doses, route of administration,

labeling, and testing under which an OTC drug is

generally recognized as safe and effective (GRASE).

The Organisation for Professionals in Regulatory Affairs

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US OTC MONOGRAPHS

The Organisation for Professionals in Regulatory Affairs

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