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2 Nov 2017

Under USFDA, do OTC medications has same approval process as that of prescription drugs?

No. Because there are over 300,000 marketed OTC drug products, instead of individual drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids.

For each class, an OTC drug monograph is developed and published in the Federal Register

OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labeling. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients.

Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. 

New products that conform to a final monograph may be marketed without further FDA review.  Those that do not conform must be reviewed by the New Drug Application process. 

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