U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Choosing a Regulatory Pathway for Your Drug
Citizen Petition

The Citizen Petition (CP) Process can be used to request FDA to amend an OTC drug monograph at any phase of its development and after publication of a final monograph.

A CP can request that FDA amend an OTC drug monograph, for example, so that it allows marketing of a product that deviates in some way from what is stated in the monograph. A CP, however, must include data or information demonstrating that a product based on the proposed deviation is generally recognized among scientific experts as safe and effective.

It is important to note that you can't market a product with the new condition until the final monograph is ultimately amended, or until such time as FDA publishes an enforcement policy allowing for marketing on an interim basis, pending publication of an amendment to a developing or final monograph.

In addition, the CP can only be used to request an amendment to include an ingredient that would have been eligible for inclusion in the original tentative monograph (i.e., it was marketed for the same purpose before the OTC Drug Review began in 1972).


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