Data Submitted to the Agency

Data regarding OTC drug monographs can be submitted by anyone- such as a drug company, health professional, consumer, or citizen's group. If the submission is a request to amend an existing OTC drug monograph or is an opinion regarding an OTC drug monograph, it needs to be submitted in the form of a citizen petition or as correspondence to an established monograph docket. However, if no OTC drug monograph exists, data must be submitted in the format as outlined in the Code of Federal Regulations (CFR) section 10.30.

Data is submitted to the Dockets Management Branch where it is logged in and a copy is made for the public files. The data is then forwarded to the Division of Over-the-Counter Drug Products for review and action.