part_subject: "OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED"
subpart_code: "B"
subpart_subject: "Administrative Procedures"
section_number: "330.11"
section_subject: "NDA deviations from applicable monograph."
cfr_reference: "21 CFR 330.11"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
A new drug application requesting approval of an OTC drug deviating in any respect from a monograph that has become final shall be in the form required by § 314.50 of this chapter, but shall include a statement that the product meets all conditions of the applicable monograph except for the deviation for which approval is requested and may omit all information except that pertinent to the deviation.