21 CFR 330.11
§ 330.11 NDA deviations from applicable monograph.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 330.11, § 330.11 NDA deviations from applicable monograph, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86486
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58811177d068124fcc93fe2997e130d2d67cbe3d7956f1d2447794cd29eab8ec
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.