Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 330.11 - NDA deviations from applicable monograph.

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.

[39 FR 11741, Mar. 29, 1974, as amended at 55 FR 11581, Mar. 29, 1990]
authority: 21 U.S.C. 321,351,352,353,355,360,360fff-6,371
source: 39 FR 11741, Mar. 29, 1974, unless otherwise noted.
cite as: 21 CFR 330.11