[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR330.11]

[Page 211]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 330_OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY 
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED--Table of Contents
 
                   Subpart B_Administrative Procedures
 
Sec. 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 Sec. 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]