21 CFR 330.11 - NDA deviations from applicable monograph.

§ 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 330 after this date.

  • 2016-11-23; vol. 81 # 226 - Wednesday, November 23, 2016
    1. 81 FR 84465 - Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 23, 2016.
      21 CFR Part 330