[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.30]

[Page 7]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
        Subpart B--Specific Administrative Rulings and Decisions
 
Sec. 500.30  Gentian violet for animal drug use.

    The Food and Drug Administration (FDA) has determined that gentian 
violet is not generally recognized as safe and effective for any 
veterinary drug use in food animals and is a new animal drug subject to 
section 512 of the Federal Food, Drug, and Cosmetic Act. FDA has 
determined that gentian violet is not exempted from new animal drug 
status under the ``grandfather'' provisions of the Drug Amendments of 
1962 (21 U.S.C. 342).

[56 FR 40507, Aug. 15, 1991]