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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 500.30: Gentian violet for animal drug use.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
  4. PART 500—GENERAL
  5. Subpart B—Specific Administrative Rulings and Decisions

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).

Collected 2026-08-27T02:24:47Z. Source file · JSON

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