CFR section

21 CFR 530.20(a)(1): Conditions for permitted extralabel animal and human drug use in food-producing animals

PART 530-EXTRALABEL DRUG USE IN ANIMALS · Subpart C-Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals

Key facts

Citation 21 CFR 530.20(a)(1)
Section Conditions for permitted extralabel animal and human drug use in food-producing animals
Part PART 530-EXTRALABEL DRUG USE IN ANIMALS
Subpart Subpart C-Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals
Subchapter 21 CFR E Drugs Animal
Product types cited Veterinary
Regulation text (excerpt) (1) There is no approved new animal drug that is labeled for such use and that contains the same active ingredient which is in the required dosage form and concentration, except where a veterinarian finds, within the context of a valid veterinarian-client-patient relationship, that the approved new animal drug is clinically ineffective for its intended use.

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