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e-CFR data is current as of February 24, 2021

Title 21Chapter ISubchapter EPart 530Subpart C → §530.21


Title 21: Food and Drugs
PART 530—EXTRALABEL DRUG USE IN ANIMALS
Subpart C—Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals


§530.21   Prohibitions for food-producing animals.

(a) FDA may prohibit the extralabel use of an approved new animal or human drug or class of drugs in food-producing animals if FDA determines that:

(1) An acceptable analytical method needs to be established and such method has not been established or cannot be established; or

(2) The extralabel use of the drug or class of drugs presents a risk to the public health.

(b) A prohibition may be a general ban on the extralabel use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors.

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