Title 21

SECTION 530.21

530.21 Prohibitions for 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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