21 CFR § 530.21 Extralabel Drug Use in Animals

§ 530.21 Prohibitions for food-producing animals.

Current through Sep 8, 2026 · Read all of Part 530

(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.

← § 530.20 Conditions for permitted extralabel animal and human drug use in food-producing animals.§ 530.22 Safe levels and analytical methods for food-producing animals. →