Code of Federal Regulations · Section
§ 530.21 — Prohibitions For Food-producing Animals
21 C.F.R. § 530.21
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(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.
Authorizing Statute
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Definitions; generally21 U.S.C. § 321