21 C.F.R. § 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.
Notes of Decisions
Cited in 1
case, 2011–2011 · leading case: United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011).
United States v. Franck's Lab, Inc., 816 F. Supp. 2d 1209 (M.D. Fla. 2011). “Compare 21 C.F.R. § 530.21 (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) [a]n acceptable analytical method needs to be established and such method has not been established…”
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