§530.21. Prohibitions for food-producing animals.
21 C.F.R. § 530.21
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:
An acceptable analytical method needs to be established and such method has not been established or cannot be established; or
The extralabel use of the drug or class of drugs presents a risk to the public health.
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, amendments, and revision history
Authority
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b, 371, 379e.
Source
Source: 61 FR 57743, Nov. 7, 1996, unless otherwise noted.