Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
/ PART 530 - EXTRALABEL DRUG USE IN ANIMALS
/ Subpart C - Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals / § 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.