subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "530"
part_subject: "EXTRALABEL DRUG USE IN ANIMALS"
subpart_code: "C"
subpart_subject: "Specific Provisions Relating to Extralabel Use of Animal and Human Drugs in Food-Producing Animals"
section_number: "530.21"
section_subject: "Prohibitions for food-producing animals."
cfr_reference: "21 CFR 530.21"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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.