subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "530"
part_subject: "EXTRALABEL DRUG USE IN ANIMALS"
subpart_code: "B"
subpart_subject: "Rules and Provisions for Extralabel Uses of Drugs in Animals"
section_number: "530.11"
section_subject: "Limitations."
cfr_reference: "21 CFR 530.11"
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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In addition to uses which do not comply with the provision set forth in § 530.10, the following specific extralabel uses are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the act:
(a)Extralabel use in an animal of an approved new animal drug or human drug by a lay person (except when under the supervision of a licensed veterinarian);
(b)Extralabel use of an approved new animal drug or human drug in or on an animal feed;
(c)Extralabel use resulting in any residue which may present a risk to the public health; and
(d)Extralabel use resulting in any residue above an established safe level, safe concentration or tolerance.