subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.2645"
section_subject: "Tylvalosin."
cfr_reference: "21 CFR 520.2645"
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)Specifications. Granules containing 62.5 percent tylvalosin (w/w) as tylvalosin tartrate.
(b)Sponsor. See No. 066916 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.748 of this chapter.
(d)Conditions of use in swine—(1) Amount. Administer 50 parts per million (ppm) tylvalosin continuously in drinking water for 5 consecutive days.
(2)Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis,
Pasteurella multocida, and Streptococcus suis in groups of swine in buildings experiencing an outbreak of SRD.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.