Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 558 - New Animal Drugs for Use in Animal Feeds |
Subpart B - Specific New Animal Drugs for Use in Animal Feeds |
§ 558.633 - Tylvalosin.
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§ 558.633 Tylvalosin.
(a) Specifications. Type A medicated articles containing 77.12 grams tylvalosin per pound 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) Special considerations.
(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) VFDs for tylvalosin shall not be refilled.
(3) Pelleted Type C medicated feeds must bear an expiration date of 30 days after the date of manufacture. Crumbled Type C medicated feeds must bear an expiration date of 7 days after the date of manufacture.
(e) Conditions of use.
Tylvalosin in
grams/tonIndications for use Limitations Sponsor (i) 38.6 Swine: For the control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE. Feed continuously as the sole ration for 14 consecutive days. 066916 (ii) [Reserved] [81 FR 36790, June 8, 2016, as amended at 81 FR 67153, Sept. 30, 2016; 84 FR 12504, Apr. 2, 2019; 87 FR 17948, Mar. 29, 2022; 87 FR 58968, Sept. 29, 2022]