Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 520.2645: Tylvalosin.

(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 intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter and female swine intended for breeding 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.

Where this section sits in the code

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 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

(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.

(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 intended for slaughter and female swine intended for breeding in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter and female swine intended for breeding 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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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