21 CFR § 522.2471Chapter I

§ 522.2471 Tilmicosin.

Primary source

Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

Full Text

(a) Specifications. Each milliliter of solution contains 300 milligrams (mg) tilmicosin base as tilmicosin phosphate.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.735 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica.

(iii) Limitations. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Do not use in lactating dairy cattle 20 months of age or older. Use of tilmicosin in this class of cattle may cause milk residues. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Sheep—(i) Amount. 10 mg/kg body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of ovine respiratory disease (ORD) associated with Mannheimia (P.) haemolytica.

(iii) Limitations. Not for use in lactating ewes producing milk for human consumption. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 72367, Dec. 5, 2002, as amended at 75 FR 9334, Mar. 2, 2010; 81 FR 48703, July 26, 2016; 88 FR 16548, Mar. 20, 2023]

eCFR data current as of: June 12, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.