§ 522.2630 Tulathromycin.

Specifications.(a) Each milliliter of solution contains:

(1) 100 milligrams (mg) tulathromycin

(2) 25 mg tulathromycin

Sponsors.(b) See sponsor numbers in § 510.600(c) of this chapter.

(1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, 061133, 068504, and 069043 for use of product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section.

(2) Nos. 013744, 051311, 054771, 058198, 068504, and 069043 for use of product described in paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.

Related tolerances.(c) See § 556.745 of this chapter.

Conditions of useCattleAmount.(d) —(1) —(i) 2.5 mg per kilogram (/kg) body weight as a single subcutaneous injection in the neck.

Indications for useBeef and non-lactating dairy cattle.Mannheimia haemolytica, Pasteurella multocida,Histophilus somni,Mycoplasma bovis.M. haemolytica, P. multocida,H. somni,M. bovis.Moraxella bovis.Fusobacterium necrophorumPorphyromonas levii.(ii) —(A) For the treatment of bovine respiratory disease (BRD) associated with and For the control of respiratory disease in cattle at high risk of developing BRD associated with and For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with For the treatment of bovine foot rot (interdigital necrobacillosis) associated with and

Suckling calves, dairy calves, and veal calves.Mannheimia haemolytica, Pasteurella multocida,Histophilus somni,Mycoplasma bovis.(B) For the treatment of bovine respiratory disease (BRD) associated with and

Limitations.(iii) (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Calves intended for human consumption must not be slaughtered within 22 days from the last treatment. Not for use in ruminating cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

SwineAmount.(2) —(i) 2.5 mg/kg body weight as a single intramuscular injection in the neck.

Indications for use.Actinobacillus pleuropneumoniaeP. multocidaBordetella bronchisepticaHaemophilus parasuisMycoplasma hyopneumoniaeA. pleuropneumoniaeP. multocidaM. hyopneumoniae(ii) For the treatment of swine respiratory disease (SRD) associated with , , , , and ; and for the control of SRD associated with , , and in groups of pigs where SRD has been diagnosed.

Limitations.(iii) Swine intended for human consumption must not be slaughtered within 5 days from the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[70 FR 39918, July 12, 2005, as amended at 71 FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. 8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872, Oct. 25, 2013; 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015; 81 FR 67151, Sept. 30, 2016; 86 FR 57997, Oct. 20, 2021; 87 FR 58962, Sept. 29, 2022; 88 FR 16548, Mar. 20, 2023; 88 FR 27700, May 3, 2023; 89 FR 95103, Dec. 2, 2024; 90 FR 6801, Jan. 21, 2025]