21 CFR 522.2471 - Tilmicosin.

§ 522.2471 Tilmicosin.

(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)Special considerations.

(1) Not for human use. Use of this antibiotic in humans may prove fatal. Do not use in automatically powered syringes.

(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e)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. Do not use in female dairy cattle 20 months of age or older. Use of this antibiotic in this class of cattle may cause milk residues. Do not slaughter within 42 days of last treatment.

(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. Do not slaughter within 28 days of last treatment.

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

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 09-Nov-2018 03:23

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2018-09-28; vol. 83 # 189 - Friday, September 28, 2018
    1. 83 FR 48940 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective September 28, 2018, except for amendatory instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR 520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR 522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR 558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.
      21 CFR Parts 510, 520, 522, 524, 529, 556, and 558