21 CFR 522.2640 - Tylosin.

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There are 5 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.2640 Tylosin.
(a) Specifications. Each milliliter of solution contains 50 or 200 milligrams of tylosin activity (as tylosin base).
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000986 for use in paragraphs (d)(1), (2), and (3) of this section.
(2) No. 000010 for use as in paragraphs (d)(1) and (2) of this section.
(c) Related tolerances. See § 556.740 of this chapter.
(d) Conditions of use—
(1) Beef cattle and nonlactating dairy cattle—
(i) Amount. 8 milligrams per pound of body weight once daily.
(ii) Indications for use. Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by Arcanobacterium pyogenes.
(iii) Limitations. Administer intramuscularly for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear. Use a 50-milligram-per-milliliter solution for calves weighing less than 200 pounds. Do not inject more than 10 milliliters per site. Do not administer within 21 days of slaughter. This drug product 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. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(2) Swine—
(i) Amount. 4 milligrams per pound of body weight twice daily.
(ii) Indications for use. Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed.
(iii) Limitations. Administer intramuscularly for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. Do not inject more than 5 milliliters per site. Do not administer within 14 days of slaughter. If tylosin medicated drinking water is used as followup treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues.
(3) Dogs and cats—
(i) Amount. Administer 3 to 5 milligrams per pound of body weight by intramuscular injection at 12- to 24-hour intervals. Use 50 milligram per milliliter solution only.
(ii) Indications for use— (a) Dogs. Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., hemolytic Streptococci spp., and Pasteurella multocida.
(b) Cats. Treatment of upper respiratory infections when caused by Staphylococci spp. and hemolytic Streptococci spp. and for feline pneumonitis when caused by tylosin susceptible organisms.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[46 FR 48643, Oct. 2, 1981, as amended at 47 FR 9398, Mar. 5, 1982; 50 FR 49841, Dec. 5, 1985; 50 FR 50292, Dec. 10, 1985; 53 FR 40728, Oct. 18, 1988; 59 FR 14365, Mar. 28, 1994; 62 FR 35077, June 30, 1997; 68 FR 24879, May 9, 2003; 70 FR 16935, Apr. 4, 2005. Redesignated and amended at 74 FR 11644, Mar. 19, 2009; 79 FR 16198, Mar. 25, 2014]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556

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

Title 21 published on 2014-04-01

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

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556