21 CFR 522.522 - Danofloxacin.

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There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.522 Danofloxacin.
(a) Specifications. Each milliliter of solution contains 180 milligrams (mg) danofloxacin as the mesylate salt.
(b) Sponsor. See No. 000069 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.169 of this chapter.
(d) Conditions of use in cattle—
(1) Amount: Administer by subcutaneous injection either:
(i) 6 mg per kilogram (mg/kg) of body weight, repeated in 48 hours; or
(ii) 8 mg/kg of body weight, as a single dose.
(2) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida.
(3) Limitations. Animals intended for human consumption should not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.
[67 FR 78972, Dec. 27, 2002, as amended at 77 FR 4227, Jan. 27, 2012]

Title 21 published on 2013-04-01

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.

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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

Title 21 published on 2013-04-01

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

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522