21 CFR 522.536 - Detomidine hydrochloride injection.

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There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.536 Detomidine hydrochloride injection.
(a) Specification. Each milliliter of sterile aqueous solution contains 10 milligrams of detomidine hydrochloride.
(b) Sponsor. See 052483 in § 510.600(c) of this chapter.
(c) Conditions of use—
(1) Amount. For sedation, analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, depending on depth and duration required.
(2) Indication for use. As a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings.
(3) Limitations. For sedation administer intraveneously (IV) or intramuscularly (IM); for analgesia by IV; for both sedation and analgesia by IV. Do not use in horses with pre-existing atrioventricular or sinoauricular block, with severe coronary insufficiency, cerebrovascular disease, respiratory disease, or chronic renal failure. Do not use in breeding animals. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[54 FR 50365, Dec. 6, 1989; 54 FR 51551, Dec. 15, 1989]

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