21 CFR 522.558 - Dexmedetomidine.

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There are 5 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.558 Dexmedetomidine.
(a) Specifications. Each milliliter of solution contains 0.1 or 0.5 milligrams dexmedetomidine hydrochloride.
(b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.
(c) Conditions of use—
(1) Dogs—
(i) Indications for use and amount. (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.
(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m2 of body surface area or 375 µg/m2 of body surface area by intramuscular injection.
(ii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats—
(i) Amount. 40 µg/killogram by intramuscular injection.
(ii) Indications for use. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. 30, 2013; 78 FR 33699, June 5, 2013]

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