21 CFR 522.2474 - Tolazoline 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)
§ 522.2474 Tolazoline hydrochloride injection.
(a) Specifications. Each milliliter of sterile aqueous solution contains tolazoline hydrochloride equivalent to 100 milligrams of base activity.
(b) Sponsor. See No. 061690 in § 510.600(c) of this chapter.
(c) Conditions of use. It is used as follows:
(1) Horses—
(i) Amount. Administer slowly by intravenous injection 4 milligrams per kilogram of body weight or 1.8 milligrams per pound (4 milliliters per 100 kilograms or 4 milliliters per 220 pounds).
(ii) Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.
(iii) Limitations. The safety of TolazineTM has not been established in pregnant mares, lactating mares, horses intended for breeding, foals, or horses with metabolically unstable conditions. The safety of TolazineTM has not been evaluated for reversing xylazine used as a preanesthetic to a general anesthetic. This drug is for use in horses only and not for use in food-producing animals. Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid accidental exposure to this product.
Accidental spillage on the skin should be washed off immediately with soap and water. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[61 FR 25785, May 23, 1996]

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