21 CFR 522.2424 - Sodium thiamylal for injection.

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There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.2424 Sodium thiamylal for injection.
(a) Specifications. The drug is a sterile dry powder. It is reconstituted aseptically with sterile distilled water, water for injection, or sodium chloride injection, to a desired concentration of 0.5 to 4 percent sodium thiamylal.
(b) Sponsors. See code Nos. 000010 and 000856 in § 510.500(c) of this chapter.
(c) Conditions of use.
(1) It is used as an ultra-short-acting anesthetic in dogs, cats, swine, horses, and cattle.
(2) When diluted aseptically to the desired concentration and administered intravenously to effect, the average single dose is:
(i) Dogs and cats: 8 milligrams per pound of body weight (when used with a preanesthetic, generally one-half the normal dose).
(ii) Swine: 40 milligrams per 5 pounds of body weight.
(iii) Horses: Light anesthesia, 1 gram per 500 pounds to 1,100 pounds of body weight; deep anethesia, 1 gram per 300 pounds of body weight (40 milligrams per 12 pounds of body weight).
(iv) Cattle: Short duration, 20 milligrams per 5 pounds of body weight; longer duration, 40 milligrams per 7 pounds of body weight.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) NAS/NRC status: The conditions of use specified in this paragraph are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in § 514.111 of this chapter, but may require bioequivalency and safety information.
[40 FR 25812, June 19, 1975, as amended at 49 FR 8434, Mar. 7, 1984; 53 FR 23390, June 22, 1988; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, June 30, 1997]

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