21 CFR 522.1890 - Sterile prednisone suspension.

Status message

There are 12 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1890 Sterile prednisone suspension.
(a) [Reserved]
(b)
(1) Specifications. Each milliliter of sterile aqueous suspension contains 10 to 40 milligrams of prednisone.
(2) Sponsor. See 000061 in § 510.600(c) of this chapter.
(3) Conditions of use—
(i) Amount. Administer intramuscularly as follows:
(a) Horses. 100 to 400 milligrams, repeating if necessary. If no response is observed after 3 to 4 days of therapy, reevaluate diagnosis.1
(b) Dogs and cats. 0.25 to 1.0 milligram per pound of body weight for 3 to 5 days or until a response is noted. Treatment may be continued with an orally administered dose.1
(ii) Indications for use. It is used for conditions requiring an anti-inflammatory agent.1
(iii) Limitations. 1 Do not use in viral infections. Except in emergency therapy, do not use in animals with tuberculosis, chronic nephritis, or Cushings's disease. With infections, use appropriate antibacterial therapy with and for at least 3 days after discontinuance of use and disappearance of all signs of infection. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Footnote(s):
1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

[45 FR 13446, Feb. 29, 1980, as amended at 50 FR 6160, Feb. 14, 1985; 52 FR 7832, Mar. 13, 1987]

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

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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