21 CFR 522.1885 - Prednisolone tertiary butylacetate suspension.

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§ 522.1885 Prednisolone tertiary butylacetate suspension.
(a) Specifications. Prednisolone tertiary butylacetate (Pregna-1,4-diene-3, 20-dione-11B, 17α 21-triol 21-(3,3, dimethyl butyrate) suspension contains 20 milligrams of prednisolone tertiary butylacetate per milliliter. It is sterile.
(b) Sponsor. See No. 050604 in § 510.600(c) of this chapter.
(c) Conditions of use.
(1) It is used as an anti-inflammatory agent in horses, dogs, and cats.1
(2) It is administered to horses intramuscularly at a dosage level of 100 to 300 milligrams and intrasynovially at a dosage level of 50 to 100 milligrams. It is administered intramuscularly to dogs and cats at a dosage level of 1 milligram per 5 pounds of body weight and intrasynovially at a dosage level of 10 to 20 milligrams. Intramuscular retreatment of horses in 24 to 48 hours may be necessary, depending on the general condition of the animal and the severity and duration of the disease.1
(3) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered late in pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.1
(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1
[40 FR 13858, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]

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.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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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.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558