21 CFR 522.960c - Flumethasone solution.

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§ 522.960c Flumethasone solution.
(a) Specifications. Each milliliter of sterile aqueous solution contains 0.5 milligram flumethasone.
(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.
(c) Conditions of use. It is used as follows:
(1) Horses—
(i) Amount. 1.25 to 2.5 milligrams daily, intravenously, intramuscularly, or intra-articularly.
(ii) Indications for use. It is used for the treatment of musculoskeletal conditions due to inflammation, where permanent structural changes do not exist, e.g., bursitis, carpitis, osselets, and myositis; and allergic states, e.g., hives, urticaria, and insect bites.
(iii) Limitations— (a) 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.
(b) When a long-term therapy is used, the dose should be individually adjusted to the minimum maintenance dose. A protein-rich diet is useful in dogs and cats on long-term therapy to counteract nitrogen loss if it should occur. A small amount of potassium chloride daily in the diet will counteract excessive potassium loss if this is present.
(c) It has been demonstrated that corticosteroids, especially at high dose levels, may result in delayed wound and fracture healing.
(d) Flumethasone may be administered to animals with bacterial diseases provided appropriate antibacterial therapy is administered simultaneously.
(e) The drug is not to be used in horses intended for slaughter for food purposes.
(f) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs—
(i) Amount. 0.0625 to 0.25 milligram daily, intravenously, intramuscularly, or subcutaneously; 0.125 to 1.0 milligram daily, intralesionally, depending on the size and location of the lesion; 0.166 to 1.0 milligram daily, intra-articularly, depending on the severity of the condition and the size of the involved joint.
(ii) Indications for use. It is used for the treatment of musculoskeletal conditions due to inflamation of muscles or joints and accessory structures where permanent structural changes do not exist, e.g., arthritis, osteoarthritis, disc syndrome, and myositis (in septic arthritis, appropriate antibacterial therapy should be concurrently administered); certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation; otitis externa in conjunction with topical medication; allergic states, e.g., hives, urticaria, and insect bites; and shock and shock-like states by intravenous administration.
(iii) Limitations. See paragraph (c)(1)(iii) of this section.
(3) Cats—
(i) Amount. 0.03125 to 0.125 milligram daily intravenously, intramuscularly, or subcutaneously.
(ii) Indications for use. It is used for the treatment of certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation.
(iii) Limitations. See paragraph (c)(1)(iii) of this section.
[44 FR 16011, Mar. 16, 1978, as amended at 61 FR 5507, Feb. 13, 1996]

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.

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  • 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
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      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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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