21 CFR 522.540 - Dexamethasone solution.

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§ 522.540 Dexamethasone solution.
(a)
(1) Specifications. Each milliliter of solution contains 2 milligrams (mg) dexamethasone.
(2) Sponsors. See sponsors in § 510.600(c) of this chapter:
(i) Nos. 000061, 000859, and 061623 for use as in paragraph (a)(3) of this section.
(ii) Sponsors. See Nos. 054925 and 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section.
(3) Conditions of use—
(i) Amount. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows:
(A) Dogs. 0.25 to 1 mg.
(B) Cats. 0.125 to 0.5 mg.
(C) Horses. 2.5 to 5 mg.
(D) Cattle. 5 to 20 mg, depending on the severity of the condition.
(ii) Indications for use. The drug is indicated:
(A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses;
(B) As an anti-inflammatory agent in dogs and cats.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)
(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(2) Sponsor. See number in § 510.600(c) of this chapter as follows:
(i) No. 061623 for use of 2.0 milligrams dexamethasone or 4.0 milligrams dexamethasone sodium phosphate injections.
(ii) No. 000402 for use of 2.0 milligrams dexamethasone or 4.0 milligrams dexamethasone sodium phosphate injections.
(3) Conditions of use—
(i) Amount. Administer 0.25 to 1 mg by intravenous injection, repeated for 3 to 5 days or until a response is noted.
(ii) Indications for use. For use in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis, as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)
(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(2) Sponsor. See Nos. 000402 and 061623 in § 510.600(c) of this chapter.
(3) Conditions of use—
(i) Amount. Administer 2.5 to 5.0 mg by intravenous injection.
(ii) Indications for use. For use in horses as a rapid adrenal glucocorticoid and/or anti-inflammatory agent.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)
(1) Specifications. Each milliliter of solution contains 2.0 mg of dexamethasone or 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg of dexamethasone).
(2) Sponsors. See the following numbers in § 510.600(c) of this chapter:
(i) Nos. 000859 and 054771 for intravenous or intramuscular use of 2.0 milligrams dexamethasone injection.
(ii) No. 054771 for intravenous use of 2.0 milligrams dexamethasone injection.
(3) Conditions of use—
(i) Amount. Administer by intravenous or intramuscular injection as follows:
(A) Dogs: 0.25 to 1 mg.
(B) Cats: 0.125 to 0.5 mg.
(C) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs, cats, and horses as an anti-inflammatory agent.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)
(1) Specifications. Each milliliter of solution contains 4.0 mg of dexamethasone sodium phosphate (equivalent to 3.0 mg dexamethasone).
(2) Sponsor. See No. 000859 in § 510.600(c) of this chapter.
(3) Conditions of use—
(i) Amount. Administer by intravenous injection as follows:
(A) Dogs: 0.25 to 1 mg; may be repeated for 3 to 5 days.
(B) Horses: 2.5 to 5 mg.
(ii) Indications for use. For use in dogs and horses for glucocorticoid and anti-inflammatory effect.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[41 FR 28265, July 9, 1976]
Editorial Note:
For Federal Register citations affecting § 522.540, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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