subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.540"
section_subject: "Dexamethasone solution."
cfr_reference: "21 CFR 522.540"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
(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.
(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 No. 061133 in § 510.600(c) of this chapter.
(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.
(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 No. 061133 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.
(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. 016592 and 051031 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:
(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.
(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.
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.govinfo.gov.