CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.960c]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.960c Flumethasone solution.

(a) Specifications. Each milliliter of solution contains 0.5 milligrams (mg) of flumethasone.

(b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.

(c) Conditions of use. It is used as follows:

(1) Horses - (i) Amount. Administer 1.25 to 2.5 milligrams (mg) daily by intravenous, intramuscular, or intra-articular injection.

(ii) Indications for use. For use in 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. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Dogs - (i) Amount. Administer 0.0625 to 0.25 mg daily by intravenous, intramuscular, or subcutaneous injection; 0.125 to 1.0 mg daily by intra-lesional injection, depending on the size and location of the lesion; or 0.166 to 1.0 mg daily by intra-articular injection, depending on the severity of the condition and the size of the involved joint.

(ii) Indications for use. For use in the treatment of musculoskeletal conditions due to inflammation 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Cats - (i) Amount. Administer 0.03125 to 0.125 mg daily by intravenous, intramuscular, or subcutaneous injection.

(ii) Indications for use. For use in the treatment of certain acute and chronic dermatoses of varying etiology to help control associated pruritus, irritation, and inflammation.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16188, Mar. 25, 2014, as amended at 88 FR 55564, Aug. 16, 2023]