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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 17, 2023.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1410]



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. 522.1410 Methylprednisolone.

(a) Specifications. Each milliliter of suspension contains 20 or 40 milligrams (mg) of methylprednisolone acetate.

(b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use - (1) Dogs - (i) Amount. Administer 2 to 40 mg (up to 120 mg in extremely large breeds or dogs with severe involvement) by intramuscular injection or up to 20 mg by intrasynovial injection.

(ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections.

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

(2) Cats - (i) Amount. Administer 10 to 20 mg by intramuscular injection.

(ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections.

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

(3) Horses - (i) Amount. Administer 200 mg by intramuscular injection or 40 to 240 mg by intrasynovial injection.

(ii) Indications for use. For treatment of inflammation and related disorders.

(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.

[43 FR 59058, Dec. 19, 1978, as amended at 51 FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 76 FR 53051, Aug. 25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, Mar. 25, 2014; 83 FR 48946, Sept. 28, 2018]

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