CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 28, 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: 21CFR522.1885]

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. 522.1885 Prednisolone tertiary butylacetate.

(a) Specifications. Each milliliter of suspension contains 20 milligrams (mg) of prednisolone tertiary butylacetate.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount - (i) Horses: Administer by intramuscular injection 100 to 300 mg or by intrasynovial injection at a dosage level of 50 to 100 mg. Retreatment of horses in 24 to 48 hours may be necessary, depending on the general condition of the animal and the severity and duration of the disease.

(ii) Dogs and cats: Administer by intramuscular injection 1 mg per 5 pounds of body weight or intrasynovially at a dosage level of 10 to 20 mg.

(2) Indications for use. It is used as an anti-inflammatory agent in horses, dogs, and cats.

(3) 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.

[79 FR 16194, Mar. 25, 2014, as amended at 84 FR 39184, Aug. 9, 2019]