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: 21CFR520.540c]

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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.540c Dexamethasone chewable tablets.

(a) Specifications. Each half-scored tablet contains 0.25 milligram of dexamethasone.

(b) Sponsor. See No. 051031 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer by free-choice feeding or crumbled over food 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved.

(2) Indications for use. As supportive therapy in nonspecific dermatosis and inflammatory conditions.

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

[44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 79 FR 28820, May 20, 2014; 82 FR 11508, Feb. 24, 2017]