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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 01, 2021.

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: 21CFR520.540b]



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. 520.540b Dexamethasone tablets and boluses.

(a)(1) Specifications. Each bolus is half-scored and contains 10 milligrams of dexamethasone.

(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(3) Conditions of use in cattle and horses - (i) Amount. Administer orally 5 to 10 milligrams on the first day, then 5 milligrams per day as required.

(ii) Indications for use. As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.

(b)(1) Specifications. Each tablet contains 0.25 milligram of dexamethasone.

(2) Sponsors. See Nos. 000061 and 061133 in § 510.600(c) of this chapter.

(3) Conditions of use in dogs and cats - (i) Amount. Dogs: Administer orally 0.25 to 1.25 milligrams per day for up to 7 days. Cats: Administer orally 0.125 to 0.5 milligrams per day for up to 7 days.

(ii) Indications for use. As an anti-inflammatory agent.

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

[40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005; 79 FR 28819, May 20, 2014; 84 FR 8972, Mar. 13, 2019]

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