CFR - Code of Federal Regulations Title 21

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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: 21CFR520.1341]

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. 520.1341 Megestrol.

(a) Specifications. Each tablet contains 5 or 20 milligrams of megestrol acetate.

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

(c) Conditions of use in dogs - (1) Amount. Administer orally, intact, or crushed and mixed with food as follows:

(i) For the postponement of estrus by proestrus treatment: 1 milligram per pound of body weight per day for 8 days.

(ii) For the postponement of estrus by anestrus treatment: 0.25 milligram per pound of body weight per day for 32 days.

(iii) For alleviation of false pregnancy: 1 milligram per pound of body weight per day for 8 days.

(2) Indications for use. For the postponement of estrus and the alleviation of false pregnancy in female dogs.

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

[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 78 FR 28824, May 20, 2014]