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: 21CFR520.1705]

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. 520.1705 Pergolide.

(a) Specifications. Each tablet contains 1 milligram (mg) peroglide (as pergolide mesylate).

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

(c) Conditions of use in horses - (1) Amount. Administer orally at a starting dose of 2 micrograms/kilograms ([micro]/kg) once daily. Dosage may be adjusted to effect, not to exceed 4 [micro]g/kg daily.

(2) Indications for use. For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing's Disease).

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

[77 FR 15960, Mar. 19, 2012, as amended at 81 FR 22523, Apr. 18, 2016]