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CFR > 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 (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.1100—Griseofulvin.

CFR

520.1100—Griseofulvin.

(a) Specifications— (1) The powder complies with U.S.P. for griseofulvin, microsize.
(2) Each bolus contains 2.5 grams griseofulvin.
(3) Each tablet contains 125 or 500 milligrams griseofulvin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter.
(1) No. 000061 for use of products described in paragraph (a) for use as in paragraph (d) of this section.
(2) No. 059130 for use of the powder described in paragraph (a)(1) for use as in paragraphs (d)(1)(i)(A) and (d)(1)(ii) of this section.
(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d) Conditions of use— (1) Horses— (A) For equine ringworm infection caused by Trichophyton equinum or Microsporum gypseum, administer soluble powder described in paragraph (a)(1) of this section daily as a drench or as a top dressing on feed for not less than 10 days as follows: adults, 2.5 grams; yearlings, 1.25 to 2.5 grams; and foals, 1.25 grams.
(B) For treating ringworm infection caused by T. equinum, administer boluses described in paragraph (a)(2) of this section daily for not less than 10 days as follows: adults, 1 bolus; yearlings, one-half to 1 bolus; and foals, one-half bolus.
(ii) Limitations. Not for use in horses intended for food.
(2) Dogs and cats: (i) Amount. 125- and 500-milligram tablets administered orally as follows:
(A) Daily (single or divided) dose:
Body weight (pounds) Dosage (milligrams)
Up to 6 62.5
6 to 18 125
18 to 36 250
36 to 48 375
48 to 75 500
(B) Weekly (single) dose: If experience indicates that treatment is more effective for the drug given in large doses, administer at intervals of 7 to 10 days, a dose equal to 10 milligrams/pound of body weight × body weight × number of days between treatments. Dosage should be adjusted according to response. Administer additional dose after the animal is free of infection.
(ii) Indications for use. For treatment of fungal infections of the skin, hair, and claws caused by Trichophyton mentagrophytes, T. rubrum, T. schoenleini, T. sulphurem, T. verrucosum, T. interdigitale, Epidermophyton floccosum, Microsporum gypseum, M. canis, M. audouini.

Code of Federal Regulations

[40 FR 13838, Mar. 27, 1975, as amended at 41 FR 42948, Sept. 29, 1976; 43 FR 28458, June 30, 1978; 52 FR 7832, Mar. 13, 1987; 54 FR 30205, July 19, 1989; 71 FR 38073, July 5, 2006]
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