---

21 C.F.R. § 520.1720a   Phenylbutazone tablets and boluses.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

Browse Previous |  Browse Next

§ 520.1720a   Phenylbutazone tablets and boluses.

(a) Specifications. Each tablet contains 100, 200, or 400 milligrams, or 1 gram of phenylbutazone. Each bolus contains 2 or 4 grams of phenylbutazone.

(b) Sponsor. See sponsor numbers in §510.600(c) of this chapter, as follows:

(1) No. 000061 for use of 100- or 400-milligram or 1-gram tablets, or 2- or 4-gram boluses, in dogs and horses.

(2) Nos. 000010 and 059130 for use of 100- or 200- milligrams or 1-gram tablets in dogs and horses.

(3) Nos. 000856, 058829 and 061623 for use of 100-milligram or 1-gram tablets in dogs and horses.

(4) No. 055246 for use of 100-milligram tablets in dogs.

(5) No. 000143 for use of 1-gram tablets in horses.

(c) Conditions of use—(1) Dogs—(i) Amount. Twenty milligrams per pound of body weight daily.¹

(ii) Indications for use. The drug is used for the relief of inflammatory conditions associated with a musculoskeletal system.¹

(iii) Limitations. Administer in three divided doses daily. Do not exceed a total daily dose of 800 milligrams regardless of body weight. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at a level capable of producing the desired clinical response. Federal law restricts this drug to use by or on the order of a licensed veterinarian.¹

(2) Horses—(i) Amount. One to two grams per 500 pounds weight daily.¹

(ii) Indications for use. This drug is used for the relief of inflammatory conditions associated with the musculoskeletal system.¹

(iii) Limitations. Do not exceed a daily dosage of 4 grams per day. Administer at a relatively high dosage level for the first 48 hours and then reduce gradually to a maintenance dosage level with the lowest dosage maintained at the level capable of producing the desired clinical response. Not for use in animals intended for food purposes. Federal law restricts this drug to use by or on the order of a licensed veterinarian.¹

¹ See footnote 1 to §520.1660b.

[42 FR 44227, Sept. 2, 1977]

Editorial Note:  For Federal Register citations affecting §520.1720a, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

Browse Previous |  Browse Next