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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 Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1720a]



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. 520.1720a Phenylbutazone tablets and boluses.

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

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

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

(2) No. 069043 for use of 100- or 200-mg or 1-g tablets in dogs and horses.

(3) Nos. 054771 and 061133 for use of 100-mg or 1-g tablets in dogs and horses.

(4) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses.

(5) No. 058198 for use of 1-g tablets in horses.

(c) Conditions of use - (1) Dogs - (i) Amount. 20 mg per pound of body weight daily.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

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

(2) Horses - (i) Amount. 1 to 2 g per 500 pounds of body weight daily.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law prohibits the use of this drug in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[73 FR 8192, Feb. 13, 2008, as amended at 74 FR 1146, Jan. 12, 2009; 76 FR 11331, Mar. 2, 2011; 76 FR 17777, Mar. 31, 2011; 78 FR 21060, Apr. 9, 2013; 78 FR 28826, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 85 FR 45307, July 28, 2020; 86 FR 14819, Mar. 19, 2021; 87 FR 58961, Sept. 29, 2022]

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