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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
520.1720b - Phenylbutazone granules.
(a) Specifications. The drug is in granular form. It is packaged to contain either 8 grams of phenylbutazone per package or 1 gram of phenylbutazone per package.
(b) Sponsor. See 000061 in 510.600(c) for 8-gram package, see 059320 for 1-gram package.
(c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and found effective. NADA's for approval of drugs for these conditions of use need not include effectiveness data specified by 514.111 of this chapter, but may require bioequivalency and safety information.
(d) Conditions of use(1) Horses(i) Amount. 1 to 2 grams per 500 pounds of body weight, not to exceed 4 grams, daily, as required.
(ii) Indications. For the treatment of inflammatory conditions associated with the musculoskeletal system.
(iii) Limitations. Administer orally by adding to a portion of the usual grain ration. Use a relatively high dose for the first 48 hours, then gradually reduce to a maintenance level at the lowest level capable of producing the desired clinical response. Treated animals should not be slaughtered for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[46 FR 18960, Mar. 27, 1981, as amended at 46 FR 48642, Oct. 2, 1981; 57 FR 2836, Jan. 24, 1992; 61 FR 8873, Mar. 6, 1996; 62 FR 61625, Nov. 19, 1997; 65 FR 20731, Apr. 18, 2000]
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