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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 > 520.2088—Roxarsone tablets.

CFR

520.2088—Roxarsone tablets.

(a) (1) Specifications. Each tablet contains 36 milligrams of roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
(2) Sponsor. See No. 046573 in § 510.600(c) of this chapter.
(3) Related tolerances. See § 556.60 of this chapter.
(4) NAS/NRC status. The weight gain, feed efficiency, and pigmentation claims are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
(5) Conditions of use— (i) Growing chickens and growing turkeys—(a) Amount. Dissolve 2 tablets in each gallon of drinking water (0.002 percent roxarsone).
(b) Indications for use. For increased rate of weight gain, improved feed efficiency, and improved pigmentation.
(c) Limitations. Administer continuously throughout growing period. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.
(ii) Growing chickens— (a) Amount. Dissolve 8 tablets in each gallon of drinking water (0.008 percent roxarsone).
(b) Indications for use. As an aid in the prevention of coccidiosis due to Eimeria tenella.
(c) Limitations. Administer for not more than 10 consecutive days. Treatment may be repeated after 5 days off medication. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.
(b) (1) Specifications. Each tablet contains 400 milligrams of roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
(2) Sponsor. See No. 046573 in § 510.600(c) of this chapter.
(3) Related tolerances. See § 556.60 of this chapter.
(4) NAS/NRC status. These conditions are NAS/NRC reviewed and found effective. NADA's for these uses need not include effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.
(5) Conditions of use— (i) Swine— (a) Amount. 1 tablet (400 milligrams) per gallon of drinking water for no more than 6 days, or 1 tablet (400 milligrams) per 2 fluid ounces of warm water per 50 pounds of body weight as a drench once daily for 1 to 2 days.
(b) Indications for use. As an aid in the treatment of swine dysentery (hemorrhagic enteritis or bloody scours).
(c) Limitations. Treatment may be repeated after 5 days off medication. If no improvement is observed, consult a veterinarian. Treated animals must consume enough medicated water to provide a therapeutic dose. Withdraw 5 days before slaughter. Use as sole source of organic arsenic.
(ii) [Reserved]
(c) (1) Specifications. Each tablet contains 72 milligrams of roxarsone (3-nitro-4-hydroxyphenylarsonic acid).
(2) Sponsor. See No. 046573 in § 510.600(c) of this chapter.
(3) Related tolerances. See § 556.60 of this chapter.
(4) Conditions of use in growing chickens and growing turkeys— (i) Amount. 1 tablet in each gallon of drinking water (0.002 percent roxarsone).
(ii) Indications for use. For improved rate of weight gain, improved feed efficiency, and improved pigmentation.
(iii) Limitations. Administer continuously throughout growing period. Do not administer to chickens producing eggs for human consumption. Withdraw 5 days before slaughter. Use as sole source of organic arsenic. Overdosage or the lack of water intake may result in weakness or paralysis of legs.

Code of Federal Regulations

[46 FR 41040, Aug. 14, 1981, as amended at 46 FR 42448, Aug. 21, 1981; 47 FR 15238, Apr. 9, 1982; 55 FR 8460, Mar. 8, 1990; 57 FR 8577, Mar. 11, 1992; 58 FR 65664, Dec. 16, 1993; 65 FR 10705, Feb. 29, 2000]
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