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21 C.F.R. § 520.154a   Soluble bacitracin methylene disalicylate.

Title 21 - Food and Drugs

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

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§ 520.154a   Soluble bacitracin methylene disalicylate.

(a) Specifications. Each pound of soluble powder contains the equivalent of 50 grams of bacitracin activity for use as in paragraph (d)(1) or (d)(2) of this section, or the equivalent of 200 grams of bacitracin activity for use as in paragraph (d) of this section.

(b) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.70 of this chapter.

(d) Conditions of use—(1) Growing turkeys—(i) Amount. 400 milligrams per gallon in drinking water.

(ii) Indications for use. Aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylene disalicylate.

(iii) Limitations. Prepare a fresh solution daily.

(2) Broiler and replacement chickens—(i) Amount. 100 milligrams per gallon in drinking water.

(A) Indications for use. Aid in the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to bacitracin methylene disalicylate.

(B) Limitations. Prepare a fresh solution daily.

(ii) Amount. 200 to 400 milligrams per gallon in drinking water.

(A) Indications for use. Aid in the control of necrotic enteritis caused by C. perfringens susceptible to bacitracin methylene disalicylate.

(B) Limitations. Prepare a fresh solution daily.

(3) Swine—(i) Amount. 1 gram per gallon in drinking water.

(ii) Indications for use. Treatment of swine dysentery associated with Treponema hyodysenteriae. Administer continuously for 7 days or until signs of dysentery disappear.

(iii) Limitations. Prepare a fresh solution daily. Treatment not to exceed 14 days. If symptoms persist after 4 to 5 days consult a veterinarian. Not to be given to swine that weigh more than 250 pounds.

(4) Growing quail—(i) Amount. 400 milligrams per gallon in drinking water.

(ii) Indications for use. For prevention of ulcerative enteritis due to Clostridium colinum susceptible to bacitracin methylene disalicylate.

(iii) Limitations. Prepare fresh solution daily. Use as sole source of drinking water.

[57 FR 37322, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 63 FR 38474, July 17, 1998; 64 FR 13068, Mar. 17, 1999]

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