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21 C.F.R. § 520.1484   Neomycin sulfate soluble powder.

Title 21 - Food and Drugs

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

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§ 520.1484   Neomycin sulfate soluble powder.

(a) Specifications. Each ounce of powder contains 20.3 grams of neomycin sulfate (equivalent to 14.2 grams of neomycin base).

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) Nos. 000069 and 054925 for use as in paragraph (d)(1) of this section.

(2) Nos. 000009, 046573, and 061623 for use as in paragraphs (d)(1) and (d)(2) of this section.

(c) Related tolerances. See §556.430 of this chapter.

(d) Conditions of use—(1) Cattle (excluding veal calves), swine, sheep, and goats. (i) Amount. 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) in divided doses for a maximum of 14 days.

(ii) Indications for use. For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep, and goats.

(iii) Limitations. Add to drinking water or milk; not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 14 consecutive days. Discontinue treatment prior to slaughter as follows: Cattle (not for use in veal calves), 1 day; sheep, 2 days; swine and goats, 3 days.

(2) Turkeys—(i) Amount. 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) for 5 days.

(ii) Indications for use. For the control of mortality associated with E. coli organisms susceptible to neomycin sulfate in growing turkeys.

(iii) Limitations. Add to drinking water; not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 5 consecutive days.

[64 FR 31497, June 11, 1999, as amended at 66 FR 14073, Mar. 9, 2001; 67 FR 72366, Dec. 5, 2002; 67 FR 78971, Dec. 27, 2002; 68 FR 4914, Jan. 31, 2003; 71 FR 13542, Mar. 16, 2006]

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