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21 C.F.R. § 520.2123b   Spectinomycin dihydrochloride pentahydrate soluble powder.

Title 21 - Food and Drugs

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

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§ 520.2123b   Spectinomycin dihydrochloride pentahydrate soluble powder.

(a) Specifications. The spectinomycin dihydrochloride pentahydrate used in manufacturing the drug is the antibiotic substance produced by growth of Streptomyces flavopersicus (var. Abbott) or the same antibiotic substance produced by any other means.

(b) Sponsor. See No. 061623 in §510.600(c) of this chapter.

(c) Special considerations. The quantities of spectinomycin cited in this section refer to the equivalent weight of base activity for the drug.

(d) Related tolerances. See §556.600 of this chapter.

(e) Conditions of use. (1) It is administered in the drinking water of growing chickens at 2 grams of spectinomycin per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination It is administered as an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO). Do not administer to laying chickens. Do not administer within 5 days of slaughter.

(2) It is administered in the drinking water of floor-raised broiler chickens at 0.5 gram of spectinomycin per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination. It is administered for increased rate of weight gain and improved feed efficiency. Do not administer to laying chickens. Do not administer within 5 days of slaughter.

(3) It is administered in drinking water of broiler chickens at 1 gram of spectinomycin per gallon of water as the only source of drinking water for the first 3 to 5 days of life as an aid in controlling infectious synovitis due to Mycoplasma synoviae. Do not administer to laying chickens. Do not administer within 5 days of slaughter.

[40 FR 13838, Mar. 27, 1975, as amended at 45 FR 56798, Aug. 26, 1980; 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]

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