21 C.F.R. § 520.1265   Lincomycin and spectinomycin soluble powder.


Title 21 - Food and Drugs


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

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§ 520.1265   Lincomycin and spectinomycin soluble powder.

(a) Specifications. The following salts of lincomycin and spectinomycin are present in a soluble powder in the ratio of 1 to 2 on the basis of equivalency of lincomycin base to equivalency of spectinomycin base:

(1) Lincomycin hydrochloride monohydrate and spectinomycin sulfate tetrahydrate.

(2) Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate.

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

(1) No. 000009 for use of product described in paragraph (a)(1) of this section.

(2) Nos. 059130 and 061623 for use of product described in paragraph (a)(2) of this section.

(c) Tolerances. See §§556.360 and 556.600 of this chapter.

(d) Conditions of use in chickens—(1) Amount. 2 grams of antibiotic activity per gallon of drinking water; administer as the sole source of water for the first 5 to 7 days of life.

(2) Indications for use. As an aid in the control of airsacculitis caused by either Mycoplasma synoviae or M. gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.

[69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005]

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