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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2018]
[CITE: 21CFR520.1265]



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

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1265 Lincomycin and spectinomycin 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. 054771 for use of product described in paragraph (a)(1) of this section.

(2) Nos. 057561, 061623, and 066104 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.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 13220, Mar. 22, 2004, as amended at 70 FR 40881, July 15, 2005; 71 FR 71038, Dec. 8, 2006; 77 FR 56770, Sept. 14, 2012; 78 FR 28823, May 20, 2014; 81 FR 94989, Dec. 27, 2016]

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