[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR529.1044b]

[Page 328]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  529.1044b  Gentamicin sulfate solution.

    (a) Specifications. Each milliliter of solution contains gentamicin 
sulfate equivalent to 50 milligrams of gentamicin base.
    (b) Sponsor. See Nos. 000061 and 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is recommended as an aid in the 
reduction or elimination of the following microorganisms from turkey-
hatching eggs: Arizona hinshawii (paracolon), Salmonella st. paul, and 
Mycoplasma meleagridis.
    (2) The drug is added to clean water to provide a dip solution with 
a gentamicin concentration of 250 to 1,000 parts per million. A 
concentration of 500 parts per million is recommended. Clean eggs should 
be held submerged in the gentamicin solution under a vacuum of about 
27.5 to 38 centimeters of mercury for 5 minutes followed by additional 
soaking in gentamicin solution for approximately 10 minutes at 
atmospheric pressure. Eggs can also be treated by warming them for 3 to 
6 hours at approximately 100 [deg]F. then immediately submerging them in 
gentamicin solution maintained at about 40 [deg]F., keeping the eggs 
submerged for 10 to 15 minutes.
    (3) For use in the dipping treatment of turkey-hatching eggs only. 
Eggs which have been dipped in the drug shall not be used for food.

[40 FR 13881, Mar. 27, 1975, as amended at 52 FR 7833, Mar. 13, 1987; 62 
FR 22889, Apr. 28, 1997]