[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.468]

[Page 226-227]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 522.468  Colistimethate sodium powder for injection.

    (a) Specifications. Each vial contains colistimethate sodium 
equivalent to 10 grams colistin activity and mannitol to be 
reconstituted with 62.5 milliliters sterile saline or sterile water for 
injection. The resulting solution contains colistimethate sodium 
equivalent to 133 milligrams per milliliter colistin activity.
    (b) Sponsor. See 046573 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]

[[Page 227]]

    (d) Conditions of use. (1) 1- to 3-day-old chickens.
    (i) Dosage. 0.2 milligram colistin activity per chicken.
    (ii) Indications for use. Control of early mortality associated with 
Escherichia coli organisms susceptible to colistin.
    (iii) Limitations. For subcutaneous injection in the neck of 1- to 
3-day-old chickens. Not for use in laying hens producing eggs for human 
consumption. Do not use in turkeys. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 13123, Mar. 18, 1998]