21 C.F.R. § 522.468

Current through May 31, 2024
Section 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 054771 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.167 of this chapter.
(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]

21 C.F.R. §522.468

63 FR 13123, Mar. 18, 1998, as amended at 79 FR 16185, Mar. 25, 2014; 84 FR 32992, July 11, 2019
84 FR 32992, 9/9/2019