21 CFR 522.468 - Colistimethate sodium powder for injection.

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§ 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) [Reserved]

(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, as amended at 79 FR 16185, Mar. 25, 2014]

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.

  • 2016-09-30; vol. 81 # 190 - Friday, September 30, 2016
    1. 81 FR 67149 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 30, 2016.
      21 CFR Parts 510, 520, 522, 524, 529, and 558