[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: 21CFR529.469]

[Page 326]
 
                        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.  529.469  Competitive exclusion culture.

    (a) Specifications. Each packet of lyophilized culture contains 
either 2,000 or 5,000 doses in frozen pellets to be reconstituted for 
use.
    (1) For 2,000-dose packet, add contents of one 2,000-dose packet of 
reconstitution powder to 490 milliliters of deionized water. Mix. Add 
contents of one 2,000-dose packet of lyophilized culture. Mix 
thoroughly.
    (2) For 5,000-dose packet, add contents of one 5,000-dose packet of 
reconstitution powder to 1,250 milliliters of deionized water. Mix. Add 
contents of one 5,000-dose packet of lyophilized culture. Mix 
thoroughly. Allow to stand for 45 minutes before use. Use within 5 hours 
of reconstitution.
    (b) Sponsor. See No. 032761 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use. Chickens--(1) Amount. Apply 25 milliliters of 
reconstituted culture as a topical spray on each tray of 100 chicks 
(0.25 milliliter per chick).
    (2) Indications for use. For early establishment of intestinal 
microflora in chickens to reduce Salmonella colonization.
    (3) Limitations. Administer as soon as possible after hatch, 
preferably at less than 1 day of age. Expose chicks to light for at 
least 5 minutes after spray treatment to encourage preening for oral 
uptake of the organisms. Provide access to feed and water as soon as 
possible after treatment. Do not administer antibiotics to treated 
chickens.

[63 FR 25164, May 7, 1998]