21 C.F.R. § 529.469 Competitive exclusion culture.
Title 21 - Food and Drugs
(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 §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]
Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
§ 529.469 Competitive exclusion culture.
