CFR

516.1215—Florfenicol.

(a) Specifications. Type A medicated article containing 500 grams (g) florfenicol per kilogram.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Special considerations. Labeling shall bear the following: “Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-259. Extra-label use of this drug in or on animal feed is strictly prohibited.”

(d) Related tolerances. See § 556.283 of this chapter.

(e) Conditions of use— (1) Catfish— Feed 182 to 1816 g florfenicol per ton of feed as a sole ration for 10 consecutive days to deliver 10 milligrams florfenicol per kilogram of fish.

(ii) Indications for use. For the control of mortality due to columnaris disease associated with Flavobacterium columnare.

(iii) Limitations. Feed containing florfenicol shall not be fed to catfish for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 12 days prior to slaughter. Federal law limits this drug to use under the professional supervision of a licensed veterinarian. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 15 days from the date of prescribing. VFDs for florfenicol shall not be refilled. See § 558.6 of this chapter for additional requirements.

(2) [Reserved]

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