21 C.F.R. § 558.261 Florfenicol.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated article containing 500 grams florfenicol per kilogram. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter. (c) Special considerations—(1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See §558.6 of this chapter for additional requirements. (2) The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 15 days from the date of issuance. VFDs for florfenicol shall not be refilled. (d) Related tolerances. See §556.283 of this chapter. (e) Conditions of use—(1) Catfish—(i) Amount. 10 milligrams per kilogram of fish daily for 10 consecutive days. (ii) Indications for use. For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri. (iii) Limitations. Feed containing florfenicol shall not be fed to catfish for more than 10 days. Following 10 days administration, fish should be re-evaluated by a licensed veterinarian before reinitiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for the 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 Feeds containing florfenicol must be withdrawn 12 days prior to slaughter. (2) [Reserved] [70 FR 70047, Nov. 21, 2005]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.261 Florfenicol.
