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21 C.F.R. § 522.955   Florfenicol.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.955   Florfenicol.

(a) Specifications. Each milliliter of solution contains 300 milligrams (mg) of florfenicol.

(b) Sponsor. See 000061 in §510.600(c) of this chapter.

(c) Related tolerance. See §556.283 of this chapter.

(d) Conditions of use—(1) Cattle—(i) Amount. 20 mg per kilogram (/kg) of body weight as an intramuscular injection. A second dose should be administered 48 hours later.

(A) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pasteurella) haemolytica,P. multocida, and Haemophilus somnus. For treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum andBacteroides melaninogenicus.

(B) [Reserved]

(ii) Amount. 40 mg/kg body weight as a single subcutaneous injection.

(A) Indications for use. As in paragraph (d)(1)(i)(A) of this section; for control of respiratory disease in cattle at high risk of developing BRD associated with M. (Pasteurella) haemolytica, P. multocida, and H. somnus.

(B) [Reserved]

(iii) Limitations. Do not slaughter within 28 days of last intramuscular treatment or within 38 days of subcutaneous treatment. Do not use in female dairy cattle 20 months of age or older. Use may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[61 FR 42383, Aug. 15, 1996, as amended at 63 FR 26981, May 15, 1998; 63 FR 41191, Aug. 3, 1998; 64 FR 5596, Feb. 4, 1999; 64 FR 9435, Feb. 26, 1999; 67 FR 6866, Feb. 14, 2002]

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