CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS > 522.955—Florfenicol.

522.955—Florfenicol.

(a) Specifications. Each milliliter (mL) of solution contains:
(1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin.
(2) 300 mg florfenicol in the inactive vehicle n-methyl-2-pyrrolidone.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) as in paragraph (d)(1)(i) and for use of product described in paragraph (a)(2) as in paragraph (d)(1)(ii).
(c) Related tolerance. See § 556.283 of this chapter.
(d) Conditions of use— (1) Cattle— 300 mg/mL florfenicol in 2-pyrrolidone and triacetin (inactive vehicles).
(A) Amount. 40 mg/kilogram (kg) body weight as a single subcutaneous injection.
(B) Indications for use. For treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.
(C) Limitations. Do not slaughter within 44 days of 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.
(ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive vehicle).
(A) (1) Amount. 20 mg/kg of body weight as an intramuscular injection. A second dose should be administered 48 hours later. Alternatively, 40 mg/kg of body weight as a single subcutaneous injection may be used.
(2) Indications for use. For treatment of 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 and Bacteroides melaninogenicus.
(B) (1) Amount. 40 mg/kg of body weight as a single subcutaneous injection.
(2) Indications for use. For control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
(C) 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]

Code of Federal Regulations

[73 FR 21041, Apr. 18, 2008, as amended by 74 FR 66574, Dec. 16, 2009]