§558.261. Florfenicol.
21 C.F.R. § 558.261
Specifications. Type A medicated articles containing florfenicol in the following concentrations:
40 grams per kilogram for use as in paragraph (e)(1) of this section.
500 grams per kilogram for use as in paragraph (e)(2) of this section.
Sponsors. See sponsor numbers as in § 510.600(c) of this chapter.
No. 000061 for use of products described in paragraph (a) of this section as in paragraph (e) of this section.
No. 066104 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.
Related tolerances. See § 556.283 of this chapter.
Special considerations.
Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
The expiration date of VFDs for florfenicol medicated feeds—
For swine must not exceed 90 days from the date of issuance.
For fish must not exceed 6 months from the date of issuance.
VFDs for florfenicol shall not be refilled.
Type A medicated articles and medicated feeds intended for use in fish shall bear the following: “Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.”
Conditions of use—
Swine—
Fish—
Notes, amendments, and revision history
Amendments
[70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016; 86 FR 14822, Mar. 19, 2021; 87 FR 10971, Feb. 28, 2022; 89 FR 85428, Oct. 28, 2024; 90 FR 6802, Jan. 21, 2025]
Authority
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Source
Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.
Amendments
[70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016; 86 FR 14822, Mar. 19, 2021; 87 FR 10971, Feb. 28, 2022; 89 FR 85428, Oct. 28, 2024; 90 FR 6802, Jan. 21, 2025]