Title 21
SECTION 558.261
558.261 Florfenicol.
§ 558.261 Florfenicol.(a) Specifications. Type A medicated articles containing florfenicol in the following concentrations:
(1) 40 grams per kilogram for use as in paragraph (e)(1) of this section.
(2) 500 grams per kilogram for use as in paragraph (e)(2) of this section.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.283 of this chapter.
(d) Special considerations. (1) 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.
(2) The expiration date of VFDs for florfenicol medicated feeds:
(i) For swine must not exceed 90 days from the date of issuance.
(ii) For fish must not exceed 6 months from the date of issuance.
(3) VFDs for florfenicol shall not be refilled.
(4) 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.”
(e) Conditions of use - (1) Swine -
| Florfenicol in grams/ton of feed | Indications for use | Limitations |
|---|---|---|
| 182 | For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD. | Feed continuously as a sole ration for 5 consecutive days. The safety of florfenicol on swine reproductive performance, pregnancy, and lactation have not been determined. Feeds containing florfenicol must be withdrawn 13 days prior to slaughter. |
(2) Fish -
| Florfenicol in grams/ton of feed | Indications for use | Limitations |
|---|---|---|
| (i) 182 to 2,724 | Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri | Feed as a sole ration for 10 consecutive days to deliver 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish. Feed containing florfenicol shall not be fed 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 15 days prior to slaughter. |
| (ii) 182 to 1,816 | Freshwater-reared salmonids: For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida | Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. |
| (iii) 182 to 2,724 | Freshwater-reared finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare | Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish for freshwater-reared warmwater finfish and other freshwater-reared finfish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, 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 15 days prior to slaughter. |
| (iv) 273 to 2,724 | Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae | Feed as a sole ration for 10 consecutive days to deliver 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, 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 15 days prior to slaughter. |