(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 Sec. 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 Sec. 558.6 of this chapter for additional requirements.
(1) Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements.
(2) The expiration date of veterinary feed directives (VFDs) for florfenicol medicated feeds:
(i) For freshwater-reared finfish, must not exceed 15 days from the date of issuance.
(ii) For swine must not exceed 90 days from the date of issuance.
(3) VFDs for florfenicol shall not be refilled.
(d) Related tolerances. See Sec. 556.283 of this chapter.
(e) Conditions of use--(1) Swine-- ------------------------------------------------------------------------
Florfenicol in grams/ton of
feed Indications for use Limitations------------------------------------------------------------------------182......................... For the control of Feed continuously as
swine respiratory a sole ration for 5
disease (SRD) consecutive days.
associated with The safety of
Actinobacillus florfenicol on
pleuropneumoniae, swine reproductive
Pasteurella performance,
multocida, pregnancy, and
Streptococcus suis, lactation have not
and Bordetella been determined.
bronchiseptica in Feeds containing
groups of swine in florfenicol must be
buildings withdrawn 13 days
experiencing an prior to slaughter.
outbreak of SRD..------------------------------------------------------------------------
(2) Fish-- ------------------------------------------------------------------------
Florfenicol in grams/ton of
(i) 182 to 2,724............ Catfish: For the Feed as a sole
control of ration for 10
mortality due to consecutive days to
enteric septicemia deliver 10 to 15
of catfish milligrams (mg)
associated with florfenicol per
Edwardsiella kilogram (kg) of
ictaluri. 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 Feed as a sole
salmonids: For the ration for 10
control of consecutive days to
mortality due to deliver 10 to 15 mg
coldwater disease florfenicol per kg
associated with of fish. Feed
Flavobacterium containing
psychrophilum and florfenicol shall
furunculosis not be fed for more
associated with than 10 days.
Aeromonas Following
salmonicida. 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 Feed as a sole
finfish: For the ration for 10
control of consecutive days to
mortality due to deliver 10 to 15 mg
columnaris disease florfenicol per kg
associated with of fish for
Flavobacterium freshwater-reared
columnare. 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 Feed as a sole
warmwater finfish: ration for 10
For the control of consecutive days to
mortality due to deliver 15 mg
streptococcal florfenicol per kg
septicemia of fish. Feed
associated with containing
Streptococcus iniae. 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.------------------------------------------------------------------------ [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]