(a) Specifications. Type A medicated article containing 90.7 grams (g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).
(b) Approvals. See Nos. 000986 and 016592 in Sec. 510.600(c) of this chapter.
(c) Special considerations--(1) Tilmicosin medicated feeds are restricted to use under a veterinary feed directive (VFD). See Sec. 558.6 of this chapter for required label statements and other limitations.
(1) Tilmicosin medicated feeds are restricted to use under a veterinary feed directive (VFD). See Sec. 558.6 of this chapter for required label statements and other limitations.
(2) VFDs for tilmicosin phosphate shall not be refilled.
(3) Labeling of tilmicosin Type B or Type C medicated feeds must bear the following warnings:
(i) Do not allow horses or other equines access to feeds containing tilmicosin.
(ii) [Reserved]
(4) Special considerations for use of tilmicosin medicated swine feeds include the following:
(i) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance.
(ii) Labeling of tilmicosin Type B or Type C medicated feeds for swine must bear the following warning: ``Do not use in any feeds containing bentonite. Bentonite in feeds may affect the efficacy of tilmicosin.''
(iii) Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production without ceasing administration for reevaluation of antimicrobial use by a licensed veterinarian before reinitiating a further course of therapy with an appropriate antimicrobial.
(5) Special consideration for use of tilmicosin medicated cattle feeds include the following:
(i) The expiration date of VFDs for cattle must not exceed 45 days from the time of issuance.
(ii) Labeling of tilmicosin Type B or Type C medicated feeds for cattle must bear the following warning: ``Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cottonseed hulls in feeds may affect the efficacy of tilmicosin.''
(iii) To assure both food safety and responsible use in cattle, administration of feed containing tilmicosin to cattle experiencing an outbreak of BRD must be initiated during the first 45 days of the production period, shall not exceed a single 14-consecutive-day treatment, should not occur concurrent with or following administration of an injectable macrolide, and should not occur within 3 days following administration of a nonmacrolide injectable BRD therapy. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical illness should be evaluated for individual treatment with an alternative non-macrolide therapy.
(d) Related tolerances. See Sec. 556.735 of this chapter.
(e) Conditions of use. It is used in feed as follows:
(1) Swine-- ----------------------------------------------------------------------------------------------------------------
Tilmicosin phosphate in
(i) 181 to 363............. .......................... Swine: For the Feed continuously as 000986,
control of swine the sole ration for 016592
respiratory disease 21-day period,
associated with beginning
Actinobacillus approximately 7 days
pleuropneumoniae and before an
Pasteurella anticipated disease
multocida. outbreak. The safety
of tilmicosin has
not been established
in male swine
intended for
breeding purposes.
Swine intended for
human consumption
must not be
slaughtered within 7
days of the last
treatment with this
drug product.(ii) [Reserved]............ .......................... ..................... ..................... .........----------------------------------------------------------------------------------------------------------------
(2) Cattle--
----------------------------------------------------------------------------------------------------------------
Tilmicosin phosphate in
(i) 568 to 757............ .......................... Beef and nonlactating Feed continuously for 000986
dairy cattle: For 14 days to provide
the control of 12.5 mg tilmicosin/kg
bovine respiratory of bodyweight/day.
disease (BRD) The safety of
associated with tilmicosin has not
Mannheimia been established in
haemolytica, cattle intended for
Pasteurella breeding purposes.
multocida, and This drug product is
Histophilus somni in not approved for use
groups of beef and in female dairy
nonlactating dairy cattle 20 months of
cattle, where active age or older. Use in
BRD has been these cattle may
diagnosed in at cause drug residues
least 10 percent of in milk. This drug
the animals in the product is not
group. approved for use in
calves intended to be
processed for veal. A
withdrawal period has
not been established
in preruminating
calves. Cattle
intended for human
consumption must not
be slaughtered within
28 days of the last
treatment with this
drug product.(ii) 568 to 757........... Monensin, 5 to 40......... Cattle fed in Feed continuously for 000986
confinement for 14 days to provide
slaughter: For 12.5 mg tilmicosin/kg
improved feed of bodyweight/day.
efficiency; and for The safety of
the control of tilmicosin has not
bovine respiratory been established in
disease (BRD) cattle intended for
associated with breeding purposes.
Mannheimia This drug product is
haemolytica, not approved for use
Pasteurella in female dairy
multocida, and cattle 20 months of
Histophilus somni in age or older. Use in
groups of cattle fed these cattle may
in confinement for cause drug residues
slaughter, where in milk. This drug
active BRD has been product is not
diagnosed in at approved for use in
least 10 percent of calves intended to be
the animals in the processed for veal. A
group. withdrawal period has
not been established
in pre-ruminating
calves. Cattle
intended for human
consumption must not
be slaughtered within
28 days of the last
treatment with this
drug product. See
Sec. 558.355(d) of
this chapter.(iii) 568 to 757.......... Monensin, 10 to 40........ Cattle fed in Feed continuously for 000986
confinement for 14 days to provide
slaughter: For 12.5 mg tilmicosin/kg
prevention and of bodyweight/day.
control of The safety of
coccidiosis due to tilmicosin has not
Eimeria bovis and E. been established in
zuernii; and for the cattle intended for
control of bovine breeding purposes.
respiratory disease This drug product is
(BRD) associated not approved for use
with Mannheimia in female dairy
haemolytica, cattle 20 months of
Pasteurella age or older. Use in
multocida, and these cattle may
Histophilus somni in cause drug residues
groups of cattle fed in milk. This drug
in confinement for product is not
slaughter, where approved for use in
active BRD has been calves intended to be
diagnosed in at processed for veal. A
least 10 percent of withdrawal period has
the animals in the not been established
group. in pre-ruminating
calves. Cattle
intended for human
consumption must not
be slaughtered within
28 days of the last
treatment with this
drug product. See
Sec. 558.355(d) of
this chapter.---------------------------------------------------------------------------------------------------------------- [61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR 19987, Apr. 3, 2013]