§558.618. Tilmicosin.
21 C.F.R. § 558.618
Specifications. Type A medicated article containing 90.7 grams (g) per pound tilmicosin as tilmicosin phosphate (200 g per kilogram).
Sponsor. See Nos. 016592 and 058198 in § 510.600(c) of this chapter.
Related tolerances. See § 556.735 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.
VFDs for tilmicosin phosphate shall not be refilled.
Labeling of tilmicosin Type B or Type C medicated feeds must bear the following warnings:
Do not allow horses or other equines access to feeds containing tilmicosin.
[Reserved]
Special considerations for use of tilmicosin medicated swine feeds include the following—
The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance.
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.”
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.
Special consideration for use of tilmicosin medicated cattle feeds include the following—
The expiration date of VFDs for cattle must not exceed 45 days from the time of issuance.
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.”
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.
Conditions of use. It is used in feed as follows:
Swine—
Cattle—
Notes, amendments, and revision history
Amendments
[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; 80 FR 61298, Oct. 13, 2015; 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, 2016; 81 FR 59135, Aug. 29, 2016; 81 FR 67153, Sept. 30, 2016; 85 FR 18123, Apr. 1, 2020; 86 FR 14827, Mar. 19, 2021]
Authority
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Source
Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 80 FR 61298, Oct. 13, 2015; 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, 2016; 81 FR 59135, Aug. 29, 2016; 81 FR 67153, Sept. 30, 2016; 85 FR 18123, Apr. 1, 2020; 86 FR 14827, Mar. 19, 2021]