21 CFR § 558.68
Avilamycin
June 25, 2020
(a) Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin.
(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.60 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 avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.
(e) Conditions of use. Administer in feed as follows:
(1) Chickens—
Open Table
| Avilamycin in grams/ton |
Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 13.6 to 40.9 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens | Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age | 058198 | |
| (ii) 13.6 to 40.9 | Monensin, 90 to 110 | Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens in broiler chickens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Do not feed to chickens over 16 weeks of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow horses or other equines access to feed containing avilamycin and monensin. Ingestion of monensin by horses has been fatal. Do not feed to chickens producing eggs for human consumption. Monensin as provided by No. 058198 in §510.600(c) of this chapter | 058198 | |
| (iii) 13.6 to 40.9 | Narasin, 54 to 90 | Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to chickens producing eggs for human consumption. Narasin as provided by No. 058198 in §510.600(c) of this chapter | 058198 | |
| (iv) 13.6 to 40.9 | Narasin 27 to 45; nicarbazin 27 to 45 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima | Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 10 days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Withdraw 5 days before slaughter. Narasin and nicarbazin as provided by No. 058198 in §510.600(c) of this chapter | 058198 |
| (v) 13.6 to 40.9 | Salinomycin sodium, 40 to 60 | Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. May be fatal if fed to adult turkeys or to horses. Not approved for use with pellet binders. Do not feed to laying hens producing eggs for human consumption. Salinomycin as provided by No. 016592 in §510.600(c) of this chapter | 058198 |
(2) Swine—
Open Table
| Avilamycin in grams/ton |
Combinationin grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 73 | Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs | Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older | 058198 | |
| (ii) [Reserved] |
[80 FR 61297, Oct. 13, 2015, as amended at 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR 11509, Feb. 24, 2017; 83 FR 14587, Apr. 5, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 33001, July 11, 2019; 85 FR 4209, Jan. 24, 2020]
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