21 C.F.R. § 558.635

Current through September 30, 2024
Section 558.635 - Virginiamycin
(a)Specifications. Type A medicated articles containing 10, 20, 50, or 227 grams virginiamycin per pound.
(b)Sponsors. See No. 066104 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.750 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 virginiamycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for virginiamycin shall not be refilled.
(3) Not for use in breeding swine over 120 pounds.
(4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.
(e)Conditions of use -
(1)Chickens -

Virginiamycin
grams/ton
Combination in grams/tonIndications for useLimitationsSponsors
(i) 20Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycinNot for use in layers066104
(ii) 20Amprolium 72.6 to 113.5Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenellaFor field conditions where only E. tenella is the major problem, feed continuously as the sole ration. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter066104
(iii) 20Amprolium 113.5 to 227Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis where immunity to coccidiosis is not desiredFor most field conditions as they exist under modern management practices, feed 113.5 g/ton amprolium continuously. Where severe coccidiosis conditions exist, feed 227 g/ton. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter066104
(iv) 20Diclazuril, 0.91Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maximaFeed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Diclazuril as provided by No. 058198 in § 510.600(c) of this chapter058198
(v) 20Lasalocid 68 to 113Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix,E. acervulina, E. brunetti,E. mivati, and E. maximaFeed continuously as the sole ration. Do not feed to laying chickens. For broiler or fryer chickens only. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter066104
(vi) 20Monensin 90 to 110Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,E. acervulina, E. brunetti,E. maxima, and E. mivatiFeed continuously as the sole ration. Do not feed to laying chickens. See § 558.355(d) in this chapter. Monensin as provided by No. 058198 in § 510.600(c) of this chapter066104
(vii) 20Narasin, 54 to 90Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed as the sole ration for broiler chickens. Do not feed to chickens producing eggs for human consumption. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in § 510.600(c) of this chapter066104
(viii) 20Narasin, 27 to 54 plus nicarbazin, 27 to 54Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed as the sole ration for broiler chickens. Do not feed to chickens producing eggs for human consumption. Nicarbazin medicated broilers may show reduced heat tolerance if exposed to high temperature and high humidity. Provide adequate drinking water and ventilation during these periods. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in § 510.600(c) of this chapter066104
(ix) 20Salinomycin 40 to 60Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix,E. acervulina, E. maxima, E. brunetti, and E. mivatiFeed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by No. 016592 in § 510.600(c) of this chapter
(x) 20Semduramicin 22.7Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti,E. maxima, E mivati/mitis,E. necatrix, and E. tenellaFeed continuously as the sole ration. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter066104
(xi) 20Semduramicin (biomass) 22.7Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin; and for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti,E. maxima, E mivati/mitis,E. necatrix, and E. tenellaFeed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to laying hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter066104

(2)Swine -

Virginiamycin grams/tonCombination in grams/tonIndications for useLimitationsSponsor
(i) 25Growing-finishing swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred066104
(ii) 50 or 100Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 poundsFeed 100 grams per ton for 2 weeks, 50 grams per ton thereafter066104
(iii) 100Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 poundsFeed for 2 weeks066104

(3)Cattle -

Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(i) 13.5 to 16.0Cattle fed in confinement for slaughter: For reduction of incidence of liver abscessesFeed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals intended for breeding066104
(ii) [Reserved]

21 C.F.R. §558.635

81 FR 95022, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 82 FR 21692, May 10, 2017; 85 FR 18125, Apr. 1, 2020; 87 FR 10972, Feb. 28, 2022; 88 FR 14908, Mar. 10, 2023
81 FR 95022, 12/27/2016; as amended at 82 FR 11512, 2/24/2017; 82 FR 21692, 5/10/2017; 85 FR 18125, 4/1/2020; 87 FR 10972, 2/28/2022; 88 FR 14908, 3/10/2023