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21 CFR 558.635 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 590-599) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 590-599) — Animal Drugs, Feeds, And Related Products (Subpart A To Parts 590-599) — New Animal Drugs For Use In Animal Feeds (§ 558.3 To § 558.680) — Specific New Animal Drugs For Use In Animal Feeds (§ 558.55 To § 558.680) — Virginiamycin.

4 Aug 2016

(a) Approvals. See sponsors in § 510.600(c) of this chapter:

(1) No. 066104: Type A medicated articles containing 5, 10, 20, 50, or 227 grams per pound virginiamycin for use as in paragraph (d) of this section; and 136.2 grams per pound for use as in paragraph (d)(3) of this section.

(2) No. 054771: Type A medicated articles containing 10 grams per pound virginiamycin for use as in paragraphs (d)(1)(iv) and (v) of this section.

(b) Related tolerances. See § 556.750 of this chapter.

(c) Special considerations. (1) Not for use in breeding swine over 120 pounds.

(2) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed.

(d) Conditions of use - (1) Swine. It is used as follows:

(i) 100 grams per ton for 2 weeks, for treatment of swine dysentery in nonbreeding swine over 120 pounds.

(ii) 100 grams per ton for 2 weeks, 50 grams per ton thereafter, for treatment and control of swine dysentery in swine up to 120 pounds.

(iii) 25 grams per ton, as an aid in control of dysentery in swine up to 120 pounds. For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred.

(iv) 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 grams per ton to market weight for increased rate of weight gain and improved feed efficiency. For continuous use from weaning to market weight.

(v) 10 grams per ton from weaning up to 120 pounds for increased rate of weight gain and improved feed efficiency, followed by 5 to 10 grams per ton to market weight for increased rate of weight gain. For continuous use from weaning to market weight.

(2) Poultry. It is used as follows:

(i) 5 to 15 grams per ton for increased rate of weight gain, for use in broiler chickens, not for use in layers.

(ii) 5 grams per ton for increased rate of weight gain and improved feed efficiency in broiler chickens, not for use in layers.

(iii) 20 grams per ton for prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin in broiler chickens; not for use in layers.

(iv) 10 to 20 grams per ton for increased rate of weight gain and improved feed efficiency in growing turkeys.

(3) Cattle. It is used as follows:

(i) 16.0 to 22.5 grams per ton to provide 100 to 340 milligrams per head per day for increased rate of weight gain.

(ii) 13.5 to 16.0 grams per ton to provide 85 to 240 milligrams per head per day for reduction of incidence of liver abscesses.

(iii) 11.0 to 16.0 grams per ton to provide 70 to 240 milligrams per head per day for improved feed efficiency.

(iv) Feed continuously as sole ration to cattle fed in confinement for slaughter. Not for use in animals intended for breeding.

(4) Virginiamycin may be used in combination with:

(i) Amprolium and ethopabate as in § 558.58.

(ii) Diclazuril as in § 558.198.

(iii) Halofuginone as in § 558.265.

(iv) Lasalocid as in § 558.311.

(v) Monensin as in § 558.355.

(vi) Salinomycin as in § 558.550.

(vii) Semduramicin as in § 558.555.


Editorial Note:

For Federal Register citations affecting § 558.635, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

21 CFR 558.635
[40 FR 13959, Mar. 27, 1975]