Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2008]
[CITE: 21CFR558.635]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B--Specific New Animal Drugs for Use in Animal Feeds
Sec. 558.635 Virginiamycin.

(a)Approvals. Type A medicated articles. (1) 1.1 percent activity (5 grams per pound), 2.2 percent activity (10 grams per pound), 4.4 percent activity (20 grams per pound), 11 percent activity (50 grams per pound), and 50 percent activity (227 grams per pound) used as in paragraph (d) of this section; and 30 percent activity (136.2 grams per pound) for the manufacture of Type C medicated feed for cattle used as in paragraph (d)(3); to 066104 in 510.600(c) of this chapter.

(2) 2.2 percent activity (10 grams per pound) to 046573, 016968, and 017790 in 510.600(c) of this chapter for use as in paragraphs (d)(1)(iv) and (d)(1)(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 byClostridium 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 alone or with roxarsone as in 558.355.

(vi) Salinomycin alone or with roxarsone as in 558.550.

(vii) Semduramicin alone or with roxarsone as in 558.555.

[40 FR 13959, Mar. 27, 1975]

Editorial Note:

ForFederal Registercitations affecting 558.635, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

Database Updated April 1, 2008

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH