[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.198] [Page 402-403] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents Subpart B--Specific New Animal Drugs for Use in Animal Feeds Sec. 558.198 Diclazuril. (a) Specifications. Type A medicated article containing 0.2 percent diclazuril. (b) Approvals. See No. 000061 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.185 of this chapter. (d) Conditions of use. (1) Chickens. For chickens it is used as follows: ---------------------------------------------------------------------------------------------------------------- Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 0.91 (1 part per million ..................... Broiler chickens: Feed continuously. 000061 (ppm)). For the prevention Not for use in hens of coccidiosis producing eggs for caused by Eimeria human food.. 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 lesion scores and improve performance and health of birds challenged with E. maxima.. (ii) 0.91 (1 ppm)................. Bacitracin methylene Broiler chickens: As As in item (i) of 000061 disalicylate 4 to 50. in item (i) of this this table. table; for Bacitracin increased rate of methylene weight gain and disalicylate improved feed provided by 046573.. efficiency.. (iii) 0.91 (1 ppm)................ Bacitracin methylene Broiler chickens: As Feed continuously as 000061 disalicylate 50 plus in item (i) of this the sole ration roxarsone 22.7 to table; as an aid in throughout growing 45.4. the prevention of period. Use as sole necrotic enteritis source of organic caused or arsenic; drug complicated by overdose or lack of Clostridium spp. or water may result in other organisms leg weakness. Not susceptible to for use in hens bacitracin; for producing eggs for increased rate of human consumption. weight gain, Withdraw 5 days improved feed before slaughter. efficiency, and Bacitracin improved methylene pigmentation.. disalicylate and roxarsone provided by No. 046573 in Sec. 510.600(c) of this chapter.. [[Page 403]] (iv) 0.91 (1 ppm)................. Bacitracin methylene Broiler chickens: As Feed continuously as 000061 disalicylate 100 to in item (i) of this the sole ration 200 plus roxarsone table; as an aid in throughout growing 22.7 to 45.4. the control of period. Start at necrotic enteritis first clinical caused or signs of disease; complicated by vary dosage of Clostridium spp. or bacitracin based on other organisms severity of susceptible to infection; bacitracin; for administer increased rate of continuously for 5 weight gain, to 7 days or as improved feed long as clinical efficiency, and signs persist, then improved reduce bacitracin pigmentation.. to prevention level (50 grams per ton (g/ton). Use as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. Not for use in hens producing eggs for human consumption. Withdraw 5 days before slaughter. Bacitracin methylene disalicylate and roxarsone provided by No. 046573 in Sec. 510.600(c) of this chapter.. (v) 0.91 (1 ppm).................. Bambermycins 1 to 2.. Broiler chickens: As As in item (i) of 000061 in item (i) of this this table. table); for Bambermycins increased rate of provided by 057926.. weight gain and improved feed efficiency.. (vi) 0.91 (1 ppm)................. Virginiamycin 5...... Broiler chickens: As As in item (i) of 000061 in item (i) of this this table; table; for Virginiamycin increased rate of provided by 066104.. weight gain and improved feed efficiency.. (vii) 0.91 (1 ppm)................ Virginiamycin 5 to 15 Broiler chickens: As As in item (i) of 000061 in item (i) of this this table. table; for Virginiamycin increased rate of provided by 066104.. weight gain.. ---------------------------------------------------------------------------------------------------------------- (2) Turkeys. For turkeys it is used as follows: ---------------------------------------------------------------------------------------------------------------- Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 0.91 (1 ppm).................. ..................... Growing turkeys: For Feed continuously as 000061 the prevention of the sole ration. Do coccidiosis caused not feed to by E. adenoeides, breeding turkeys. E. gallopavonis and Not for use in hens E. meleagrimitis.. producing eggs for human consumption.. (ii) 0.91 (1 ppm)................. Bacitracin methylene Growing turkeys: As As in paragraph 000061 disalicylate 4 to in paragraph (d)(2)(i) of this 50.. (d)(2)(i) of this section. Bacitracin section; for methylene increased rate of disalicylate weight gain and provided by No. improved feed 046573 in Sec. efficiency.. 510.600(c) of this chapter.. (iii) 0.91 (1 ppm)................ Bambermycins 1 to 2.. Growing turkeys: As As in paragraph 000061 in paragraph (d)(2)(i) of this (d)(2)(i) of this section. section; for Bambermycins improved feed provided by No. efficiency.. 057926 in Sec. 510.600(c) of this chapter.. (iv) 0.91 (1 ppm)................. Bambermycins 2....... Growing turkeys: As As in paragraph 000061 in paragraph (d)(2)(i) of this (d)(2)(i) of this section. section; for Bambermycins increased rate of provided by No. weight gain and 057926 in Sec. improved feed 510.600(c) of this efficiency.. chapter.. ---------------------------------------------------------------------------------------------------------------- [64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002]