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CFR > 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 (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.665—Zilpaterol.

CFR

558.665—Zilpaterol.

(a) Specifications. Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound.
(b) Approvals. See No. 000061 in § 510.600(c) of this chapter.
(c) Tolerances. See § 556.765 of this chapter.
(d) Special considerations —(1) Labeling of Type B and Type C cattle feeds shall bear the following:
(i) Do not allow horses or other equines access to feed containing zilpaterol.
(ii) Not for use in animals intended for breeding.
(iii) Do not use in veal calves.
(2) Type B Liquid Feeds can be manufactured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
(e) Conditions of use in cattle. It is administered in feed as follows:
Zilpaterol in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(1) 6.8 to provide 60 to 90 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Feed continuously as the sole ration during the last 20 to 40 days on feed. Withdrawal period: 3 days. 000061
(2) 6.8 to provide 60 to 90 mg/head/day Melengestrol acetate to provide 0.25 to 0.5 mg/ head/day Heifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; and for suppression of estrus (heat). As in paragraph (e)(1) of this section; see paragraph §§ 558.342(d) of this chapter. Melengestrol acetate as provided by Nos. 000009 or 021641 in § 510.600(c) of this chapter. 000061021641
(3) 6.8 to provide 60 to 90 mg/head/day Monensin 10 to 40 Cattle fed in confinement for slaughter: As in paragraph (e)(1) of this section; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. As in paragraph (e)(1) of this section; see paragraph § 558.355(d) of this chapter. Monensin as provided by No. 000986 in § 510.600(c) of this chapter. 000061
Code of Federal Regulations 515
(4) 6.8 to provide 60 to 90 mg/head/day Melengestrol acetate to provide 0.25 to 0.5 mg/ head/day Heifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat). As in paragraph (e)(1) of this section; see §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 000986; melengestrol acetate as provided by Nos. 000009 or 021641 in § 510.600(c) of this chapter. 000061021641
(5) 6.8 to provide 60 to 90 mg/head/day Monensin 10 to 40, plus tylosin 8 to 10 Cattle fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. As in paragraph (e)(1) of this section; see §§ 558.355(d) and 558.625(c) of this chapter. Monensin and tylosin as provided by No. 000986 in § 510.600(c) of this chapter. 000061
(6) 6.8 to provide 60 to 90 mg/head/day. Monensin 10 to 40, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat). As in paragraph (e)(1) of this section; see §§ 558.342(d), 558.355(d), and 558.625(c) of this chapter. Monensin and tylosin as provided by No. 000986; melengestrol acetate as provided by Nos. 000009 or 021641 in § 510.600(c) of this chapter. 000061021641

Code of Federal Regulations

[71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010]
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