[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: 21CFR558.342] [Page 424-427] 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. 558.342 Melengestrol. (a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound. (2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound. (b) Approvals. See No. 000009 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.380 of this chapter. (d) Special considerations. (1) Type B or C medicated feeds may be manufactured from melengestrol acetate liquid Type A articles or Type B or C medicated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows: (i) For liquid Type B or C feeds stored in recirculating tank systems: Recirculate immediately prior to use for no 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. (ii) For liquid Type B or C 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. (2) A positionally stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mixing directions prescribed in paragraphs (c)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months. (3) Combination Type B or C medicated feeds containing lasalocid must be labeled in accordance with Sec. 558.311(d)(5) of this chapter. (4) Liquid combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be manufactured in accordance with Sec. 558.311(d) of this chapter. (5) Combination Type B or C medicated feeds containing monensin must be labeled in accordance with Sec. 558.355(d) of this chapter. (6) Liquid combination Type B or C medicated feeds containing melengestrol acetate and monensin must be manufactured in accordance with Sec. 558.355(f)(3)(i) of this chapter. (7) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with Sec. 558.625(c) of this chapter. [[Page 425]] (8) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement. (e) Conditions of use--(1) Cattle. ------------------------------------------------------------------------ Melengestrol Combination acetate in mg/ in mg/head/ Indications for Limitations Sponsor head/day day use ------------------------------------------------------------------------ (i) 0.25 to ............ Heifers fed in Administer 0.5 000009 0.5 confinement for to 2.0 pounds slaughter: For (lb)/head/day increased rate of medicated of weight gain, feed containing improved feed 0.125 to 1.0 mg efficiency, and melengestrol suppression of acetate/lb to estrus (heat). provide 0.25 to 0.5 mg melengestrol acetate/head/ day. (ii) 0.5 ............ Heifers intended Administer 0.5 000009 for breeding: to 2.0 lb/head/ For suppression day of Type C of estrus feed containing (heat). 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/ day. Do not exceed 24 days of feeding. (iii) 0.25 to Lasalocid Heifers fed in Add at the rate 000009 0.5 100 to 360 confinement for of 0.5 to 2.0 slaughter: As lb/head/day a in paragraph medicated feed (e)(1)(i) of (liquid or dry) this section. containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 grams (g) of lasalocid per ton; or add at the rate of 0.5 to 2.0 lb/head/ day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/lb to a ration of nonmedicated feed to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 mg lasalocid/head/ day. Lasalocid provided by No. 046573 in Sec. 510.600(c) of this chapter. (iv) 0.25 to Lasalocid Heifers fed in To administer 000009 0.5 100 to 360 confinement for 0.25 to 0.5 mg plus slaughter: As melengestrol tylosin 90 in paragraph acetate plus (e)(1)(i) of 100 to 360 mg this section; lasalocid plus and for reduced 90 mg tylosin/ incidence of head/day: liver 1. Add 0.5 to abscesses. 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to a medicated feed containing 10 to 30 g lasalocid and 8 to 10 g tylosin per ton; or 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 50 to 720 mg lasalocid/lb to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or 3. Add 0.5 to 2.0 lb/head/day of a dry pelleted medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 50 to 720 mg lasalocid, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed. Lasalocid provided by No. 046573 and tylosin as tylosin phosphate by No. 000986 in Sec. 510.600(c) of this chapter. [[Page 426]] (v) 0.25 to Monensin 50 Heifers fed in ................ 000009 0.4 to 360 confinement for Add at the rate slaughter: As of 0.5 to 2.0 in paragraph lb/head/day a (e)(1)(i) of medicated feed this section. (liquid or dry) containing 0.125 to 0.80 mg melengestrol acetate/lb to a feed containing 5 to 30 g monensin per ton; or add at the rate of 0.5 to 2.0 lb/head/ day a medicated feed (liquid or dry) containing 0.125 to 0.80 mg melengestrol acetate plus 25 to 720 mg monensin/lb to a nonmedicated feed to provide 0.25 to 0.40 mg melengestrol acetate and 50 to 360 mg monensin/head/ day. Monensin provided by No. 000986 in Sec. 510.600(c) of this chapter. (vi) 0.25 to Monensin 50 Heifers fed in ................ 000009 0.4 to 360 confinement for Add at the rate slaughter: As of 0.5 to 2.0 in item lb/head/day a paragraph medicated feed (e)(1)(i) of (liquid or dry) this section; containing and for the 0.125 to 0.80 prevention and mg melengestrol control of acetate/lb to a coccidiosis due feed containing to Eimeria 10 to 30 g bovis and E. monensin per zuernii. ton; or add at the rate of 0.5 to 2.0 lb/head/ day a medicated feed (liquid or dry) containing 0.125 to 0.80 mg melengestrol acetate plus 25 to 720 mg monensin/lb to a nonmedicated feed to provide 0.25 to 0.40 mg melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight, up to 360 mg monensin/head/ day. Monensin provided by No. 000986 in Sec. 510.600(c) of this chapter. (vii) 0.25 to Monensin 50 Heifers fed in To administer 000009 0.5 to 360 plus confinement for 0.25 to 0.50 mg tylosin 60 slaughter: As melengestrol to 90 in paragraph acetate to 50 (e)(1)(i) of to 360 mg this section; monensin plus for the 60 to 90 mg prevention and tylosin/head/ control of day: coccidiosis due 1. Add 0.5 to to E. bovis and 2.0 lb/head/day E. zuernii; and of a liquid or for reduced dry medicated incidence of feed containing liver abscesses 0.125 to 1.0 mg caused by melengestrol Fusobacterium acetate/lb to a necrophorum and medicated feed Actinomyces containing 5 to (Corynebacteriu 30 g monensin m) pyogenes. and 8 to 10 g tylosin per ton; or 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 25 to 720 mg monensin per pound to 4.5 to 18 lb of a dry medicated feed containing 10 to 40 g tylosin per ton; or 3. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article), 25 to 600 mg monensin, and 45 to 180 mg tylosin/lb to a ration of nonmedicated feed. Monensin and tylosin as tylosin phosphate provided by No. 000986 in Sec. 510.600(c) of this chapter. [[Page 427]] (viii) 0.25 Oxytetracycl Heifers fed in Add at the rate 000009 to 0.5 ine 75 confinement for of 0.5 to 2.0 slaughter: As lb/head/day a in paragraph medicated feed (e)(1)(i) of (liquid or dry) this section; containing and for 0.125 to 1.0 mg reduction of melengestrol liver acetate/lb per condemnation pound to a feed due to liver containing 6 to abscesses. 10 g oxytetracycline per ton; or add at the rate of 0.5 to 2.0 lb/ head/day a dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate plus 37.5 to 150 mg oxytetracycline/ lb to provide 0.25 to 0.5 mg melengestrol acetate and 75 mg oxytetracycline/ head/day. Oxytetracycline as provided by No. 066104 in Sec. 510.600(c) of this chapter. (ix) 0.25 to Tylosin 60 Heifers fed in To administer 000009 0.5 to 90 confinement for 0.25 to 0.5 mg slaughter: As melengestrol in paragraph acetate with 60 (e)(1)(i) of to 90 mg this section; tylosin/head/ and for reduced day: incidence of 1. Add 0.5 to liver abscesses 2.0 lb/head/day caused by F. of a liquid or necrophorum and dry medicated Actinomyces feed containing (Corynebacteriu 0.125 to 1.0 mg m) pyogenes. melengestrol acetate/lb to a medicated feed containing 8 to 10 g tylosin per ton; or 2. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to 4.5 to 18 pounds of a dry medicated feed containing 10 to 40 g tylosin per ton; or 3. Add 0.5 to 2.0 lb/head/day of a liquid or dry medicated feed containing 0.125 to 1.0 mg melengestrol acetate (from a dry Type A article) plus 45 to 180 mg tylosin/lb to a ration of nonmedicated feed. Tylosin as tylosin phosphate provided by No. 000986 in Sec. 510.600(c) of this chapter. ------------------------------------------------------------------------ (2) [Reserved] [42 FR 28535, June 3, 1977, as amended at 46 FR 18967, Mar. 27, 1981; 49 FR 39842, Oct. 11, 1984; 50 FR 1843, Jan. 14, 1985; 50 FR 16228, Apr. 25, 1985; 51 FR 7398, Mar. 3, 1986; 51 FR 36222, Oct. 9, 1986; 52 FR 2685, Jan. 26, 1987; 52 FR 33804, Sept. 8, 1987; 53 FR 27959, July 26, 1988; 55 FR 31828, Aug. 6, 1990; 57 FR 5053, Feb. 12, 1992; 59 FR 41241, Aug. 11, 1994; 60 FR 11028, Mar. 1, 1995; 62 FR 8373, Feb. 25, 1997; 62 FR 14304, Mar. 26, 1997; 63 FR 27845, May 21, 1998; 63 FR 41191, Aug. 3, 1998; 63 FR 66018, Dec. 1, 1998; 67 FR 47688, July 22, 2002]