21 C.F.R. § 558.342 Melengestrol.
Title 21 - Food and Drugs
(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 sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section. (1) No. 000009 for use of products described in paragraph (a) of this section. (2) No. 021641 for use of product described in paragraph (a)(2) of this section. (c) Related tolerances. See §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 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 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 physically 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 §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 §558.311(d) of this chapter. (5) Combination Type B or C medicated feeds containing monensin must be labeled in accordance with §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 §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 §558.625(c) of this chapter. (8) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement. (e) Conditions of use—(1) Cattle. (2) Melengestrol may also be used with ractopamine alone or in combination as in §558.500 of this chapter. [42 FR 28535, June 3, 1977] Editorial Note: For
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.342 Melengestrol.
---------------------------------------------------------------------------------------------------------------- Melengestrol acetate in mg/head/ Combination in mg/ day head/day Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.25 to 0.5.................. .................... Heifers fed in Administer 0.5 to 000009, confinement for 2.0 pounds (lb)/ 021641 slaughter: For head/day of increased rate of medicated feed weight gain, improved containing 0.125 feed efficiency, and to 1.0 mg suppression of estrus melengestrol (heat).. acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/day..(ii) 0.5......................... .................... Heifers intended for Administer 0.5 to 000009, breeding: For 2.0 lb/head/day of 021641 suppression of estrus Type C feed (heat).. containing 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 0.5................ Lasalocid 100 to 360 Heifers fed in Add at the rate of 000009 confinement for 0.5 to 2.0 lb/head/ slaughter: As in day a medicated paragraph (e)(1)(i) of feed (liquid or this section.. dry) 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 § 510.600(c) of this chapter..(iv) 0.25 to 0.5................. Lasalocid 100 to 360 Heifers fed in To administer 0.25 000009, plus tylosin 90. confinement for to 0.5 mg 021641 slaughter: As in melengestrol paragraph (e)(1)(i) of acetate plus 100 this section; and for to 360 mg reduced incidence of lasalocid plus 90 liver abscesses.. mg tylosin/head/ day:. 1. 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 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 § 510.600(c) of this chapter..(v) 0.25 to 0.4.................. Monensin 50 to 360.. Heifers fed in ................... 000009, confinement for Add at the rate of 021641 slaughter: As in 0.5 to 2.0 lb/head/ paragraph (e)(1)(i) of day a medicated this section.. feed (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 § 510.600(c) of this chapter.. (vi) 0.25 to 0.4................ Monensin 50 to 360.. Heifers fed in ................... 000009, confinement for Add at the rate of 021641 slaughter: As in item 0.5 to 2.0 lb/head/ paragraph (e)(1)(i) of day a medicated this section; and for feed (liquid or the prevention and dry) containing control of coccidiosis 0.125 to 0.80 mg due to Eimeria bovis melengestrol and E. zuernii.. acetate/lb to a feed containing 10 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 0.14 to 0.42 mg monensin/lb body weight, up to 360 mg monensin/head/ day.. Monensin provided by No. 000986 in § 510.600(c) of this chapter..(vii) 0.25 to 0.5................ Monensin 50 to 360 Heifers fed in To administer 0.25 000009, plus tylosin 60 to confinement for to 0.50 mg 021641 90. slaughter: As in melengestrol paragraph (e)(1)(i) of acetate to 50 to this section; for the 360 mg monensin prevention and control plus 60 to 90 mg of coccidiosis due to tylosin/head/day:. E. bovis and E. 1. Add 0.5 to 2.0 zuernii; and for lb/head/day of a reduced incidence of liquid or dry liver abscesses caused medicated feed by Fusobacterium containing 0.125 necrophorum and to 1.0 mg Actinomyces melengestrol (Corynebacterium) acetate/lb to a pyogenes.. medicated feed containing 5 to 30 g monensin 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, 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 § 510.600(c) of this chapter..(viii) 0.25 to 0.5............... Oxytetracycline 75.. Heifers fed in Add at the rate of 000009 confinement for 0.5 to 2.0 lb/head/ slaughter: As in day a medicated paragraph (e)(1)(i) of feed (liquid or this section; and for dry) containing reduction of liver 0.125 to 1.0 mg condemnation due to melengestrol liver abscesses.. acetate/lb per pound to a feed containing 6 to 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 § 510.600(c) of this chapter..(ix) 0.25 to 0.5................. Tylosin 60 to 90.... Heifers fed in To administer 0.25 000009, confinement for to 0.5 mg 021641 slaughter: As in melengestrol paragraph (e)(1)(i) of acetate with 60 to this section; and for 90 mg tylosin/head/ reduced incidence of day:. liver abscesses caused 1. Add 0.5 to 2.0 by F. necrophorum and lb/head/day of a Actinomyces liquid or dry (Corynebacterium) medicated feed pyogenes.. containing 0.125 to 1.0 mg 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 § 510.600(c) of this chapter..----------------------------------------------------------------------------------------------------------------
