Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / 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 / § 558.625 Tylosin.
§ 558.625 Tylosin.
(a) Specifications. Type A medicated articles containing tylosin phosphate.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 016592: Type A medicated articles containing 40 or 100 grams per pound (g/lb).
(2) No. 054771: Type A medicated article containing 40 g/lb.
(3) No. 058198: Type A medicated articles containing 10, 40, or 100 g/lb.
(4) No. 066104: Type A medicated articles containing 20 or 40 g/lb.
(c) Related tolerances. See § 556.746 of this chapter.
(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2) The expiration date of VFDs for tylosin medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin shall not be refilled.
(3) Type C medicated feeds for cattle may be manufactured from tylosin liquid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as follows:
(i) 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.
(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.
(4) Tylosin liquid Type B medicated feeds must bear an expiration date of 31 days after the date of manufacture.
(5) Do not use tylosin liquid Type B medicated feeds in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate, or complete feed) containing in excess of 2 percent bentonite.
(e) Conditions of use - (1) Swine -
| Tylosin
grams/ton | Combination in
grams/ton | Indications for use | Limitations | Sponsors |
|---|---|---|---|---|
| (i) 40 or 100 | For control of swine dysentery associated with | Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight | 016592
054771 058198 066104 | |
| (ii) 40 or 100 | Pyrantel, 96 | For control of swine dysentery associated with | Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter | 066104 |
| (iii) 40 or 100 | For control of porcine proliferative enteropathies (ileitis) associated with | Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight | 016592
054771 058198 066104 | |
| (iv) 40 or 100 | Pyrantel, 96 | For control of porcine proliferative enteropathies (ileitis) associated with | Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Follow with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter | 066104 |
| (v) 40 or 100 | Ractopamine, 4.5 to 9.0 | Finishing swine: For the control of swine dysentery associated with | Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for at least 3 weeks, followed by 40 g/ton until market weight. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter | 016592
054771 058198 |
| (vi) 40 to 100 | For the treatment and control of swine dysentery associated with | Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter | 016592
054771 058198 066104 | |
| (vii) 40 or 100 | Pyrantel, 96 | For the treatment and control of swine dysentery associated with | Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter | 066104 |
| (viii) 40 to 100 | For the control of porcine proliferative enteropathies (PPE, ileitis) associated with | Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter | 016592
054771 058198 066104 | |
| (ix) 40 or 100 | Pyrantel, 96 | For the control of porcine proliferative enteropathies (PPE, ileitis) associated with | Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter | 066104 |
| (x) 40 to 100 | Ractopamine, 4.5 to 9.0 | Finishing swine: For the treatment and control of swine dysentery associated with | Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 40 to 100 grams of tylosin phosphate per ton of complete feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter | 016592
054771 058198 |
| (xi) 100 | For reduction in severity of effects of atrophic rhinitis | Feed continuously as the sole ration | 016592
054771 058198 066104 | |
| (xii) 100 | Pyrantel, 96 | For reduction in severity of effects of atrophic rhinitis; aid as an aid in the prevention of migration and establishment of large roundworm ( | Feed continuously as the sole ration. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter | 066104 |
| (xiii) 100 | Ractopamine, 4.5 to 9.0 | For the control of porcine proliferative enteropathies (PPE, ileitis) associated with | Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for 3 weeks. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter | 016592
054771 058198 |
(2) Cattle -
| Tylosin
grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsors |
|---|---|---|---|---|
| (i) 8 to 10 | Beef cattle: For reduction of incidence of liver abscesses caused by | Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin | 016592
054771 058198 066104 | |
| (ii) 8 to 10 | Lasalocid, 100 to 1440; plus melengestrol, 0.25 to 2.0 | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 016592 and 058198; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.342(d) in this chapter | 016592
054771 058198 |
| (iii) 8 to 10 | Melengestrol, 0.25 to 2.0 | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol acetate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by Nos. 016592 and 058198; melengestrol provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See § 558.342(d) in this chapter | 016592
054771 058198 |
| (iv) 8 to 10 | Monensin, 5 to 40 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration to provide 50 to 480 monensin mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter | 016592
058198 |
| (v) 8 to 10 | Monensin, 10 to 40 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter | 016592
058198 |
| (vi) 8 to 10 | Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/head/day, and 60 to 90 mg of tylosin/head/day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by Nos. 016592 and 058198; monensin as provided by No. 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d) in this chapter | 016592
054771 |
| (vii) 8 to 10 | Monensin, 5 to 40 plus lubabegron fumarate, 1.25 to 4.54 | Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight; for reduction of incidence of liver abscesses associated with | Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day, and 60 to 90 mg tylosin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal | 058198 |
| (viii) 8 to 10 | Monensin, 10 to 40 plus lubabegron fumarate, 1.25 to 4.54 | Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, for reduction of incidence of liver abscesses associated with | Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, up to 480 mg/head/day, and 60 to 90 mg tylosin/head/day during the last 14 to 91 days on feed. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal | 058198 |
| (ix) 8 to 10 | Monensin, 10 to 40 plus melengestrol, 0.25 to 2.0 | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d) and 558.355(d) in this chapter | 016592
054771 058198 |
| (x) 8 to 10 | Monensin, 10 to 40 plus ractopamine, 8.2 to 24.6 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration to provide 70 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter | 054771
058198 |
| (xi) 8 to 10 | Monensin, 10 to 40 plus ractopamine, not to exceed 800 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed a minimum of 1.0 lb/head/day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter | 054771
058198 |
| (xii) 8 to 10 | Monensin 10 to 40 plus ractopamine 9.8 to 24.6 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.500(d) in this chapter | 054771
058198 |
| (xiii) 8 to 10 | Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6 plus melengestrol, 0.125 to 1 mg/lb | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; ractopamine as provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d), and 558.500(d) in this chapter | 054771
058198 |
| (xiv) 8 to 10 | Monensin, 10 to 40 plus zilpaterol, 6.8 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter | 000061
016592 |
| (xv) 8 to 10 | Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 | Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Do not use in veal calves. Withdrawal period 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter | 000061
016592 |
| (xvi) 8 to 10 | Monensin, 10 to 40 plus zilpaterol, 6.8 plus melengestrol, 0.125 to 1 mg/lb | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to provide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter | 000061
016592 058198 |
| (xvii) 8 to 10 | Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 plus melengestrol, 0.125 to 1 mg/lb | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by | Feed this component feed continuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol provided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter | 000061
016592 058198 |