21 C.F.R. § 558.300 Ivermectin.
Title 21 - Food and Drugs
(a) Approvals. (1) Type A medicated articles: 0.6 percent (2.72 grams per pound; 6 grams per kilogram) to 050604 in §510.600(c) of this chapter, and (2) Type B medicated feeds for ivermectin alone or with lincomycin. See §558.4 of this chapter for maximum drug levels to 050604 in §510.600(c) of this chapter. (b) Related tolerances. See §556.344 of this chapter. (c) [Reserved] (d) Conditions of use. It is used in swine feed as follows: (1) Amount per ton. For weaned, growing-finishing swine, feed 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day). For adult and breeding swine, feed 1.8 to 11.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day). For adult and breeding swine, may be top-dressed on daily ration for individual treatment at levels of 18.2 to 1180 grams (to provide 0.1 milligram per kilogram of body weight per day). (i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). (ii) Limitations. For use in swine feed only. Feed as only feed for 7 consecutive days. Withdraw 5 days before slaughter. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (2) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 20 grams of lincomycin. (i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For increased rate of weight gain. (ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days. Withdraw 5 days before slaughter. A separate feed containing 20 grams per ton lincomycin may be continued. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (3) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 40 grams of lincomycin. (i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For control of swine dysentery. For use in swine on premises with a history of swine dysentery, but where symptoms have not yet occurred. (ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days. Withdraw 5 days before slaughter. A separate feed containing 40 grams per ton lincomycin may be continued. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. (4) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 100 grams of lincomycin. (i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). Treatment of swine dysentery. (ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days followed by a separate feed containing 100 grams per ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (5) Amount per ton. 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day) with 200 grams of lincomycin. (i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis). For reduction in severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae. (ii) Limitations. For weaned, growing-finishing swine. Feed as only feed for 7 consecutive days followed by a separate feed containing 200 grams per ton lincomycin for an additional 14 days to complete the lincomycin treatment. Withdraw 6 days before slaughter. Not to be fed to swine that weigh more than 250 pounds. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (6) Amount per ton. For weaned, growing-finishing pigs, feed 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day), and 10 to 30 or 250 grams of bacitracin methylene disalicylate. For adult and breeding swine, feed 1.8 grams of ivermectin (to provide 0.1 milligram per kilogram of body weight per day), and 10 to 30 or 250 grams of bacitracin methylene disalicylate. (i) Indications for use. For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). For increased rate of weight gain and improved feed efficiency in growing and finishing swine. For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. For control of swine dysentery associated with Treponema hypdysenteriae on premises with a history of swine dysentery but where signs of disease have not yet occurred, or following an approved treatment of disease condition. (ii) Limitations. For use in swine feed only. Feed as the only feed for 7 consecutive days. For weaned growing and finishing swine, feed bacitracin methylene disalicylate Type C medicated feed from weaning to market weight for increased rate of weight gain and improved feed efficiency. For pregnant sows, feed bacitracin methylene disalicylate to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Withdraw ivermectin-containing feeds 5 days before slaughter. [58 FR 58653, Nov. 3, 1993, as amended at 60 FR 39848, Aug. 4, 1995; 61 FR 32652, June 25, 1996; 62 FR 63271, Nov. 28, 1997; 63 FR 54353, Oct. 9, 1998; 64 FR 13342, Mar. 18, 1999]
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
§ 558.300 Ivermectin.
