[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: 21CFR558.300]

[Page 413-415]
 
                        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.  558.300  Ivermectin.

    (a) Approvals. (1) Type A medicated articles: 0.6 percent (2.72 
grams per pound; 6 grams per kilogram) to 050604 in Sec.  510.600(c) of 
this chapter, and
    (2) Type B medicated feeds for ivermectin alone or with lincomycin. 
See Sec.  558.4 of this chapter for maximum drug levels to 050604 in 
Sec.  510.600(c) of this chapter.
    (b) Related tolerances. See Sec.  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

[[Page 414]]

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

[[Page 415]]

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]