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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2018]
[CITE: 21CFR558.325]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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

Sec. 558.325 Lincomycin.

(a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride) per pound.

(b) Sponsors. See No. 054771 in 510.600(c) of this chapter.

(c) Related tolerances. See 556.360 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 lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled.

(3) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following:

(i) "CAUTION: 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."

(ii) [Reserved]

(4) Labeling of medicated feeds containing lincomycin intended for use in swine shall bear the following:

(i) "CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment."

(ii) "CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined."

(e) Conditions of use --(1) Chickens --

Lincomycin
grams/ton
Combination in grams/ton Indications for use Limitations Sponsors
(i) 2Broilers: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycinFeed as the sole ration. Not for use in layers, breeders, or turkeys054771
(ii) 2Halofuginone 2.72Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maximaFeed continuously as sole ration. Withdraw 4 days before slaughter. Do not feed to laying chickens or waterfowl. Halofuginone hydrobromide as provided by No. 016592 in 510.600 of this chapter016592

(2) Swine --

Lincomycin
grams/ton
Combination in grams/ton Indications for use Limitations Sponsors
(i) 40For control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularisFeed as sole ration. For use in swine on premises with a history of swine dysentery but where symptoms have not yet occurred, or following use of lincomycin at 100 grams (g)/ton for the treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis)054771
(ii) 40Fenbendazole, 10 to 80For control of swine dysentery in animals on premises with a history of swine dysentery, but where symptoms have not yet occurred; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages--liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages--intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus)Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in 510.600(c) of this chapter000061
(iii) 40Ivermectin, 1.8Weaned, growing and finishing swine: For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; and 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); kidney worms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis)Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 40 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 5 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in 510.600(c) of this chapter050604
(iv) 40Pyrantel, 96For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infectionsFeed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(v) 40Pyrantel, 96For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infectionsFeed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(vi) 40 or 100Pyrantel, 96For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infectionsFor treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of lincomycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(vii) 40Pyrantel, 800For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infectionsFeed as a single therapeutic treatment at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb and 5 lb of feed per head for animals over 200 lb. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See paragraph (d) of this section. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(viii) 100For treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularisFeed as the sole ration for 3 weeks or until clinical signs of the disease disappear054771
(ix) 100Fenbendazole, 10 to 80For the treatment of swine dysentery; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages--liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages--intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus)Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in 510.600(c) of this chapter000061
(x) 100Ivermectin, 1.8Weaned, growing and finishing swine: For the treatment of swine dysentery; and 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)Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 100 g/ton lincomycin may be continued to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in 510.600(c) of this chapter050604
(xi) 100Pyrantel, 96For the treatment of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infectionsFeed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(xii) 100Pyrantel, 96For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infectionsFeed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(xiii) 100Pyrantel, 800For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infectionsFeed as a single therapeutic treatment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter066104
(xiv) 100 to 200For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniaeFeed as sole ration for 21 days054771
(xv) 200Fenbendazole, 10 to 80For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages--liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages--intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus)Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in 510.600(c) of this chapter000061
(xvi) 200Ivermectin, 1.8For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and 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)Feed as the only feed for 7 consecutive days to provide 0.1 mg ivermectin/kg of body weight per day. A separate feed containing 200 g/ton lincomycin may be continued for an additional 14 days to complete the lincomycin treatment. Not to be fed to swine that weigh more than 250 lbs. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; ivermectin as provided by No. 050604 in 510.600(c) of this chapter050604
(xvii) 200Pyrantel, 96For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infectionsFeed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in 510.600(c) of this chapter054771

[81 FR 95005, Dec. 27, 2016, as amended at 82 FR 12170, Mar. 1, 2017; 82 FR 21691, May 10, 2017; 83 FR 13637, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018]

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