21 CFR 558.325 - Lincomycin.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart B [§ 558.55 - § 558.680]

§ 558.325 - Lincomycin.

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

(b) Sponsor. See No. 054771 in § 510.600(c) 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) 2		Broilers: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin	Feed as the sole ration. Not for use in layers, breeders, or turkeys	054771
(ii) [Reserved]
(iii) 2	Clopidol, 113.5	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of cecal and intestinal coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati	Feed as the sole ration to broiler chickens. Do not feed to chickens over 16 weeks of age. Not for use in laying hens, breeding chickens, or turkeys. 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. Clopidol as provided by No. 016592 in § 510.600 of this chapter	054771
(iv) 2	Decoquinate, 27.2	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima	Feed as the sole ration. Do not use in feeds containing bentonite. Not for use in laying hens, breeding chickens, or turkeys. 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. Decoquinate as provided by No. 054771 in § 510.600 of this chapter	054771
(v) 2	Halofuginone 2.72	Broiler 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. maxima	Feed 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 chapter	016592
(vi) 2	Lasalocid, 68 to 113	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E maxima	Feed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. 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. Lasalocid as provided by No. 054771 in § 510.600 of this chapter	054771
(vii) 2	Monensin, 90 to 110	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima	Feed as the sole ration. Must be thoroughly mixed in feeds before use. Do not feed undiluted. Not for use in laying hens, breeding chickens, or turkeys. Do not allow horses, or other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. 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. Monensin as provided by No. 058198 in § 510.600 of this chapter	054771
(viii) 2	Robenidine hydrochloride, 30	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix	Feed as the sole ration. Do not use in feeds containing bentonite. Do not feed to laying hens producing eggs for human consumption. Not for use in laying hens, breeding chickens, or turkeys. 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. Withdraw 5 days prior to slaughter. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by No. 054771 in § 510.600 of this chapter	054771
(ix) 2	Salinomycin, 40 to 60	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E maxima, E. brunetti, and E. mivati	Feed as the sole ration to broiler chickens. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Not for use in laying hens, breeding chickens, or turkeys. 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. Salinomycin as provided by No. 054771 in § 510.600 of this chapter	05477
(x) 2	Zoalene, 113.5	Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention and control of coccidiosis	Feed as the sole ration from the time chicks are placed in floor pens until slaughtered for meat. Not for use in laying hens, breeding chickens, or turkeys. 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. Zoalene as provided by No. 054771 in § 510.600 of this chapter	054771

(2) Swine—

Lincomycin grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsors
(i) 40		For control of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis	Feed 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) [Reserved]
(iii) 40	Pyrantel, 96	For 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.) infections	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 chapter	066104
(iv) 40	Pyrantel, 96	For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections	Feed 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 chapter	066104
(v) 40 or 100	Pyrantel, 96	For 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.) infections	For 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 chapter	066104
(vi) 40	Pyrantel, 800	For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections	Feed 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 chapter	066104
(vii) 100		For treatment of swine dysentery and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis	Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear	054771
(viii) [Reserved]
(ix) 100	Pyrantel, 96	For 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.) infections	Feed 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 chapter	066104
(x) 100	Pyrantel, 96	For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections	Feed 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 chapter	066104
(xi) 100	Pyrantel, 800	For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections	Feed 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 chapter	066104
(xii) 100 to 200		For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae	Feed as sole ration for 21 days	054771
(xiii) [Reserved]
(xiv) 200	Pyrantel, 96	For 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.) infections	Feed 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 chapter	054771

[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; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8976, Mar. 13, 2019; 84 FR 12501, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019; 86 FR 14824, Mar. 19, 2021; 88 FR 55570, Aug. 16, 2023]

authority: 21 U.S.C. 354,360b,360ccc,360ccc-1,371

source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 558.325