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[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2008]
[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)Approvals. Type A articles and Type B feeds approved for sponsors in 510.600(c) of this chapter for specific uses as in paragraph (d) of this section as follows:

(1) No. 000009 for 20 and 50 grams per pound.

(2)-(4) [Reserved]

(5) No. 043733 for 8 and 20 grams per pound.

(6)-(12) [Reserved]

(13) No. 051311 for 2.5 and 8 grams per pound.

(14)-(15) [Reserved]

(b)Related tolerances. See 556.360 of this chapter.

(c)Special considerations --(1) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin shall bear the following directions: "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."

(2) Labeling of Type A medicated articles and Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions: "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."

(3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following directions:

(i) No. 000009: "CAUTION: The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed."

(ii) Nos. 043733 and 051311: "CAUTION: Not to be fed to swine that weigh more than 250 lb."

(d)Conditions of use --(1)Chickens . It is used in feed as follows:

Lincomycin grams/tonIndications for useLimitationsSponsor
(i) 2Broilers: For control of necrotic enteritis caused byClostridiumspp. or other susceptible organisms.As lincomycin hydrochloride monohydrate.000009
(ii) 2 to 4Broilers: For increased rate of weight gain and improved feed efficiency.As lincomycin hydrochloride monohydrate.000009

(2)Swine . It is used in feed as follows:

Lincomycin grams/tonIndications for useLimitationsSponsor
(i) 20Growing-finishing swine: For increased rate of weight gain.Feed as sole ration.000009
(ii) 401. For control of swine dysentery.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 treatment of swine dysentery.000009043733051311
2. For control of porcine proliferative enteropathies (ileitis) caused byLawsonia intracellularis.Feed as sole ration, or following use of lincomycin at 100 g/ton for control of porcine proliferative enteropathies (ileitis).000009
(iii) 1001. For treatment of swine dysentery.Feed as sole ration for 3 weeks or until signs of disease disappear.000009043733051311
2. For control of porcine proliferative enteropathies (ileitis) caused byLawsonia intracellularis.Feed as sole ration for 3 weeks or until signs of disease disappear.000009
(iv) 200For reduction in the severity of swine mycoplasmal pneumonia caused byMycoplasma hyopneumoniae.Feed as sole ration for 3 weeks.000009051311

(3) Lincomycin may also be used in combination with:

(i) Amprolium and ethopabate or amprolium and ethopabate with roxarsone in accordance with 558.58.

(ii) Clopidol in accordance with 558.175.

(iii) Decoquinate in accordance with 558.195.

(iv) Fenbendazole as provided in 558.258.

(v) Halofuginone in accordance with 558.265.

(vi) Ivermectin as in 558.300.

(vii) Lasalocid alone or with roxarsone in accordance with 558.311.

(viii) Monensin alone or with roxarsone in accordance with 558.355.

(ix) Nicarbazin alone or with narasin or roxarsone as in 558.366.

(x) Pyrantel as in 558.485.

(xi) Robenidine in accordance with 558.515.

(xii) Roxarsone in accordance with 558.530.

(xiii) Salinomycin with or without roxarsone as in 558.550.

(xiv) Zoalene in accordance with 558.680.

[40 FR 13959, Mar. 27, 1975]

Editorial Note:

ForFederal Registercitations affecting 558.325, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

Database Updated April 1, 2008

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