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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: 21CFR520.1263c]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1263c Lincomycin powder.

(a) Specifications. Each gram of soluble powder contains lincomycin hydrochloride equivalent to 0.4 grams of lincomycin.

(b) Sponsors. See sponsor numbers in 510.600(c) of this chapter as follows:

(1) Nos. 016592 and 054771 for use as in paragraph (d) of this section.

(2) Nos. 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.

(c) Tolerances. See 556.360 of this chapter.

(d) Conditions of use --(1) Swine --(i) Amount. 250 milligrams per gallon of drinking water to provide 3.8 milligrams per pound of body weight per day.

(ii) Indications for use. For the treatment of swine dysentery (bloody scours).

(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. For No. 054925: Do not slaughter swine for 6 days following last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Chickens --(i) Amount. 64 milligrams per gallon of drinking water.

(ii) Indications for use. For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens.

(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Administer for 7 consecutive days. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Not for use in layer and breeder chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Honey bees --(i) Amount. Mix 100 milligrams lincomycin with 20 grams confectioners'/powdered sugar and dust over the top bars of the brood chamber once weekly for 3 weeks.

(ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae ).

(iii) Limitations. The drug should be fed early in the spring or late in the fall and consumed by the bees before the main honey flow begins to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 3966, Jan. 28, 1983, as amended at 55 FR 3209, Jan. 31, 1990; 60 FR 14217, Mar. 16, 1995; 62 FR 65020, Dec. 10, 1997; 64 FR 13341, Mar. 18, 1999; 64 FR 13508, Mar. 19, 1999; 64 FR 66382, Nov. 26, 1999; 65 FR 10705, Feb. 29, 2000; 67 FR 17284, Apr. 10, 2002; 67 FR 71819, Dec. 3, 2002; 67 FR 78356, Dec. 24, 2002; 68 FR 3817, Jan. 27, 2003; 70 FR 1818, Jan. 11, 2005; 77 FR 20988, Apr. 9, 2012; 77 FR 29217, May 17, 2012; 78 FR 28823, May 20, 2014; 81 FR 22523, Apr. 18, 2016; 81 FR 94989, Dec. 27, 2016]

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