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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 Mar 22, 2024.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1260]



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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1260 Lincomycin.

(a) Specifications. Each milliliter of solution contains lincomycin hydrochloride monohydrate equivalent to:

(1) 25, 50, 100, or 300 milligrams (mg) lincomycin.

(2) 25, 100, or 300 mg lincomycin.

(3) 300 mg lincomycin.

(4) 100 or 300 mg lincomycin.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (e) of this section.

(1) No. 054771 for use of concentrations in paragraph (a)(1) of this section as in paragraph (e) of this section.

(2) Nos. 016592 and 058005 for use of concentrations in paragraph (a)(2) of this section as in paragraph (e)(2) of this section.

(3) No. 054771 for use of concentration in paragraph (a)(3) of this section as in paragraph (e)(2) of this section.

(4) No. 061133 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section.

(c) Special considerations. When common labeling for use of the drug in dogs, cats, and swine is included with the drug, all such uses are subject to the labeling requirements of § 201.105 of this chapter.

(d) Related tolerances. See § 556.360 of this chapter.

(e) Conditions of use. It is used for animals as follows:

(1) Dogs and cats - (i) Amount. 5 mg per pound (/lb) of body weight twice daily or 10 mg/lb body weight once daily by intramuscular injection; 5 to 10 mg/lb body weight one or two times daily by slow intravenous injection.

(ii) Indications for use. Infections caused by Gram-positive organisms, particularly streptococci and staphylococci.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Swine - (i) Amount. 5 mg/lb body weight once daily by intramuscular injection for 3 to 7 days.

(ii) Indications for use. Treatment of infectious arthritis and mycoplasma pneumonia.

(iii) Limitations. Do not treat within 48 hours of slaughter. For No 054771: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 50 FR 31351, Aug. 2, 1985; 67 FR 34388, May 14, 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR 51996, Sept. 1, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. 29, 2016; 84 FR 8974, Mar. 13, 2019; 88 FR 16548, Mar. 20, 2023]

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