subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.1260"
section_subject: "Lincomycin."
cfr_reference: "21 CFR 522.1260"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. Each milliliter of solution contains lincomycin hydrochloride monohydrate equivalent to:
(1)25, 50, 100, or 300 milligrams (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.