---
kind: "section"
citation: "21 C.F.R. § 522.1260"
title: "21"
number: "522.1260"
heading: "Lincomycin."
url: "https://uscodex.org/cfr/21/522.1260"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter for uses as in [paragraph (e)](#e) of this section.
  - (1) **No.** 054771 for use of concentrations in [paragraph (a)(1)](#a-1) of this section as in [paragraph (e)](#e) of this section.
  - (2) **Nos.** 016592 and 058005 for use of concentrations in [paragraph (a)(2)](#a-2) of this section as in [paragraph (e)(2)](#e-2) of this section.
  - (3) **No.** 054771 for use of concentration in [paragraph (a)(3)](#a-3) of this section as in [paragraph (e)(2)](#e-2) of this section.
  - (4) **No.** 061133 for use of concentrations in [paragraph (a)(4)](#a-4) of this section as in [paragraph (e)(2)](#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](/cfr/21/201.105.md) of this chapter.
- (d) **Related tolerances.** See [§ 556.360](/cfr/21/556.360.md) 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian

## Notes

### Amendments

[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; 90 FR 40970, Aug. 22, 2025]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[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; 90 FR 40970, Aug. 22, 2025]