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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 Oct 01, 2021.

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: 21CFR520.447]



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. 520.447 Clindamycin solution.

(a) Specifications. Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.

(b) Sponsors. See Nos. 051311, 054771, 058829, 061133, and 069043 in § 510.600(c) of this chapter.

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use - (1) Dogs - (i) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius ), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum , and Clostridium perfringens ; dental infections due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens ; and osteomyelitis due to susceptible strains of S. aureus , B. fragilis , P. melaninogenicus , F. necrophorum , and C. perfringens.

(2) Cats - (i) Amount. 5.0 to 15.0 mg/lb body weight every 24 hours for a maximum of 14 days.

(ii) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of Staphylococcus aureus , S. intermedius , Streptococcus spp. ; deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis ; and dental infections due to susceptible strains of S. aureus , S. intermedius , Streptococcus spp. , C. perfringens , and B. fragilis.

[67 FR 54954, Aug. 27, 2002, as amended at 67 FR 78684, Dec. 26, 2002; 68 FR 55824, Sept. 29, 2003; 69 FR 31734, June 7, 2004; 71 FR 39543, July 13, 2006; 72 FR 19796, Apr. 20, 2007; 78 FR 17596, Mar. 22, 2013; 78 FR 30197, May 22, 2013; 79 FR 28819, May 20, 2014; 81 FR 17607, Mar. 30, 2016; 84 FR 8972, Mar. 13, 2019]

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