CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR526.465]

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 526 -- INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

Sec. 526.465 Cloxacillin sodium.

(a) Specifications. Each single-dose, 10-milliliter syringe contains cloxacillin sodium equivalent to 200 milligrams (mg) cloxacillin.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.165 of this chapter.

(d) Conditions of use in lactating cows - (1) Amount. Infuse the contents of one syringe (equivalent to 200 mg cloxacillin) into each infected quarter. Treatment should be repeated at 12-hour intervals for a total of 3 doses.

(2) Indications for use. For the treatment of mastitis in lactating cows due to Streptococcus agalactiae and Staphylococcus aureus, nonpenicillinase-producing strains.

(3) Limitations. Milk taken from treated animals within 48 hours (4 milkings) after the latest treatment should not be used for food. Treated animals should not be slaughtered for food within 10 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37335, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003. Redesignated at 85 FR 18120, Apr. 1, 2020. Redesignated and amended at 86 FR 13186, Mar. 8, 2021]