21 CFR 526.464b - Cloxacillin benzathine for intramammary infusion, sterile.

Code of Federal Regulations - Title 21: Food and Drugs

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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 FORMS

526.464b - Cloxacillin benzathine for intramammary infusion, sterile.

  (a) Specifications. Each 6 milliliter dose contains cloxacillin benzathine equivalent to 500 milligrams of cloxacillin.

  (b) Related tolerances. See 556.165 of this chapter.

  (c) Sponsor. See No. 055529 in 510.600(c) of this chapter.

  (1) Amount. 6 milliliters per infected quarter aseptically immediately after last milking at the time of drying-off of the cow.

  (2) Indications for use. Treatment of mastitis caused by Staphylococcus aureus and Streptococus agalactiae in dairy cows at the time of drying-off of the cow.

  (3) Limitations. For use in dry cows only. Not to be used within 30 days of calving. Milk taken from treated cows prior to 72 hours (6 milkings) after calving must not be used for human food. Animals infused with this product must not be slaughtered for food from the time of infusion until 72 hours after calving. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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

  (1) Amount. One dose per infected quarter immediately after last milking.

  (2) Indications for use. Treatment and prophylaxis of bovine mastitis in nonlactating cows due to Streptococcus agalactiae and Staphylococcus aureus.

  (3) Limitations. For use in dry cows only. Not to be used within 4 weeks (28 days) of calving. Animals infused with this product must not be slaughtered for food use for 4 weeks (28 days) after the latest infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003]

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