21 CFR 526.88 - Amoxicillin trihydrate for intramammary infusion.

Code of Federal Regulations - Title 21: Food and Drugs (December 2005)


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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

526.88 - Amoxicillin trihydrate for intramammary infusion.

  (a) Specifications. Each single dose syringe contains amoxicillin trihydrate equivalent to 62.5 milligrams of amoxicillin.

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

  (c) Related tolerances. See 556.38 of this chapter.

  (d) Conditions of useLactating cows(1) Amount. One syringe (equivalent to 62.5 milligrams amoxicillin) per quarter.

  (2) Indications for use. For the treatment of subclinical infectious bovine mastitis due to Streptococcus agalactiae and Straphylococcus aureus (penicillin sensitive).

  (3) Limitations. Administer after milking. Clean and disinfect the teat.

Use one syringe per infected quarter every 12 hours for a maximum of 3 doses. Do not use milk taken from treated animals for food purposes within 60 hours (5 milkings) after last treatment. Do not slaughter treated animals for food purposes within 12 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37334, Aug. 18, 1992, as amended at 60 FR 55660, Nov. 2, 1995; 68 FR 44878, July 31, 2003]

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