Code of Federal Regulations (Last Updated: November 8, 2024) |
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 |
§ 526.88 - Amoxicillin.
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§ 526.88 Amoxicillin trihydrate for intramammary infusion.
(a) Specifications. Each single-dose, 10-milliliter syringe contains amoxicillin trihydrate equivalent to 62.5 milligrams of (mg) 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 use - Lactating in lactating cows -
(1) Amount. One Infuse the contents of one syringe (equivalent to 62.5 milligrams mg amoxicillin) per quarterinto each infected quarter every 12 hours for a maximum of 3 doses.
(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 Milk taken from animals during treatment and for 60 hours (5 milkings) after the last treatment . Do not slaughter treated animals must not be used for food. Treated animals must not be slaughtered 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; 86 FR 13185, Mar. 8, 2021]