Federal Register - March 8, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
required. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
4 Special considerations. Federal law prohibits extralabel use of this drug in lactating dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food-producing species/
production classes.
e Conditions of use for syringe described in paragraph a2 of this section in dry cows1 Amount. Infuse the contents of one syringe 500 mg ceftiofur equivalents into each affected quarter at the time of dry off.
2 Indications for use. For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
3 Limitations. Milk taken from cows completing a 30-day dry-off period may be used for food with no milk discard due to ceftiofur residues. Following intramammary infusion, a 16-day preslaughter withdrawal period is required for treated cows. No preslaughter withdrawal period is required for neonatal calves from treated cows regardless of colostrum consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
4 Special considerations. Federal law prohibits extralabel use of this drug in dry dairy cattle for disease prevention purposes; at unapproved doses;
frequencies, durations, or routes of administration; and in unapproved major food-producing species/
production classes.
24. In 526.363, revise paragraphs a and d to read as follows:
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526. 363
Cephapirin benzathine.
a Specifications. Each single-dose, 10-milliliter syringe contains 300
milligrams cephapirin activity as cephapirin benzathine.
d Conditions of use in dry cows1
Amount. Infuse the contents of one syringe 300 mg cephapirin activity into each quarter following last milking, but no later than 30 days before calving.
2 Indications for use. For the treatment of mastitis caused by susceptible strains of Streptococcus agalactiae and Staphylococcus aureus, including penicillin-resistant strains.
3 Limitations. For use in dry cows only. Milk from treated cows must not be used for food during the first 72
hours after calving. Animals infused with this product must not be
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slaughtered for food until 42 days after the latest infusion.
25. In 526.365, revise paragraphs a and d1 to read as follows:
526.365
Cephapirin sodium.
a Specifications. Each single-dose, 10-milliliter syringe contains 200
milligrams mg cephapirin sodium activity.
d
1 Amount. Infuse the contents of one syringe 200 mg cephapirin activity into each infected quarter immediately after the quarter has been completely milked out. Do not milk out for 12
hours. Repeat once only in 12 hours.
26. Revise 526.464 to read as follows:
526.464
Cloxacillin benzathine.
a Specifications. Each single-dose, 7.5- or 10-milliliter syringe contains cloxacillin benzathine equivalent to 500
milligrams mg cloxacillin.
b Sponsor. See No. 000010 in 510.600c of this chapter.
c Related tolerances. See 556.165
of this chapter.
d Conditions of use in dry cows1
Amount. Infuse the contents of one syringe equivalent to 500 mg cloxacillin into each quarter immediately after last milking, but no later than 30 days before calving.
2 Indications for use. For the treatment of mastitis caused by Staphylococcus aureus and Streptococcus agalactiae including penicillin resistant strains in dairy cows during the dry period.
3 Limitations. Animals infused with this product must not be slaughtered for food until 30 days after the latest infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
526.464a
Removed
27. Remove 526.464a.
525.464b
Redesignated as 526.464
28. Redesignate 526.464b as 526.465 and revise the section heading and paragraphs a and d to read as follows:
526.465
Cloxacillin sodium.
a Specifications. Each single-dose, 10-milliliter syringe contains cloxacillin sodium equivalent to 200 milligrams mg cloxacillin.
d Conditions of use in lactating cows1 Amount. Infuse the contents of one syringe equivalent to 200 mg
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cloxacillin into each infected quarter.
Treatment should be repeated at 12hour 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.
29. Revise 526.820 to read as follows:
526.820
Erythromycin.
a Specifications1 Each singledose, 6-milliliter mL syringe contains 300 milligrams mg erythromycin as the base.
2 Each single-dose, 12-mL syringe contains 600 mg erythromycin as the base.
b Sponsors. See Nos. 054771 and 061133 in 510.600c of this chapter.
c Related tolerances. See 556.230
of this chapter.
d Conditions of use for syringe described in paragraph a1 of this section in lactating cows1 Amount.
Infuse the contents of one 6-mL syringe 300 mg erythromycin base into each infected quarter. Repeat infusion at 12hour intervals for a maximum of 3
infusions.
2 Indications for use. For the treatment of mastitis due to Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.
3 Limitations. Milk taken from animals during treatment and for 36
hours 3 milkings after the latest treatment must not be used for food.
e Conditions of use for syringe described in paragraph a2 of this section in dry cows1 Amount. Infuse the contents of one 12-mL syringe 600
mg erythromycin base into each infected quarter at the time of drying off.
2 Indications for use. For the treatment of mastitis due to Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in dry cows.
3 Limitations. For use in dry cows only.
30. In 526.1130, revise paragraph a, the paragraph d subject heading, and paragraphs d1 and 2 to read as follows:
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08MRR1