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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 526 - Intramammary Dosage Form New Animal Drugs |
§ 526.313 - Ceftiofur.
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§ 526.313 Ceftiofur.
(a) Specifications. Each single-usedose, 10-milliliter syringe of ceftiofur hydrochloride suspension contains contains:
(1) 125 milligrams (mg) ceftiofur equivalents as the hydrochloride salt; or
(2) 500 mg ceftiofur equivalents as the hydrochloride salt.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.113 of this chapter.
(d) Conditions of use for syringe described in cattle - paragraph (a)(1)
Lactatingof this section in lactating cows -
(
i1) Amount. Infuse the contents of one syringe (125 mg
perceftiofur equivalents) into each affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.
ii(
use in lactating dairy cattle: (A) For2) Indications for use. For
(B) Forthe treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli; and
the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and S. dysgalactiae.
iii(
eight3) Limitations. Milk taken from cows during treatment (a maximum of
8 daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to 8 consecutive days, a 2-day preslaughter withdrawal period is required. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
extra-label(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.
2)Dry(
ie) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows -
(
per1) Amount . Infuse the contents of one syringe (500 mg
iiceftiofur equivalents) into each affected quarter at the time of dry off.
(
iii2) 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.
(
Following label use, no3) 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.
extra-labelNo 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.
[70 FR 9516, Feb. 28, 2005, as amended at 70 FR 20048, Apr. 18, 2005. Redesignated and amended at 71 FR 39545, July 13, 2006; 79 FR 10973, Feb. 27, 2013; 79 FR 18159, Apr. 1, 2014; 80 FR 34279, June 16, 2015; 86 FR 13185, Mar. 8, 2021]