Title 21—Food and Drugs--Volume 1
PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
§ 526.88   Amoxicillin.
(a) Specifications. Each single-dose, 10-milliliter syringe contains amoxicillin trihydrate equivalent to 62.5 milligrams (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 in lactating cows —(1) Amount. Infuse the contents of one syringe (equivalent to 62.5 mg amoxicillin) into 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. Milk taken from animals during treatment and for 60 hours (5 milkings) after the last treatment 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.
§ 526.313   Ceftiofur.
(a) Specifications. Each single-dose, 10-milliliter syringe 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 paragraph (a)(1) of this section in lactating cows —(1) Amount. Infuse the contents of one syringe (125 mg ceftiofur equivalents) into each affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.
(2) Indications for use. For the 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 .
(3) 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.
(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 (a)(2) of this section in dry cows —(1) 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.
§ 526.363   Cephapirin benzathine.
(a) Specifications. Each single-dose, 10-milliliter syringe contains 300 milligrams cephapirin activity (as cephapirin benzathine).
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.115 of this chapter.
(d) Conditions of use in dry cows —(1) 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. Not to be used within 30 days of calving. 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 slaughtered for food until 42 days after the latest infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 526.365   Cephapirin sodium.
(a) Specifications. Each single-dose, 10-milliliter syringe contains 200 milligrams (mg) cephapirin sodium activity.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.115 of this chapter.
(d) Conditions of use in lactating cows —(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.
(2) Indications for use. For the treatment of mastitis in lactating cows caused by susceptible strains of Streptococcus agalactiae and Staphylococcus aureus including strains resistant to penicillin.
(3) Limitations. Milk that has been taken from animals during treatment and for 96 hours after the last treatment must not be used for food. Treated animals must not be slaughtered for food until 4 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 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 § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.165 of this chapter.
(d) Conditions of use in dry cows —(1) 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.
§ 526.465   Cloxacillin sodium.
(a) Specifications. Each single-dose, 10-milliliter syringe contains cloxacillin sodium equivalent to 200 milligrams (mg) cloxacillin.
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.165 of this chapter.
(d) Conditions of use in lactating cows —(1) Amount. Infuse the contents of one syringe (equivalent to 200 mg cloxacillin) into each infected quarter. Treatment should be repeated at 12-hour 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.
§ 526.820   Erythromycin.
(a) Specifications. (1) Each single-dose, 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 § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.230 of this chapter.
(d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows —(1) Amount. Infuse the contents of one 6-mL syringe (300 mg erythromycin base) into each infected quarter. Repeat infusion at 12-hour 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows —(1) 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 526.1130   Hetacillin.
(a) Specifications. Each single-dose, 10-milliliter syringe contains hetacillin potassium equivalent of 62.5 milligrams (mg) ampicillin.
(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.316 of this chapter.
(d) Conditions of use in lactating cows —(1) Amount . Infuse the contents of one syringe (equivalent to 62.5 mg ampicillin) into each infected quarter. Repeat at 24-hour intervals for a maximum of 3 treatments.
(2) Indications for use. For the treatment of acute, chronic, or subclinical mastitis in lactating cows caused by susceptible strains of Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus aureus, and Escherichia coli .
(3) Limitations. Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food until 10 days after the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 526.1590   Novobiocin.
(a) Specifications. Each single-dose, 10-milliliter syringe contains:
(1) 150 milligrams (mg) of novobiocin equivalents as sodium novobiocin, or
(2) 400 mg of novobiocin equivalents as sodium novobiocin.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.460 of this chapter.
(d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows —(1) Amount . Infuse the contents of one syringe (equivalent to 150 mg novobiocin) into each infected quarter after milking. Repeat treatment once after 24 hours. Do not milk for at least 6 hours after treatment.
(2) Indications for use. For the treatment of mastitis caused by susceptible strains of Staphylococcus aureus in lactating cows.
(3) Limitations. Milk taken from treated animals within 72 hours (6 milkings) after latest treatment should not be used for food. Do not slaughter treated animals for food for 15 days following latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows —(1) Amount . Infuse the contents of one syringe (equivalent to 400 mg novobiocin) into each quarter at the time of drying off.
(2) Indications for use. For the treatment of mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae in dry cows.
(3) Limitations. For udder installation for the treatment of mastitis in dry cows only. Infuse each quarter at the time of drying off, but not less than 30 days prior to calving. Do not slaughter treated animals for food for 30 days following udder infusion.
§ 526.1696   Penicillin G procaine.
(a) Specifications. Each single-dose, 10-milliliter syringe contains penicillin G procaine equivalent to 100,000 units of penicillin G.
(b) See Nos. 042791 and 061133 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.510 of this chapter.
(d) Conditions of use in lactating cows —(1) Amount . Infuse the contents of one 10-milliliter syringe (equivalent to 100,000 units penicillin G) into each infected quarter. Treatment may be repeated at 12-hour intervals for not more than 3 doses, as indicated by clinical response.
(2) Indications for use. For the treatment of mastitis caused by Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating cows.
(3) Limitations. For intramammary infusion in lactating cows only. Discard all milk for 60 hours (5 milkings) after the latest treatment. Animals intended for human consumption must not be slaughtered within 3 days of latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use in dry cows —(1) Amount . Infuse the contents of one 10-milliliter syringe (equivalent to 100,000 units penicillin G) into each infected quarter at time of drying-off.
(2) Indications for use. For the treatment of mastitis caused by Streptococcus agalactiae in dry cows.
(3) Limitations. For intramammary infusion in dry cows only. Animals intended for human consumption must not be slaughtered within 14 days of last treatment. Discard all milk for 72 hours (6 milkings) following calving, or later as indicated by the marketable quality of the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 526.1697   Penicillin G procaine and dihydrostreptomycin.
(a) Specifications. Each single-use, 10-milliliter syringe contains a suspension of:
(1) Penicillin G procaine equivalent to 200,000 units penicillin G and dihydrostreptomycin sulfate equivalent to 300 milligrams dihydrostreptomycin; or
(2) Penicillin G procaine equivalent to 1 million units penicillin G and dihydrostreptomycin sulfate equivalent to 1 gram dihydrostreptomycin.
(b) Sponsor. See No. 042791 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.200 and 556.510 of this chapter.
(d) Conditions of use for syringe described in paragraph (a)(1) of this section in dry cows —(1) Amount . Infuse the contents of one syringe (equivalent to 200,000 units penicillin G and 300 milligrams dihydrostreptomycin) into each quarter at the last milking prior to drying off.
(2) Indications for use. For the treatment of subclinical mastitis in dairy cows at the time of drying off, specifically against infections caused by Staphylococcus aureus and Streptococcus agalactiae .
(3) Limitations. For use in dry cows only. Not to be used within 6 weeks of calving. Milk taken from cows within 24 hours (2 milkings) after calving must not be used for food. Animals infused with this drug must not be slaughtered for food within 60 days of treatment or within 24 hours after calving. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use for syringe described in paragraph (a)(2) of this section in dry cows —(1) Amount . Infuse the contents of one syringe (equivalent to 1 million units penicillin G and 1 gram dihydrostreptomycin) into each quarter at the last milking prior to drying off.
(2) Indications for use. To reduce the frequency of existing infection and to prevent new infections with Staphylococcus aureus in dry cows.
(3) Limitations. Not for use in lactating cows. Not to be used within 6 weeks of calving. Milk taken from cows within 96 hours (8 milkings) after calving must not be used for food. Animals infused with this drug must not be slaughtered for food within 60 days from the time of infusion or within 96 hours after calving. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 526.1698   Penicillin G procaine and novobiocin.
(a) Specifications. Each single-use, 10-milliliter syringe contains a suspension of:
(1) Penicillin G procaine equivalent to 100,000 units penicillin G and 150 milligrams (mg) novobiocin as novobiocin sodium; or
(2) Penicillin G procaine equivalent to 200,000 units penicillin G and 400 mg novobiocin as novobiocin sodium.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 556.460 and 556.510 of this chapter.
(d) Conditions of use for syringe described in paragraph (a)(1) of this section in lactating cows —(1) Amount. Infuse the contents of one syringe (equivalent to 100,000 units penicillin G and 150 mg novobiocin) into each infected quarter after milking. Repeat once after 24 hours.
(2) Indications for use. For the treatment of mastitis caused by susceptible strains of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.
(3) Limitations. For udder instillation in lactating cows only. Do not milk for at least 6 hours after treatment; thereafter, milk at regular intervals. Milk taken from treated animals within 72 hours (6 milkings) after the latest treatment must not be used for food. Treated animals must not be slaughtered for food for 15 days following the latest treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Conditions of use for syringe described in paragraph (a)(2) of this section in lactating cows —(1) Amount. Infuse the contents of one syringe (equivalent to 200,000 units penicillin G and 400 mg novobiocin) into each quarter at dry off.
(2) Indications for use. For the treatment of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae in dry cows.
(3) Limitations. For udder instillation in dry cows only. Do not use less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving. Treated animals must not be slaughtered for food for 30 days following udder infusion. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§ 526.1810   Pirlimycin.
(a) Specifications. Each single-dose, 10-milliliter syringe contains 50 milligrams (mg) of pirlimycin (as pirlimycin hydrochloride).
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.515 of this chapter.
(d) Conditions of use in lactating cows —(1) Amount. Infuse the contents of one syringe (50 mg pirlimycin) into each infected quarter. Daily treatment may be repeated at 24-hour intervals for up to 8 consecutive days.
(2) Indications for use. For the treatment of clinical and subclinical mastitis in lactating dairy cattle associated with Staphylococcus species such as Staphylococcus aureus and Streptococcus species such as Streptococcus agalactiae , Streptococcus dysgalactiae , and Streptococcus uberis.
(3) Limitations. Milk taken from animals during treatment and for 36 hours following the last treatment must not be used for food regardless of treatment duration. Following infusion twice at a 24-hour interval, treated animals must not be slaughtered for 9 days. Following any extended duration of therapy (infusion longer than twice at a 24-hour interval, up to 8 consecutive days), animals must not be slaughtered for 21 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.