subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "526"
part_subject: "INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "526.1590"
section_subject: "Novobiocin infusion."
cfr_reference: "21 CFR 526.1590"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
(1)Specifications. Each 10 milliliters of oil suspension contains the equivalent of 400 milligrams of novobiocin (present as sodium novobiocin).
(2)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3)Related tolerances. See § 556.460 of this chapter.
(4)Conditions of use—(i) Amount. Ten milliliters (equivalent to 400 milligrams of novobiocin) infused in each quarter.
(ii)Indications for use. It is used in dry cows for the treatment of mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae.
(iii)Limitations. 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 use for 30 days following udder infusion. For udder installation for the treatment of mastitis in dry cows only.
(1)Specifications. Each 10 milliliters of oil suspension contains the equivalent of 150 milligrams of novobiocin (present as sodium novobiocin).
(2)Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(3)Related tolerances. See § 556.460 of this chapter.
(4)Conditions of use—(i) Amount. Infuse 10 milliliters (equivalent to 150 milligrams of novobiocin) in each quarter after milking. Repeat treatment once after 24 hours.
(ii)Indications for use. Use in lactating cows for treatment of mastitis caused by susceptible strains of Staphylococcus aureus.
(iii)Limitations. Do not milk for at least 6 hours after treatment; afterwards, milk at regular intervals. Milk taken from treated animals within 72 hours (6 milkings) after latest treatment must not be used for food. Do not slaughter treated animals for food for 15 days following latest treatment. If redness, swelling, or abnormal milk persists or increases after treatment, discontinue use and consult a veterinarian. For udder instillation in lactating cattle only. Federal law restricts this drug to use by or on the order of a licensed veterinarian.